Download - Gastrointestinal Cancer Chemo Protocols
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
1/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 34
Protocol: Modified Machover
Indications: Colonic Cancer - Adjuvant
Schedule:Drug Dose iv/infusion/oral qCalcium Folinate 50mg iv Days 1-55-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
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, 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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
2/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 35
Protocol: Weekly QUASAR
Indications: Colonic Cancer Adjuvant
Schedule:Drug Dose iv/infusion/oral qCalcium Folinate 50mg iv Day 15-Fluorouracil 370mg/m2 iv Day 1
Cycle frequency: Every week Total number of cycles: 30
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
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine LDH
Mid Treatment: Re-assess after every 6 cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle
Reference: Quasar 2000. Lancet, 6; pages 1588-1596
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
3/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 36
Protocol: Mayo
Indications: Colonic Cancer - Adjuvant
Schedule:Drug Dose iv/infusion/oral qCalcium 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 > 1week, reduce 5-FU dose by approximately 20%
Administration and safety:
Anti-emetic group Low
Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 10
9/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
InvestigationsPre-treatment:
History and Examination Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC U & Es, LFTs, creatinine
LDH
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle
Reference: OConnell et al, 1997. J. Clin. Oncol., 15; pages 246-250
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
4/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 37
Protocol: FLOX
Indications: Colon Cancer (Adjuvant)
Schedule:Drug Dose iv/infusion/oral qOxaliplatin 85mg/m
2250mls 5% dex/2hrs Days 1, 15 & 29
Calcium Folinate 350mg 250mls 5% dex/2hrs Days 1,8,15,22,29,365-Fluorouracil 500mg/m
2 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 10
9/L
Oxaliplatin and Calcium Folinate given concurrently
Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea &vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, paraesthesia, severediarrhoea, pharyngolaryngeal dysaesthesia, palmar-plantar syndrome, conjunctivitis,carcinogenesis, infertility
Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals
InvestigationsPre-treatment:
History and Examination (CNS examination)
Performance score, weight FBC
U & Es, LFTs, Ca2+
, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
CNS examination
Performance score, weight
FBC U & Es, 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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
5/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 38
Protocol: Modified de Gramont
Indications: Colonic Cancer - Metastatic
Schedule:Drug Dose iv/infusion/oral qCalcium Folinate 350mg
250mls N. Saline/2hrs Day 1
5-Fluorouracil 400mg/m2 iv (5 mins) Day 15-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 10
9/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
InvestigationsPre-treatment:
History and Examination Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC U & Es, 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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
6/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 39
Protocol: Irinotecan
Indications: Colonic Cancer Palliative, Recurrent
Schedule:Drug Dose iv/infusion/oral qIrinotecan 350mg/m
2250mls 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 g (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 andsalivation, flushing, abdominal cramps, infertility
Symptomatic treatment of side effects: Mouth care, Loperamide, encourage oral fluids
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH,
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle
Reference: Rougieret al, 1997. J. Clin. Oncol., 15; pages 251-260
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
7/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 40
Protocol: Oxaliplatin
Indications: Colonic Cancer - Metastatic
Schedule:Drug Dose iv/infusion/oral qOxaliplatin 130mg/m
2250mls 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,
InvestigationsPre-treatment:
History and Examination (CNS mandatory)
Performance score, weight
FBC
U & Es, LFTs, Mg2+, Ca2+, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
CNS examination
Performance score, weight
FBC
U & Es, LFTs, Mg2+, Ca2+, creatinine
LDH,
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle
Reference: Ducreux et al, 2004. Ann. Oncol., 15; pages 467-473
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
8/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 41
Protocol: Oxaliplatin with Modified de Gramont(FOLFOX6)
Indications: Colonic Cancer - Metastatic
Schedule:Drug Dose iv/infusion/oral qOxaliplatin 85mg/m
2250mls 5% dex/2hrs Day 1
Calcium Folinate 350mg 250mls 5% dex/2hrs Day 15-Fluorouracil 400mg/m
2 iv (5mins) Day 15-Fluorouracil 2.4g/m
24L 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 10
9/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, severediarrhoea, pharyngolaryngeal dysaesthesia, carcinogenesis, infertility
Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals
InvestigationsPre-treatment:
History and Examination (CNS mandatory) Performance score, weight
FBC
U & Es, LFTs, Mg2+, Ca2+, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
CNS examination
Performance score, weight FBC
U & Es, 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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
9/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 42
Protocol: Irinotecan with Modified de Gramont (FOLFIRI)
Indications: Colonic Cancer - Metastatic
Schedule:Drug Dose iv/infusion/oral qIrinotecan 180mg/m
2250mls 5% dex/30mins Day 1
Calcium Folinate 350mg 250mls N. Saline/2hrs Day 15-Fluorouracil 400mg/m
2 iv (5mins) Day 15-Fluorouracil 2.4g/m
24L 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 10
9/L
Pre-medication with atropine 300g (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, increasedsweating and salivation, flushing, abdominal cramps, infertility
Symptomatic treatment of side effects: Prophylactic mouth care, Loperamide, encourageoral fluids
InvestigationsPre-treatment:
History and Examination (CNS mandatory)
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
CNS examination
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH,
Mid Treatment; Restage after 6 cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle
Reference: Tournigandet al
, 2004. J. Clin. Oncol., 22 ; pages 229-237
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
10/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 43
Protocol: Capecitabine
Indications: Colonic Cancer Adjuvant or Metastatic
Schedule:Drug Dose iv/infusion/oral qCapecitabine 1250mg/m
2bd 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-plantarsyndrome, infertility.
Symptomatic treatment of side effects: Mouth care
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH
Mid Treatment: Re-assess after every two cycles
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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
11/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 44
Protocol: Irinotecan/Capecitabine (XELIRI)
Indications: Colonic Cancer Metastatic
Schedule:Drug Dose iv/infusion/oral qIrinotecan 240mg/m
2250mls 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
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight FBC
U & Es, LFTs, creatinine
LDH
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology outpatients 4 weeks after last cycle
Reference: Park et al, 2004. Oncology, 66; pages 353-357
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
12/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 45
Protocol: Oxaliplatin/Capecitabine (XELOX)
Indications: Colonic Cancer Metastatic
Schedule:Drug Dose iv/infusion/oral qOxaliplatin 130mg/m
2250mls 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
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC U & Es, LFTs, creatinine
LDH
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology outpatients 4 weeks after last cycle
Reference: Cassidy et al, 2004. Clin. Oncol., 22; pages 2084-2091
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
13/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 46
Protocol: Cetuximab (Erbitux)
Indication: Colorectal cancer - metastatic
Schedule:Drug Dose iv/infusion/oral qCetuximab 400mg/m
2iv (2hrs) Day 1as 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 10
9/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: History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH
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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
14/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 47
Protocol: Bevacizumab (Avastin)
Indication: Colorectal cancer - metastatic
Schedule:Drug Dose iv/infusion/oral qBevacizumab 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 qBevacizumab 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
InvestigationsPre-treatment:
History and Examination
Performance score, weight, blood pressure, proteinuria
FBC
U & Es, LFTs, creatinine, urate
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight, blood pressure, proteinuria
FBC
U & Es, 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 2335-2342Milleret al, 2005. J. Clin. Oncol., 23; pages 792-799
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
15/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 48
Protocol: Modified OConnell (5-Fluorouracil/RT)
Indication: Rectal Cancer Adjuvant
Schedule:Drug Dose iv/infusion/oral q5-Fluorouracil 425mg/m
2iv Days 1-5
Radiotherapy 45Gy 5 weeks Start day 56With 5-Fluorouracil 225mg/m
2/24hrs 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 > 1weeks, 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 10
9/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
InvestigationsPre-treatment
History and Examination Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CEA
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH,
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle
Reference: OConnell et al, 1994, N. Engl. J. Med., 331; pages 502-507
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
16/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 49
Protocol: ECF (Epirubicin/Cisplatin/5-Fluorouracil)
Indications: Oesophageal/Gastric Neoadjuvant, Metastatic, Locally advanced
Schedule:Drug Dose in/infusion/oral qEpirubicin 50mg/m
2iv Day 1
Cisplatin 60mg/m2 1L N. Saline/2hrs Day 15-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 10
9/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-plantarsyndrome, Nephrotoxicity, diarrhoea, carcinogenesis, infertility
Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, Mg2+, Ca2+, creatinine, urate, creatinine clearance
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC U & Es, LFTs, Mg
2+, Ca
2+, 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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
17/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 50
Protocol: CF (Cisplatin/5-Fluorouracil)
Indications: Oesophageal Neoadjuvant
Schedule:Drug Dose iv/infusion/oral qCisplatin 75mg/m
21L 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 10
9/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-plantarsyndrome, nephrotoxicity, ototoxicity, diarrhoea, carcinogenesis, infertility
Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, Mg2+
, Ca2+
, creatinine, urate, creatinine clearance
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, Mg
2+
, Ca
2+
, creatinine LDH
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
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8/2/2019 Gastrointestinal Cancer Chemo Protocols
18/21
Department of Medical Oncology Chemotherapy Protocols
3rd
Edition 51
Protocol: Herskovic (Cisplatin/5-Fluorouracil/RT)
Indication: Oesophageal Locally advanced (inoperable)
Schedule:Drug Dose iv/infusion/oral qCisplatin 75mg/m
21L N. Saline/2hrs Day 1
5-Fluorouracil 1g/m2/24hrs continuous infusion Days 1-4Radiotherapy 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 10
9/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-plantarsyndrome, nephrotoxicity, ototoxicity, diarrhoea, carcinogenesis, infertility
Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine
InvestigationsPre-treatment
History and Examination
Performance score, weight
FBC
U & Es, LFTs, Mg2+, Ca2+, creatinine, urate, creatinine clearance
LDH
ECG
Staging investigations as per protocol
Prior to each cycle: Performance score, weight
FBC
U & Es, LFTs, Mg2+
, Ca2+
, creatinine
LDH
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
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Protocol: MMC with Modified de Gramont
Indications: Gastric Cancer Advanced
Schedule:Drug Dose iv/infusion/oral qMitomycin C 6mg/m
2iv Day 1
Calcium Folinate 350mg 250mls N. Saline/2hrs Day 15-Fluorouracil 400mg/m
2 iv (5mins) Day 15-Fluorouracil 2.4g/m
24L 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 10
9/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-plantarsyndrome
Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals,pyridoxine cream
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH
Blood film
Mid Treatment: Re-assess after every two cycles
Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle.
Reference: Ross et al, 1997, Ann Oncol., 8; pages 995-1001
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Protocol: Modified MacDonald (5-Fluorouracil/FA/RT)
Indications: Gastric Cancer Adjuvant
Schedule:Drug Dose iv/infusion/oral qCalcium Folinate 40mg/m
2iv Days 1-5
5-Fluorouracil 425mg/m2 iv Days 1-5Radiotherapy 45Gy 5 weeks Start day 29Calcium Folinate 20mg/m
2iv 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: 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-diarrheals, pyridoxine
cream
InvestigationsPre-treatment
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH,
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, LFTs, creatinine
LDH,
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
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Protocol: Gemcitabine
Indications: Pancreatic Cancer Palliative
Schedule:Drug Dose iv/infusion/oral qGemcitabine 1000mg/m
2200mls 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
InvestigationsPre-treatment:
History and Examination
Performance score, weight
FBC
U & Es, LFTs, creatinine, urate
LDH, CA19-9
ECG
Staging investigations as per protocol
Prior to each cycle:
Performance score, weight
FBC
U & Es, 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