Diffuse large B-cell and peripheral T-cell non-Hodgkin's lymphoma in the frail elderly A phase II EORTC trial with a progressive and cautious treatment emphasizing geriatric assessment

Objectives: Many frail elderly patients with diffuse large B-cell lymphoma (DLBCL) cannot tolerate standard chemotherapy treatment. The objective of this phase II trial was to assess the efficacy of a cautious COP-based (cyclophosphamide, vincristine, prednisone) regimen with comprehensive geriatric assessment (CGA). Trial registration number: NCT00039351. Materials and methods: DLBCL patients aged >= 70 years with poor physiological functioning received cyclophosphamide (750 mg/m(2) IV at dl), vincristine (1.4 mg/m(2) IV at dl, maximum of 2 mg) and prednisone (40 mg/m(2) dl to d5) for six cycles. Comprehensive Geriatric Assessment (CGA) was performed for all patients before and after treatment. Results: Thirty-two patients were included, of whom 27 were evaluable for efficacy. Low response rates were observed with only 18.5% complete response and 25.9% partial response leading to the early termination of the trial. Despite strict dose reduction rules, high toxicity rates were observed with four severe tcodcities and eight early deaths. CGA data showed that over 90% of patients were depressed, over 80% dependent for instrumental activities of daily living (IADL) and almost half of our patients had severe comorbidities showing that we clearly selected a population of "frail" elderly. Conclusion: This adapted COP regimen for vulnerable patients produced an 18.5% complete response rate. Future research will include the addition of rituximab to determine if it can improve treatment efficacy. The geriatric assessment should be part of routine management of frail patients with aggressive lymphomas as it allows us to identify specific issues of vulnerability in this population on which intervention should be focused. (C) 2010 Elsevier Ltd. All rights reserved.