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Phase 2 trial of rituximab plus hyper‐CVAD alternating with rituximab plus methotrexate‐cytarabine for relapsed or refractory aggressive mantle cell lymphoma
Author(s) -
Wang Michael,
Fayad Luis,
Cabanillas Fernando,
Hagemeister Fredrick,
McLaughlin Peter,
Rodriguez Maria A,
Kwak Larry W.,
Zhou Yuhong,
Kantarjian Hagop,
Romaguera Jorge
Publication year - 2008
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.23880
Subject(s) - medicine , mantle cell lymphoma , cytarabine , rituximab , neutropenia , vincristine , regimen , gastroenterology , cyclophosphamide , febrile neutropenia , surgery , phases of clinical research , chemotherapy , lymphoma
BACKGROUND. Relapsed or refractory mantle cell lymphoma has a very poor prognosis. The authors evaluated the response rates and survival times of patients treated with an intense regimen known to be effective against untreated aggressive mantle cell lymphoma: rituximab plus hyper‐CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) alternating with rituximab plus methotrexate‐cytarabine. METHODS. In this prospective, open‐label, phase 2 study, patients received this combination for 6 to 8 cycles. Twenty‐nine patients were evaluable for response. RESULTS. The median number of cycles received was 5 (range, 1‐7 cycles), and the overall response rate was 93% (45% complete response [CR] or CR unconfirmed [CRu] and 48% partial response [PR]). All 5 patients previously resistant to treatment had a response (1 CR, 4 PR), and both patients whose disease did not change in response to prior therapy had PRs. Toxic events occurring in response to the 104 cycles given included neutropenic fever (11%), grade 3 or 4 neutropenia (74%), and grade 3 or 4 thrombocytopenia (63%). There were no deaths from toxicity. At a median follow‐up of 40 months (range, 5‐48 months), the median failure‐free survival time was 11 months with no plateau in the survival curve. CONCLUSIONS. This combination chemotherapy was effective for refractory/relapsed mantle cell lymphoma. Cancer 2008. © 2008 American Cancer Society.