Burkitt lymphoma, double hit lymphoma or high IPI diffuse large B-cell lymphoma.

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1 INDICATION Burkitt lymphoma, double hit lymphoma or high IPI diffuse large B-cell lymphoma. TREATMENT INTENT Curative. PRE-ASSESSMENT 1. Ensure histology is confirmed prior to administration of chemotherapy and document in notes. 2. Record stage of disease - MRI scan of brain (+/- spinal cord) with Gadolinium enhancement, CT scan (neck, chest, abdomen and pelvis) +/- PET, presence or absence of B symptoms, clinical extent of disease, bone marrow aspirate and trephine (with cytogenetics/fish as indicated). 3. Blood tests - FBC, DAT, U&Es, LDH, ESR, urate, calcium, magnesium, creatinine, LFTs, glucose, Igs, β 2 microglobulin, hepatitis B core antibody and hepatitis BsAg, hepatitis C antibody, EBV, CMV, VZV, HIV 1+2 after consent, group and save. 4. Patients MUST NOT receive co-trimoxazole in the week before the first methotrexate infusion. Restart co-trimoxazole once methotrexate level is <0.1 micromol/l and neutrophil count recovery 5. A number of drugs can interfere with Tubular secretion of methotrexate. These include penicillins, aspirin and NSAIDs. Tazocin should NOT be used during high dose methotrexate administration or rescue. Consider using meropenem or other alternative. Review indications for aspirin and NSAIDs and consider stopping during methotrexate treatment. 6. CSF examination - cell count +/- immunophenotype, protein and glucose: can be done as part of 1 st intrathecal. 7. Ophthalmic examination - if clinically indicated. 8. Urine pregnancy test - before cycle 1 of each new chemotherapy course in women aged years of age unless they have been sterilised or undergone a hysterectomy. 9. ECG +/- Echo - if clinically indicated. 10. Record performance status (WHO/ECOG). 11. Record height and weight. 12. Consent - ensure patient has received adequate verbal and written information regarding their disease, treatment and potential side effects. Document in medical notes all information that has been given. Obtain written consent on the day of treatment. 13. Fertility - it is very important the patient understands the potential risk of infertility. All patients should be offered fertility advice (see fertility guidelines). 14. Hydration - in patients with bulky disease pre-hydrate with sodium chloride 0.9% 1 litre over 4-6 hours. Patients at high risk of tumour lysis refer to tumour lysis protocol. 15. Consider dental assessment / Advise dental check is carried out by patient's own dental practitioner before treatment starts. 16. Record IPI score. 17. R-CODOX-M. Patients at high risk of tumour lysis, refer to tumour lysis protocol. 18. Arrange insertion of double-lumen central venous catheter. 1 of 7

2 19. Treatment should be agreed in the relevant MDT. DRUG REGIMEN For low-risk patients, give 3 courses of CODOX-M. For high-risk patients, give alternate CODOX-M and IVAC for four cycles. Risk groups can be identified as follows: Patients in the low-risk group must meet at least 3 of the following criteria: o Normal lactate dehydrogenase (LDH) level o WHO performance status 0-1 o Ann Arbor stage I or II o No more than 1 extranodal site (e.g., bone marrow, gastrointestinal tract, or CNS) Patients in the high-risk group must meet at least 2 of the following criteria: o Raised LDH level o WHO performance status 2-4 o Ann Arbor stage III or IV o More than 1 extranodal site See dose modification for patients over 65 years. R-CODOX-M Pre-Hydration with sodium chloride 0.9% at a rate of 3 L/m 2 minimum immediately until day 1. Monitor U&E, calcium, phosphate and urate every 4 hours and urinary ph. Refer to tumour lysis protocol. Day 1 Pre med - paracetamol 1g po, chlorphenamine 10 mg iv, hydrocortisone 100 mg iv 30 minutes before rituximab. RITUXIMAB 375 mg/m 2 iv infusion daily in 500 ml sodium chloride 0.9%. DOXORUBICIN 40 mg/m 2 iv bolus. VINCRISTINE 1.5 mg/m 2 (maximum 2 mg) iv infusion in 50 ml sodium chloride 0.9% over 10 minutes. Maximum 1 mg for patients > 70 years. CYCLOPHOSPHAMIDE 800 mg/m 2 iv bolus. CYTARABINE 70 mg INTRATHECAL. Days 2 to 5 CYCLOPHOSPHAMIDE 200 mg/m 2 iv bolus daily. Day 3 CYTARABINE 70 mg INTRATHECAL. Day 8 VINCRISTINE 1.5 mg/m 2 (maximum 2 mg) iv infusion in 50 ml sodium chloride 0.9% over 10 minutes. Maximum 1 mg for patients > 70 years. Hydration /Alkalinisation - Pre methotrexate (starting T= -12 hours). Refer to High Methotrexate protocol. Day 10 (T=0) Day 13 Day 15 Day 16 METHOTREXATE 300 mg/m 2 iv infusion [start at hrs] over 1 hour then 2700 mg/m 2 iv infusion over next 23 hours* (Ordered as 3 g/m 2 in exactly 500 ml sodium chloride 0.9%). Calcium folinate (Folinic acid) post methotrexate (starting 36 hours after the start of methotrexate). Refer to High Methotrexate protocol. G-CSF as per local policy. METHOTREXATE 12 mg INTRATHECAL. Folinic acid (calcium folinate) 15 mg po 24 hours post IT methotrexate (15 mg tablets). * Methotrexate levels: Initially take 24 hours after completion of methotrexate infusion, and then every 24 hours until methotrexate level <0.1 micromol/l. No need to take levels outside regular working hours. 2 of 7

3 Where a CODOX-M cycle starts on either a Thursday or a Friday, the day 3 IT Cytarabine is due during the weekend, centres should: Start on a Thursday, but give the day 3 IT Cytarabine 2 days late Start on a Friday, but give the day 3 IT Cytarabine a day late Day 1 Pre med - paracetamol 1g po, chlorphenamine 10 mg iv and hydrocortisone 100 mg iv 30 minutes before rituximab. RITUXIMAB 375 mg/m 2 iv infusion daily in 500 ml sodium chloride 0.9%. (Refer to protocol for titration of dose rate.) Days 1 to 5 ETOPOSIDE 60 mg/m 2 IV infusion daily in 500 ml sodium chloride 0.9% over 1 hr. IFOSFAMIDE 1.5 g/m 2 together with MESNA 300mg/m 2 daily iv infusion daily in 500 ml sodium chloride 0.9% over 1 hour. MESNA 300 mg/m 2 iv infusion 4 & 8 hours post ifosfamide in 50 ml sodium chloride 0.9% over 15 minutes. Days 1 to 2 CYTARABINE 2 g/m 2 iv infusion twice a day (4 doses) in 500 ml sodium chloride 0.9% over 3 hours. Day 5 METHOTREXATE 12 mg INTRATHECAL. Day 6 Day 7 CALCIUM FOLINATE 15 mg po 24 hours post IT methotrexate (15 mg tablets) G-CSF as per local policy (continue until neutrophils >1.0 x 10 9 /L for 3 consecutive days). Where IVAC starts on a Tuesday or a Wednesday, the day 5 IT Methotrexate is due during the weekend, centres should: Start on a Tuesday but give the day 5 IT Methotrexate 2 days late Start on a Wednesday but give the day 5 IT Methotrexate a day late Hydration - ensure patient has a fluid input of >3 litres, supplement intravenously as necessary. CNS DISEASE For patients with CNS disease, intensified intrathecal treatment is given to all patients for THE FIRST TWO CYCLES ONLY, regardless of age. Cycle Day Drug INTRATHECAL dose 1 CODOX-M 2 IVAC 1, 3, 5 15, 17 16, , 9 Cytarabine Methotrexate Calcium Folinate Methotrexate Calcium Folinate Cytarabine 70 mg 12.5 mg 15 mg po 24 hours after each lumbar puncture 12.5 mg 15 mg po 24 hours after each lumbar puncture 70 mg Tazocin can prolong the excretion of methotrexate and should NOT be used during high dose methotrexate administration or rescue. Consider using meropenem or other alternative. IFOSFAMIDE-INDUCED ENCEPHALOPATHY Refer to nomogram to assess risk. 3 of 7

4 CYCLE FREQUENCY The next cycle may be given once there is bone marrow recovery. If neutrophil count is 1.0 x 10 9 /L and platelets >75 x 10 9 /L, stop the G-CSF, if counts are maintained after 24 hours, commence next cycle of chemotherapy. If neutrophil count is >1.0 x 10 9 /L but platelets are <75 x 10 9 /L, stop G-CSF and await platelet recovery. RESTAGING At completion of the protocol, for low-risk patients after 3 cycles and for high-risk patients after 4 cycles. DOSE MODIFICATIONS Haematological toxicity There are no dose modifications for haematological toxicity. CODOX-M: In patients over 65 years, reduce methotrexate dose to 100 mg/m 2 over 1 hour and 900 mg/m 2 infusion over 23 hours (Order as 1 g/m 2 in exactly 500 ml sodium chloride 0.9%). A fluid space, e.g. pleural effusion or ascites, is potentially very dangerous as methotrexate can accumulate and cause prolonged toxicity. High dose methotrexate should not be given in such cases. Discuss with consultant: Doxorubicin: Discuss with consultant if renal impairment severe Bilirubin micromol/l % >85 omit If AST 2-3 x normal, give 75% dose If AST >3 x ULN, give dose Doxorubicin maximum cumulative dose (additive to other anthracyclines): mg/m 2 (in normal cardiac function) 400 mg/m 2 (in patients with cardiac dysfunction or exposed to mediastinal irradiation). Consider dose reduction in the event of cardiac impairment. Vincristine: No dose reduction necessary Bilirubin micromol/l or ALT/AST u/l dose Bilirubin >51 micromol/l & normal ALT/AST dose Bilirubin >51 micromol/l & ALT/ AST >180 u/l omit Clinical decision Vincristine In the presence of motor weakness or severe sensory symptoms, discuss reducing or withholding vincristine with a consultant. 4 of 7

5 Cyclophosphamide: GFR (ml/min) > % <10 Clinical decision consider whether patient is being treated with high dose treatment. Clinical decision. Exposure to active metabolites may not be increased, suggesting dose reduction may not be necessary. Methotrexate - clinical judgment discuss with consultant. A fluid space, e.g. pleural effusion or ascites, is potentially very dangerous as methotrexate can accumulate and cause prolonged toxicity. High dose methotrexate should not be given in such cases. BOPA guidelines CrCl (ml/min) > % 45 <30 CI Bilirubin micromol/l < >85 BOPA guidelines AST And <180 Or >180 75% CI It is expected that patients receiving high dose methotrexate will develop hypertransaminasemia and occasionally hyperbilirubinemia. These elevations can last up to 2 weeks following the methotrexate infusion and are not considered toxicity requiring discontinuation of repeated administration of methotrexate. Persistant hyperbilirubinemia and/or grade 3-4 hypertransaminasemia for longer than 3 weeks should result in discontinuation of the drug. reduce, particularly in patients with concomitantly impaired renal function. Severe hepatic impairment CI IVAC: In patients over 65 years, reduce ifosfamide dose to 1 g/m 2, mesna to 200 mg/m 2, cytarabine infusion to 1 g/m 2. Discuss with consultant: Etoposide: CrCl (ml/min) > <15 75% Subsequent doses should be based on clinical response. Consider Bilirubin micromol/l or AST u/l dose Bilirubin >51 micromol/l or AST >180 u/l - clinical decision 5 of 7

6 Ifosfamide: GFR >60 ml/min dose GFR ml/min 70% dose GFR <40 ml/min clinical decision. Cytarabine: - dose reduction may not be necessary High dose 1-3 g/m 2 consider GFR (ml/min) > <30 60% CI - discuss with consultant SPC recommendations: not recommended in patients with a Bilirubin >17 micromol/l or serum transaminases or ALP >2.5 x ULN. Clinical decision. Bilirubin >34 micromol/l give dose. Escalate doses in subsequent cycles in the absence of toxicity. INVESTIGATIONS First cycle - FBC, U&Es, calcium, magnesium, LFTs, urate Subsequent cycles - FBC, U&Es, calcium, magnesium, LFTs, urate, (creatinine clearance if serum creatinine is increased by 20% of previous value) CONCURRENT MEDICATION A number of drugs can interfere with Tubular secretion of methotrexate. These include penicillins, aspirin and NSAIDs. Tazocin should NOT be used during high dose methotrexate administration or rescue. Consider using meropenem or other alternative. Review indications for aspirin and NSAIDs and consider stopping during methotrexate treatment. Patients MUST NOT receive co-trimoxazole in the week before the first methotrexate infusion. Restart co-trimoxazole once methotrexate level is <0.1 micromol/l and neutrophil count recovery. Refer to tumour lysis protocol consider Rasburicase. Fluconazole 50 mg daily po for duration of chemotherapy. Ranitidine po or where indicated a Proton pump inhibitor daily po for duration of chemotherapy. Aciclovir 200 mg three times a day po for duration of chemotherapy and for 3 months after completion. Norethisterone 5 mg three times a day po as appropriate. Prednisolone eye drops 0.5% 1 drop into both eyes 4 hourly from day 1 of IVAC to day 6. Patients currently on co-trimoxazole should stop and change to/or start pentamidine 4 mg/kg iv monthly before each CODOX-M and ensure the patient is not on co-trimoxazole. Commence co-trimoxazole 480 mg od Monday/W/F after final cycle of chemotherapy and when neutrophils >2.0 and continue for 3 months. Tazocin can prolong the excretion of methotrexate and should NOT be used during high dose methotrexate administration or rescue. Consider using meropenem or other alternative. 6 of 7

7 EMETIC RISK CODOX-M: Day 1: High Days 2-5: Moderate Day 8: Minimal Days 10 and 11: Moderate IVAC: Days 1-2: High Days 3-5: Moderate POTENTIALLY HAZARDOUS INTERACTIONS WITH OTHER DRUGS: Ifosfamide possibly enhances effect of warfarin. METHYLENE BLUE: If patient develops neurotoxcicity, STOP ifosfamide and administer: Methylthioninium chloride (methylene blue) can be given as prophylaxis against, or treatment of, ifosfamide-induced encephalopathy. This should be started on the day of ifosfamide administration and continued for 24 hours after administration or until neurotoxic symptoms subside. : 50 mg tds iv or orally. NB: 50 mg = 5 ml of 1% solution. IV: Administer 50 mg in 50 to 100 ml sodium chloride 0.9% or glucose 5%, over 15 to 30 minutes. Orally: Use injection for oral administration. Dilute one ampoule in 100 ml water before taking orally to minimise GI effects. Drink through a straw to avoid staining teeth % oral absorption. ADVERSE EFFECTS / REGIMEN SPECIFIC COMPLICATIONS Cyclophosphamide / ifosfamide may irritate bladder mucosa. Patients should be encouraged to drink a minimum of three litres of fluid per 24 hours. Vincristine may cause neurotoxicity. Cardiotoxicity - monitor cardiac function. Doxorubicin may be stopped in future cycles if signs of cardiotoxicity, e.g. cardiac arrhythmias, pericardial effusion, tachycardia with fatigue. Methotrexate induced mucositis - folinic acid (calcium folinate) rescue (see Concurrent Medication above). REFERENCES 1. Cancer Research UK.1 LY10 A Clinicopathological Study in Burkitt's and Burkitt's like non- Hodgkin's lymphoma September (Simon Clawson Clinical Trials Manager Tel: ). 2. British Oncology Pharmacy Association (BOPA) - Dosage Adjustment for Cytotoxics in Hepatic and Renal Impairment. S Daniels Guy's & St Thomas' NHS Trust Nov Küpfer A, Aeschlimann C, Wermuth B, Cerny T. Prophylaxis and reversal of ifosfamide encephalopathy with methylene-blue. Lancet Mar 26;343(8900): Ifosfamide Chemotherapy Management. Professor Bass Hassan and Bharti Tailor. Final version approved by BHOC Chemotherapy Group 16/09/ UCLH - Dosage Adjustment for Cytotoxics in Hepatic Impairment ( 3 - updated January 2009). 6. UCLH - Dosage Adjustment for Cytotoxics in Renal Impairment ( 3 - updated January 2009). 7 of 7

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