A phase ii study of doxorubicin, vincristine, cyclophosphamide, prednisolone (CHOP) chemotherapy with intathecal (IT) methotrexate and prophylactic cranial irradiation in a patients with high grade non Hodgkin`s lymphoma (NHL)

Objective: The objective of this phase II study was to evaluate the efficacy and toxicity of (CHOP) chemotherapy with intrathecal methotrexate and prophylactic cranial irradiation in patients with high-grade Non Hodgkin`s lymphoma. Method: From January 2002 to December 2002 tewenty consecutive patients with histopathologically and immunohistochemically confirmed high grade NHL with Ann Arbor stage III & IV were enrolled. ECOG performance status of 0 or 1 was required. Written informed consent was obtained from all patients. Patients with symptomatic meningeal or brain involvement were excluded from the study. Cyclophosphamide 750 mg /m2, vincristine 1.4 mg / m2 (maximum 2 mg), doxorubicin 50 mg / m2 was given I/V on D1 and prednisolone 100 mg PO was given from D1 - D5. Cycles were repeated after every 21 days. Intrathecal methotrexate was given at a dose of 12 mg once during 3rd week, twice weekly on 5th & 6th week and once during 7th week. A total dose of 1800 cGy was given to whole brain in 10 fraction s with a daily tumor dose of 180 cGy using a Cobalt 60. Common Toxicity Criteria was used for evaluation of toxicity and WHO criteria for response evaluation. Result: All 20 patients were able to complete the planned therapy. Grade IV neutropenia was observed in 45% (9/20) of patients. Episodes of febrile neutropenia were seen in 20%(4/20). Grade II diarrhea was seen in 25%(05/20). 20%(4/20) had grade II cutaneous toxicity. No immediate radiation related toxicity was seen except grade II nausea and vomiting. Overall response was found in 75%(15/20) of patients, CR in 60%(12/20) and PR in 15%(03/20). 15%(03/20) patients showed stable disease and 10%(02/20) had progressive disease. Conclusion: This combined modality treatment of CHOP chemotherapy with intrathecal methotrexate and prophylactic cranial irradiation has been feasible and effective with acceptable toxicity in this group of patients with high-grade Non Hodgkin`s lymphoma.