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Regimen: Docetaxel for locally advanced or metastatic non-small cell lung cancer ICD10 Codes Codes Pre-fixed with C34. Indication NICE approved for second-line treatment of locally advanced or metastatic NSCLC cancer who have relapsed after previous chemotherapy. (NICE CG121) Day Drug Dose Route 1 Docetaxel 75mg/m2 IV Docetaxel is administered in a 250ml PVC-free sodium chloride 0.9% bag over 60 minutes. Regimen detail Administration Doses >190mg should be diluted in 500ml (maximum concentration 0.74mg/ml). Patients should be observed closely for hypersensitivity reactions, particularly during the first and second infusions. Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel and therefore facilities for the treatment of hypotension and bronchospasm must be available. Frequency Extravasation Premedication Emetogenicity Additional recommended supportive medication Pre- treatment evaluation Regular investigation If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require discontinuation of therapy. The infusion may be temporarily interrupted and when symptoms improve re-started at a slower infusion rate. Severe reactions, such as hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy. Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel. Every 21 days for 4 – 6 cycles, depending on response. Docetaxel is an exfoliant (Group 4) Dexamethasone 8mg bd PO for 3 days, starting the morning of the day prior to chemotherapy. Patient should receive 3 doses prior to treatment. In the case where 3 doses have not been taken, dexamethasone 16 -20mg IV should be administered 30-60 minutes prior to chemotherapy and the remaining 3 oral doses should be administered as per normal prescription This regimen has moderate-low emetic potential – refer to local protocol Mouthwashes as per local policy H2 antagonist or proton-pump inhibitor if required Scalp cooling may be offered. Loperamide if required. FBC Baseline - results valid for 14 days LFT Baseline - results valid for 14 days U&E (inc. SrCr) Baseline - results valid for 14 days Baseline radiology Baseline – results valid for 14 days CXR/CT FBC Pre D1 – results valid for 72 hours LFT Pre D1 – results valid for 7 days Controlled document Document No Version Number ASWCS12 LU002 0.1.a Last printed 25/03/2013 *ONLY VALID ON DATE OF PRINTING* Page 1 of 3 Standard limits for administration to go ahead – if blood results not within range, authorisation to administer must be given by prescriber/consultant U&E (inc. SrCr) CXR CT Scan Neutrophil count Platelet count Bilirubin AST/ALT Alk Phos Pre D1 – results valid for 7 days Every cycle Every 3 cycles. ≥1.5 x 109/L ≥100 x 109/L ≤ ULN ≤1.5 x ULN ≤2.5 x ULN Dose modifications Haematological toxicity Renal impairment Hepatic impairment NCI Common Toxicity Criteria Day 1: If neutrophils <1.5 x 109/L and/or platelets <100 x 109/L delay 1 week or until recovery. If febrile neutropenia occurs, or neutrophils <0.5 x 109/L for more than 1 week, reduce dose to 60mg/m2 for all subsequent cycles. If platelets <25 x 109/L, consider dose reduction to 60mg/m2 after recovery – discuss with consultant. No dose adjustment for renal impairment AST/ALT ≤1.5 x ULN > 1.5 ULN > 3.5 x ULN Grade 3 cutaneous reactions Grade 2 neuropathy Grade 3 or 4 neuropathy Any other grade 3 or 4 toxicities Adverse effects – the contents of the table indicate the adverse effects that should be documented on consent to treatment forms Significant drug interactions – For full details consult product literature/ reference texts Alk Phos Bilirubin ≤2.5 x ULN < ULN 2.6 - 6 x ULN < ULN > 6 x ULN > ULN Once patient recovered, reduce dose to 60mg/m2. Once patient recovered, reduce dose to 60mg/m2. Discontinue treatment permanently Discontinue treatment after discussion with consultant Docetaxel dose 100% 75% Not recommended If symptoms return, stop docetaxel. If symptoms return, stop docetaxel. Rare but Serious Side Effects Secondary malignancy Infusion-related reaction Teratogenicity Infertility Cardiotoxicity Anaphylaxis Frequently occurring Side Effects Myelosuppression Nausea and vomiting Stomatitis and mucositis Diarrhoea; constipation Fatigue Peripheral neuropathy Myalgia and arthralgia Other Alopecia; fluid retention; phlebitis; skin and nail changes, raised LFTs CYP3A4 Enzyme inducers/inhibitors - in vitro studies suggest that CYP3A inhibitors (such as ketoconazole,ritonavir, clarithromycin and erythromycin) may raise docetaxel levels, whereas CYP3A inducers (such as rifampicin and barbiturates) may reduce docetaxel levels. Comments N/A Cumulative N/A Doses References • National Institute of Health and Clinical Excellence Guideline CG121. Lung Cancer. The diagnosis Controlled document Document No Version Number ASWCS12 LU002 0.1.a Last printed 25/03/2013 *ONLY VALID ON DATE OF PRINTING* Page 2 of 3 and treatment of lung cancer April 2011 [internet] Accessed online on 25/07/2012 available at http://www.nice.org.uk/nicemedia/live/13465/54202/54202.pdf • • • • • • Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O’Rourke M, et al. Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy. J Clin Oncol 2000; 18 (10): 2095-2103. Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, et al. Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non–Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens. J Clin Oncol 2000; 18 (2): 2354-2362. Roszkowski K, Pluzanska A, Krzakowski M, Smith AP, Saigi E, Aasebo U, et al. A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 2000; 27(3):145-57. Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in hepatic impairment [internet]. accessed 04/01/2012 available at http://www.nlcn.nhs.uk/sites/default/files/pro_board_gu/2008/07/Hepatic%20impairment%20%20Dosage%20adjustment%20for%20cytotoxics.doc Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in renal impairment [internet]. accessed 04/01/2012 available at http://www.nlcn.nhs.uk/sites/default/files/pro_board_gu/2008/07/Renal%20impairment%20%20%20Dosage%20adjustment%20for%20cytotoxics.doc Summary of Product Characteristics Taxotere® (Docetaxel) 160mg/8ml concentrate and solvent for solution for infusion (Sanofi Aventis) [internet] accessed 25/07/2012 available from http://www.medicines.org.uk/EMC/medicine/25464/SPC Document title Document number Approval date Written by Docetaxel for NSCLC ASWCS12 LU002 19/03/2013 Adam Dangoor, Consultant Medical Oncologist, BHOC Checked by Georgina Holmes, Pharmacist, UHBristol Georgina Holmes Authorised by Jeremy Braybrooke, Consultant Oncologist, BHOC Jeremy Braybrooke Review date Document reviewed by Version number Summary of changes 19/03/2015 Controlled document Adam Dangoor Digitally signed by Adam Dangoor DN: cn=Adam Dangoor, o=University Hospitals Bristol NHS Foundation Trust, ou=Consultant in Medical Oncology, [email protected], c=GB Date: 2013.03.25 14:56:52 Z Digitally signed by Georgina Holmes DN: cn=Georgina Holmes, o=NHS, ou=NHS, [email protected], c=GB Date: 2013.03.25 14:57:19 Z Digitally signed by Jeremy Braybrooke DN: cn=Jeremy Braybrooke, o, ou, [email protected], c=GB Date: 2013.03.25 14:57:46 Z 0.1.a Version Document No Version Number ASWCS12 LU002 0.1.a Last printed 25/03/2013 *ONLY VALID ON DATE OF PRINTING* Page 3 of 3