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R-Codox-M / R-Ivac Indication Lymphoma group R-CODOX-M / R-IVAC 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, consider 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, β2 microglobulin, hepatitis B core antibody and hepatitis BsAg, hepatitis C antibody, EBV, CMV, VZV, HIV 1+2 after consent, group and save. 4. 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. 5. Patients MUST NOT receive co-trimoxazole, starting from the week before the first methotrexate infusion. Consider pentamidine treatment if considered at risk from Pneumocystis infection. 6. CSF examination • cell count +/- immunophenotype, protein and glucose: can be done as part of 1st intrathecal. 7. Ophthalmic examination - if clinically indicated. 8. Urine pregnancy test • before cycle 1 of each new chemotherapy for women of child-bearing age unless they are post-menopausal, have been sterilised or undergone a hysterectomy. 9. ECG +/- Echo - if clinically indicated. 10. Record performance status (WHO/ECOG), height and weight. 11. 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. 12. Fertility - it is very important the patient understands the potential risk of infertility. All patients should be offered fertility advice by referring to the Oxford Fertility Unit. 13. 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. 14. Consider dental assessment / Advise dental check is carried out by patient's own dental practitioner before treatment starts. 15. Record IPI score. 16. Arrange insertion of double-lumen central venous catheter. 17. Treatment should be agreed in the relevant MDT. This is a controlled document and therefore must not be changed or photocopied 1 of 9 L.49 Authorised by Lymphoma lead Published: September 2008 Version R-CODOX-M / Dr Graham Collins Reviewed: May 2018 4.4 R-IVAC Date: May 2018 Updated: Aug 2020 Review: May 2022 Lymphoma group 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/m2 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/m2 IV infusion daily in 500 mL sodium chloride 0.9%. DOXORUBICIN 40 mg/m2 IV bolus. VINCRISTINE 1.5 mg/m2 (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/m2 IV bolus. CYTARABINE 70 mg INTRATHECAL. Days 2 to 5 CYCLOPHOSPHAMIDE 200 mg/m2 IV bolus daily. Day 3 CYTARABINE 70 mg INTRATHECAL. Day 8 VINCRISTINE 1.5 mg/m2 (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 sections below. Day 10 METHOTREXATE 300 mg/m2 IV infusion [start at 10.00 hrs] over 1 hour then (T=0) 2700 mg/m2 IV infusion over next 23 hours* (Ordered as 3 g/m2 in exactly 500 mL sodium chloride 0.9%). Calcium folinate (folinic acid) post-methotrexate (starting 36 hours after the start of methotrexate). Refer to sections below Day 13 G-CSF as per local policy. Day 15 METHOTREXATE 12 mg INTRATHECAL. Day 16 Folinic acid (calcium folinate) 15 mg PO 24 hours post IT methotrexate (15 mg tablets). 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 This is a controlled document and therefore must not be changed or photocopied 2 of 9 L.49 Authorised by Lymphoma lead Published: September 2008 Version R-CODOX-M / Dr Graham Collins Reviewed: May 2018 4.4 R-IVAC Date: May 2018 Updated: Aug 2020 Review: May 2022 Lymphoma group INTRAVENOUS HYDRATION Start: T = -12 hours. Fluid: 1000 mL glucose 2.5%, sodium chloride 0.45% with potassium chloride 20 mmol and sodium bicarbonate 100 mmol added. Following completion of methotrexate infusion, decrease amount of sodium bicarbonate in fluids to 50 mmol/L. Flow rate: 200 mL/hour (or 150 mL/hour if less than 1.6 m2). Duration: Continue fluids during methotrexate infusion (run concurrently with methotrexate, through one arm of Y extension). Administer fluids until methotrexate level <0.1 micromol/L. METHOTREXATE INTRAVENOUS INFUSION Start: T = 0 (aim to start at 10.00 am) Levels: Check 48 hours after the start of the methotrexate infusion, and every 24 hours thereafter until methotrexate level less than 0.1 micromol/L. URINE OUTPUT Check: Every 4 hours. Aim: 400 mL/m2/4 hours (approx. 700 mL over 4 hours). Furosemide: Administer 20-40 mg to maintain urine output. FOLINIC ACID RESCUE Start: 36 hour from start of methotrexate infusion. Dose: 30 mg every 3 hours for 5 doses, then every 6 hours until methotrexate level is less than 0.1 micromol/L. Administration: Give intravenous boluses for at least the first 4 doses then change to oral if the patient is compliant and not vomiting. GLUCARPIDASE – reversal agent NHS England will fund Glucarpidase (unlicensed in UK) for adults receiving high-dose methotrexate chemotherapy (doses >1g/m2) - Who develop significant deterioration in renal function (>1.5x ULN and rising, or the presence of oliguria) OR - Have toxic plasma methotrexate level AND - Have been treated with all standard rescue and supportive measures AND - At risk of life-threatening methotrexate-induced toxicities The recommended dose is one single intravenous injection of 50units/kg This is a controlled document and therefore must not be changed or photocopied 3 of 9 L.49 Authorised by Lymphoma lead Published: September 2008 Version R-CODOX-M / Dr Graham Collins Reviewed: May 2018 4.4 R-IVAC Date: May 2018 Updated: Aug 2020 Review: May 2022 Lymphoma group R-IVAC Day 1 Pre med - paracetamol 1g PO, chlorphenamine 10 mg IV and hydrocortisone 100 mg IV 30 minutes before rituximab. RITUXIMAB 375 mg/m2 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/m2 IV infusion daily in 500 mL sodium chloride 0.9% over 1 hr. IFOSFAMIDE 1.5 g/m2 together with MESNA 300mg/m2 daily IV infusion daily in 500 mL sodium chloride 0.9% over 1 hour. *MESNA 300 mg/m2 IV infusion 4 & 8 hours post ifosfamide in 50 mL sodium chloride 0.9% over 15 minutes. *for patients with good oral intake, consider replacing the second and third MESNA intravenous infusion of each day with oral MESNA 600mg/m2 PO at 2 hours and 6 hours after the START of ifosfamide infusion. Days 1 to 2 CYTARABINE 2 g/m2 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 CALCIUM FOLINATE 15 mg PO 24 hours post IT methotrexate (15 mg tablets) Day 7 G-CSF as per local policy (continue until neutrophils >1.0 x 109/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, 3, 5 Cytarabine 70 mg 1 15, 17 Methotrexate 12.5 mg CODOX-M 16, 18 Calcium Folinate 15 mg PO 24 hours after each lumbar puncture 5 Methotrexate 12.5 mg 2 6 Calcium Folinate 15 mg PO 24 hours after each lumbar puncture IVAC 7, 9 Cytarabine 70 mg IFOSFAMIDE-INDUCED ENCEPHALOPATHY Refer to nomogram to assess risk.
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