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Department of Medical Oncology Chemotherapy Protocols Protocol: AC (Doxorubicin/Cyclophosphamide) Indications: Breast Cancer – Adjuvant, Palliative Schedule: Drug Dose Doxorubicin 60mg/m2 Cyclophosphamide 600mg/m2 Cycle frequency: iv/infusion/oral iv iv Every three weeks q Day 1 Day 1 Total number of cycles: 4 (Adjuvant) 6 (Palliative) 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 • Check liver function • Treatment every 2 weeks if given on a neo-adjuvant or accelerated basis with pegylated G-CSF on day 2 Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, haematuria, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle. Reference: Fisher et al, 1990. J. Clin. Oncol., 8; pages 1483-1496 3rd Edition 18 Department of Medical Oncology Chemotherapy Protocols Protocol: Paclitaxel Indications: Breast Cancer – Adjuvant (high risk), Palliative Schedule: Drug Paclitaxel Dose 175mg/m2 Cycle frequency: Every three weeks iv/infusion/oral 500mls 5% dex/3hrs q Day 1 Total number of cycles: 4 (adjuvant) 6 (palliative) 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 • Following 4 cycles of AC if adjuvant • Pre-medication (chlorpheniramine, ranitidine, dexamethasone) Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, fluid retention, sensitivity reaction, peripheral neuropathy, diarrhoea, tiredness, carcinogenesis, 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 Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: After AC, prior to commencing Taxol Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Sledge et al, 2003. J. Clin. Oncol., 21; pages 588-592 3rd Edition 19 Department of Medical Oncology Chemotherapy Protocols Protocol: EC (Epirubicin/Cyclophosphamide) Indications: Breast Cancer – Adjuvant, Palliative Schedule: Drug Dose Epirubicin 75mg/m2 Cyclophosphamide 750mg/m2 Cycle frequency: iv/infusion/oral iv iv Every three weeks q Day 1 Day 1 Total number of cycles: 4 (Adjuvant) 6 (Palliative) 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 • Check liver function • Treatment every 2 weeks if given on a neo-adjuvant or accelerated basis with pegylated G-CSF on day 2 Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Re-assess every two cycles if palliative Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Lalisang et al, 1997. J. Clin. Oncol., 15; pages 1367-1376 3rd Edition 20 Department of Medical Oncology Protocol: ET (Epirubicin/Taxol) Indications: Breast Cancer – Metastatic Schedule: Drug Epirubicin Paclitaxel Dose 75mg/m2 175mg/m2 Cycle frequency: Every three weeks Chemotherapy Protocols iv/infusion/oral iv 500mls 5% dex/3hrs q Day 1 Day 1 Total number of cycles: 4-6 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 (chlorpheniramine, ranitidine, dexamethasone) Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, peripheral neuropathy, diarrhoea, hypersensitivity reactions, skin rash, fluid retention, hepatic dysfunction, abdominal pain, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, buscopan Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Re-assess after every two cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Razis and Fountzilas, 2001. Ann. Oncol., 12; pages 593-598 3rd Edition 21 Department of Medical Oncology Chemotherapy Protocols Protocol: Canadian FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) Indications: Breast Cancer – Adjuvant (high risk) Schedule: Drug 5-Fluorouracil Epirubicin Cyclophosphamide Dose 500mg/m2 60mg/m2 500mg/m2 Cycle frequency: Every four weeks iv/infusion/oral iv iv iv q Days 1 & 8 Days 1 & 8 Days 1 & 8 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 • Check liver function Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, conjunctivitis, diarrhoea, palmar-plantar syndrome, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, codeine phosphate, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Review formally after every 2 cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Levine et al, 1998. J. Clin. Oncol., 16; pages 2651-2658 3rd Edition 22 Department of Medical Oncology Chemotherapy Protocols Protocol: FEC100 (5-Fluorouracil/Epirubicin/Cyclophosphamide) Indications: Breast Cancer – Adjuvant (moderate & high risk – pre-menopausal) Schedule: Drug 5-Fluorouracil Epirubicin Cyclophosphamide Dose 500mg/m2 100mg/m2 500mg/m2 Cycle frequency: Every three weeks iv/infusion/oral iv iv iv q Day 1 Day 1 Day 1 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 • Check liver function Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, conjunctivitis, diarrhoea, palmar-plantar syndrome, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, codeine phosphate, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Review formally prior to fourth cycle Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: French Adjuvant Study Group, 2001. J. Clin. Oncol., 19; pages 602611 3rd Edition 23 Department of Medical Oncology Chemotherapy Protocols Protocol: FEC60 (5-Fluorouracil/Epirubicin/Cyclophosphamide) Indications: Breast Cancer – Adjuvant (moderate risk – post-menopausal) Schedule: Drug 5-Fluorouracil Epirubicin Cyclophosphamide Dose 600mg/m2 60mg/m2 600mg/m2 Cycle frequency: Every three weeks iv/infusion/oral iv iv iv q Day 1 Day 1 Day 1 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 • Check liver function Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, conjunctivitis, diarrhoea, palmar-plantar syndrome, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, codeine phosphate, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Review formally prior to fourth cycle Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Levine et al, 1998. J. Clin. Oncol., 16: pages 2651-2658 3rd Edition 24 Department of Medical Oncology Chemotherapy Protocols Protocol: MMM (Methotrexate/Mitozantrone/Mitomycin C) Indications: Breast Cancer – Palliative Schedule: Drug Methotrexate Mitozantrone Mitomycin C Dose 30mg/m2 7mg/m2 7mg/m2 Cycle frequency: Every six weeks iv/infusion/oral iv 100mls N. Saline/10mins iv q Days 1 & 21 Days 1 & 21 Day 1 Total number of cycles: 3 Dose modifications: Discuss with Consultant Administration and safety: • Mitomycin C once every six weeks only • Anti-emetic group – Moderate • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Ensure no third space and no renal impairment Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, hair thinning, mucositis, amenorrhoea, diarrhoea, discoloured urine, 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 Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Re-assess after every each cycle Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Powles et al, 1991. Br. J. Cancer, 64; pages 406-410 3rd Edition 25 Department of Medical Oncology Chemotherapy Protocols Protocol: TAC (Taxotere/Doxorubicin/Cyclophosphamide) Indications: Breast Cancer – Adjuvant (high risk), Palliative Schedule: Drug Docetaxel Doxorubicin Cyclophosphamide Dose 75mg/m2 50mg/m2 500mg/m2 Cycle frequency: Every three weeks Dose modification: Discuss with Consultant iv/infusion/oral 250mls N. Saline/1hr iv iv q Day 1 Day 1 Day 1 Total number of cycles: 6 Administration and safety: • Anti-emetic group – Moderately high • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Pre-medication dexamethasone 8mg bd oral, for three days, starting 1 day prior Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nauseas & vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, conjunctivitis, hyper-sensitivity reaction, skin rash, fluid retention, diarrhoea, constipation, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, codeine phosphate, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Review formally after 3 cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Martin et al, 2005, N. Engl. J. Med., 352; pages 2302-2313 3rd Edition 26 Department of Medical Oncology Protocol: XT (Xeloda/Docetaxel) Indications: Breast Cancer – Metastatic Schedule: Drug Docetaxel Capecitabine Dose 75mg/m2 1250mg/m2 bd Cycle frequency: Every three weeks Chemotherapy Protocols iv/infusion/oral 250mls N. Saline/1hr oral q Day 1 Days 1-14 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 • Pre-medication dexamethasone 8 mg bd oral, for three days, starting 1 day prior • Ensure patient education regarding palmar-plantar syndrome • Round Capecitabine tablets to the nearest 150mg or 500mg Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, peripheral neuropathy, diarrhoea, hypersensitivity reactions, skin rash, palmar-plantar syndrome, fluid retention, hepatic dysfunction, 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 Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Re-assess after every two cycles Post Treatment: Review in Medical Oncology outpatients 4 weeks after last cycle Reference: O’Shaughnessy et al, 2002. J. Clin. Oncol., 20; pages 2812 -2823 3rd Edition 27 Department of Medical Oncology Protocol: Docetaxel Indications: Breast Cancer – Metastatic Schedule: Drug Docetaxel Dose 100mg/m2 Cycle frequency: Every three weeks Chemotherapy Protocols iv/infusion/oral 250mls N. Saline/1hr q Day 1 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 • Pre-medication dexamethasone 8 mg bd oral, for three days, starting 1 day prior Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, peripheral neuropathy, diarrhoea, hypersensitivity reactions, skin rash, fluid retention, hepatic dysfunction, 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 Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Re-assess after every two cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Chan et al, 1999. J. Clin. Oncol., 17; pages 2341-2354 3rd Edition 28 Department of Medical Oncology Protocol: Vinorelbine Indications: Breast Cancer – Palliative Schedule: Drug Vinorelbine Dose 30mg/m2 Cycle frequency: Every three weeks Chemotherapy Protocols iv/infusion/oral 20mls N. Saline/10mins q Days 1, 8 &15 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 Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, amenorrhoea, peripheral neuropathy, diarrhoea, constipation, hair thinning, allergic reaction, infertility Symptomatic treatment of side effects: Mouth care, encourage oral fluids Investigations Pre-treatment: • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: Re-assess after every 2 cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Weber et al, 1995, J. Clin. Oncol., 13; pages 2722-2730 3rd Edition 29 Department of Medical Oncology Chemotherapy Protocols Protocol: Trastuzumab/Paclitaxel Indications: Breast Cancer – Metastatic (Her2/neu – positive) Schedule: Drug Trastuzumab Trastuzumab Dose 4mg/kg 2mg/kg Paclitaxel 175mg/m2 Cycle frequency: Every three weeks iv/infusion/oral q 500mls N. Saline/90mins Day -1 250mls N. Saline/90mins Days 1, 8 &15 (↓ 30 min. if infusions are well tolerated) 500mls 5% dex/3hrs Day 1 Total number of cycles: 6 Dose modifications: Discuss with Consultant • First dose – administer Trastuzumab on day 1 and Paclitaxel on day 2 • Subsequent doses – administer both on day 1 Administration and safety: • Anti-emetic group – Low • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Loading dose of Trastuzumab once. • Chlorpheniramine 10 mg iv pre-Trastuzumab if required • Paclitaxel pre-med – ranitidine, dexamethasone Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, cardiotoxicity, peripheral neuropathy, hair thinning, fluid retention, sensitivity reaction, diarrhoea, carcinogenesis, 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, Echocardiogram • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: After every two cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Slamon et al, 2001. N. Engl. J. Med., 344; pages 783-792 3rd Edition 30 Department of Medical Oncology Chemotherapy Protocols Protocol: Trastuzumab/Docetaxel Indications: Breast Cancer – Metastatic (Her2/neu – positive) Schedule: Drug Trastuzumab Trastuzumab Dose 4mg/kg 2mg/kg Docetaxel 100mg/m2 Cycle frequency: Every three weeks iv/infusion/oral q 500mls N. Saline/90min Day -1 250mls N. Saline/90min Days 1, 8 &15 (↓ 30 min. if infusions are well tolerated) 250mls N. Saline/1hr Day 1 Total number of cycles: 6 Dose modifications: Discuss with Consultant • First dose – administer Trastuzumab day 1 and Docetaxel on day 2 • Subsequent doses – administer both on same day Administration and safety: • Anti-emetic group – Low • Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L • Loading dose of Trastuzumab once • Chlorpheniramine 10 mg iv pre-Trastuzumab if required • Pre-medication dexamethasone 8mg bd oral, for three days, starting 1 day prior Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, cardiotoxicity, peripheral neuropathy, hair thinning, fluid retention, sensitivity reaction, diarrhoea, carcinogenesis, 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, Echocradiogram • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: After every two cycles Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Marty et al, 2005. J. Clin. Oncol., 23; pages 4265-4274 3rd Edition 31 Department of Medical Oncology Chemotherapy Protocols Protocol: Trastuzumab (Weekly) Indications: Breast Cancer – Metastatic (Her2/neu – positive) Schedule: Drug Trastuzumab Trastuzumab Dose 4mg/kg 2mg/kg iv/infusion/oral q 500mls N. Saline/90mins once 250mls N. Saline/90mins weekly (↓ 30 min. if infusions are well tolerated) Cycle frequency: Weekly Total number of cycles: Dose modification: Discuss with Consultant Indefinite Administration and safety: • Anti-emetic group – Low • Delay if neutrophils < 1.0 x 109/L or platelets < 100 x 109/L • Loading dose of Trastuzumab once • Chlorpheniramine 10mg iv pre-Trastuzumab, if required Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, cardiotoxicity, hyper-sensitivity reaction, carcinogenesis, infertility, allergic-like reaction, bronchospasm Symptomatic treatment of side effects: Supportive therapy Investigations Pre-treatment • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG, Echocardiogram • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: After every four weeks Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Baselga et al, 1999. Semin. Oncol., 26 (suppl 12); pages 78-83 3rd Edition 32 Department of Medical Oncology Chemotherapy Protocols Protocol: Trastuzumab (3-weekly) Indications: Breast Cancer – Metastatic or Adjuvant (Her2/neu – positive) Schedule: Drug Trastuzumab Trastuzumab Dose 8mg/kg 6mg/kg Cycle frequency: Every three weeks Dose modification: Discuss with Consultant iv/infusion/oral q 500mls N. Saline/90min once 500mls N. Saline/90min 3 weekly (↓ 30 min. if infusions are well tolerated) Total number of cycles: Indefinite (1 year if adjuvant) Administration and safety: • Anti-emetic group – Low • Delay if neutrophils < 1.0 x 109/L or platelets < 100 x 109/L • Loading dose of Trastuzumab once • Chlorpheniramine 10mg iv pre-Trastuzumab if required Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, cardiotoxicity, hyper-sensitivity reaction, carcinogenesis, infertility, allergic-like reaction, bronchospasm Symptomatic treatment of side effects: Supportive therapy Investigations Pre-treatment • History and Examination • Performance score, weight • FBC • U & E’s, LFTs, creatinine, urate • LDH • ECG, Echocardiogram • Staging investigations as per protocol Prior to each cycle: • Performance score, weight • FBC • U & E’s, LFTs, creatinine • LDH Mid Treatment: After every nine weeks and Echocrdiogram Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference: Piccart-Gebhart et al, 2005. N. Engl. J. Med., 353; pages 1659-1672 3rd Edition 33 Department of Medical Oncology Chemotherapy Protocols Protocol: AC/T (Accelerated) Indications: Breast Cancer - Adjuvant (high risk) Schedule: Drug Doxorubicin Cyclophosphamide Then Paclitaxel Cycle frequency: Dose 60mg/m2 600mg/m2 175mg/m2 iv/infusion/oral IV IV q Day 1, cycles 1-4 Day 1, cycles 1-4 IV 500mls 5% dex/3hrs Every two weeks (14 days) Day 1, cycles 5-8 Total number of cycles: 8 Dose modifications: Discuss with Consultant Administration and safety: • Anti-emetic group - Moderately High • Delay if neutrophils < 1.5 x 10^9/L or platelets < 100 x 10^9/L • Pre-medication required for Paclitaxel (chlorpheniramine, ranitidine, dexamethasone) • Pegylated G-CSF on day 2 of each cycle Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea and vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, fluid retention, sensitivity reaction, peripheral neuropathy, diarrhoea, tiredness, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care 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 Consultant Review: After AC, prior to commencing Paclitaxel Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference; Citron et al, 2003. J. Clin. Oncol; 21, pp1431-1439 3rd Edition 109 Department of Medical Oncology Chemotherapy Protocols Protocol: AC/T Indications: Breast Cancer - Adjuvant (high risk) Schedule: Drug Doxorubicin Cyclophosphamide Then Paclitaxel Cycle frequency: Dose 60mg/m2 600mg/m2 175mg/m2 iv/infusion/oral IV IV IV 500mls 5% dex/3hrs Every three weeks (21days) q Day 1, cycles 1-4 Day 1, cycles 1-4 Day 1, cycles 5-8 Total number of cycles: 8 Dose modifications: Discuss with Consultant Administration and safety: • Anti-emetic group - Moderately High • Delay if neutrophils < 1.5 x 10^9/L or platelets < 100 x 10^9/L • Pre-medication required for Paclitaxel (chlorpheniramine, ranitidine, dexamethasone) Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea and vomiting, mucositis, alopecia, cardiotoxicity, amenorrhoea, fluid retention, sensitivity reaction, peripheral neuropathy, diarrhoea, tiredness, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care 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 Consultant Review: After AC, prior to commencing Paclitaxel Post Treatment: Review in Medical Oncology Clinic 4 weeks after last cycle Reference; Citron et al, 2003. J. Clin. Oncol; 21, pp1431-1439 3rd Edition 110