protocol: modified machover - mid-western cancer · pdf filedepartment of medical oncology...

Department of Medical Oncology Chemotherapy Protocols

3rd Edition 34

Protocol: Modified Machover Indications: Colonic Cancer - Adjuvant Schedule: Drug Dose iv/infusion/oral q Calcium Folinate 50mg iv Days 1-5 5-Fluorouracil 370mg/m2 iv Days 1-5 Cycle frequency: Every four weeks Total number of cycles: 6 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Low • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week • Suck ice before and during 5-FU injection • Calcium Folinate given first

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment:

• History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH, CEA • ECG • Staging investigations as per protocol

Prior to each cycle:

• Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH, CEA

Mid Treatment: Re-assess after every two cycles

Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle

Reference: Quasar 2000. Lancet, 6; pages 1588-1596


3rd Edition 35

Protocol: Weekly QUASAR Indications: Colonic Cancer – Adjuvant Schedule: Drug Dose iv/infusion/oral q Calcium Folinate 50mg iv Day 1 5-Fluorouracil 370mg/m2 iv Day 1 Cycle frequency: Every week Total number of cycles: 30 Dose modifications: Discuss with Consultant Administration and safety:





• Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH

Mid Treatment: Re-assess after every 6 cycles


Reference: Quasar 2000. Lancet, 6; pages 1588-1596


3rd Edition 36

Protocol: Mayo Indications: Colonic Cancer - Adjuvant Schedule: Drug Dose iv/infusion/oral q Calcium Folinate 50mg iv Days 1-5 5-Fluorouracil 425mg/m2 iv Days 1-5 Cycle frequency: Every four weeks Total number of cycles: 6 Dose modifications: Discuss with Consultant. If toxicity experienced, or if delayed for > 1

week, reduce 5-FU dose by approximately 20% Administration and safety:








Reference: O’Connell et al, 1997. J. Clin. Oncol., 15; pages 246-250


3rd Edition 37

Protocol: FLOX Indications: Colon Cancer (Adjuvant) Schedule: Drug Dose iv/infusion/oral q Oxaliplatin 85mg/m2 250mls 5% dex/2hrs Days 1, 15 & 29 Calcium Folinate 350mg 250mls 5% dex/2hrs Days 1,8,15,22,29,36 5-Fluorouracil 500mg/m2 iv (5 min) Days 1,8,15,22,29,36 Cycle frequency: Every eight weeks Total number of cycles: 3 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group - Moderately high with Oxaliplatin • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Oxaliplatin and Calcium Folinate given concurrently

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, paraesthesia, severe diarrhoea, pharyngolaryngeal dysaesthesia, palmar-plantar syndrome, conjunctivitis, carcinogenesis, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals Investigations Pre-treatment:

• History and Examination (CNS examination) • Performance score, weight • FBC • U & E’s, LFTs, Ca2+, creatinine, urate • LDH, CEA • ECG • Staging investigations as per protocol


• CNS examination • Performance score, weight • FBC • U & E’s, LFTs, Ca2+, creatinine • LDH,

Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Wolmark et al, 2005. J. Clin. Oncol., 23(16s); abstract LBA3500


3rd Edition 38

Protocol: Modified de Gramont Indications: Colonic Cancer - Metastatic Schedule: Drug Dose iv/infusion/oral q Calcium Folinate 350mg 250mls N. Saline/2hrs Day 1 5-Fluorouracil 400mg/m2 iv (5 mins) Day 1 5-Fluorouracil 2.8g/m2 4L N. Saline/46hrs Days 1 & 2 Cycle frequency: Every two weeks Total number of cycles: up to 12 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Low • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Suck ice before and during 5-FU bolus injection • Calcium Folinate given first

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, severe diarrhoea, conjunctivitis, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment:



• Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH,

Mid Treatment: Re-assess after every four cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Cheeseman et al, 2002. Br. J. Cancer, 87; pages 393-399


3rd Edition 39

Protocol: Irinotecan Indications: Colonic Cancer – Palliative, Recurrent Schedule: Drug Dose iv/infusion/oral q Irinotecan 350mg/m2 250mls 5% dex/90min Day 1 Cycle frequency: Every three weeks Total number of cycles: 6 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Moderately high • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Pre-medication with atropine 300 μg (0.5 mls) s/c, if required • Start at 250mg/ m2 if unwell, or PS=2, or aged 70 years +

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, severe diarrhoea, increased sweating and salivation, flushing, abdominal cramps, infertility Symptomatic treatment of side effects: Mouth care, Loperamide, encourage oral fluids Investigations Pre-treatment:





Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Rougier et al, 1997. J. Clin. Oncol., 15; pages 251-260


3rd Edition 40

Protocol: Oxaliplatin Indications: Colonic Cancer - Metastatic Schedule: Drug Dose iv/infusion/oral q Oxaliplatin 130mg/m2 250mls 5% dex/2hrs Day 1 Cycle frequency: Every three weeks Total number of cycles: 6 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Moderately high • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, peripheral neuropathy, paraesthesia, diarrhoea, pharyngolaryngeal dysaesthesia, carcinogenesis, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, Investigations Pre-treatment:

• History and Examination (CNS mandatory) • Performance score, weight • FBC • U & E’s, LFTs, Mg2+, Ca2+, creatinine, urate • LDH, CEA • ECG • Staging investigations as per protocol


• CNS examination • Performance score, weight • FBC • U & E’s, LFTs, Mg2+, Ca2+, creatinine • LDH,


Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Ducreux et al, 2004. Ann. Oncol., 15; pages 467-473


3rd Edition 41

Protocol: Oxaliplatin with Modified de Gramont (FOLFOX6) Indications: Colonic Cancer - Metastatic Schedule: Drug Dose iv/infusion/oral q Oxaliplatin 85mg/m2 250mls 5% dex/2hrs Day 1 Calcium Folinate 350mg 250mls 5% dex/2hrs Day 1 5-Fluorouracil 400mg/m2 iv (5mins) Day 1 5-Fluorouracil 2.4g/m2 4L N. Saline/46hrs Days 1 & 2 Cycle frequency: Every two weeks Total number of cycles: up to 12 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Moderately high with Oxaliplatin • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Oxaliplatin and Calcium Folinate given concurrently • Plan Bevacizumab if appropriate

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, (alopecia), cardiotoxicity, peripheral neuropathy, paraesthesia, severe diarrhoea, pharyngolaryngeal dysaesthesia, carcinogenesis, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals Investigations Pre-treatment:

• History and Examination (CNS mandatory) • Performance score, weight • FBC • U & E’s, LFTs, Mg2+, Ca2+, creatinine, urate • LDH, CEA • ECG • Staging investigations as per protocol


• CNS examination • Performance score, weight • FBC • U & E’s, LFTs, Mg2+, Ca2+, creatinine • LDH,

Mid Treatment: Restage after 6 cycles

Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Cheeseman et al, 2002. Br. J. Cancer, 87; pages 393-399


3rd Edition 42

Protocol: Irinotecan with Modified de Gramont (FOLFIRI) Indications: Colonic Cancer - Metastatic Schedule: Drug Dose iv/infusion/oral q Irinotecan 180mg/m2 250mls 5% dex/30mins Day 1 Calcium Folinate 350mg 250mls N. Saline/2hrs Day 1 5-Fluorouracil 400mg/m2 iv (5mins) Day 1 5-Fluorouracil 2.4g/m2 4L N. Saline/46hrs Days 1 & 2 Cycle frequency: Every two weeks Total number of cycles: up to 12 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Moderately high with Irinotecan • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Pre-medication with atropine 300µg (0.5mls) s/c may be required • Suck ice before and during 5-FU bolus injection • Plan Bevacizumab if appropriate

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, severe diarrhoea, amenorrhoea, increased sweating and salivation, flushing, abdominal cramps, infertility Symptomatic treatment of side effects: Prophylactic mouth care, Loperamide, encourage oral fluids Investigations Pre-treatment:

• History and Examination (CNS mandatory) • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH, CEA • ECG • Staging investigations as per protocol


• CNS examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH,

Mid Treatment; Restage after 6 cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Tournigand et al, 2004. J. Clin. Oncol., 22 ; pages 229-237


3rd Edition 43

Protocol: Capecitabine Indications: Colonic Cancer – Adjuvant or Metastatic Schedule: Drug Dose iv/infusion/oral q Capecitabine 1250mg/m2 bd oral Days 1-14 Cycle frequency: Every three weeks Total number of cycles: 8 (if adjuvant) Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Low • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Ensure patient education regarding palmar-plantar syndrome • Round Capecitabine tablets to the nearest 150mg or 500mg (see data sheet)

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, hair thinning, amenorrhoea, diarrhoea, skin rash, palmar-plantar syndrome, infertility. Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment:

• History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol




Post Treatment: Review in Medical Oncology outpatients 4 weeks after last cycle Reference: Van Cutsem et al, 2000. J. Clin. Oncol., 18; pages 1337-1345


3rd Edition 44

Protocol: Irinotecan/Capecitabine (XELIRI) Indications: Colonic Cancer – Metastatic Schedule: Drug Dose iv/infusion/oral q Irinotecan 240mg/m2 250mls 5% dex/30min Day 1 Capecitabine 1000mg/m2 bd oral Days 1-14 Cycle frequency: Every three weeks Total number of cycles: 6 -12 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group - Moderately high with Irinotecan • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Pre-medication with atropine 300ug (0.5mls) s/c may be required • Ensure patient education regarding palmar-plantar syndrome • Round Capecitabine dose to nearest 500mg or 150mg (see data sheet) • Plan Bevacizumab if appropriate

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, peripheral neuropathy, severe diarrhoea, increased sweating and salivation, flushing, hypersensitivity reactions, skin rash, cardiotoxicity, palmar-plantar syndrome, fluid retention, hepatic dysfunction, infertility Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment:





Post Treatment: Review in Medical Oncology outpatients 4 weeks after last cycle Reference: Park et al, 2004. Oncology, 66; pages 353-357


3rd Edition 45

Protocol: Oxaliplatin/Capecitabine (XELOX) Indications: Colonic Cancer – Metastatic Schedule: Drug Dose iv/infusion/oral q Oxaliplatin 130mg/m2 250mls 5% dex/2hrs Day 1 Capecitabine 1000mg/m2 bd oral Days 1-14 Cycle frequency: Every three weeks Total number of cycles: 6 -12 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group - Moderately high with Oxaliplatin • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Ensure patient education regarding palmar-plantar syndrome • Round Capecitabine dose to nearest 500mg or 150mg (see data sheet) • Plan Bevacizumab if appropriate

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, peripheral neuropathy, severe diarrhoea, paraesthesia, pharyngolaryngeal dysaesthesia,, hypersensitivity reactions, skin rash, cardiotoxicity, palmar-plantar syndrome, hepatic dysfunction, infertility Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment:





Post Treatment: Review in Medical Oncology outpatients 4 weeks after last cycle Reference: Cassidy et al, 2004. Clin. Oncol., 22; pages 2084-2091


3rd Edition 46

Protocol: Cetuximab (Erbitux) Indication: Colorectal cancer - metastatic Schedule: Drug Dose iv/infusion/oral q Cetuximab 400mg/m2 iv (2hrs) Day 1 as per datasheet Cetuximab 250mg/m2 iv (1hr) weekly as per datasheet Cycle frequency: Every week Total number of cycles: Indefinite Dose modification: Discuss with Consultant Administration and safety:

• Anti-emetic group – Low • Delay if neutrophils < 1.0 x 109/L or platelets < 100 x 109/L • Pre-med with Chlorpheniramine • With Irinotecan (180 – 350mg/m2 ) every three weeks

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, hyper-sensitivity reaction, carcinogenesis, infertility, allergic-like reaction, bronchospasm, hypotension, chills/fevers, rigors, skin rash, asthenia, stomatitis, anorexia, constipation, acne Symptomatic treatment of side effects: Supportive therapy Investigations Pre-treatment:




Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Cunningham et al, 2004. N. Engl. J. Med., 351; pages 337-345


3rd Edition 47

Protocol: Bevacizumab (Avastin) Indication: Colorectal cancer - metastatic Schedule: Drug Dose iv/infusion/oral q Bevacizumab 5mg/kg 100mls N. Saline each cycle (as below) Cycle frequency: Every 2 weeks Total number of cycles: Indefinite OR Drug Dose in/infusion/oral q Bevacizumab 7.5mg/kg 100mls N. Saline each cycle (as below) Cycle frequency: Every 3 weeks Total number of cycles: Indefinite Dose modification: Discuss with Consultant Administration and safety:

• Anti-emetic group – Low • Delay if neutrophils < 1.0 x 109/L or platelets < 100 x 109/L • 1st infusion – 90mins; 2nd infusion – 60mins; 3rd infusion – 30mins • If the patient is a candidate for surgery, administer 4 cycles only

Toxicities: Hypersensitivity reaction, allergic-like reaction, hypertension, skin rash, proteinuria, thromboembolism, impaired wound healing, GI perforation Symptomatic treatment of side effects: Supportive therapy Investigations Pre-treatment:

• History and Examination • Performance score, weight, blood pressure, proteinuria • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol


• Performance score, weight, blood pressure, proteinuria • FBC • U & E’s, LFTs, creatinine • LDH

Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Hurwitz et al, 2004. N. Engl. J. Med., 350; pages 2335-2342 Miller et al, 2005. J. Clin. Oncol., 23; pages 792-799


3rd Edition 48

Protocol: Modified O’Connell (5-Fluorouracil/RT) Indication: Rectal Cancer – Adjuvant Schedule: Drug Dose iv/infusion/oral q 5-Fluorouracil 425mg/m2 iv Days 1-5 Radiotherapy 45Gy 5 weeks Start day 56 With 5-Fluorouracil 225mg/m2/24hrs continuous infusion for 5 weeks Cycle frequency: Every four weeks Total number of cycles: 4 Dose modification: Discuss with Consultant. If toxicity experienced, or if delayed for > 1

weeks, reduce 5-FU dose by 20% Administration and safety:

• Anti-emetic group – Low • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week • Suck ice before and during 5-FU injection

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment




Mid Treatment: Re-assess after every two cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: O’Connell et al, 1994, N. Engl. J. Med., 331; pages 502-507


3rd Edition 49

Protocol: ECF (Epirubicin/Cisplatin/5-Fluorouracil) Indications: Oesophageal/Gastric – Neoadjuvant, Metastatic, Locally advanced Schedule: Drug Dose in/infusion/oral q Epirubicin 50mg/m2 iv Day 1 Cisplatin 60mg/m2 1L N. Saline/2hrs Day 1 5-Fluorouracil 200mg/m2/24hrs continuous infusion Days 1-21 Cycle frequency: Every three weeks Total number of cycles: 6 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – High • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Ensure adequate renal function • Hickman line required • Pre & post hydration, mannitol, potassium & magnesium

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, Cardiotoxicity, peripheral neuropathy, palmar-plantar syndrome, Nephrotoxicity, diarrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine Investigations Pre-treatment:

• History and Examination • Performance score, weight • FBC • U & E’s, LFTs, Mg2+, Ca2+, creatinine, urate, creatinine clearance • LDH • ECG • Staging investigations as per protocol


• Performance score, weight • FBC • U & E’s, LFTs, Mg2+, Ca2+, creatinine • LDH

Mid Treatment: Re-assess after 3 cycles (endoscopy +/- radiology) Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Findlay et al, 1994. Ann, Oncol., 5; pages 609-616


3rd Edition 50

Protocol: CF (Cisplatin/5-Fluorouracil) Indications: Oesophageal – Neoadjuvant Schedule: Drug Dose iv/infusion/oral q Cisplatin 75mg/m2 1L N. Saline/2hrs Day 1 5-Fluorouracil 1g/m2/24 hrs continuous infusion Days 1-4 Cycle frequency: Every three weeks Total number of cycles: 2 (neoadjuvant)

Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – High • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Ensure adequate renal function • Pre & post hydration, mannitol, potassium & magnesium

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, palmar-plantar syndrome, nephrotoxicity, ototoxicity, diarrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine Investigations Pre-treatment:




Mid Treatment: Re-assess after 2 cycles (endoscopy +/- radiology)

Post Treatment: Review in Medical Oncology Clinic 3 weeks after last cycle Reference: MRC Oesophageal Cancer WP, 2002. Lancet, 359; pages 1727-1733


3rd Edition 51

Protocol: Herskovic (Cisplatin/5-Fluorouracil/RT) Indication: Oesophageal – Locally advanced (inoperable) Schedule: Drug Dose iv/infusion/oral q Cisplatin 75mg/m2 1L N. Saline/2hrs Day 1 5-Fluorouracil 1g/m2/24hrs continuous infusion Days 1-4 Radiotherapy 50Gy 5 weeks Start Day 1 Cycle frequency: Every four weeks Total number of cycles: 4 (First 2 cycles with RT) Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – High • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Ensure adequate renal function • Pre & post hydration, mannitol, potassium & magnesium • Concurrent radiotherapy may be necessary • Doses may change according to radiotherapy schedule

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, palmar-plantar syndrome, nephrotoxicity, ototoxicity, diarrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine Investigations Pre-treatment




Mid Treatment: Review in Medical Oncology post-radiotherapy Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Herskovic et al, 1992, N. Engl. J. Med., 326; pages 1593-1598


3rd Edition 52

Protocol: MMC with Modified de Gramont Indications: Gastric Cancer – Advanced Schedule: Drug Dose iv/infusion/oral q Mitomycin C 6mg/m2 iv Day 1 Calcium Folinate 350mg 250mls N. Saline/2hrs Day 1 5-Fluorouracil 400mg/m2 iv (5mins) Day 1 5-Fluorouracil 2.4g/m2 4L N. Saline/46hrs Days 1 & 2 Cycle frequency: Every three weeks Total number of cycles: 4 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group – Moderate • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Suck ice before and during 5-Fluorouracil bolus injection • Ensure serum creatinine is within normal levels • Blood film is normal i.e. no red cell fragmentation

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, severe diarrhoea, infertility, conjunctivitis, palmar-plantar syndrome Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment:



• Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH • Blood film


Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle.

Reference: Ross et al, 1997, Ann Oncol., 8; pages 995-1001


3rd Edition 53

Protocol: Modified MacDonald (5-Fluorouracil/FA/RT) Indications: Gastric Cancer – Adjuvant Schedule: Drug Dose iv/infusion/oral q Calcium Folinate 40mg/m2 iv Days 1-5 5-Fluorouracil 425mg/m2 iv Days 1-5 Radiotherapy 45Gy 5 weeks Start day 29 Calcium Folinate 20mg/m2 iv First 4 & last 3 days of RT 5-Fluorouracil 400mg/m2 iv First 4 & last 3 days of RT Cycle frequency: Every four weeks Total number of cycles: 3 (1 cycle prior to RT) Dose modifications: Discuss with Consultant. If toxicity experienced, or if delayed for > 1 week, reduce 5-FU dose by 20% Administration and safety:


Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrheals, pyridoxine cream Investigations Pre-treatment

• History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH, • ECG • Staging investigations as per protocol



Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Macdonald et al, 2001. N. Engl. J. Med., 345; pages 725-730


3rd Edition 54

Protocol: Gemcitabine Indications: Pancreatic Cancer – Palliative Schedule: Drug Dose iv/infusion/oral q Gemcitabine 1000mg/m2 200mls N. Saline/30mins Days 1, 8 &15 Cycle frequency: Every four weeks Total number of cycles: 6 Dose modifications: Discuss with Consultant Administration and safety:

• Anti-emetic group - Moderate • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • If unable to tolerate, omit day 15 and give every 3 weeks

Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, amenorrhoea, rash, flu-like symptoms, hair thinning, diarrhoea, infertility Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment:

• History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH, CA19-9 • ECG • Staging investigations as per protocol


• Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH, CA19-9

Mid Treatment: After every two cycles

Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Burris et al, 1997. J. Clin. Oncol., 15; pages 2403-2413

protocol: modified machover - mid-western cancer · pdf filedepartment of medical oncology...

Documents