Concomitant & Adjuvant Temozolomide and radiotherapy for malignant Glioma Cumbria, Northumberland, Tyne & Wear Area Team DRUG ADMINISTRATION SCHEDULE Day Drug Daily Dose mg/m2 Route Duration Comments 1 Hour before 75mg/m² Radiotherapy 1 to 42 TEMOZOLOMIDE (Rounded to ORAL 42 days (Mornings and nearest 5mg) Weekends) Day 70 TEMOZOLOMIDE 150mg/m² ORAL 5 Days Adjuvant cycle 1 (week 10) Day 98 (week 14) TEMOZOLOMIDE Adjuvant Cycle Then 200mg/m² ORAL 5 Days 2,3,4 etc every 28 days * Day 1 = start day radiotherapy DOSE FORM 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg hard capsules. A liquid preparation is available as a special from Newcastle Hospitals NHS Trust NUMBER OF DAYS PER CYCLE Starting from day 70 temozolomide is given for 5 days 28 days to a maximum of 6 cycles. Note average number of cycles given in trial = 3.2. Take after 1 hour fast (ideally overnight and no food until 1 hour after) INDICATIONS Adjuvant therapy High Grade Gliomas; for all performance status (PS) = 0 or 1 patients Note also used for 2nd line recurrent malignant glioma see separate protocol Concomitant & adjuvant Temozolomide with radiotherapy at presentation malignant glioma performance status 0 or 1 Note this protocol may be used in young adults and paediatric patients- seek specialist advise on supportive care medication and doses for these patients. INVESTIGATIONS / MONITORING REQUIRED Pre treatment On radiotherapy: Twice weekly FBC. Once weekly treatment/exam – review Advice for action if haematology/non-haematology toxicity occur. Prior to each cycle Adjuvant:FBC, U&E’s, LFT’s If toxicities re-schedule may need delay or dose reducing. Adjuvant Temozolomide CNTW protocol CRP08 CNS002 v1.5 Page 1 of 3 Issue Date 22/05/2014 Expiry Date May 2016 Concomitant & Adjuvant Temozolomide and radiotherapy for malignant Glioma Cumbria, Northumberland, Tyne & Wear Area Team PREMEDICATION (see comment on doses above) Concurrent: Pre day 1 (with radiotherapy) Ondansetron 8mg and then as required. Adjuvant: Ondansetron 8mg BD for 5 days whilst having temozolomide. RECOMMENDED TAKE HOME MEDICATION (see comment on doses above) Ondansetron 8mg BD for 5 days. ASSESSMENT OF RESPONSE Adjuvant There will be no visible disease to monitor for adjuvant treatment. REVIEW BY CLINICIAN Concurrent Weekly in radiotherapy floor clinic for review and two weekly FBC. Adjuvant Monthly for blood review and clinical review NURSE LED REVIEW Prior to each cycle ANTI-EMETICS As above ADMINISTRATION NOTES Fasting recommended when taking tablets (see above) Observation haematology toxicity criteria Ensure prophylaxis against Pneumocystis carinii pneumonia PCP prophylaxis Co- trimoxazole (Septrin) 960mg 3 x week during radiotherapy & until lymphocytopenia recovers. Oral preparation, therefore advise patients to swallow and not open the capsules. If a capsule becomes damaged, avoid contact of the powder contents with skin or mucous membrane. If contact does occur, wash the affected area. TOXICITIES Nausea Alopecia Constipation Bone Marrow Depression; anaemia, neutropenia, thrombocytopenia Lethargy Anorexia Headaches Adjuvant Temozolomide CNTW protocol CRP08 CNS002 v1.5 Page 2 of 3 Issue Date 22/05/2014 Expiry Date May 2016 Concomitant & Adjuvant Temozolomide and radiotherapy for malignant Glioma Cumbria, Northumberland, Tyne & Wear Area Team DOSE MODIFICATION Haematological Toxicity: Delay by one week if: ANC < 1.5 or Platelets < 100. Reduce dose if ANC<1.0 x 109/l or platelets <50 x 109/l 2 2 If dose is 200mg/m reduce to 150mg/m 2 2 If dose is 150mg/m reduce to 100mg/m If dose is 100mg/m2 discontinue. Non- Haematological Toxicity: Any CTC Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) reduce dose as described above Any CTC Grade 4 Non-haematological toxicity discontinue TREATMENT LOCATION Given at Cancer Centre for concurrent with RXT. Adjuvant doses may be given at Cancer Unit REFERENCES: Stupp et al Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma NEJM March 2005 352;10 NICE Technology Appraisal 121: Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma. National Institute of Clinical Excellence. June 2007. Document Control Document Adjuvant Temozolomide CNTW protocol CRP08 CNS002 Title: Current Document No: CRP-08-CNS002 1.5 Version: S Williamson Approval Author: Consultant Pharmacist Signature* Dr Jo Lewis Date Approved by: 22/.5/2014 Consultant Clinical Oncologist Approved: Due for Review: May 2016 Summary of 1.2 Reformatted into new joint network format Changes 1.3 Amended paediatric details 1.4 Protocol reviewed. Typing errors corrected. 1.5 Protocol reviewed and approval dates updated Adjuvant Temozolomide CNTW protocol CRP08 CNS002 v1.5 Page 3 of 3 Issue Date 22/05/2014 Expiry Date May 2016 .