ÐÏà¡±á>þÿ <>þÿÿÿ56789:;ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥Á` ø¿Tbjbjæ‡æ‡ 4ª„í„íŠ4I/ÿÿÿÿÿÿ¤j j j j îîî*{*{*{8b{D¦€îv ¶„Îˆ(öˆöˆöˆÞš2žìüžxAuCuCuCuCuCuCu$ŽxhözvguAî<§Ú–¦€š^<§<§guj j öˆöˆä ¨vÖéÖéÖé<§Ô;j úöˆîöˆAuÖé<§AuÖéÖé¶I\`dŠî¹eöˆª„Ö4€J’Ç*{ãv©_\ísT¾v0îv`´l{†ãæl{¸¹el{î¹e4tŸ|ð¡ÆÖé¶£l"¥tŸtŸtŸguguléjtŸtŸtŸîv<§<§<§<§$g&z&zj j j j j j ÿÿÿÿ North Wales Cancer Network Chemotherapy Protocols 2006/07 North Wales Cancer Network Chemotherapy Protocols -2006/7 TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc166489074" INTRODUCTION PAGEREF _Toc166489074 \h 4 HYPERLINK \l "_Toc166489075" Breast Cancer Regimens PAGEREF _Toc166489075 \h 6 HYPERLINK \l "_Toc166489076" GASTROINTESTINAL CANCER PAGEREF _Toc166489076 \h 23 HYPERLINK \l "_Toc166489077" OESOPHAGEAL CANCER CHEMOTHERAPY REGIMENS PAGEREF _Toc166489077 \h 23 HYPERLINK \l "_Toc166489078" PANCREATIC CANCER CHEMOTHERAPY REGIMENS PAGEREF _Toc166489078 \h 31 HYPERLINK \l "_Toc166489079" 1. Burris HA, et al. J Clin oncol 1997; 15(6): 2403-13 PAGEREF _Toc166489079 \h 33 HYPERLINK \l "_Toc166489080" 2. National Institute for Health and Clinical Excellence, Guidance on gemcitabine for pancreatic cancer. 2001 PAGEREF _Toc166489080 \h 33 HYPERLINK \l "_Toc166489081" Colorectal cancer chemotherapy regimens PAGEREF _Toc166489081 \h 35 HYPERLINK \l "_Toc166489082" GYNAECALOGICAL CANCER PAGEREF _Toc166489082 \h 42 HYPERLINK \l "_Toc166489083" Ovarian Cancer Chemotherapy Regimens PAGEREF _Toc166489083 \h 42 HYPERLINK \l "_Toc166489084" Endometrial Cancer Chemotherapy Regimens PAGEREF _Toc166489084 \h 46 HYPERLINK \l "_Toc166489085" Cervical Cancer Chemotherapy Regimens PAGEREF _Toc166489085 \h 48 HYPERLINK \l "_Toc166489086" Small Cell Lung Cancer Chemotherapy regimens PAGEREF _Toc166489086 \h 50 HYPERLINK \l "_Toc166489087" Non-small Cell Lung Cancer Treatment regimens PAGEREF _Toc166489087 \h 51 HYPERLINK \l "_Toc166489088" Mesothelioma Chemotherapy Regimens PAGEREF _Toc166489088 \h 53 HYPERLINK \l "_Toc166489089" Head and Neck Cancer Chemotherapy Regimes PAGEREF _Toc166489089 \h 54 HYPERLINK \l "_Toc166489090" BLADDER CANCER CHEMOTHERAPY Regimens PAGEREF _Toc166489090 \h 56 HYPERLINK \l "_Toc166489091" renal cancer Chemotherapy Regimens PAGEREF _Toc166489091 \h 59 HYPERLINK \l "_Toc166489092" Prostate Cancer Chemotherapy Regimens PAGEREF _Toc166489092 \h 59 HYPERLINK \l "_Toc166489093" Germ Cell Tumour Chemotherapy Regimens PAGEREF _Toc166489093 \h 61 HYPERLINK \l "_Toc166489094" mALIGNANT MELANOMA CHEMOTHERAPY REGIMENS PAGEREF _Toc166489094 \h 63 HYPERLINK \l "_Toc166489095" BILLIARY TREE CHEMOTHERAPY REGIMES PAGEREF _Toc166489095 \h 67 HYPERLINK \l "_Toc166489096" COCKCROFT-GAULT CREATININE CLEARANCE FORMULA PAGEREF _Toc166489096 \h 68 HYPERLINK \l "_Toc166489097" CISPLATIN DOSE GUIDELINES PAGEREF _Toc166489097 \h 69 HYPERLINK \l "_Toc166489098" HAEMATOLOGICAL PARAMETERS PAGEREF _Toc166489098 \h 70 HYPERLINK \l "_Toc166489099" ANTI-EMETIC POLICY FOR CYTOTOXIC CHEMOTHERAPY PAGEREF _Toc166489099 \h 71 HYPERLINK \l "_Toc166489100" INTRATHECAL CHEMOTHERAPY PAGEREF _Toc166489100 \h 72 HYPERLINK \l "_Toc166489101" PLATELET TRANSFUSION POLICY PAGEREF _Toc166489101 \h 73 INTRODUCTION This list of protocols for the drug treatment of cancer has been compiled, with the active contribution of the oncology clinicians and the lead oncology pharmacists in the three trusts in North Wales, with the aim of Identifying the core regimen used for the most common forms of cancer Informing Trusts and commissioners of the baseline utilisation of chemotherapy Acting as an agreed dispensing formulary for pharmacists in terms of the diseases and application of drugs therein Providing uniform access to cancer treatment for patients across North Wales. The editor has compiled this formulary as a list of treatment regimens which are intended to be a guide to baseline chemotherapy only. It is neither a legal or prescriptive document and should not utilised in anyway as a formal guide to prescribing. This list contains the protocols which are available and funded for use during the year beginning April 1st 2006 to March 31st 2007. With the exception of drug/regime assessments from NICE, there will be generally no alterations during the current year. All oncologists will be canvassed during November, for any changes, additions or deletions for the protocol list commencing April 2007. Exclusions The formulary largely concentrates on regimen used as first and second line. The formulary recognises that third line or indvidualised use of chemotherapy is more difficult to standardise and this therefore is omitted. This approach also extends to certain other elements of oncology, haemato-oncology and supportive care though these issues will be addressed in future versions. Future inclusions It is hoped that future versions will include sections on, Haemato-oncology chemotherapy Use of blood products Pain control Use of growth factors Resource issues. All the regimens within this formulary are funded and this includes all NICE drugs approved up to the point of publication July 2006. However though all the protocols are funded and therefore available it cannot be automatically assumed that all the protocols can be delivered. Clinicians are advised that they must ensure that the regimen in question is deliverable within the identified clinical environment before they offer it to the patient. In light of this both clinicians and managers are advised to use this formulary as a basis for identifying which chemotherapy regimen should be available to patient sin North Wales in 2006/07. In doing so these regimens should be available in all three Trusts assuming clinical governance and capacity parameters are met. New drugs Inevitable situations will arrive that are not covered by the standard North Wales Cancer network protocols. These may include expensive drugs or combinations prior to a NICE appraisal or not in the NICE development programme. Consultants who wish to use a non-protocol regimen should apply to their local Drugs and Therapeutic Committee for clinical approval. Once achieved they should then refer to their Directorate or Division to achieve funding. If funding is unavailable within the Directorate or Division then a submission can be made to individual commissioners but should emanate from the Directorate or Divisional leads not the individual clinician. Breast Cancer Regimens Neo-adjuvant EC/DOCETAXEL Patient group: Standard 1st line regimen. If complete clinical response to four cycles of EC – then 6 cycles of EC in total and no docetaxel. Chemotherapy: EC x 4 cycles followed by docetaxel x 4 cycles EC Patient Group: For patients with locally advanced disease, or to allow less radical surgery in patients with operable tumours. If limited response after 2 to three cycles, consider switching to docetaxel Chemotherapy Epirubicin 75mg/m2 Cyclophosphamide 600mg/m2 repeated at 21 day intervals x 4-6 cycles Anti-emetics for high emetic potental Investigations Weight, FBC, U&E’s, LFT’s before each cycle LV ejection fraction prior to cycle 1 if history of cardiac problems DOCETAXEL Chemotherapy: Docetaxel 100mg/m2 for 4 cycles Dexamethasone 8mg bd x 3 days. Start 24 hours pre docetaxel Prophylactic ciprofloxacin 500mg po twice daily days 5 - 14 Anti-emetic for intermediate emetic potental Investigations Weight, FBC, U&E’s, LFT’s before each cycle. Where renal/hepatic function is abnormal, treatment is at consultant physician discretion. Dose modification Neutrophils < 1.0 x 109/l defer dose Platelets < 100 x 109/l defer dose AST or ALT > 1.5 x upper limit normal reduce dose by 25% > 3.5 x upper limit normal discontinue Non-haematological toxicities (excluding alopecia): if necessary delay treatment by one or more weeks until recovery to grade 0 or 1; if recovery takes longer than one week or if toxicity of grade 3+ is documented during during chemotherapy, the dose should be reduced by 20% in all subsequent cycles. Adjuvant EPI-CMF Patient group: First choice Node –ve tumours Chemotherapy: Epirubicin 100mg/m2 repeated at 21 day intervals x 4 cycles Followed by CMF 4 cycles (Classical Bonnadonna) Anti-emetic for high emetic potental Investigations Weight, FBC, U&E’s, LFT’s before each cycle Where renal/hepatic function are abnormal, treatment is at the consultant physician discretion. LV ejection fraction prior to cycle 1, if history of cardiac problems Chemotherapy: CMF Cyclophosphamide 100mg/m2 po days 1 to 14 Methotrexate 40mg/m2 iv days 1 and 8 5 fluorouracil 600mg/m2 iv days 1 and 8 cycles are repeated at 28 day intervals from day 1 to a total of 6 cycles for patients unable to tolerate oral cyclophosphamide, substitute iv cyclophosphamide 600mg/m2 days 1 and 8 Folinic acid rescue not normally required unless patients develop signs of methotrexate toxicity, then 15mg p.o. 6hourly x 6 doses starting 24 hours post methotrexate with subsequent cycles. Anti-emetic for high emetic potental Investigations Weight, FBC, U&E’s, LFT’s before each cycle Where renal/hepatic function are abnormal, treatment is at consultant physician discretion, but methotrexate is hazardous in the presence of renal insufficiency and presence of third space fluids. prior to each cycle but generally not required on day 8 Dose modification WBC d"3.0 x 109/l and neutrophils d"1.0 x 109/l or platelets 100 x 109/l: delay day 1 treatment by one week (EPI) cancel day 8 treatment but continue oral cyclophosphamide if possible. (CMF) Grade 3 mucositis (EPI) reduce dose of epirubicin by 20% Neutropenic sepsis (EPI) reduce dose of epirubicin and/or cyclophosphamide by 20% or consider G-CSF support to maintain e" 85% dose Additional therapy and information Patients on sequential chemotherapy who require adjuvant radiotherapy should have this after epirubicin and during CMF ( between cycles 1 & 2) or at the discretion of the clinical oncologist. Patients may or may not have adjuvant tamoxifen. This would normally be started on completion of chemotherapy. 1. Bonnadonna G et al. JAMA 1995; 273(7): 542-7 2. National Breast Cancer Study of Epirubicin + CMF vs Classical CMP Adjuvant Therapy, CRC BR3014 FEC Patient group: PS 0-1 Older patients Unsuitable for Epi-CMF Chemotherapy: 5 fluorouracil 600mg/m2 epirubicin 60mg/m2 cyclophosphamide 600mg/m2 repeat at 21 day intervals for 6 cycles anti-emetic: for high emetic potential Investigations Weight, FBC, U&E’s, LFT’s before each cycle. LV ejection fraction prior to cycle 1 if history of cardiac problems 1. Early Breast Cancer Trialists Collaborative Group. Lanct 1998; 352: 930-42 2. Levine MN, Bramwell VH, Pritchard KL et al. J Clin Oncol 1998; 16: 2651-8 NB: see above for dose modifications and precautions. FEC/DOCETAXEL Patient group: This protocol is available for young women wishing to maintain fertility or where previous treatment restricts anthracycline dose. Node positive ER –ve PS 0 – 1 Selected patients only (restricted, not NICE) Chemotherapy: 5 fluorouracil 500mg/m2 epirubicin 100mg/m2 cyclophosphamide 500mg/m2 repeat at 21 day intervals for 3 cycles followed by docetaxel 100mg/m2 x 3 cycles at 21 day intervals Dexamethasone 8mg bd x 3 days. Start 24 hours pre-docetaxel. Prophylactic ciprofloxacin 500mg po twice daily days 5 - 14 Anti-emetic: for high emetic potential NB: see above for laboratory investigations See above for dose modifications and precautions. 1. Roche H et al.Breast Cancer Res Treat, 2004; abstract 270; 88 supl 1:S16 TRASTUZAMAB Patient profile: Women with primary breast cancer Over expressing HER-2 (3+ on IHC or FISH +) Completed (neo)adjuvant chemotherapy within the preceding 6 weeks LVEF measured by echocardiography or MUGA e" 55% ER+ women to be receiving appropriate hormonal therapy Willing to undergo cardiac monitoring and regular follow up No history of allergy to mice or mouse proteins Chemotherapy: Trastuzumab Initial dose: 8mg/kg over 90 minutes Subsequent: 6mg/kg q 21 days for 18 doses Reload if dose delayed by > 7 days. Antiemetic Low emetic potential 1. National Institute for Health and Clinical Excellence.bTrastuzumab for the adjuvant treatment of early stage HER2-positive Breast Cancer. TA107; August 2006 Hormonal treatments Please refer to HYPERLINK "The%20use%20of%20hormone%20therapy%20for%20breast%20cancer.doc" The Use of Hormone Therapy for Breast Cancer METASTATIC/ADVANCED DISEASE EC Patient group: Standard chemotherapy Anthracycline naive Chemotherapy: epirubicin 75mg/m2 Cyclophosphamide 600mg/m2 Repeat at 21 day intervals to a maximum of 6 cycles Anti-emetics For intermediate emesis protection Investigations Weight, FBC, U&E’s, LFT’s before each cycle LV ejection fraction prior to cycle 1 if history of cardiac problems 1. Fisher B et al. J Clin Oncol 1990; 8: 2483-96 2. UKCCCR ABO1 Breast Cancer trial (1996) EPIRUBICIN Patient group: For patients with compromised liver or marrow function due to tumour infiltration. Combination therapy inappropriate Chemotherapy: Epirubicin 20 - 25mg/m2 weekly Anti-emetics For intermediate emesis protection Investigations Weight, FBC, U&E’s, LFT’s before each cycle. Patients with abnormal hepatic function may be treated cautiously LV ejection fraction prior to cycle 1 if history of cardiac problems Normal limits for administration apply with the exception of patients with marrow infiltration. Treatment may be continued at lower platelet and neutrophil counts at treating physicians discretion. 1. Twelves CJ. Et al. British Journal of Cancer, 1989; 60(6): 938-41 2. Gasparini G. et al. Am J Clin Oncol 1991; 14(1): 38-44 3. Twelves CJ. Et al. Annals of Oncology 1991 2(9): 663-6 4. Jeonsuu H et al. J Clin Oncol, 1008; 16(12): 3720-30 MMM Patient Group: 3rd – 4th line or unfit for other treatment Chemotherapy: Mitomycin 7mg/m2 Methotrexate 35mg/m2 Mitomycin 7mg/m2 21 day cycle Antiemetics: For moderate emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. Powles TJ et al. Royal Society of Medicine Services, 1987; International Congress and Symposium Series no. 110 2. Smith IE, Powles TJ, Oncology, 1993 Apr; 50CY: Switzerland: 9-15 DOCETAXEL/CAPECITABINE Patient group: younger patient, NICE regimen PS 0-1 Chemotherapy: Docetaxel 75mg/m2 iv day 1 Capecitabine 1250mg/m2 twice daily orally for 14 days. (rounded to nearest 150mg) prophylaxis: dexamethasone 8mg po twice daily for 3 days starting the day before treatment. Required for all cycles. Anti-emesis: for intermediate emetic potental Repeat at 21 day cycles. Max 6 cycles. Investigations: Weight, U&E’s, FBC, creatinine clearance, LFT’s before each cycle Dose reductions/modifications for grade 2 toxicity or higher: No recovery from toxicity within 2 weeks, discontinue docetaxel Capecitabine doses missed should not be replaced Toxicity > grade 2 still present at end of 3 week cycle should have a further delay of 1 week Doses that have been reduced in a previous cycle should not be increased subsequently First event grade 2: delay until recovery (maximum 2 weeks) Second event grade 2: delay until recovery and restart at 75% capecitabine dose and docetaxel at 55mg/m2 First event grade 3: delay until recovery and restart at 75% capecitabine dose and docetaxel 55mg/m2 Third event grade 2, second event grade 3, or any 4 event: discontinue docetaxel and restart capecitabine at 50% of starting dose. Further events, any grade: discontinue both drugs. 1. Mational Institute for Health and Clinical Excellence. Technology Apraisal no. 62 May 2003 2. O’Shaughnessy L et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline pretreated patients with advanced breast cancer. J.Clin. Oncol. 2002;20(12):2812-2823 PACLITAXEL/GEMCITABINE Less myelosuppressive than docetaxel/capecitabine Patient group: Usually given after an anthracycline containing regime PS = 0, 1, 2 May also be given third line after a vinorelbine containing regime. Chemotherapy: Paclitaxel 90mg/m2 days 1 and 8 Gemcitabine 1000mg/m2 days 1 and 8 Pre-medication to be given 30 minutes before paclitaxel: Dexamethasone 16mg iv Ranitidine 50mg iv Chlorpheniramine 10mg iv Repeat at 21 day intervals Anti-emetic: for intermediate emetic control Laboratory investigations Fbc, U&E,LFT prior to each cycle Where renal/hepatic function are abnormal, treatment is at consultant physician discretion Dose Modifications: Day 1: if WBC<3.0 x 109/l, or neutrophils<1.5 x 109/l or platelets<150 x 109/l, delay treatment one week Day 8: if WBC<2.0 x 109/l or neutrophils<1.0 x 109/l or platelets<75 x 109/l, omit treatment If grade 4 haematological toxicity occurs then reduce dose by 25% for subsequent cycles Peripheral neurotoxicity may occur and severity < grade 3 is an indication to stop treatment. 1. National Institute for Health and Clinical Excellence. Technology Appraisal no.116 January 2007 2. Joensuu H et al. J Clin Oncol; 1998: 16(12): 3720-30 3. Wright TL, Twelves CJ. Eur J Cancer; 2002; 38(15): 1957-60 4. Smorenburg CH et al. Eur J Cancer; 2001; 37(18): 2310-23 5. Albain KS et al. Proceedings ASCO, 2004. 23:abstract 50165. 6. Seidman AD et al. Proceedings ASCO 2004. 23 abstract 512. PACLITAXEL weekly Patient group: 2nd or 3rd line therapy Heavily pre-treated patients PS < 2 Chemotherapy: Paclitaxel 80mg/m2 weekly Pre-medication to be given 30 minutes before paxlitaxel dexamethasone 8mg iv 1st cycle, 4mg iv subsequent cycles if tolerated Ranitidine 50mg iv Chlorpheniramine 10mg Repeat weekly for 12 to 18 cycles depending on tolerability and response. Anti-emetics: intermediate emetic control Laboratory investigations: FBC, U&E, Creatinine, LFT’s prior to each cycle Patients with abnormal hepatic function may be treated cautiously Where renal/hepatic function is abnormal, treatment is at consultant physician discretion. Normal limits for administration apply with the exception that for patients with marrow infiltration, treatment may be continued at lower platelet and neutrophil levels at treating physicians discretion. Dose modifications: Neutrophils <0.8 x 109/l omit dose Platelets <75 x 109/l omit dose AST or ALT >1.5 x upper limit normal reduce dose by 25% >3.5 x upper limit normal discontinue Grade 3 Neurotoxicity discontinue 1. Seidman AD, Hudis CA, Albanel , ,et al: Dose-density therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. L Clin Oncol 16:3353-61,1998 2. Perez EA, Vogel CL, Irwin DH, et al: Multicentre phase II trial of weekly paclitaxel in women with metastatic breast cancer. L Clin Oncol 19:4216-23, 2001 DOCETAXEL weekly Patient profile: 2nd or 3rd line Heavily pretreated patients PS < 2 Chemotherapy Docetaxel 25 – 30 mg/m2 i.v weekly Pre-medication: Dexamethasone 8mg po 12 hourly for 3 doses starting night before (consider reducing to 8mg od for 3 days from cycle 2) Response assessment after 4 cycles. If evidence of response/clinical benefit, continue up to 18 cycles if well tolerated Antiemetics: for intermediate emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle Dose modifications: Neutrophils < 0.8 x 109/l omit dose Platelets <75 x 109/l omit dose AST or ALT >1.5 x upper limit normal reduce dose 25% <3.5 x upper limit normal discontinue Non-haematological malignancies (excluding alopecia); if necessary delay treatment by 1 or more weeks until recovery to grade 0 or 1; if recovery takes longer than 1 week or if toxicity of grade 3+ is documented during chemotherapy, the dose should be reduced by 20% in subsequent cycles. 1. Loffler TM, Freund W et al; ASCO 1998; 17:113a 2. Karroussis et al; Cancer Chemothera Pharmacol 2000;46: 488-492 3. Luck HJ, Donne S et al; Eur J Cancer 1997; 33: 703 VINORELBINE/CAPECITABINE Patient group: Previous anthracycline or taxane Older frailer patients Chemotherapy: Vinorelbine 25mg/m2 i.v. days 1 and 8 Capecitabine 1000mg/m2 p.o. twice daily for 14 days Treatment for up to 8 cycles depending on response Anti-emetics: For low emetic control Laboratory investigations: FBC, U&E, LFT’s before each cycle Calculated creatinine clearance (should be >30ml/min) Dose modifications: Modifications on day 1 should be made as follows Modifications on day 8 should be made as follows Modifications on day 8 should be made as follows: CTC GradeNeutrophilsPlateletsChemotherapy Dosage0 – 2 <_ 1.0 50100%3 – 40.9 – 0.549 – 10Omit vinorelbine and stop capecitabine. Restart on day 1 of next cycle If severe haematological toxicity (grade 3 or grade 3 requiring supportive therapy) occurs, the cessation of treatment should be considered. Dose modifications in case of hepatic or renal insufficiency Bilirubin >2.5 x ULN reduce vinoralbine dose by 50% Bilirubin >5 x ULN Reduce vinorelbine dose by 75% Biliribin >10 x ULN omit vinorelbine Creatinine Clearance 30 – 50mls/min reduce capecitabine by 75% If CC<30mls/min, omit capecitabine. Dose modification for stomatitis, diarrhoea or palmar-plantar syndrome due to capecitabine. Grade 1st Occurrence2nd Occurrence3rd Occurrence4th Occurrence1ContinueContinueContinueContinue2 – 3Stop until recovery to grade 0 – 1 Restart at 75%Stop until recovery to grade 0 – 1 Restart at 75% StopStop4Stop until recovery To grade 0 – 1 If in patient’s interest to continue, restart at 50%. Otherwise stopStopStopStop VINORELBINE Patient group: as Vinorelbin/capecitabine Not fit for combination chemotherapy Inappropriate for oral chemotherapy, or previous problems with capecitabine or 5 fluorouracil. Chemotherapy Vinorelbine 30mg/ m2 day 1 and day 8 ( maximum dose 60mg) Antiemetics Low emetic control Laboratory Investigations: See above vinorelbine/capecitabine Dose modifications: See above, vinorelbine/capecitabine 1. Degardin M et al. Ann Oncol 1994; 5: 423-6 2. Romero A et al. J Clin Oncol 1994; 12:336-41 HER2 positive tumours PACLITAXEL/TRASTUZUMAB Patient group: First line therapy with HER2 positive disease PS 1-2 Care within close proximity to anthracycline therapy (<6 months) Chemotherapy Paclitaxel 90mg/m2 Weekly premedication to be given 30 minutes before paclitaxel Dexamethasone 16mg Ranitidine 50mg Chlorpheniramine 10mg Trastuzumab week 1 loading dose 4mg/kg subsequent maintenance dose 2mg/kg Chemotherapy Paclitaxel 175mg/m2 Three weekly premedication to be given 30 minutes before paclitaxel Dexamethasone 16mg Ranitidine 50mg Chlorpheniramine 10mg Traztuzumab week 1 loading dose 8mg/kg subsequent maintenance dose 6mg/kg Anti-emetics: moderate emetic control Investigations: Prior to first course, assessment of cardiac function using cardiac echo or MUGA scan is mandatory, and also at 3 monthly intervals during therapy. Weight, FBC, U&E’s, LFT’s, tumour markers prior to each course. Dose modifications: Neutrophils <1.0 x 109/l omit dose Platelets <100 x 109/l omit dose Grade 3 neurotoxicity discontinue AST or ALT > 1.5 x upper limit normal reduce dose by 25% > 3.5 x upper limit normal discontinue 1. Norton L Proc ASCO 1999; 18:127A 2. Slamon D, Proc ASCO 1998; 17:98A 3. Seidman A. J Clin Oncol 1998; 16:1-10 4 Gelman K. Proc ASCO 2001 20:69a abstract 271 5. National Institute for Health and Clinical Excellence. Guidance on the use of trastuzumab for the treatment of advanced breast cancer. Technology appraisal no. 34 March 2002 TRASTUZUMAB (weekly) Patient group: For patients not appropriate for paclitaxel/combined treatment Prior treatment or disease progression on taxol single agent. Chemotherapy: Trastuzumab week 1 loading dose 4mg/kg week 2 onwards 2mg/kg Anti-emetics: low emetic control Investigations: Prior to 1st course FBC, U&E’s, LFT’s, tumour markings ECG, ECHO Prior to each course, FBC, U&E’s LFT’s, tumour markings. Cardiac function should be monitored after 3 months during treatment. Dose modifications: not needed for traztuzumab alone 1. Vogel CL et al. J Clin Oncol 2000; 20:719-26 2. Slalom DJ et al; New Engl Med 2001; 334:783-92 3. Cobleigh MA et al. J Clin Oncol 1999; 17: 2639-48 4 Balsega J et al. J Clin Oncol; 14: 737-44 5 National institute for Health and Clinical Excellence. Guidance for the use of trastuzumab for the treatment of advanced breast cancer. Technology Appraisal no.32 March 2002 DOCETAXEL/TRASTUZUMAB (3 weekly) Patient group: 1st line therapy for patients with HER2 PS 0 – 1 Paclitaxel allergy/intolerance Chemotherapy: Docetaxel 75mg/m2 Prophylaxis: dexamethasone 8mg twice daily for 3 days starting day before treatment. Required for all cycles Trastuzumab 8mg/kg cycle 1 loading dose Capped at 750mg 6mg/kg maintainence dose Capped at 600mg Anti-emetics: Intermediate emetic control Investigations: Weight, FBC, U&E’s, LFT’s each cycle 1. Extra JM et al, San Antonie Breast Cancer Smyposium 2003; abstr 217 2. Leyland-Jones B et al, J Clin Oncol, 2003 Nov 1; 21(21): 3965-71 VINORELBINE/TRASTUZUMAB Patient group: Prior treatment Reaction to taxane Chemotherapy: Trastuzumab 8mg/kg cycle 1 loading dose 6mg/kg maintenance 3 weekly Vinorelbine 25mg/m2 Days 1 and 8 Treatment is repeated every 21 days. Anti-emetics Low emetic control Investigations weight, FBC, U&E’s, LFT’s each treatment Dose modifications: Neutrophila <1.0x109/l omit vinorelbine, and reduce subsequent doses by 25% Platelets < 75x109/l omit vinorelbine and reduce subsequent doses by 25% AST or ALT >5xupper normal limit reduce vinorelbine by 50% Bilirubin 3-5 x ULN reduce vinorelbine by 50% Bilirubin 5-10 x ULN reduce vinorelbine by 75% Bilirubin >10 x ULN omit vinorelbine 1. Chan A et al, San Antonio Breast Cancer Symposium 2002; abstr 434 2. Leyland-Jones B et al, J Clin Oncol, 2003 Nov 1; 21(21): 3965-71 Bisphonates Patient group: PS 0 – 2 Symptomatic/extensive bone pain/metastases Zoledronic acid 4mg iv in 100mls 0.9%saline over 15 minutes repeat at 28 day intervals (ensure patient adequately hydrated) Pre-treatment: Pre-treatment dental screening is recommended due to the risk of ostenonecrosis of the jaw. Calcium supplements: Patients should have their serum calcium measured every four weeks and calsium with vitamin D e.g calcichew D3 forte tablets, prescribed as necessary. Dose modifications: creatinine dose clearance >60 4.0mg 50 – 60 3.5mg 40 – 49 3.3mg 30 – 30 3.0mg <30 no treatment serum creatinine should be repeated every 4 weeks and if it rises significantly during treatment, zoledronic acid should be withheld until the creatinine has returned to within 10% of the baseline prior to starting 1. Hillner BE et al, J Clin Oncol 2003; 21: 4042-57 2. Rosen LS et al, Cancer J, 2001; 7: 377-87 Ibandronate specific circumstances Patient not receiving parenteral chemotherapy ( YG only) Poor renal function Poor venous access Patient refuses i.v. GASTROINTESTINAL CANCER OESOPHAGEAL CANCER CHEMOTHERAPY REGIMENS Adjuvant No proven role Neoadjuvant CISPLATIN/5FU Patient group: Standard first line, prior to surgery PS 0-1 CrC l>50ml/min Operable oesophageal cancer Chemotherapy: Cisplatin 80mg/m2 day 1 5 fluorouracil 1000mg/m2 over 24 hours days 1 to 4 Ciprofloxacin 500mg BD for 7 days starting day 8 of cycle. Urine output should be maintained above 100ml/hr throughout treatment. If output falls below 400mls in any 4 hour period, then give furosemide 20mg iv or 40mg po. Repeated as necessary. Alternately, mannitol may be used…………dose? Repeat at 21 day cycles for two cycles only Anti-emetics: High emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines. Dose modifications: CrCl >50mls/min full dose cisplatin 40-50ml/min reduce cisplatin 50% <40mls/min omit cisplatin Walsh T et al, N Eng J Med 1996; 335: 452-7 Herskovic A et al N Eng J Med 1992; 326: 1593-8 Wobst et al Ann Oncol 1998; 9(9): 951-62 CHEMO-RADIATION PROTOCOL Patient group: May be offered as an alternative to surgery if MDT decides appropriate Chemotherapy: Cisplatin 80mg/m2 day 1 and 29 5 fluorouracil 1000mg/m2 over 24 hours days 1-4 and 29-32 + XRT Anti-emetics: High emetic control Investigations and dose modifications as above. Advanced metastatic disease ECF Patient group: Standard 1st line regimen Chemotherapy: Epirubicin 50mg/m2 Cisplatin 60mg/m2 5 fluorouracil 200mg/m2/day continuous infusion and continue until 3 weeks after last cycle (unless disease is progressing) Advise patient to drink 2 litres fluid over next 24 hours. Check urine output and give furosemide 20mg iv or 40mg po if output falls below 400ml/hr Alternately, mannitol may be used…………dose? Treatment every 21 days. 4 – 8 cycles Antiemetics: High emetic potential Inverstgations: Weight, FBS, U&E’s, LFT’s before each cycle Calculate creatinine clearance before each cycle. Dose modifications: If day 21 WBC < 3.0 x 109/l or platelets <100 x 109/l then delay chemotherapy by one week (but continue 5FU). If 2 week delay needed, reduce doses by 25%. If > 2 week delay, reduce dose by 50% Patients developing plantar-palmar erythema should receive pyridoxine 50mg po tds continuously. If grade 3 or grade 3 mucositis reduce 5FU dose by 25% If grade 2 neuropathy or creatinine clearance < 50ml/min, change cisplatin to carboplatin (AUC = 5) and increase treatment cycle to 28 days. 1. Walters JS et al. Br J Cancer 1999; 80: 269-72 2. Findlay M et al. Ann Oncol. 1994; 5: 609-15 ECX Patient group: For patients who are fit enough for ECF regime but for whom a central venous line is inadvisable or contraindicated. Patient choice. Chemotherapy: Capecitabine 1250mg/m2/day in 2 divided doses for up to 24 weeks (8 cycles) Epirubicin 50mg/m2 Cisplatin 60mg/m2 TTH loperamide with detailed instructions on when and how to take them . No more than 2 cycles unless response is seen Maximum of 8 cycles Anti-emetics: High emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines. Dose modifications: CrCl >50mls/min full dose cisplatin, full dose capecitabine 40-50ml/min reduce cisplatin 50%, and capecitabine 25% <40mls/min omit cisplatin, and capecitabine. Hand & food syndrome or diarrhoea grade 3 or 4: Stop capecitabine until toxicity has resolved. Restart with 25% dose reduction. Platelets 50 - 74 x 109/l or neutrophils 0.5 – 0.9 x 109/l Stop capecitabine, delay epirubicin and cisplatin until recovery. Restart capecitabine at full dose and reduce epirubicin By 25% on subsequent cycles Platelets 25 – 49 x 109/l or neutrophils <0.5 x 109/l Stop capecitabine and delay epirubicin cisplatin until recovery Restart capecitabine at full dose Reduce epirubicin by 50% on subsequent cycles Platelets <25 x 109/l or neutrophils <0.5 x 109/l Stop capecitabine & delay cisplatin until recovery Restart capecitabine at full dos Omit epirubicin from subsequent cycles. E-CARBO F Patient profile: Patients with poor renal function (CCl calc < 50mls/min) PS<2 Chemotherapy: Epirubicin 50mg/m2 Carboplatin AUC 4 – 5 fluorouracil200mg/m2/day continuous infusion and continue until 3 weeks after last cycle. Anti-emetics: High emetic control Investigations: Weight, FBS, U&E’s, LFT’s before each cycle Dose modifications: If day 21 WBC<3.0 x 109/l or platelets , 100 x 109/l, then Delay chemotherapy by 1 week (but continue 5FU). If week 2 delay needed, reduce dose by 25%. If .2 week delay reduce dose by 50%. Patients developing plantar-palmar erythema should receive pyridoxine 50mg po tds continuously. If grade 3 or grade 3 mucositis, reduce 5FU dose by 25%. 1. Webb A et al J Clin Oncol 1997; 15: 261-7 E-CARBO-X Patient profile: For patients who may not be able to tolerate ECF , Poor renal function (CCl calc < 50mls/min) Patient choice. Chemotherapy: Epirubicin50mg/m2 day 1 Carboplatin AUC 4 – 5 day 1 Capecitabine 1000mg/m2 b.d continuously Repeated on a 21 day cycle. Anti-emetics: High emetic control Investigations: Weight, FBC, U&E’s. LFT’s before each cycle. Dose modifications: Platelets <100 x 109/l or/neutrophils 0.5 – 0.9 x 109/l Stop treatment until neutrophils >1.0 x 109/l. Restart capecitabine at full dose. Reduce epirubicin & carboplatin by 25%. Neutrophils <0.5 x 109/l: Stop treatment until neutrophils > 1.0 x 109/l. Restart capecitabine at full dose. Reduce dose of epirubicin and carboplatin by 50%. Hand and foot syndrome or diarrhoea grade 3 or 4: Stop capecitabine until toxicity has resolved. Restart with 25% dose reduction. 1. Ross PJ, Rao S, Cunningham D. Pathol Oncol Res, 1998. 4(2): 87-95 2. Evans TR et al. Ann Oncology 2002 13(9): 1469-78 3. Calvert AH et al, Carboplatin dodage: prospective evaluation of a simple formula based on renal function. L Clin Oncol: 1989: 7(11) 1748-56 OESOPHAGOGASTRIC CANCER CHEMOTHERPAY REGIMENS Neoadjuvant ECF/ECX Patient profile: For operable gastric or oesophago-gastric cancer 3 cycles pre-op and 3 cycles post-op Regimes are equivalent patient choice. 1. Walters JS et al. Br J Cancer 1999; 80: 269-72 E CARBO F/ E CARBO X Patient profile: as above but for patients with poor renal function i.e. CCl calc <30mL/min 1. Ross PJ, Rao S, Cunningham D. Pathol Oncol Res, 1998. 4(2): 87-95 2. Evans TR et al. Ann Oncology 2002 13(9): 1469-78 3. Calvert AH et al, Carboplatin dodage: prospective evaluation of a simple formula based on renal function. L Clin Oncol: 1989: 7(11) 1748-56 Peri-operative 5FU/FA + XRT CHEMORADIATION Patient profile: Selected cases only, patients with high risk of occurrence High risk/toxicity Metastatic Advanced disease ECF/ECX Patient profile: standard first line Patient choice, regimes are equivalent E CARBO F/E CARBO X Patient profile: Patients with poor renal function. See above, oesophageal cancer for oesophagastric regime details PANCREATIC CANCER CHEMOTHERAPY REGIMENS Adjuvant CAPECITABINE Patient profile: standard 1st line Chemotherapy capecitabine 1250mg/m2 p.o. twice daily days 1 to 14 TTH loperamide with detailed instructions on when and how to take them . Repeat at 21 day intervals from day 1 for 8 cycles Antiemetic Low emetic potential Investigations Weight, FBC, U&E’s, FFT’s before each cycle Dose modifications:1000mg/m2 bd. p.o if heavily pretreated or elderly 5FU/FA Patient profile: standard first line regime. Patient preference Chemotherapy: 5 fluorouracil 425mg/m2 days 1 to 5 Folinic acid 50mg days 1 to 5 For patients over 70 years reduce fluorouracil dose to 370mg/m2 Repeat at 28 day intervals for a maximum of 6 cycles. Antiemetics: Low emetic potential Investigations: Weight, FBC, U&E’s, LFT’s before each cycle. Investigations Weight, FBC, U&E’s, FFT’s before each cycle Advanced disease GEMCITABINE Patient profile: Standard first line (NICE standard) PS 0-1 Chemotherapy initial: gemcitabine 1000mg/m2 weekly for 7 weeks followed by one week break Subsequent: gemcitabine 1000mg/m2 weekly for 3 weeks followed by one weeks break Antiemetics For intermediate emetic control Investigations: Weight, FBC, U&E’s, LFT,s before each cycle NB: transaminases my rise during gemcitabine therapy. Dose modifications: If WBC is <3.0x109/l or neutrophils <1.0 x 109/l or platelets <100 x 109/l, then delay treatment by one week. 1. National Instutie for Health and Clinical Excellence: Technology appraisal no 25: 2001 2. Burns HA et al. J Clin Oncol 1997 15(6): 2404-13 3. Rothenburg ML et at. Ann Oncol; 1996 7(4) 347-53 GEM/CAP Patient profile: Locally advanced (inoperable) or metastatic PS 0 – 1 Fit to tolerate combination therapy and able to take oral chemotherapy. Older patients or those with PS = 2 should receive SA Gemcitabine Chemotherapy: Gemcitabine !000mg/m2 days 1, 8 and 15 Capecitabine 1660mg/m2/day po in two divided doses days 1 – 21 TTH loperamide with detailed instructions on when and how to take them . If well tolerated, assess response after 2 cycles and continue to 4 cycles if responding. Antiemetics: Low emetic control Investigations: weight, LFT’s, FBC, U&E’s before each cycle 1. Burris HA, et al. J Clin oncol 1997; 15(6): 2403-13 2. National Institute for Health and Clinical Excellence, Guidance on gemcitabine for pancreatic cancer. 2001 3. Berlin JD et al. J Clin Oncol, 2002; 20(15) : 3270-3275 4. Maisey N et al. J Clin Oncol, 2002; 20(14): 3130-3136 5. Banu E et al, Proceedings American Society of Clinical Oncology 2005 6. Herrmann R et al, Proceedings American Society of Clinical Oncology 2005 7. Liang H, Proceedings American Society of Clinical Oncology 2005 8. Cunningham D et al. European Journal of Cancer Supplements, 2005 3(4) 4 Anal Cancer Chemotherapy Regimens Radical chemoradiation FuMi/XRT Patient profile: PS 0-2 T 1 – 4 N 1 – 3 Chemotherapy: Mitomycin C 12mg/m2 day 1 (max 20mg) 5 fluorouracil 1000mg/m2 / 24 hours days 1 to 4 5 fluorouracil 1000mg/m2 / 24 hours daily x 4 during final week of XRT Antiemetics: High emetic potential Investigations: Weight, FBC, U&E’s, LFT’s prior to each cycle. 1 Cummings BJ et al. Int J Radiat Biol Phys 1991; 21: 11115-25 2 UKCCCR Anal Cancer Trial. Lancet 1996; 348: 1049-54 Adjuvant No proven role Advanced/metastatic disease Cisp/5FU Patient profile: If prior Fu/Mi chemotherapy given Chemotherapy: Cisplatin 60mg/m2 day 1 5 fluorouracil 1000mg/m2/24hrs days 2 to 5 Repeat at 21 day intervals for max 4 courses. Antiemetics: High emetic potential Investigations: Weight, U&E’s, FBC, LFT’s prior to each cycle. 1. Rich T Oncology 1999; 13 (10 supp 5): 131-4 2. Stafford s, Martenson J Oncology 1998; 12(3): 373-7 3. Myerson RJ Rays 1997; 22(3): 393-9 Colorectal cancer chemotherapy regimens Neo-adjuvant CAPECITABINE + XRT Patient profile: Rectal threatening mesorectal fascia Downstaging pre-operatively Failed venous catheterisation Receiving anticoagulants Chemotherapy: Capecitabine 825mg/m2 mon to fri during XRT TTH loperamide with detailed instructions on when and how to take them . Antiemetics: Low emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle CI 5FU WITH OR WITHOUT XRT Patient profile: Rectal threatening mesorectal fascia Downstaging pre-operatively Chemotherapy: 200mg/m2/d continuously days 1 to 35 300mg/m2/d continuously days 1 to 35 when given without XRT Antiemetics: Low emetic control Investigations: Weight, FBC. U&E’s, LFT’s 1. Lokich JJ et al. J Clin Oncol 1989; 7: 425-32 2. O’Connell et al. N Engl J Med 1994; 331: 502-7 Adjuvant CAPECITABINE Patient profile: High risk Dukes B and Dukes C Chemotherapy: 1250mg/m2 oral twice daily for 14 days followed by 7 days off TTH loperamide with detailed instructions on when and how to take them . Repeat at 21 days from day 1 for 8 cycles. Antiemetics Low emetic control Investigations: weight, FBC, U&E’s, LFT’s before each cycle. 1. National Institute for Health and Clinical Excellence. Technology Appraisal Guidance 100. Capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes’ C) Colon cancer April 2006 2. Hoff PM et al. J Clin Oncol, 2001; 19(8): 2282-92 3. Twelves C. Eur J Cancer, 2002; 38 Suppl 2: 15-20 4. Scheithaurer W et al. Ann Oncol, 2003; 14(12): 1735-43 5. Twelves C et al. Eur J Cancer, 2001; 37(5): 597-604 6. Reddy GK, Clin Colorectal Cancer, 2004; 4(2): 87-8 5FU/FA Patent profile: High risk Dukes B & Dukes C Patient choice Chemotherapy 5 fluorouracil 370mg/m2 Folinic acid 50mg weekly for 30 weeks Antiemetics Low emetic control Investigations: Weight, FBC, U&E’s, LFT’s monthly 1. O’Connell M. et al. J Clin Oncol, 1997; 15: 246-60 2. QASAR 1 –a UKCCR study of adjuvant chemotherapy for colorectal cancer 3. QASAR 2 –a UKCCR study of adjuvant chemotherapy for colorectal cancer Modified de Gramont Patient profile: Stage III (dukes’C) colon cancer. PS = 0,1 or 2 Chemotherapy: Ca levofolinate 175mg 2 hour infusion 5 fluorouracil 400mg/m2 15 minute bolus 5 fluorouracil 2400mg/m2 46 hour infusion Repeat at 14 day intervals for 4 cycles. If evidence of response/clinical benefit , continue for up to 12 cycles Antiemetics: Low emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. De Gramont A. et al, J Cancer Clin Oncol, 1988; 24(9); 1499-503 2. Mortel CG, et al. N Eng J Med. 1990; 322(6): 352-8 3. Andre t, et al. J Clin Oncol. 2003; 21(5): 2896-903 FOLFOX Patient profile: Stage III (dukes’C) colon cancer. Chemotherapy: Oxaliplatin 85mg/m2 Ca levofolinate 175mg 2 hour infusion 5 fluorouracil 400mg/m2 15 minute bolus 5 fluorouracil 2400mg/m2 46 hour infusion Repeat at 14 day intervals for 4 cycles. If evidence of response/clinical benefit , continue for up to 12 cycles Antiemetics: High emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. National Institute for Health and Clinical Excellence. Technology Appraisal Guidance 100. Capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes’ C) colon cancer April 2006 Advanced Metastatic Disease FOLFOX Patient profile: PS 0 – 1 Standard 1st line, alternative to FOLFIRI Chemotherapy: Oxaliplatin 85mg/m2 Ca levofolinate 175mg 2 hour infusion 5 fluorouracil 400mg/m2 15 minute bolus 5 fluorouracil 2400mg/m2 46 hour infusion Repeat at 14 day intervals for 4 cycles. If evidence of response/clinical benefit , continue for up to 12 cycles Antiemetics: High emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. National Institute for Health and Clinical Excellence. Technology Appraisal 33. Irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer. August 2005. 2. Giacchetti S, et al. J Clin Oncol. 2000; 18(1): 136- 3 De Gramont A, et al. J Clin Oncol. 2000; 18(16) 2938-2947 4. Giacchetti S, et al. Ann Oncol. 1999; 10(6): 663-669 XelOx Patient profile: Standard 1st line, Failed venous catheterisation Chemotherapy: Oxaliplatin 85mg/m2 Capecitabine 1000mg/m2 orally twice daily for 14 days TTH loperamide with detailed instructions on when and how to take them . Repeat at 21 day intervals for 4 cycles, then re-assess Antiemetics High emetic control during oxaliplatin administration Investigations Weight, FBC, U&E’s, LFT’s before each cycle Normal FBC limits for administration apply with the exception that the lower limit for platelets for administration of XelOx is 75 x 109/l 1. Cassidy J. et al. J Clin Oncol. 2004; 22(11): 2084-91 FOLFIRI Patient Profile: PS 0 – 1, alternative to FOLFOX Neuropathy risk/poor renal function Chemotherapy: Irinotecan 180mg/m2 + atropine sc 450microgrammes prior to irinotecan MdG Ca levofolinate 175mg 2 hour infusion 5 fluorouracil 400mg/m2 15 minute bolus 5 fluorouracil 2400mg/m2 46 hour infusion TTH loperamide with detailed instructions on when and how to take them . Ciprofloxacin 500mg PO BD for 7 days. Antiemetics: For high emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. National Institute for Health and Clinical Excellence. Technology Appraisal 33. Irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer. August 2005. 2. Douillard JY et al Pro ASCO 1999; 18: 233a, abstract 899 3. Saltz LB et al Pro ASCO 1999; 18: 233a, abstract 898 FOLFOX + BEVACIZUMAB Approved clinically by YGC DTC Patient profile: Metastatic disease confined to liver Disease might be rendered respectable Good performance status Chemotherapy as above plus Bevacizumab 5mg/kg Repeat every 14 days for 4 cycles + 2 cycles FOLFOX then scan. Continue with chemotherapy. 1. Folprecht C, et al. Annals oncol. 2005; 16:1311-1319 2. Hurwitz, et al. N Engl J Med. 2004; 250(23): 2335-2342 3. Mass RD, et al. Proc An Soc Clin Oncol. 2004; Abs 3515 FOLFIRI + BEVACIZUMAB approved clinically by YGC DTC Patient profile: Metastatic disease confined to liver Disease might be rendered respectable Good performance status Chemotherapy as above plus Bevacizumab 5mg/kg Repeat every 14 days for 4 cycles the 2 cycles FOLFIRI then scan. Continue with chemotherapy. 1. Folprecht C, et al. Annals oncol. 2005; 16:1311-1319 2. Hurwitz, et al. N Engl J Med. 2004; 250(23): 2335-2342 3. Mass RD, et al. Proc An Soc Clin Oncol. 2004; Abs 3515 CETUXIMAB Patient profile: 3rd line (to be reviewed) AWMSG approved Chemotherapy: Irinotecan 350mg/m2 iv q 21 days Cetuximab 400mg/m2 day1, then Cetuximab 250mg/m2 weekly Treatment can continue to progression or can be intermittent with breaks from treatment and reintroduction of the same chemotherapy if still responding when treatment stopped. 1. Use of cetuximab (Ebitux®) within NHS Wales. All Wales Medicines Strategy Group, June 14 2006 MdG Patient profile: Unfit for combination therapy Chemotherapy: Ca levofolinate 175mg 2 hour infusion 5 fluorouracil 400mg/m2 15 minute bolus 5 fluorouracil 2400mg/m2 46 hour infusion Repeat at 14 day intervals for 4 cycles. If evidence of response/clinical benefit , continue for up to 12 cycles Antiemetics: Low emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. De Gramont A. et al, J Cancer Clin Oncol, 1988; 24(9); 1499-503 2. Mortel CG, et al. N Eng J Med. 1990; 322(6): 352-8 3. Andre t, et al. J Clin Oncol. 2003; 21(5): 2896-903 4. de Graumont A et al. J Clin Oncol; 1997; 15: 808-15 CAPECITABINE Patient profile Unfit for combination therapy As per NICE guidance Chemotherapy: 1250mg/m2 oral twice daily for 14 days followed by 7 days off TTH loperamide with detailed instructions on when and how to take them . Repeat at 21 days from day 1 for 8 cycles. Antiemetics Low emetic control Investigations: weight, FBC, U&E’s, LFT’s before each cycle. 1. National Instittute for Health and Clinical Excellence, Technology appraisal no. 61: 2003 2. Hoff PM et al. J Clin Oncol 2001; 19 2282-92 3. Van Cutsem E et al Eur J Clin Oncol 2001; 19: 4097-106 4 Twelves C. Eur J Cancer 2002; 38: 515-520 5. Callidy J et al. Anals Oncol 2002; 13: 566-75 MITOMYCIN + 5FU Patient Profile: 3rd line PS < 2 Chemotherapy: Mitomycin–C 6mg/m2 day 1 repeat every 6 weeks + Folinic Acid 175mg/m2 2 hour infusion 5-fluorouracil 400mg/m2 15 minute bolus 5-fluorouracil 2400mg/m2 46 hour infusion Repeated at 14 day intervals, maximum 4 doses of mitomycin Antiemetics: Intermediate emetic control for mitomycin administration. Investigations: Weight, FBC, U&E’s, LFT’s before each cycle MITOMYCIN + CAPECITABINE (MX) Patient profile 3rd line PS < 2 Failed venous catheterisation Chemotherapy: Mitomycin-C 6mg/m2 day 1 3-6 weekly for 4 cycles Capecitabine 1250 mg/m2 orally twice daily for 14 days each 21 day cycle Antiemetics: Intermediate emetic control for mitomycin administration. Investigations: weight, FBC, U&E’s LFT’s before each cycle 1. Ross et al. Ann Oncol 1997; 8: 95-1001 GYNAECALOGICAL CANCER Ovarian Cancer Chemotherapy Regimens Adjuvant CARBOPLATIN Patient profile: stage 1 A/B Poorly differentiated Chemotherapy: Carboplatin AUC 6 (or 5 for measured Creatine Clearance) 21 day intervals for a maximum of 6 cycles Antiemetics: For intermediate emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle. Dose Modifications: 1. Taylor A et al. J Clin Onc, 1994; 12: 2066-70 2. Harper P. Seminars in Oncology 1997; 24(5 suppl 15):S15-25 CARBOPLATIN/PACLITAXEL Patient profile: Stage 1C or high risk of recurrence Chemotherapy: Carboplatin AUC = 6 (calculated) Paclitaxel 175mg/m2 Repeat at 21 day intervals. Premedication to be given 30 minutes paclitaxel administration. Chlorpheniramine 10mg i.v Dexamethasone 16mg i.v. Ranitidine 50mg i.v. Antiemetics: for intermediate emetic control Investigations: Weight, FBC, U&E’s, UFT’s before each cycle Dose modifications: 1. Harper P. Seminars in Oncology 1997; 24(5 suppl 15): S15-25 2. Anon. The Lancet 1998; 352: 1571-6Metastatic/advanced disease CARBOPLATIN/PACLITAXEL Patient Profile: stage 2 PS d" 2 See Adjuvant treatment for details 1. McGuire WP, et al. N Engl J Med. 1997; 334: 1-6 2. Piccart MJ, et al.J Natl Cancer Inst. 2000; 9: 699-708 3. Colombo N. Proc Am Soc Clin Oncol.2000; 19:A1500 4. Neijt et al. Proc Am Soc Clin Oncol.1997; 16:A352 5. DuBois A et Al. Proc Am Soc Clin Oncol.1998; 17:A361 6. Ozols RF. Et al. Proc Am Soc Clin Oncol.1999; 18:A1373 CARBOPLATIN/DOCETAXEL Patient profile: Patients allergic to paclitaxel 1. Vasey P et al J Natl Cancer Inst 2004 Nov 17; 96(22): 1682-21 LIPOSOMAL DOXORUBICIN Patient profile: PS d" 2 Platinum resistant/refactory 2nd line after platinum/taxane failure (NICE) Chemotherapy: 50mg/m2 every 28 days by iv infusion initially 1mg/minute.If no reaction, give subsequent doses over 60 minutes. Max 6 cycles. Antiemetics: For intermediate emetic control Investigations: CA125, weight, FBC, U&E’s, LFT’s before each cycle. Dose modifications: Impaired renal function: Dose reduction should be considered in patients with raised bilirubin above 4x upper limit of normal. For mlelosupression: Delay treatment until neutrophils >1.5x109/l and platelets >150x109/l.. Reduce dose by 25% if grad 4 myelosupression occurs. For stomatitis or palmar-plantar syndrome: Delay treatment until toxicity has recoverd to grade 1 or better. If a 2 week delay is required for recovery, reduce dose by 25%. If grade 3 or 4 toxicity is still apparent at 6 weeks then stop treatment. National Institute for Health and Clinical Excellence Technology Appraisal no. 91. Ovarian Cancer (advanced) – paclitaxel, pegylated liposomal doxorubicin hydrochloride and topotecan (review) TOPOTECAN Patient profile: PS 0 – 1 Resistant/refractory to platinum based combination therapy and after liposomal doxorubicin failure. Chemotherapy: Topotecan 1.25mg/m2 daily x 5 days every 21 days. Max 6 cycles Antiemetics: Intermediate antiemetic treatment Investigations: CA125, weight, FBC, U&E’s, LFT’s prior to each cycle. Dose Neutrophils < 1.0 x 109/l defer treatment Modifications: Platlets <75 x 109/l defer treatment CrCl < 40mls/min 50% dose reduction National Institute for Health and Clinical Excellence Technology Appraisal no. 91. Ovarian Cancer (advanced) – paclitaxel, pegylated liposomal doxorubicin hydrochloride and topotecan (review) PACLITAXEL Patient profile: Relapse after single agent carboplatin Chemotherapy Paclitaxel 175mg/m2* repeat every 21 days Pre-medication 30 minutes before chemotherapy Dexamethasone 16mg iv bolus Ranitidine 50 mg slow iv bolus Chlorpheniramine 10mg iv bolus *Paclitaxel is licensed for administration over 3 hours. In practice, it has been given over 1 hour (out of license). To compromise, the infusion should be commenced at a reduced rate of 167ml/hour for the first 15 minutes. If no problems arise, the remaining infusion can be administered over 1 hour at a rate of 458ml/hour. Antiemetics: For intermediate emetic control Investigations: weight, CA125, FBC, U&E’s LFT’s before each cycle. Dose modifications: If WBC<3.5x109/l (neutrophils <1.5x109/l) or platelets <100x109/l then delay treatment for 1 week If neutropenia is prolonged (more than 7 days) of severe neuropathy occurs then reduce dose by 20%. No anticipatory dose reduction is needed for frail or elderly patients. 1. National Institute for Health and Clinical Excellence Technology Appraisal no. 91. Ovarian Cancer (advanced) – paclitaxel, pegylated liposomal doxorubicin hydrochloride and topotecan (review) 2. Trimble EL et al. J Clin Oncol 1993; 11: 2405-10 3. Eisenhauer EA et al. J Clin Oncol 1994; 12: 2654-66 Endometrial Cancer Chemotherapy Regimens Adjuvant No proven role Metastatic/advanced CARBOPLATIN Patient profile: Fit PS 2 Chemotherapy Carboplatin AUC 6 (or 5 for measured CC) 21 day intervals for a maximum of 6 cycles Antiemetics: For intermediate emetic control Investigations: Weight, FBC, U&E’s, LFT’s, before each cycle. Dose modifications. 1. Burke TW et al Gynecol Oncol 1993; Dec; 51(3): 397-400 2. Muggia FM et al Semin Oncol 1994; Apr; 21(2 suppl 2): 35-42 Mixed Mullerian DOXORUBICIN Patient profile: PS 1 - 2 Chemotherapy: Doxorubicin 75mg/m2 x 6cycles at 21 day intervals depending on response Antiemetics: Intermediate emetic control Investigations: Weight, FBC, U&E’s LFT’s before each cycle Consider LV ejection fraction if history of cardiac disease. 1. Muss NB et al. Cancer 1985; 55: 1648-53 2. Omura GA et al. Cancer 1983; 52: 626-632 or Cisplatin Chemotherapy: Cisplatin 80mg/m2 x 6 cycles Antiemetics: For high emetic control Investigations: Weight. U&E’s, FBC, LFT’s before each cycle Dose modifications: see appendix Cisplatin doses 1 Thigpen T et al, Semin Oncol 1994; 21: 114-118 2. Thigpen T et al. J Clin Oncol 1991; 9: 1962-6 Cervical Cancer Chemotherapy Regimens CISPLATIN Patient profile: In combination with radical radiotherapy Bulky 1B, 2B or 3B Normal liver/renal/haematology Chemotherapy Cisplatin 40 mg/m2/week x max 6 weeks. Antiemetics: For high emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle. 1. Rose PG, Bundy BN. J Clin Oncol 2002; 20: 891-3 2. Green JA. Lancet. 2001; 358: 781-6 3. Morris M, et al. N Eng J Med. 1999; 340: 1137-43 4. Rose PG, et al. N Eng J Med. 1999; 340: 1144-53 BMC Patient profile: Fit young patients Chemotherapy Mitomycin-C 10mg/m2 cycles 1 & 3 only Bleomycin 30,000 iu Cisplatin 50mg/m2 2 – 4 cycles Repeat every 21 days Special Precautions: Urine should be maintained above 100ml/l/hr throughout treatment. If output falls below 400ml in any 4 hour period, then give furosemide 20mg i.v. repeated as necessary Alternatively mannitol may be used. Antiemetics High emetic control Investigations Weight, FBC, U&E’s LFT’s . creatinine clearance before each cycle Dose modifications: If WBC < 3.5 x 109/l or platelets < 100 x 109/l delay treatment by one week. 1. Kumar L, et al. J Obst Gynaecol Res. 1998; 24(6): 401-9 2. Omura GA, et al. J Clin Oncol. 1997; 15(1): 165-71 3. Buxton EJ, et al. J Natl Cancer Inst. 1989; 81(5): 359-61 4. Smith HO, et al. Gynaecol Oncol. 1993; 48(1): 11-15 or BMCarbo Patient profile: If renal function inadequate fot cisplatin (in BMC) Chemotherapy: Mitomycin C 10mg/m2 cycles 1 & 3 only Bleomycin 30,000 iu Carboplatin AUC 5 Antiemetics: For intermediate emetic control Investigations: Weight, Creatine clearance, FBC, U&E’s, LFT’s before each cycle. LUNG CANCER Small Cell Lung Cancer Chemotherapy regimens Adjuvant CARBOPLATIN + ETOPOSIDE Patient profile: For rare cases of resected small cell lung cancer Chemotherapy: Carboplatin AUC 5 day 1 Etoposide 100mg/m2 iv day 1 Etoposide 200mg/m2 po daily day 2 and 3 (round down to nearest 50mg) Repeat at 21 day intervals for a maximum of 6 cycles. Antiemetics: For intermediate emetic control Prophylactic antibiotics: Ciprofloxacin 250mg bd and Fluconozole 50mg od on days 8 to 14 during first cycle and subsequent cycles if risk of infection. Investigations: Weight, FBC, U&E’s, LFT’s, Creatinine Clearance before each cycle. Dose modifications: If WBC > 3.5 x 109/l and platelets >100 x 109/l give full dose. If below these levels, delay for 1 week. If WBC < 1.0 or platelets <25 or if neutropenic sepsis occurs at any time, reduce dose by 25% for subsequent doses. 1. Smith IE et al. J Clin Oncol 1987; 5(2): 1985-9 Advanced disease CARBOPLATIN + ETOPOSIDE Patient profile: Standard regimen PS d" 2 See above 1. Skarlos DV et al. Ann Oncol 1994; 5: 601-7 CAV Patient profile: 2nd line therapy. Better chance of benefit if tumour responds well to first line carbo/etoposide PS d"2 Chemotherapy: Cyclophosphamide 800mg/m2 Doxorubicin 50mg/m2 Vincristine 1.4mg/m2 Repeat at 21 day intervals for 4 6 cycles Antiemetics For high emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle Dose modifications: If WBC > 3.5 x 109/l and platelets > 150 x 109/l give full dose If below these levels, delay for one week. 1. Greco FA et al. Brit Med J, 1978; 2: 10-11 Non-small Cell Lung Cancer Treatment regimens Adjuvant CISPLATIN/VINORELBINE Patient profile: For fitter younger patients PS 0 – 1 stage lc-llb Chemotherapy: Cisplatin 80mg/m2 day 1 Vinorelbine 30mg/m2 days 1 & 8 (max 60mg) Repeat 21 day intervals for 4 cycles Antiemetics For high emetic control Investigations Weight, Creatine Clearance, FBC, U&E’s, LFT’s before each cycle 1. Winton T. et al. N Eng J Med, 2005; 352 (25):2589-97 2. Douillard J. et al. Proc ASCO 2005; abstract: 7013 CARBOPLATIN/VINORELBINE Patient profile: stage 1 – 3 completely resected PS 0 – 1 stage lc-llb Chemotherapy: Carboplatin AUC 5 day 1 Vinorelbine 30mg/m2 days 1 & 8 (max 60mg) Repeat 21-28 day intervals for 3 cycles Antiemetics For moderate emetic control Investigations Weight, Creatine Clearance, FBC, U&E s, LFT s before each cycle Metastatic/advanced GEMCITABINE/CARBOPLATIN Patient profile: PS d" 2 Standard treatment (NICE) Chemotherapy: carboplatin AUC = 5 day 1 gemcitabine 1250mg/m2 days 1 and 8 Repeat 21 days from day 1. Assess response after 2 cycles. Max 4 cycles. Ciprofloxacin 500mg po twice daily, days 5 - 14 Antiemetics: Day 1: Intermediate emetic control Day 8: Low emetic control Investigations: Weight, FBC, U&E’s, Creat. Cl., LFT’s before each cycle Dose modifications: Gemcitabine 1000mg/m2 if PS > 1 Day 1: Neutophils <1.5x109/l or platelets <100x109/l defer treatment one week. Day 8: Neutrophils <1.0x109/l or platelets <75x109/l then cancel day 8 gemcitabine. 1. National Institute for Health and Clinical Excellence, Guidance on the use of decetaxel, paclitaxel, gemcitabine and vinorelbine for the treatment of non-small cell lung cancer. 2001; National Institute for health and clinical excellence; London. 2. Scagliotte GV. Et al. J Clin Oncol.2002. 20(21): 4285-91 3. Zatloukal P & Petruzelka L. Lung Cancer, 2002; 38 Suppl 2: S33-6 4. Kortsik C et al. Lung Cancer; 2003. 40(1): 85-90 5. Rudd RM et al. Proceedings of the Americal Society of Clinical Oncology, 2002: Abstract 1164 6. Cockcroft D & Gault MH. 1976; Nephron 16: 31-41 DOCETAXEL Patient profile: NICE Standard 2nd line treatment PS = 0 or 1 Chemotherapy: Docetaxel 75mg/m2 Premedication: Dexamethasone 8mg po twice daily for 3 days starting day before chemotherapy. Investigations: Weight, FBC, U&E,s, LFT’s before each cycle Dose modifications: Neutrophils<1.5x109/l or platelets <100x109/l: delay treatment by one week If recovery takes more than one week, or neutropenic sepsis; reduce dose by 20% For non-haematological toxicities (excluding alopecia); if necessary delay treatment by one or more weeks until recovery to grade 0 or 1. If recovery takes longer than one week, or if any toxicity of grade 3+ is documented during chemotherapy, the dose should be reduced by 20% in all subsequent cycles. 1. Shepherd FA. Et al. J Clin Oncol. 2000; 18: 2094-103 2. Fossella F. Eur J Cancer. 2001; 37 (suppl 6): S154 (Abstract) 3. Roszkowski K. et al. 2000; Lung Cancer; 27: 145-7 Mesothelioma Chemotherapy Regimens MVP Patient profile: Current treatment, MS01 trial Chemotherapy: Mitomycin C 6mg/m2 day 1 Vinblastine 6mg/m2 day 1 Cisplatin 50mg/m2 day 1 Repeat at 21 day intervals Antiemetics For high emetic control Investigations Weight, creatinine clearance, FBC, U&E’s, LFT’s before each cycle 1. Middleton GW et al. Ann Oncol. 1998; 9: 269-73 PREMETREXED/CISPLATIN Patient profile: Chemotherapy: Cisplatin 75mg/m2 day 1 Premetrexed 500mg/m2 day 1 Folic acid + B12 supplement Repeat at 21 day intervals Antiemetics: For high emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle 1. Vogelzang NL, et al. J Clin Oncol. 2003; 21 (14): 2636-44 Head and Neck Cancer Chemotherapy Regimes Adjuvant No proven role LOCALLY ADVANCED DISEASE/RADICAL THERAPY RADICAL CONCURRENT CHEMORADIATION (NASOPHARYNX) Patient profile: nasopharynx Chemotherapy: Cisplatin 100 mg/m2 weeks 1, 4, 7 concurrent with RT Consider 2 cycles neoadjuvant Antiemetics high emetic control Investigations Weight, creatinine clearance, U&E’s, FBC, LFT’s, before chemotherapy. Dose modifications: see appendix (cisplatin) RADICAL CONCURRENT CHEMORADIATION (OROPHARYNX) Patient profile: Stage III/IV Oropharynx (or nasopharynx if renal function inadequate for cisplatinum) Chemotherapy: Carboplatin 70mg/m2/day iv short infusion 5-FU 600mg/m2/24 hr continuous infusion Both drugs days 1 – 4 inclusive Weeks 1, 4 and 7 concurrent with RT Antiemetics: for moderate emetic control Investigation: Weight, creatinine clearance, U&E’s, FBC, LFT’s before each cycle. Radical Concurrent Chemoradiation (Oropharynx) Patient profile: Stage III/IV Oropharynx (if not suitable for concurrent chemotherapy) Cetuximab 400 mg/m2 iv loading dose the week before RT Then: 250 mg/m2 iv weekly x 6 or 7 weeks during RT Palliative Chemotherapy CISPLATIN + 5FU Patient profile: First line chemotherapy Head and Neck cancer PS 0-2 Chemotherapy: Cisplatin 80mg/m2 day1 5 fluorouracil 1000mg/m2 over 24 hours days 1 – 4 Outpatient if possible Repeat at 21 day intervals Antiemetics: for high emetic control Investigations weight, creatinine clearance, FBC, U&E’s, LFT’s before each cycle Dose modifications: see appendix. 1. Taylor SG et al. J Clin Oncol 1994; 12: 385-95 2. Martim M et al. Int J Radiat Oncol Biol Phys.1990; 19: 973-5 3. Jacobs C et al. J Clin Oncol; 1992; 10: 257-63 4 Forastiere AA et al. J Clin Oncol. 1992; 10: 1245-51 5 Al-Sarraf M et al. J Clin Oncol. 1998; 16: 1310-17 Second line: VBMF Chemotherapy: Vincristine 1.4 mg/m2 (max 2mg) day 1 Bleomycin 30,000 units (fixed) day1 5-FU 500 mg (fixed) day 1 Methotrexate 100 mg/m2 day 1 Folinic acid rescue 15-30mg po every four hours for 6 doses Starting 24 hours after methotrexate dose. Repeat at 14 day intervals for 6-12 cycles depending on response UROLOGICAL CANCER BLADDER CANCER CHEMOTHERAPY Regimens GEMCITABINE + CISPLATIN Patient group: prior to to radical surgery or radiotherapy in muscle invasive but non-metastatic disease. Chemotherapy: day 1: cisplatin 80mg/m2 gemcitabine 1200mg/m2 day 8: gemcitabine 1200mg/m2 repeat for 2 – 3 cycles Antiemetics: for high emetic control (day 1) Investigations: Weight, FBC, U&E’s, creatinine clearance, LFT’s before each cycle Dose modifications: Give gemcitabline 1000mg/m2 if PS=2) Neutrophils<0.8x109/l omit dose and reduce subsequent doses by 25% Platelets <75x109/l omit dose and reduce subsequent doses by 25% AST or ALF >5 x upper limit reduce dose by 25% Gemcitabline can cause elevation of transaminases which usually recovers after omitting treatment for 2-3 weeks. Resume at a lower dose. 1. Lokich J, Anderson N. Ann Oncol. 1998; 9(1): 13-21 2. Meliani E et al. Urol Int. 2003; 71 (1): 37-40 3. Lehmann J. et al. Urologe A. 2003; 42(1): 63-77 4. Neoadjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis. Lancer, 2003;361(9373): 1927-34 GEMCITABINE + CARBOPLATIN Patient group: Elderly and/or poor PS=2 and/or poor renal function (ClCr d"40 mls/min) (all patients at CTC) Chemotherapy: day 1: Carboplatin AUC = 5 (4 in frail patients) Gemcitabine 1200mg/m2 (1000mg/m2 in frail patients) day 8: gemcitabine 1200mg/m2 (1000mg/m2 in frail patients) Ciprofloxacin 500mg po BD for 7 days, starting day 8 of cycle. repeat for 2 – 3 cycles Antiemetics: for moderate emetic control (day1) Investigations: Weight, FBC, U&E’s, creatine clearance, LFT’s before each cycle. Dose modifications: Neutrophils<0.8x109/l, omit dose and reduce subsequent doses by 25% Platelets<75x109/l, omit dose & reduce subsequent doses by 25% AST or ALT > 5x upper limit reduce dose by 25% Gemcitabine can cause elevation of transaminases which usually recovers after omitting treatment for 2-3 weeks. Resume at a lower dose. 1. Lokich J, Anderson N. Ann Oncol. 1998; 9(1): 13-21 2. Meliani E et al. Urol Int. 2003; 71 (1): 37-40 3. Lehmann J. et al. Urologe A. 2003; 42(1): 63-77 4. Petrioli R. et al. Cancer 1996; 77 (2) 344-51 5. Segati R. et al. European Urology 29 (3): 312-6 CMV Patient profile: Standard treatment (transitional cell) Chemotherapy: Day 1: methotrexate* 30mg/m2 bolus vinblastine 4mg/m2 bolus Day 2: cisplatin 70mg/m2 iv Day 8: methotrexate* 30mg/m2 bolus vinblastine 4mg/m2 bolus repeat cycles every 21 days from day 1 for max. 6 cycles (Assess response after 2 cycles). * give folinic acid 15mg p.o. x 6 hourly starting 24 hours post methotrexate. Anitemetics: For high emetic control (day 2) Investigations: Weight, FBC, U&E’s, creatinine clearance, LFT’s before each cycle. Dose modifications: 1. Mead GM et al. Brit J Cancer, 1998; 78 (8): 1067-75 2. Jeffrey GM. Et al. Brit J Cancer, 1998; 66 (3): 542-6 renal cancer Chemotherapy Regimens Adjuvant No proven role/ trials only Advanced disease INTERFERON Patient profile: PS 0-1 Relapse post nephrectomy >12 months Low volume disease Patients should have 2 our of 3 criteria Chemotherapy: ± interferon 3-10mu mon, wed, fri. Antiemetics for low emetic control Investigations: weight, U&E’s, LFT’s, FBC before each cycle 1. MRC Renal Cancer Collaborators. Lancer 1999; 353: 14-7 2. Pyhonen S et al. J Clin Oncol, 1999; 17: 2859-67 3. Coppin C et al. Cochrane Database Syst Rev 2000; 3: CD001425 4. Fossa S et al. Br J Oncol 1995; 76: 286-90 5. Negrier S et al. N Eng J Med 1998; 338: 1272-8 Prostate Cancer Chemotherapy Regimens AdAd Adjuvant No proven role AdAd Advanced/metastatic disease MITOXANTRONE Patient profile Hormone refractory disease NWCTC PS 0-1 Normal FBC, renal, liver function No cardiac failure. Chemotherapy: Mitoxantrone 12mg/m2 q 21 days max dose 14mg/m2 Prednisolone 5mg p.o daily – during treatment. Response assessment after 6 weeks. If response, continue for 12 – 18 weeks if well tolerated. Antiemetics for moderate emetic control Investigations Weight, FBC, U&E’s, LFT’s before each cycle. 1. Tannock IF. Et al. J Clin Oncol 1996; 14: 1756-64 DOCETAXEL Patient profile: Hormone refractory disease YG only PS 0 – 2 Adequate hepatic and bone marrow function Patients with impaired bone marrow function could be considered for weekly rather than 3 weekly docetaxel Chemotherapy: 21 day cycle Dexamethasome 8mg po bd for 3 doses starting evening before treatment Docetaxel 75mg/m2 iv Ciprofloxacin 500mg po twice daily days 5 - 14 Weekly treatment Dexamethasome 8mg po bd for 3 doses starting evening before treatment Docetaxel 20 - 30mg/m2 iv Anti-emetics moderate emetic control Investigations weight, FBC, LFT’s U&E’s before each cycle 1. National Institute for Health and Clinical Excellence. Technology Appraisal 101. Docetaxel for the treatment of hormone refactory prostate cancer. June 2006 2. Tannock IF, et al. N Eng J Med. 2004; 351 (15): 1502-12 Germ Cell Tumour Chemotherapy Regimens Stage 1 Pure Seminoma CARBOPLATIN Patient profile: Fit, under 50. Willing to have chemo/contra indication to RT Chemotherapy: Carboplatin AUC = 7 – one dose only Antiemetics: Moderate antiemetic control Investigations: Creatinine clearance, Weight, U&E’s FBC, LFT’s 1. Patterson H. et al. Radiother Oncol 2001; 59: 5-11 EP Patient profile: as above Chemotherapy Day 1: Etoposide 165mg/m2 Cisplatin 50mg/m2 Day 2: Etoposide 165mg/m2 Cisplatin 50mg/m2 Day 3: Etoposide 165mg/m2 Repeat at 21 days for 2 cycles Antiemetics For high emetic control Investigations Weight, FBC, U&E’s, LFT’s, Creatinese clearance before each cycle 1. COIN Guidelines – Testicular Germ Cell Tumours. Clinical Oncology 2000; 12: S178-210 2. Bajorin DF. J Clin Oncol. 1993; 11:598-606 Stage 1 Non-seminomatous testicular CST BEP 500 Patient profile Low risk metastatic germ cell disease Chemotherapy Day 1: Hydrocortisone 100mg i.v. bolus Bleomycin 30,000i.u Etoposide 165mg/me Cisplatin 50mg/m2 Day 2: Etoposide 165mg/m2 Cisplatin 50mg/m2 Day 3: Etoposide 165mg/m2 Repeat at 21 days for 4 cycles. N.B. Bleomycin given for the first 3 cycles only. Antiemetics: for high emetic control Investigations: Weight, Creatinine clearance, U&E’s. FBC, LFT,s before each cycle Tumour markers:HCG, AFP,LDH weekly during treatment where appropriate 1. COIN Guidelines – Testicular Germ Cell Tumours. Clinical Oncology 2000; 12: S178-210 2. Cullen MH. J Clin Oncol, 1996; 14: 1106-12 3. de Wit r et al. Proc ASCO 1999; 18 abstract: 1187 Low risk – all GCT BEP 500 See above BEP 500 Adguvant use in high risk non seminomatous germ cell Stage 1. i.e. vascular invasion BEP 360 Chemotherapy Day 1: Hydrocortisone 100mg iv bolus Bleomycin 30000 iu Etoposide 120mg/m2 Cisplatin 50mg/m2 Day 2: Etoposide 120mg/m2 Cisplatin 50mg/m2 Day 3: Etoposide 120mg/m2 Repeat after 21 days. Give 2 cycles. Antiemetics: For high emetic control Investigations: Weight, FBC, U&E’s, creatinine clearance, LFT’s before each cycle Tumour markers: HGC, AFP, LDH where appropriate prior to each cycle, when markers negative. 1. COIN Guidelines – Testicular Germ Cell Tumours. Clinical Oncology 2000; 12: S178-210 2. Cullen MH. J Clin Oncol, 1996; 14: 1106-12 mALIGNANT MELANOMA CHEMOTHERAPY REGIMENS Adjuvant HIGH DOSE INTERFERON Patient profile: High risk/selected patients PS < 1 CT brain, chest, abdomen, pelvis normal Histological regional node involvement All macroscopic disease resected, margins clear. Chemotherapy: Interferon ±-2² 20 x 106 units/m2 daily x 5 x 4 weeks followed by +Interferon ±-2² 10 x 106 units/m2 s.c 3 x week x 48 weeks Investigations: Weight, U&E s, FBC, LFT s 1. Kirkwood JM et al. J Clin Oncol, 2001; 19(9): 2370-2380 1. Kirkwood JM et al. J Clin Oncol, 1996; 14: 7-17 Metastatic/advanced disease CARMUSTINE/DACARBAZINE/CISPLATIN (Dartmouth Regimen) Patient profile: outside trial Chemotherapy: Carmustine 150mg/m2 day 1, cycles 1,3 & 5 Dacarbazine 220mg/m2 days 1 – 3 Cisplatin 25mg/m2 days 1 – 3 repeat every 21 days Tamoxifen 20mg daily (10mg twice daily or 20mg daily) throughout treatment starting one week before first cycle. Antiemetics: High emetic regimen Investigations: Weight, FBC, U&E’s, LFT’s before each cycle. Monitor serum creatinine – adjust according to BOPA guidelines 1. Chapman PB. Et al. Phase lll multicentre randomized trial of the Datmouth Rgimen verses dacarbazine in patients with metastatic melanoma. DACARBAZINE Patient profile outside trial Chemotherapy Dacarbazine (DTIC) 800mg/m2 at 21 day intervals Antiemetics: High emetic control Investigations: Weight, FBC, U&E’s, LFT’s before each cycle. 1. Chapman PB. Et al. J Clin Oncol 1999; 17: 2745-51 2. Rusthoven JJ. Et al. J Clin Oncol, 1996; 14: 2083-90 3. Falkson CI, et al. J Clin Oncol,1998: 16: 1743-51 VINDESINE Patient profile: outside trial Chemotherapy Vindesine 5mg i.v. weekly For 8 weeks or continue to a maximum response. Antiemetics: Low emetic control Investigations Weight, U&E’s, LFT’s FBC before each cycle. SARCOMA CHEMOTHERAPY REGIMENS . Soft Tissue Sarcoma IFOSFAMIDE Patient profile: Adjuvant Chemotherapy: Ifosfamide 5000mg/m2 over 24 hours Mesna 5000mg/m2 over 24 hours 21 day cycle Antiemetics Intermediate emetic control Investigations Weight, FBC, LFT’s, U&E’s before each cycle 1. Bramwell VN et al. Eur J Cancer Clin Oncol, 1987; 23(3): 311-21 DOXORUBICIN Patient group: advanced, 1st line PS 0-1 Chemotherapy: Doxorubicin 75mg/m2 21 day cycles x 6 Antiemetics: High emetic control Investigations Weight, FBC, U&E’s LFT’s before each cycle. 1. Gottlieb JA et al, Cancer Chemother R, 1975; 6: 271-282 Gastro-intestinal Stromal Tumours Glivec Patient profile: Patients with metastatic GIST’s who have tested positive for c-Kit. Chemotherapy Starting dose: Imatinib 400mg orally daily rising to 600mg daily depending on toxicity Continue until progression/unacceptable toxicity supervenes 1. Rankin C et al, J Clin Oncol. 2004; 22(14 suppl): 9005 2. Verweij J et al. Lancet, 2005; 364(9440): 1127-34 3. Zalcberg JR et al. Eur J Cancer. 2005; 41(12): 1751-7 BILLIARY TREE CHEMOTHERAPY REGIMES Adjuvant No proven role Advanced Disease GEMCITABINE (+/- CISPLATIN) Patient profile: selected patients ABC-02 trial (standard arm) Chemotherapy Gemcitabine 1000mg/m2 days 1, 8 & 15 (total 7 weeks, then 1 week off. Repeat 3 weeks on and one week off) +/- Cisplatin 25mg/m2 day 1 and day 8 Antiemetics: Intermediate emetic control (high if cisplatin included) Investigations: Weight, FBC, U&E’s, creatinine clearance, LFT’s before each cycle. COCKCROFT-GAULT CREATININE CLEARANCE FORMULA Men ((140 – age) x wt x 1.23) / creatinine Women ((140 – age) x wt x 1.04) / creatinine Age in years, weight in kilogrammes, and plasma creatinine in micromoles per litre Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976:16:31-41. Calvert formula for carboplatin dose Carboplatin dose in mg = AUC x ( creatinine clearance + 25 ) Desired area under the curve ( AUC ) normally 4 – 6 depending on protocol and clinical situation Calvert AH,Newell DR, Gumbrell LA, et l. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989:7:1748-56. CISPLATIN DOSE GUIDELINES Cisplatin is nephrotoxic and thus patients must have their renal function measured prior to each cycle. Creatinine clearance cisplatin dose > 50 mls / min 100% 40 – 50 mls / min 75% < 40 mls / min no further cisplatin Patients should only commence cisplatin chemotherapy if they have an adequate performance status ie 0 – 2. The only exception to this is patients with advanced germ cell tumours with poor PS who may commence treatment with low dose etoposide/platinum. Patients should only receive second and subsequent cycles of cisplatin if they are well and have suffered no deterioration in performance status. HAEMATOLOGICAL PARAMETERS Haematological Indices – Guidelines for the administration of chemotherapy (1) Platelets e" 100 x 109 / l administer + Total WBC e" 3 x 109 / l administer + Neutrophils e" 1.5 x 109 / l administer (2) Platelets 75 100 x 109 / l physician discretion or Total WBC 2.0 2.9 x 109 / l physician discretion or Neutrophils < 0.5 – 1.5 x 109 / l physician discretion (3) Platelets < 75 x 109 / l defer or Total WBC < 2.0 x 109/l defer or Neutrophils < 0.5 x 109 / l defer These guidelines assume that patients are well and with good performance status, that other acute toxicities have resolved and the patient has not had a previous episode of neutropenic sepsis In some situations, chemotherapy is given despite lower count values than those noted above. These include patients receiving adjuvant chemotherapy, those with curable metastatic malignancies such as germ cell tumours and lymphomas and also patients with bone marrow infiltration. These situations will be dealt with on a case by case basis. ANTI-EMETIC POLICY FOR CYTOTOXIC CHEMOTHERAPY For highly emetogenic drugs, the most effective prophylaxis is provided by the combination dexamethasone + a 5HT antagonist. In difficult cases the addition of lorazepam is often healpful For chemotherapy of intermediate potential, dexamethasone alone, or with the addition of domperidone is equally effective to 5HT antagonist therapy Dexamethasone is the best available treatment for delayed emesis. 5HT antagonists are not effective in this situation. 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È9::::: :9:::¦:Ñ:ã:ä:é:;;<<¿<À<Ú<Û<%=&=(=-=>>ñáñÖËÄ½ÄË±Ë©Ëž©ž–ž‹ƒscžXMXh€ahâb¹OJQJh€ahuJÀOJQJh€ahÂ9í5CJ OJQJaJ h€ahÆRj5CJ OJQJaJ h%ñOJQJh%ñh€ahÆRjh ÜOJQJh€ahÆRjOJQJhñi*OJQJh€ahÂ9í5OJQJh€ah%ñh€ahÂ9íh€ahÂ9íOJQJh€ah{=DOJQJh€ah{=D6CJOJQJaJh€ah{=DCJOJQJaJ)<»<¼<½<¾<¿<Ú<Û<&='=(=,=-=<>V>¤>¾>???? ?Š?¦? @@÷îéîîä×××××××××××××××××××„p„÷^„p`„÷gd7. gd%ñgdÆRj„h^„hgdÆRj &F gdÆRj>>:><>z>|>Œ>Ž>ê>ì> ?N?P?ˆ?Š?Ø?Ú?è?ê?)@*@/@4@5@M@Q@k@l@t@u@œ@@Ë@Ì@Ú@AòBõB"C#CóèÝèóèÕèóèÊ¾ÊèÊ¾ÊÕÊ³§Ê¾œÊœœ…œœœ…z…slh€ahÄZÔh€ah%ñh€ah,&*OJQJh€ahÄZÔOJQJh€ahP†H*OJQJh€ahP†OJQJ*h€ah± DOJQJh€ah± DOJQJh€ahé˜H*OJQJh€ahé˜OJQJh ÜOJQJh€ahÆRjOJQJh€ahuJÀOJQJh€ahuJÀH*OJQJ'@Q@R@S@W@X@{@ˆ@©@µ@Ú@Û@Ü@œAAóBôBõB#C$CàCtDëDòòòòòòòòòòòòêåêØØÓÊÂÂÂ &F gd•„h^„hgd•gd%ñ„h„h^„h`„hgdÄZÔgdÄZÔ &F gdÄZÔ„p„÷^„p`„÷gd7. ëDìDE E%E&E0E5E6ECEDE_E}E™E²EÏEÚEäEðEüEýE€€€8€S€o€p€q€úúúúúúúúúúúúúúúúúúúúúúúúúúõõgdz'gd•#CìDE E%E6ECEOESETE^EoE|E‰E˜E™E¦E§E²E½EÁEÂEÎEÚEäEüEýEF€€€€H€I€o€q€r€t€u€Ž€‘€®€²€Ó€Ô€ñ€34fgst™õéõéõéõÞÖÞõÞõÞõÞÖÞõÞÖÞõÞõÞÊÈÊÞÖÞÖÞÄÀÞ·°·Ê¢Ê·Ê—‹—Ê—‹—‹—h€ahÈrŠ5OJQJh€ahÈrŠOJQJh€ah~O5>*OJQJh€ah Üh Ü5OJQJh Üh¼k‡Uh€ah~O5OJQJh ÜOJQJh€ah~OOJQJh€ah•5OJQJh€ah•OJQJ6 Bleomycin Vincristine Capecitabine Vinblastine Fluorouracil Vindesine Methotrexate Vinorelbine INTRATHECAL CHEMOTHERAPY Intrathecal chemotherapy may only be prepared and administered by specific named individuals. Prescriptions must be written on the intrathecal prescription form Patients must receive any IV chemotherapy prior to IT treatment The doctor administering the IT drugs must collect them in person from the pharmacy The drugs must be checked by the doctor and a qualified chemotherapy nurse prior to administration All staff members involved (doctor, nurse, pharmacist) must be on the current IT register. The following may be given intrethecally Hydrocortisone Methotrexate Cytosine Thiotepa All other drugs are potentially lethal when administered intrathecally Any diluent used to prepare an IT drug must be water based and preservative free. Intrathecal chemotherapy must always be given under the direction of a consultant haematologist and be administered by one of the haematologists on the Trust’s register. PLATELET TRANSFUSION POLICY Platelets required if Platelets < 10 x 109/l Platelets < 100 x 109/l and significant bleeding Hypocalcaemia Policy Calciu gluconate 10% 10mls i.v. tds ,then orally if needed Hypomagnesaemia Policy Replacement required if Mg < 0.7 and symptomatic Magnesium Sulphate 8mmol in 100mls saline over 1 hour then 65mmol in 1 litre saline over 24 hours. PAGE 73 PAGE 4 Revised 30/08/06 FBC on day of WBC>2.5x109/l WBC 2.5-2.0x109/l WBC<2.0x109/l (neuts>1.5x109/l) (neuts>1.5-1.0x109/l) (neuts<1.0x109/l) Pls > 75x109/l 100% Reduce carboplatin to Delay 1 week, then reduce AUC=5 or 4 if CCmeas carboplatin to AUC=5 or 4 If CCmeas Pls <7.5x109/l Delay 1 week then reduce Delay 1 week then reduce Delay 1 week then reduce Carboplatin to AUC=5 or carboplatin to AUC=5 or carboplatin to AUC=5 or 4 if CC meas 4 if CCmeas 4 if CCmeas FBC on day of treatment WBC > 2.5x109/l WBC < 2.5x109/l (neuts > 1.0x109/l ) (neuts < 1.0x109/l) Platelets >75x109/l Carboplatin 100% Delay 1 week then reduce Paclitaxel 100% Carboplatin to AUC=5 Paclitaxel 75% Platelets < 75x109/l Delay 1 week then reduce Delay 1 week then reduce Carboplatin to AUC=5 Carboplatin to AUC=5 Paclitaxel 100% Paclitaxel 75% FBC on day of WBC>2.5x109/l WBC 2.5-2.0x109/l WBC<2.0x109/l (neuts>1.5x109/l) (neuts 1.5-1.0x109/l) (neuts<1.0-109/l) Pls > 75x109/l 100% Reduce carboplatin to Delay 1 week, the reduce AUC=5 or 4 if CCmeas carboplatin to AUC=5 of 4 If CCmeas Pls < 75x109/l Delay 1 week then Delay 1 week,then reduce Delay 1 week, then reduce reduce carboplatin to carboplatin to AUC=5 or carboplatin to AUC=5 or 4 AUC=5 or 4 if CCmeas 4 if CCmeas if CCmea. Cisplatin methotrexate vinblastine WBC > 3.5x109/l & Platelets >100x109/l full dose full dose full dose WBC 3-3.5x109/l & Platelets >100x109/l full dose 75% 75% WBC 2.5-2.9x109/l & Platelets >100x109/l full dose 50% 50% WBC<2.5 x 109/l & Platelets <100x109/l delay treatment for one week CTC Neutrophils Platelets Chemotherapy dosage Grade (x 109/l) (x 109/l) 0 1 e" 1.5 e" 75 100% 2 4 < 1.5 < 75 delay treatment until recovery of FBC q€r€s€t€u€Ž€€€‘€Ô€ð€ñ€4tÈ+‚†‚‡‚°‚±‚À‚Í‚Ö‚úñññèÜññ××ñÏÏÏÏÏÊÊÊÂÂÂ &F#gdÈrŠgdÈrŠ &F"gd~Ogd Ü$„h^„ha$gd Ü¤¤gd Ü„h^„hgdÄZÔgdz'™µÇÈ*‚+‚…‚†‚¿‚À‚Ì‚Í‚Õ‚Ö‚Þ‚ß‚=ƒ\ƒÌƒÚƒäƒ„&„'„(„)„D„E„p„q„Š„‹„©„¾„ý„…F…ª…«…²…³…¶…·…óèóèóèóèóèóèóèóèÝèÝèÝèóÒËÄ½²¦²¦²š²š²„yqmqhÈ›jhÈ›Uh€ahà/KOJQJh€ahé˜OJQJh€ahà ÇOJQJh€ahŸ\Â5OJQJh€ahŸ\ÂH*OJQJh€ahŸ\ÂOJQJh€ahP†h€ahz'h€ahŸ\Âh€ahP†OJQJh€ahÖ9#OJQJh€ahÈrŠOJQJh€ahÈrŠ5OJQJ*Ö‚ß‚à‚'ƒ(ƒzƒ{ƒ%„&„'„(„E„F„\„]„t„u„§„¨„©„¾„¿„û„ü„ý„……÷òòòòòòòòåàååååååååååååååågdz'„p„÷^„p`„÷gd7. gdÈrŠ 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