Oxaliplatin plus Capecitabine (XELOX) Adjuvant Colorectal Cancer (GIWOS-007)
|
|
- Ashley Caldwell
- 6 years ago
- Views:
Transcription
1 West of Scotland Cancer Network Chemotherapy Protocol Indication Oxaliplatin plus Capecitabine (XELOX) Adjuvant Colorectal Cancer (GIWOS-007) 1. Duke s C colon cancer patients 2. Duke s C rectal cancer patients 3. Poor prognosis Duke s B patients: T4, perforated, obstructed, extramural vascular invasion, poorly differentiated, <12 nodes examined. No direct evidence from RCT for the routine treatment of Duke s B. Case selection CONSIDER ENTRY INTO CLINICAL TRIAL IF AVAILABLE/APPROPRIATE Patients to be treated within this protocol should fulfil all of the following criteria:- Histologically proven stage Dukes «B» (certain patients as above) and «C» (stage III: any T N 1-2 M0) colon or rectal carcinoma. Patients must have undergone complete resection of the primary tumour without gross or microscopic evidence of residual disease Patients should ideally start treatment within 8 weeks after surgery PS 0-2 (Karnofsky 60%) No biological major abnormalities: Absolute neutrophil count 1.5 x 10 9 /l, Platelets 75 x 10 9 /l, Creatinine clearance 30ml/min, bilirubin 3 times upper limit of normal (ULN). CEA falling with the appropriate half life. Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 6 months following cessation of treatment. Written informed consent Exclusion: Pregnant or lactating females / women of child bearing potential not using a contraceptive method Clinically significant cardiac disease uncontrolled coronary heart disease, unstable angina or myocardial infarction within last 6 months Malabsorption syndrome or inability to comply with oral medication Known or suspected DPD deficiency Known hypersensitivity to platinum based therapeutics Interstitial pneumonia or extensive symptomatic lung fibrosis Peripheral neuropathy of CTC (Version 3) grade 1 Other intercurrent serious illness which in the opinion of the treating consultant would render patient at risk of severe toxicity History of significant psychiatric disorder Page 1 of 9
2 Alternative therapy In some patients who may be considered for chemotherapy for advanced colorectal cancer the use of this protocol may be considered inappropriate. This may include patients with neuropathy not related to their cancer, patients with poor social circumstances or lack of support at home or those with extensive co-morbidity. Such patients may be treated with single agent capecitabine or alternative IV schedules of 5Fluorouracil (5FU). These are detailed in other protocols. Pre-treatment evaluation 1. Informed consent 2. Provision of verbal and written information. 3. Assessment of performance status 4. Height, weight and BSA 5. Referral letter from surgeon 6. Copy of pathology reports 7. Copy of CT or MRI reports 8. Baseline FBC, U&Es, LFTs and CEA calculate creatinine clearance using Cockcroft-Gault equation 9. Medical history and examination Regimen Pre-medication: Dexamethasone 8mg + Granisetron 3mg Intravenously 30 minutes prior to chemotherapy Drug Dose Route Administration Infusion fluid Oxaliplatin 130mg/m 2 I.V Over 2 hours 250ml Glucose 5%* Day to be given Day 1 Capecitabine 1000mg/m 2 Oral Twice daily N/A First dose to be taken on the evening of Day 1 following end of Oxaliplatin infusion for 14 days (last dose to be taken on morning of Day weekly for 8 cycles Capecitabine should be taken with plenty of water within 30 minutes after a meal Loperamide and Domperidone (or anti-emetic as per local policy) should be supplied to all patients with advice to be taken in the event of diarrhoea or nausea/vomiting occurring. Emetogenic Risk: MODERATE Page 2 of 9
3 Is GCSF indicated? Primary prophylaxis - Not recommended Secondary prophylaxis. Not routinely recommended. Consider dose reduction instead. Dose Banding Nomogram s calculate BSA to one decimal place (cap at 2.2 m 2 ) and select dose from table below Oxaliplatin BSA (m2) Oxaliplatin 130mg/m 2 Dose Banded dose (mg) Capecitabine Capecitabine 1000mg/m2 BSA (m 2 ) Dose Banded dose (mg) Capecitabine 750mg/m2 BSA (m 2 ) Dose Banded dose (mg) Capecitabine 500mg/m2 BSA (m 2 ) Dose Banded dose (mg) Page 3 of 9
4 Adverse effects Oxaliplatin Very Common Infection Haematological: anaemia, neutropenia,thrombocytopenia, leucopenia, lymphopenia Immune system: Allergic reaction Metabolism: anorexia, glycaemia abnormalities, hypokalaemia, natraemia abnormalities Nervous system: peripheral sensory neuropathy, sensory disturbance, headache Vascular: epistaxis Respiratory: dyspnoea, cough Gastrointestinal: nausea & vomiting, diarrhoea, stomatitis/mucositis, abdominal pain, constipation Skin: skin disorder, alopecia Musculoskeletal: back pain General: fatigue, fever,asthenia, pain, injection site reaction Investigations: increase in liver enzymes, AlkPhos, Bil Common Infection: rhinitis, febrile neutropenia Metabolism: dehydration Psychiatric disorders: depression, insomnia Nervous system: dizziness, motor neuritis Eye disorders: conjunctivitis, visual disturbances Vascular: flushing, haematuria, deep vein thrombosis, pulmonary embolism Respiratory: hiccups, chest pain Gastrointestinal: dyspepsia, gastrointestinal reflux Skin: skin exfoliation, rash, nail disorder Musculoskeletal: arthralgia, bone pain Renal: dysuria, abnormal micturition Oxaliplatin is associated with two types of neuropathy (see Dose modification table): 1. Laryngopharyngeal dysaesthesia - generally cold induced, short duration and self-limiting with no evidence bronchospasm although may cause shortness of breath. - reassure patient, avoid cold drinks and prolong oxaliplatin infusion time to 6 hours. 2. Mixed Sensory and Motor Neuropathy - transient at first between cycles becoming permanent with cumulative dosing Capecitabine Very Common Skin & Subcutaneous: palmer-plantar erythrodysesthesia Gastrointestinal: diarrhoea, nausea, stomatitis, vomiting, abdominal pain General disorders & administration site: fatigue, asthenia - may be cold induced and usually reversible. Common Haematological: neutropenia, anaemia Skin & Subcutaneous: rash, alopecia, erythema, dry skin, pruritis, skin hyperpigmentation; skin desquamation, dermatitis, nail disorder Gastrointestinal: constipation, dyspepsia, flatulence, dry mouth General disorders & administration site: lethargy, peripheral oedema, malaise Metabolism & Nutrition: dehydration, decreased appetite Nervous System: dizziness, headache, paraesthesia, lethargy Eye: increased lacrimation, conjunctivitis, eye irritation Hepatobiliary: hyperbilirubinemia Respiratory: dyspnoea, epistaxis, cough, rhinorrhea Musculoskeletal & Connective tissue: pain in extremeties, back pain, arthralgia Investigations: weight decreased Psychiatric: insomnia, depression Infection: nasopharyngitis Metabolism & Nutrition: anorexia Palmar-plantar erythrodysaesthesia should initially be managed by appropriate dose reduction see dose modifications. Pyridoxine 50 mg three times daily may have additional benefit for symptomatic relief. Page 4 of 9
5 Uncommon For more detailed information regarding Oxaliplatin and 5fluorouracil please refer to the full current summary of product characteristics (SPC). Extravasation risk category: Drug Group Category Oxaliplatin 2 Exfoliant Capecitabine N/A N/A Contraindications A known history of hypersensitivity to Oxaliplatin or Capecitabine or of severe and unexpected reactions to fluoropyrimidine therapy In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency, In pregnancy and lactation Have myelosuppression prior to starting first course, as evidenced by baseline neutrophils <2x10 9 /l and/or platelet count of <100x10 9 /l. Have a peripheral sensitive neuropathy with functional impairment prior to first course. Have a severely impaired renal function (CrCl < than 30 ml/min). Treatment with SORIVUDINE or its chemically related analogues, such as BRIVUDINE. Precautions Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiac shock, sudden death and ECG changes caution should be exercised in those patients with significant cardiac disease. There is a lack of safety and efficacy data in patients with hepatic impairment therefore use of Capecitabine should be carefully monitored regardless of the presence or absence of liver metastasis. In the case of unexplained respiratory symptoms (not as a result of pulmonary metastases) such as non-productive cough, dyspnoea, hypoxia or radiological infiltrates Oxaliplatin should be interrupted pending investigations. If interstitial pulmonary fibrosis is confirmed, discontinue Oxaliplatin. Drug Interactions Oxaliplatin Drug Interaction Action CLOZAPINE INCREASED RISK OF AGRANULOCYTOSIS AVOID CONCOMITANT USE Coumarin-derivative anticoagulants Increase in INR can occur up to one month after stopping Oxaliplatin therapy Monitor INR twice weekly consider switching to low molecular weight heparin Page 5 of 9
6 Capecitabine Drug Interaction Action SOROVUDINE AND ANALOGUES INHIBITION OF DIHYDROPYRIMIDINE DEHYDROGENASE AVOID CONCOMITANT USE POTENTIALLY FATAL Phenytoin Folinic Acid Coumarin-derivative anticoagulants Antacids Allopurinol Increase in plasma phenytoin concentration Potential for increased capecitabine toxicity Increase in INR can occur up to one month after stopping capecitabine therapy Increase capecitabine concentration Decreased efficacy of Capecitabine - theoretical Regular monitoring of plasma phenytoin levels Avoid concomitant use where possible Monitor INR twice weekly consider switching to low molecular weight heparin Not to be taken at same time of day Review risk of recurrence of Gout avoid concomitant use where possible. Investigations prior to subsequent cycles Medical review (or review by nurse/pharmacist in appropriate clinic) at each cycle with repeat FBC, U&Es, LFTs and toxicity assessment documented by CTCAE Version 3. Monitor CEA and LFTS for disease progression at each cycle visit. Monitor patients weight Dose modifications Haematological Treatment should be delayed until Neutrophils 1.5 x 10 9 /l and/or platelets 75 x 10 9 /l s are required for anaemia which should be treated by supportive transfusion if required. NEUTROPENIA GRADE 2 GRADE 3 GRADE ANC<1.5 x 10 9 /L 0.5 ANC<1.0 x 10 9 /L ANC<0.5 x 10 9 /L 1 st occurrence 2 nd occurrence 3 rd occurrence Capecitabine 75% of original dose + Oxaliplatin 100mg/m 2 Capecitabine 75% of original dose + Oxaliplatin 85mg/m 2 Stop treatment (unless it is in the best interest of the patient to continue with capecitabine monotherapy at 75% of original dose Always discuss with responsible consultant Capecitabine 50% of original dose + Oxaliplatin 85mg/m 2 - Always discuss with responsible consultant Stop treatment Not applicable Page 6 of 9
7 Dose Modifications for febrile neutropenia should be made at the discretion of the responsible consultant GRADE 2 50 Plts <75 x10 9 /L THROMBOCYTOPENIA GRADE 3 10 Plts <50 x10 9 /L GRADE 4 Plts <10 x10 9 /L 1 st occurrence 2 nd occurrence Capecitabine 75% of original dose + Oxaliplatin 100mg/m 2 Capecitabine 75% of original dose + Oxaliplatin 85mg/m 2 3 rd occurrence Capecitabine 50% of original dose + Oxaliplatin 85mg/m 2 Capecitabine 50% of original dose + Oxaliplatin 85mg/m 2 - Always discuss with responsible consultant Stop treatment (unless it is in the best interest of the patient to continue with capecitabine monotherapy at 50% of original dose Always discuss with responsible consultant Stop treatment Non Haematological Specific dose adjustments may apply to Oxaliplatin and Capecitabine if the toxicity experienced is considered to be due solely to one drug e.g neuropathy with Oxaliplatin Treatment must be interrupted for toxicities grade 2 and cannot continue until toxicities resolve to grade 1. Any grade 4 toxicity MUST be discussed with the responsible consultant for a decision on the patient s future management. The non-haematological side-effects of this regimen are usually attributable to Capecitabine. and include: hand-foot syndrome, mucositis / stomatitis, nausea and vomiting and diarrhoea CAPECITABINE GRADE 2 GRADE 3 GRADE 4 Toxicity 1 st time Interrupt treatment until then continue at same dose with prophylaxis Interrupt treatment until then restart at 75% dose with prophylaxis Discontinue unless consultant feels it is in best interests to continue at 50% dose once recovered 2 nd time Interrupt treatment until then restart at 75% dose with prophylaxis Interrupt treatment until then restart at 50% dose Discontinue 3 rd time Interrupt treatment until then restart at 50% dose 4 th time Discontinue Discontinue For grade 3 nausea and vomiting or diarrhoea the dose of Oxaliplatin should be reduced to 100 mg/m 2 in addition to above. Page 7 of 9
8 Neuropathy In the case of oxaliplatin neurotoxicity, when oxaliplatin requires to be discontinued, it is permissible to continue therapy with single agent capecitabine. OXALIPLATIN GRADE 1-7 days 7 days Persistent Toxicity Paraesthesia that does not interfere with function 1 No change No change No change Paraesthesia that does not interfere with function but 2 No change No change 100 mg/m 2 not ADL Paraesthesia with pain or functional impairment that does interfere with ADL Persistent paraesthesia that is disabling or lifethreatening ACUTE laryngopharyngeal dysaesthesia Cardiac toxicity 3 No change 100 mg/m 2 Discontinue 4 Discontinue Discontinue Increase infusion Not duration to 6 hours applicable Discontinue Not applicable For grade 2 cardiac toxicity which is attributable to capecitabine this should be discontinued. Allergic Reactions For grade 1 or 2 hypersensitivity no dose modification of oxaliplatin is required if it is the patients best interests to continue discuss with responsible consultant. Pre-medication with dexamethasone, anti-histamines and H2 blockers given intravenously 30 minutes before drug administration should be used. For acute grade 3 or 4 hypersensitivity OXALIPLATIN SHOULD BE DISCONTINUED. Renal function Drug GFR % of full dose Capecitabine > 50ml/min Full dose 30 50ml/min 75% of dose < 30ml/min discontinue Limited information available for Oxaliplatin & renal impairment Hepatic If creatinine clearance < 30ml/min discuss with responsible consultant Limited information available No studies performed with Oxaliplatin in severe hepatic impairment Transient increases in bilirubin and/or AST/ALT are common with Capecitabine Drug Bilirubin AST/ALT % of full dose Comments Capecitabine > 3 ULN > 2.5 ULN discontinue Treatment may be restarted at full dose when Bilirubin < 3 ULN or AST/ALT <2.5 ULN Page 8 of 9
9 Evaluation of response to treatment CEA to be assessed with every cycle of chemotherapy Review by consultant within 1 month of treatment cessation to ensure follow-up policy is adhered to. For more detailed information regarding oxaliplatin or capecitabine please refer to the full current Summary of product Characteristics References 1. Summary of product Characteristics for Oxaliplatin August Summary of product Characteristics for Capecitabine June Cockcroft & Gault, Nephron 16: 31-41, Cancer Therapy Evaluation Program, Common Terminolgy Criteria for Adverse Events, Version 3.0, DCTD, NCI,NIH, DHHS March 31, 2003 ( Publish date: December 12, Clinical trial protocol number N016966: A 2x2 factorial randomized Phase III study of intermittent oral capecitabine in combination with intravenous oxaliplatin ( XELOX ) with/without bevacizumab versus bolus and continuous infusion Fluorouracil / Intravenous Leucovorin with intravenous Oxaliplatin ( FOLFOX 4 ) with / without intravenous bevacizumab as first line treatment for patients with metastatic colorectal cancer. Roche August 4, 2003 Prepared By: Sarah Wilson, John Milne and Aisling Hennessey/Jim Cassidy Checked and Approved by: BOC colorectal site specific team Approved by: RCAG Prescribing Advisory Subgroup March 2007 Review date: March 2008 Page 9 of 9
WoSCAN CP Xelox Met CR version 2.0 October 2007 Page 1 of 10
West of Scotland Cancer Network Chemotherapy Protocol Oxaliplatin plus Capecitabine (XELOX) Metastatic Colorectal Cancer (GIWOS-004/2) Indication First line therapy of metastatic colorectal cancer Case
More informationCONSIDER ENTRY INTO CLINICAL TRIAL IF AVAILABLE/APPROPRIATE
West of Scotland Cancer Network Chemotherapy Protocol Capecitabine Adjuvant Colorectal Cancer (GIWOS-008) Capecitabine is an oral tumour-activated fluropyrimidine which as a result of the X-ACT trial has
More informationCAPECITABINE (METASTATIC BREAST CANCER) (BRWOS-002/1)
West of Scotland Cancer Network Chemotherapy Protocol Indication CAPECITABINE (METASTATIC BREAST CANCER) (BRWOS-002/1) Capecitabine (Xeloda) monotherapy is indicated for the treatment of locally advanced
More informationModified De Gramont with Oxaliplatin(OxMdg) Metastatic colorectal cancer (GIWOS-002) CONSIDER ENTRY INTO CLINICAL TRIAL IF AVAILABLE/APPROPRIATE
West of Scotland Cancer Network Chemotherapy Protocol Modified De Gramont with Oxaliplatin(OxMdg) Metastatic colorectal cancer (GIWOS-002) Indication Metastatic colorectal cancer Case selection Inclusion
More informationEOX. Advanced / metastatic use: 8 cycles (CT scan after cycles 4 and 8)
EOX Page 1 of 6 As an alternative to ECX: For locally advanced (inoperable) or metastatic oesophageal or gastric cancer For patients able to take oral medications Drugs/Dosage: Epirubicin 50mg/m 2 IV D1
More informationCapecitabine Oxaliplatin 21 day cycle (XELOX)
Systemic Anti Cancer Treatment Protocol Capecitabine Oxaliplatin 21 day cycle (XELOX) PROTOCOL REF: MPHAXELOX (Version No: 1.0) Approved for use in: Adjuvant colorectal cancer stage 3 or high risk stage
More informationEpirubicin, Cisplatin and Capecitabine (ECX) - Metastatic Gastric cancer (GIWOS-101/1)
West of Scotland Cancer Network Chemotherapy Protocol Indication Epirubicin, Cisplatin and Capecitabine (ECX) - Metastatic Gastric cancer (GIWOS-101/1) Patients with inoperable gastric or oesophago-gastric
More informationFluorouracil, Oxaliplatin and Docetaxel (FLOT)
Fluorouracil, Oxaliplatin and Docetaxel (FLOT) Indication Perioperative chemotherapy for resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. ICD-10 codes Codes with a prefix C15,C16 Regimen
More informationCapecitabine Oxaliplatin 21 day cycle (CAPOX)
Systemic Anti Cancer Treatment Protocol Oxaliplatin 21 day cycle (CAPOX) PROTOCOL REF: MPHACAPOX (Version No: 1.0) Approved for use in: Adjuvant colorectal cancer stage 3 or high risk stage 2 Advanced
More informationCarboplatin and Fluorouracil
Carboplatin and Fluorouracil Indication Palliative chemotherapy for recurrent or metastatic head and neck squamous cell cancer for patients where cisplatin and / or cetuximab are not appropriate. Performance
More informationOXALIPLATIN & MODIFIED DE GRAMONT. First-line or subsequent use for metastatic colorectal cancer
OXALIPLATIN & MODIFIED DE GRAMONT Indication: For use in patients following resection of stage III / high risk Stage II CRC (to be discussed with consultant) First-line or subsequent use for metastatic
More informationIrinotecan Capecitabine (14 day regimen) (I-Cap)
Systemic Anti Cancer Treatment Protocol Irinotecan (14 day regimen) (I-Cap) PROTOCOL REF: MPHAICAP (Version No: 1.0) Approved for use in: Advanced colorectal cancer first line Advanced colorectal cancer
More informationFEC-T (Fluorouracil, Epirubicin and Cyclophosphamide and Docetaxel)
FEC-T (Fluorouracil, Epirubicin and Cyclophosphamide and Docetaxel) Indication Adjuvant or neo-adjuvant treatment for high risk early and locally advanced breast cancer. (NICE CG80) ICD-10 codes Codes
More informationECX. Anti-emetics: Day 1: highly emetogenic Days 2 21: mildly emetogenic
Page 1 of 5 As an alternative to ECF: For locally advanced (inoperable) or metastatic oesophageal or gastric cancer; peri-operative use in oesophageal or gastric cancer; adenocarcinoma of unknown primary
More informationFOLFIRINOX (pancreas)
FOLFIRINOX (pancreas) Indication First or second line chemotherapy for metastatic pancreatic cancer. Eligible patients must be
More informationBreast Pathway Group EC x 4 Docetaxel x 4: Epirubicin & Cyclophosphamide followed by Docetaxel in Early Breast Cancer
Breast Pathway Group EC x 4 Docetaxel x 4: Epirubicin & Cyclophosphamide followed by Docetaxel in Early Breast Indication: Neoadjuvant therapy for high risk and fit breast cancer patients suitable for
More informationCapecitabine plus Docetaxel in Advanced Breast Cancer
Capecitabine plus Docetaxel in Advanced Breast Cancer Indication: Palliative therapy in Anthracycline-Pretreated Patients with Advanced Breast Cancer Regimen details: Docetaxel 75mg/m 2 IV D1 Capecitabine*
More informationGemcitabine + Capecitabine (ESPAC-4 Trial)
Gemcitabine + Capecitabine (ESPAC-4 Trial) European Study Group For Pancreatic Cancer - Trial 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and ampullary cancers. ***
More informationOxaliplatin and Gemcitabine
Oxaliplatin and Gemcitabine Indication Palliative treatment for relapsed metastatic seminoma, non seminoma or combined tumours. ICD-10 codes Codes pre-fixed with C38, C48, C56, C62, C63, C75.3. Regimen
More informationBreast Pathway Group FEC75 (Fluorouracil / Epirubicin / Cyclophosphamide) in Early Breast Cancer
Breast Pathway Group FEC75 (Fluorouracil / Epirubicin / Cyclophosphamide) in Early Breast Cancer Indication: Neoadjuvant or adjuvant therapy in early breast cancer Regimen details: Fluorouracil 600mg/m
More informationCarboplatin / Liposomal Doxorubicin CARBO/CAELYX Gynaecological Cancer
Systemic Anti Cancer Treatment Protocol Carboplatin / CARBO/CAELYX Gynaecological Cancer PROCTOCOL REF: MPHAGYNCCX (Version No: 1.0) Approved for use in: Advanced ovarian cancer in women who have progressed
More informationBreast Pathway Group TC (Docetaxel / Cyclophosphamide) in Early Breast Cancer
Breast Pathway Group TC (Docetaxel / Cyclophosphamide) in Early Breast Cancer Indication: Neoadjuvant or adjuvant treatment for patients in whom anthracyclines are contraindicated or inappropriate Regimen
More informationLung Pathway Group Docetaxel & Carboplatin in Non- Small Cell Lung Cancer (NSCLC)
Lung Pathway Group Docetaxel & Carboplatin in Non- Small Cell Lung Cancer (NSCLC) Indication: First line palliative therapy for previously untreated Stage IIIB or IV NSCLC patients Regimen details: Docetaxel
More informationBreast Pathway Group EC x 4 Paclitaxel x 4 (3-weekly): Epirubicin & Cyclophosphamide x 4 followed by Paclitaxel x 4 (3-weekly) in Early Breast Cancer
Breast Pathway Group EC x 4 Paclitaxel x 4 (3-weekly): Epirubicin & Cyclophosphamide x 4 followed by Paclitaxel x Indication: Neoadjuvant or adjuvant therapy for moderate to high risk node positive breast
More informationCisplatin / Capecitabine (+ Trastuzumab) in Gastric Cancer
Cisplatin / Capecitabine (+ Trastuzumab) in Gastric Cancer Page 1 of 5 Indication: Confirmed HER2-positive (3+ or FISH+) metastatic adenocarcinoma of the stomach or gastrooesophageal junction. Patient
More informationNCCP Chemotherapy Regimen. Epirubicin, Oxaliplatin and Capecitabine (EOX) -21 day
INDICATIONS FOR USE: Epirubicin, Oxaliplatin and Capecitabine (EOX) -21 day Regimen INDICATION ICD10 Code Locally advanced or metastatic gastric carcinoma C16 00239a Locally advanced or metastatic oesophageal
More informationCisplatin and Fluorouracil
Cisplatin and Fluorouracil Indication Neo-adjuvant treatment of nasopharyngeal head and neck cancer (stage II-IV) or bulky disease at other head and neck sites. Performance Status 0-1 ICD-10 codes Codes
More informationBreast Pathway Group Epirubicin & Cyclophosphamide x 4 followed by Carboplatin & Paclitaxel x 4 for Early Breast Cancer
Breast Pathway Group Epirubicin & Cyclophosphamide x 4 followed by Carboplatin & Paclitaxel x 4 for Early Breast Cancer Indication: Neoadjuvant therapy for patients with BRCA1/2 mutations EC Regimen details:
More informationOxaliplatin, Irinotecan & Fluorouracil (FOLFOXIRI) for metastatic colorectal carcinoma
Oxaliplatin, Irinotecan & Fluorouracil (FOLFOXIRI) for metastatic colorectal carcinoma Indication: Unresectable metastatic adenocarcinoma of the colon or rectum. First-line or subsequent use following
More informationNCCP Chemotherapy Regimen. FOLFOX-4 Therapy-14 day
INDICATIONS FOR USE: FOLFOX-4 Therapy-14 day INDICATION ICD10 Regimen Code Adjuvant treatment of stage II or III colon cancer after C18 00210a complete resection of primary tumour Metastatic colorectal
More informationWest of Scotland Cancer Network Chemotherapy Protocol
West of Scotland Cancer Network Chemotherapy Protocol DOCETAXEL/TRASTUZUMAB (BRWOS-005/1) Indication Docetaxel in combination with is indicated for the treatment of patients with HER2 overexpressing locally
More informationLiposomal Doxorubicin (CAELYX) Gynaecological Cancer
Systemic Anti Cancer Treatment Protocol Liposomal Doxorubicin (CAELYX) Gynaecological Cancer PROCTOCOL REF: OPHAGYNCAE (Version No: 1.0) Approved for use in: Advanced ovarian cancer second/third line treatment
More informationNECN CHEMOTHERAPY HANDBOOK PROTOCOL
DRUG ADMINISTRATION SCHEDULE First Cycle: Day Drug Daily Dose Route Diluent & Rate 1 Chlorphenamine 10mg IV bolus 1 Paracetamol 1000mg ORAL 1 Ranitidine 150mg ORAL 1 Dexamethasone 8mg IV bolus 1 Cetuximab
More informationCarboplatin / Gemcitabine Gynaecological Cancer
Systemic Anti Cancer Treatment Protocol Carboplatin / Gemcitabine Gynaecological Cancer PROCTOCOL REF: MPHAGYNCAG (Version No: 1.0) Approved for use in: Recurrent/metastatic endometrial carcinoma Previously
More informationCisplatin and Fluorouracil (palliative)
Cisplatin and Fluorouracil (palliative) Indication Palliative chemotherapy for recurrent or metastatic head and neck squamous cell cancer where combination treatment with cetuximab is not indicated. PS0-1
More informationNCCP Chemotherapy Regimen. Modified FOLFOX-6 Therapy-14 day
INDICATIONS FOR USE: Modified FOLFOX-6 Therapy-14 day INDICATION ICD10 Regimen Code Adjuvant treatment of stage II or III colon cancer after C18 00209a complete resection of primary tumour Metastatic colorectal
More informationCisplatin and Fluorouracil (head and neck)
Cisplatin and Fluorouracil (head and neck) Indication Palliative chemotherapy for recurrent or metastatic head and neck squamous cell cancer where combination treatment with cetuximab is not indicated.
More informationNCCP Chemotherapy Regimen
QUASAR (Modified) Fluorouracil (370mg/m 2 ) and Folinic Acid (50mg) Weekly INDICATIONS FOR USE: Regimen INDICATION ICD10 Code Treatment of metastatic colorectal cancer C18 00428a Adjuvant treatment of
More informationCisplatin / 5-Fluorouracil for Vulval Cancer
Cisplatin / 5-Fluorouracil for Vulval Cancer Indication: Palliative therapy in patients with Vulval Cancer Regimen details: Cisplatin 75mg/m 2 (*) IV 5-Fluorouracil (5-FU) 1000mg/m 2 /24 hours IV D4 (*)Consider
More informationCapecitabine and Oxaliplatin Therapy (XELOX)
INDICATIONS FOR USE: and Therapy (XELOX) Regimen Code *Reimbursement Status INDICATION ICD10 Adjuvant treatment of stage III (Dukes C) C18 00321a CDS colon cancer after complete resection of Hospital the
More informationTHE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST. Systemic Anti Cancer Treatment Protocol. EDP + mitotane
Systemic Anti Cancer Treatment Protocol EDP + mitotane PROCEDURE REF: MPHAHANEDP (Version No: 1.0) Approved for use in: Symptomatic treatment for advanced (unresectable, metastatic or relapsed) adrenocortical
More informationCarboplatin + Paclitaxel Cancer of the Cervix
Carboplatin + Paclitaxel Cancer of the Cervix Background: Topotecan in combination with cisplatin is recommended as a treatment option for women with recurrent or stage IVB cervical cancer only if they
More informationBEVACIZUMAB (AVASTIN ) AND XELOX PROTOCOL
Bevacizumab (Avastin ) for the first line treatment of advanced colorectal cancer with XELOX DRUG ADMINISTRATION Day Drug Daily Dose Route Diluent & Rate Day 1 Bevacizumab 7.5mg/kg Infusion Day 1 Days
More informationNCCP Chemotherapy Regimen
Modified Roswell Park (Fluorouracil 500mg/m 2 and Folinic Acid 50mg weekly x 6) Regimen INDICATIONS FOR USE: Regimen INDICATION ICD10 Code Treatment of metastatic colorectal cancer C18 00427a Adjuvant
More informationNCCP Chemotherapy Regimen
INDICATIONS FOR USE: Capecitabine Monotherapy Regimen *Reimbursement INDICATION ICD10 Code Indicator Treatment of patients with locally advanced or metastatic breast cancer C50 00216a CDS Treatment of
More informationFEC-TPH (Fluorouracil, Epirubicin and Cyclophosphamide) followed by Docetaxel, Pertuzumab and Trastuzumab (Herceptin )
FEC-TPH (Fluorouracil, Epirubicin and Cyclophosphamide) followed by Docetaxel, Pertuzumab and Trastuzumab (Herceptin ) Indication Neo-adjuvant treatment for HER2 positive, locally advanced, inflammatory
More informationCarboplatin, Paclitaxel and Bevacizumab (gynae)
Carboplatin, Paclitaxel and Bevacizumab (gynae) Indication First line treatment of recurrent or metastatic cervical cancer. WHO performance status 0 or 1. First line treatment of advanced epithelial ovarian,
More informationBCCA Protocol Summary for Combined Modality Adjuvant Therapy for High Risk Rectal Carcinoma using Capecitabine and Radiation Therapy
BCCA Protocol Summary for Combined Modality Adjuvant Therapy for High Risk Rectal Carcinoma using Capecitabine and Radiation Therapy Protocol Code: Tumour Group: Contact Physician: GIRCRT Gastrointestinal
More informationBreast Pathway Group Bevacizumab & Paclitaxel in Advanced Breast Cancer
Breast Pathway Group Bevacizumab & Paclitaxel in Advanced Breast Cancer Indication: First-line or second-line treatment of triple negative advanced breast cancer National Cancer Drug Fund criteria: Advanced
More informationBreast Pathway Group Docetaxel in Advanced Breast Cancer
Breast Pathway Group Docetaxel in Advanced Breast Cancer Indication: First-line palliative treatment, with or without trastuzumab, for advanced breast cancer in patients for whom an anthracycline is not
More informationR-FC for Chronic Lymphocytic Leukaemia LKWOS-005/01
West of Scotland Cancer Network Chemotherapy Protocol R-FC for Chronic Lymphocytic Leukaemia LKWOS-005/01 Indication B cell Chronic Lymphocytic Leukaemia First line therapy in patients under 70 years of
More informationTrastuzumab emtansine Kadcyla
Trastuzumab emtansine Kadcyla Indication Treatment of HER2 positive unresectable locally advanced or metastatic breast cancer for patients who have previously received a taxane and trastuzumab (Herceptin
More informationGemcitabine, Carboplatin and Bevacizumab (gynae)
Gemcitabine, Carboplatin and Bevacizumab (gynae) Indication Second line advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. WHO performance status 0 or 1. (Funding via the CDF) ICD-10
More informationBreast Pathway Group EC x 4: Epirubicin & Cyclophosphamide in Early Breast Cancer
Breast Pathway Group EC x 4: & in Early Breast Cancer Indication: Neoadjuvant or adjuvant treatment for moderate to high risk breast cancer Regimen details: 90 mg/m 2 IV Day 1 600 mg/m 2 IV Day 1 Administration:
More informationLung Pathway Group Carboplatin & PO Vinorelbine in Non-Small Cell Lung Cancer (NSCLC)
Lung Pathway Group Carboplatin & PO Vinorelbine in Non-Small Cell Lung Cancer (NSCLC) Indication: First line in radical/induction treatment in locally advanced NSCLC First line palliative treatment in
More informationLapatinib and capecitabine for breast cancer Funding arrangements to be set up and specified locally Page 1 of 5
Indication: Funding arrangements to be set up and specified locally Page 1 of 5 Lapatinib in combination with Capecitabine is recommended as a treatment option for people with advanced and/or metastatic
More informationFOLFIRINOX (Irinotecan, Oxaliplatin & infusional Fluorouracil) Cumbria, Northumberland, Tyne & Wear Area Team
DRUG ADMINISTRATION SCHEDULE Day Drug Dose Route Diluent & Rate Glucose 5% 250ml Infusion Fast Running for Line Flush Day 1 Ondansetron 8mg IV bolus Via dextrose drip Dexamethasone 8mg IV bolus Via dextrose
More informationDocetaxel-EC: Docetaxel followed by Epirubicin / Cyclophosphamide in Breast Cancer
Docetaxel-EC: Docetaxel followed by Epirubicin / Cyclophosphamide in Breast Cancer Indication: Neoadjuvant therapy f HER 2 negative high risk and fit Breast Cancer patients, suitable f a taxane containing
More informationTCHP Docetaxel, Carboplatin, Trastuzumab, Pertuzumab Neoadjuvant Protocol
Systemic Anti Cancer Treatment Protocol TCHP Docetaxel, Carboplatin, Trastuzumab, Pertuzumab Neoadjuvant Protocol PROTOCOL REF: MPHATCHP (Version No: 1.0) Approved for use in: Neoadjuvant breast: The neoadjuvant
More informationPaclitaxel Gynaecological Cancer
Systemic Anti Cancer Treatment Protocol Paclitaxel Gynaecological Cancer PROTOCOL REF: MPHAGYNPAC (Version No: 1.0) Approved for use in: Second/ third line option for advanced ovarian cancers (3 weekly
More informationCisplatin / 5-Fluorouracil (+ Trastuzumab) in Gastric Cancer
Cisplatin / 5-Fluorouracil (+ Trastuzumab) in Gastric Cancer Indication: Confirmed HER2-positive (3+ or FISH+) metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. For Trastuzumab doses
More informationNECN CHEMOTHERAPY HANDBOOK PROTOCOL
DRUG ADMINISTRATION SCHEDULE First Cycle: Day Drug Daily Dose Route Diluent & Rate 1 Chlorphenamine 10mg IV bolus 1 Paracetamol 1000mg ORAL 1 Ranitidine 150mg ORAL 1 Dexamethasone 8mg IV bolus 1 Cetuximab
More informationMabThera. SC. The wait is over. MabThera delivered in just 5 minutes. SC= subcutaneous injection
MabThera SC. The wait is over. MabThera delivered in just 5 minutes Abbreviated Prescribing Information MabThera 1400 mg solution for subcutaneous (SC) injection (Rituximab) Indications: Indicated in adults
More informationSunitinib (renal) ICD-10 codes Codes with a prefix C64
Sunitinib (renal) Indication First line treatment of patients with advanced and/or metastatic renal cell carcinoma who are suitable for immunotherapy and have an Eastern Cooperative Oncology Group (ECOG)
More informationCapecitabine + Concurrent Radiotherapy
Capecitabine + Concurrent Radiotherapy Available for Routine Use in Burton in-patient Derby in-patient Burton day-case Derby day-case Burton community Derby community Burton out-patient Derby out-patient
More informationPanitumumab + FOLFIRI for the 1 st line Treatment of Metastatic Colorectal Cancer
DRUG ADMINISTRATION SCHEDULE Day Drug Daily Dose Route Diluent and rate Day 1 Panitumumab 6mg/kg Intravenous 100ml Sodium Chloride 0.9% at variable rate (see administration notes) Glucose 5% 500ml Infusion
More informationFEC Docetaxel (NEOADJUVANT): Fluorouracil/ Epirubicin/ Cyclophosphamide followed by Docetaxel* in Early Breast Cancer
FEC Docetaxel (NEOADJUVANT): Fluouracil/ Epirubicin/ Cyclophosphamide followed by Docetaxel* in Early Breast Cancer Please, note that Neoadjuvant FEC-Docetaxel has only been approved f use in QEW Trust
More informationLapatinib and Capecitabine Therapy
Lapatinib and Capecitabine Therapy This protocol should be read in conjunction with NCCP protocol 00216 Capecitabine Monotherapy. INDICATIONS FOR USE: INDICATION Treatment of adult patients with breast
More informationCisplatin and Gemcitabine (bladder)
Cisplatin and Gemcitabine (bladder) Indication Palliative therapy for locally advanced or metastatic bladder cancer in patients with good renal function. Palliative therapy for urothelial transitional
More informationBCCA Protocol Summary for Adjuvant Therapy of Colon Cancer using
BCCA Protocol Summary for Adjuvant Therapy of Colon Cancer using Capecitabine Protocol Code Tumour Group Contact Physician GIAJCAP Gastrointestinal GI Systemic Therapy ELIGIBILITY: Resected Stage III or
More informationCISPLATIN Chemo-radiation regimen Gynaecological Cancer
Systemic Anti Cancer Treatment Protocol CISPLATIN Chemo-radiation regimen Gynaecological Cancer PROCTOCOL REF: MPHAGYNCIX (Version No: 1.0) Approved for use in: Locally advanced cervical cancer (adjuvant/curative)
More informationNCCP Chemotherapy Regimen. Bevacizumab 5mg/kg and Modified FOLFOX- 6 Therapy 14 days
Bevacizumab 5mg/kg and Modified FOLFOX- 6 Therapy 14 days INDICATIONS FOR USE: Regimen Code 00446a *Reimbursement Indicator INDICATION ICD10 Treatment of adult patients with metastatic carcinoma of the
More informationBCCA Protocol Summary for Curative Combined Modality Therapy for Carcinoma of the Anal Canal Using Mitomycin, Capecitabine and Radiation Therapy
BCCA Protocol Summary for Curative Combined Modality Therapy for Carcinoma of the Anal Canal Using Mitomycin, and Radiation Therapy Protocol Code: Tumour Group: Contact Physician: GICART Gastrointestinal
More informationEC-Docetaxel: Epirubicin / Cyclophosphamide followed by Docetaxel in Breast Cancer
EC-Docetaxel: Epirubicin / Cyclophosphamide followed by Docetaxel in Breast Cancer Indication: Neoadjuvant therapy f high risk and fit Breast Cancer patients, suitable f a taxane containing regimen EC
More informationThis is a controlled document and therefore must not be changed
AZACITIDINE NICE TA218 Treatment of adults not eligible for haematopoietic stem cell transplantation who have: Intermediate-2 and high-risk MDS according to the International Prognostic Scoring System
More informationLung Pathway Group Cisplatin & IV Vinorelbine in Non- Small Cell Lung Cancer (NSCLC)
Lung Pathway Group Cisplatin & IV Vinorelbine in Non- Small Cell Lung Cancer (NSCLC) Indication: First line in radical/induction treatment in locally advanced NSCLC First line palliative treatment in advanced/metastatic
More informationCisplatin / Paclitaxel Gynaecological Cancer
Systemic Anti Cancer Treatment Protocol Cisplatin / Paclitaxel Gynaecological Cancer PROCTOCOL REF: MPHAGYNCIP (Version No: 1.0) Approved for use in: First line treatment for stage Ib-IV with minimal residual
More informationPREMEDICATIONS: Antiemetic protocol for highly emetogenic chemotherapy. May not need any antiemetic with
BCCA Protocol Summary for Palliative Therapy of Metastatic or Locally Advanced Gastric, Gastroesophageal Junction Adenocarcinoma, Esophageal Squamous Cell Carcinoma, or Anal Squamous Cell Carcinoma using
More informationLung Pathway Group Cisplatin & PO Vinorelbine in Non- Small Cell Lung Cancer (NSCLC)
Lung Pathway Group Cisplatin & PO Vinorelbine in Non- Small Cell Lung Cancer (NSCLC) Indication: First line in radical/induction treatment in locally advanced NSCLC First line palliative treatment in advanced/metastatic
More informationCisplatin and Pemetrexed (NSCLC, mesothelioma)
Cisplatin and Pemetrexed (NSCLC, mesothelioma) Indication First-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) if the histology of the tumour has been confirmed as
More informationCarfilzomib and Dexamethasone (CarDex)
Carfilzomib and Dexamethasone (CarDex) Indication Relapsed multiple myeloma for patients who have had only one previous line of therapy (that did not include bortezomib). (NICE TA457) ICD-10 codes Codes
More informationThe drug cost of lenalidomide for people who remain on treatment for more than 26 cycles will be met by the company.
LENALIDOMIDE MDS NICE TA322 Treatment of patients with transfusion-dependent anaemia (< 8 consecutive weeks without RBC transfusions within 16 weeks prior to commencing treatment) due to low- or intermediate-1-risk
More informationNCCP Chemotherapy Regimen. Modified FOLFOX-6 Therapy-14 day
INDICATIONS FOR USE: Modified FOLFOX-6 Therapy-14 day INDICATION ICD10 Regimen Code *Reimbursement Status Adjuvant treatment of stage II or III colon cancer after C18 00209a Hospital complete resection
More informationPaclitaxel/Carboplatin with dose dense EC Neoadjuvant Regimen
Systemic Anti Cancer Treatment Protocol Paclitaxel/Carboplatin with dose dense EC Neoadjuvant Regimen PROTOCOL REF: MPHAPCECBR (Version No: 1.0) Approved for use in: Neoadjuvant treatment of operable,
More informationCisplatin Vinorelbine (Oral) therapy +/- radiotherapy
1 REGIMEN TITLE: Cisplatin Vinorelbine (Oral) therapy +/- radiotherapy Page 1 of 5 Indication: First line in Radical/ Induction, Adjuvant and Advanced & Palliative treatment of Non-small cell lung cancer
More informationNCCP Chemotherapy Regimen. Modified FOLFIRINOX Therapy
INDICATIONS FOR USE: Modified FOLFIRINOX Therapy Regimen *Reimbursement INDICATION ICD10 Code Status Adjuvant treatment of pancreatic ductal adenocarcinoma C25 00515a Hospital *If the reimbursement status
More informationPaclitaxel and Trastuzumab Breast Cancer
Systemic Anti Cancer Treatment Protocol Paclitaxel and Trastuzumab Breast Cancer PROTOCOL REF: MPHAPTRBR (Version No: 1.0) Approved for use in: HER2 positive breast cancer. For adjuvant use in T1 or T2
More informationTIP Paclitaxel, Ifosfamide and Cisplatin
Systemic Anti Cancer Treatment Protocol TIP Paclitaxel, Ifosfamide and Cisplatin PROTOCOL REF: MPHATIPGC (Version No: 1.0) Approved for use in: Second line treatment of germ cell tumours Dosage: Drug Dosage
More informationCisplatin and Vinorelbine and radiotherapy (NSCLC)
Cisplatin and Vinorelbine and radiotherapy (NSCLC) Indication First-line chemotherapy for use with concomitant radical radiotherapy for early or locally advanced non-small cell carcinoma (NSCLC) ICD-10
More informationNivolumab and Ipilimumab
Nivolumab and Ipilimumab Indication Advanced (unresectable or metastatic) melanoma. (NICE TA400) ICD-10 codes Codes prefixed with C43 Regimen details Cycles 1-4 Nivolumab and Ipilimumab every 3 weeks Day
More informationFEC-D with HP Fluorouracil, Epirubicin, Cyclophosphamide, Followed by Docetaxel, Trastuzumab, Pertuzumab Neoadjuvant Protocol
Approved for use in: Neoadjuvant breast cancer: The neoadjuvant treatment of HER2 positive locally advanced, inflammatory or early breast cancer at high risk of recurrence Interim CDF funding from November
More informationCetuximab in Combination with Irinotecan based Chemotherapy for the 1 st, 2 nd and 3 rd treatment Metastatic of Colorectal Cancer
Cetuximab in Combination with Irinotecan based Chemotherapy for the 1 st, 2 nd and 3 rd treatment Metastatic of Colorectal Cancer DRUG ADMINISTRATION SCHEDULE Day Drug Daily Dose Route Diluent and rate
More informationCisplatin and Vinorelbine and radiotherapy (NSCLC)
Cisplatin and Vinorelbine and radiotherapy (NSCLC) Indication First-line chemotherapy for use with concomitant radical radiotherapy for early or locally advanced non-small cell carcinoma (NSCLC) ICD-10
More informationPanobinostat, Bortezomib and Dexamethasone
Panobinostat, Bortezomib and Dexamethasone Indication Treatment of relapsed/refractory multiple myeloma in patients who have received at least 2 prior regimens, including bortezomib and an immunomodulatory
More informationCarboplatin and Paclitaxel (gynae)
Carboplatin and Paclitaxel (gynae) Indication Post surgical adjuvant or neoadjuvant or relapse therapy for stage IC to IV ovarian, fallopian tube or primary peritoneal cancer. First line or relapse therapy
More informationAxitinib (renal) Note: in some patients it may be appropriate to increase the dose to 6mg BD before increasing to 7mg BD.
Axitinib (renal) Indication Treatment of advanced renal cell carcinoma after failure of treatment with a first-line tyrosine kinase inhibitor (UK licensed indication states sunitinib) or a cytokine. (NICE
More informationX M/ (R) Dose adjusted (DA)-EPOCH-R
X M/ (R) adjusted (DA)-EPOCH-R Indication High-risk CD20+ diffuse large B cell lymphoma especially C-MYC and BCL-2 activated (i.e. double hit lymphoma) and mediastinal sclerosing (thymic) large B cell
More informationDERBY-BURTON LOCAL CANCER NETWORK FILENAME Peruse.DOC CONTROLLED DOC NO: CCPG R29
Pertuzumab + Trastuzumab + Docetaxel (Peruse study) A Multicenter, open-label, single arm study of Pertuzumab in combination with Trastuzumab and a Taxane in first-line treatment of patients with HER2-positive
More informationBC Cancer Protocol Summary for Adjuvant Therapy of Colon Cancer using Fluorouracil Injection and Infusion and Leucovorin Infusion
BC Cancer Protocol Summary for Adjuvant Therapy of Colon Cancer using Fluorouracil Injection and Infusion and Leucovorin Infusion Protocol Code: Tumour Group: Contact Physician: GIAJFL Gastrointestinal
More informationPaclitaxel Gastric Cancer
Systemic Anti Cancer Treatment Handbook Paclitaxel Gastric Cancer PROTOCOL REF: MPHAUGIPAC (Version No: 1.0) Approved for use in: Second line treatment of locally advanced and metastatic gastric / gastro-oesophageal
More information