Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2008
Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Robinson K Sue, Williams Michael E, van der Jagt Richard H, Cohen Philip, Herst Jordan A, Tulpule Anil, Schwartzberg Lee S, Lemieux Bernard, Cheson Bruce D
Аннотация
PURPOSE: Bendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab.
PATIENTS AND METHODS: Patients received rituximab 375 mg/m(2) intravenously on day 1 and bendamustine 90 mg/m(2) intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs.
RESULTS: Overall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression-free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%).
CONCLUSION: Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.
PATIENTS AND METHODS: Patients received rituximab 375 mg/m(2) intravenously on day 1 and bendamustine 90 mg/m(2) intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs.
RESULTS: Overall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression-free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%).
CONCLUSION: Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.
Предметные рубрики MeSH
AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideFemaleGastrointestinal DiseasesHeadacheHematologic DiseasesHumansInfectionsKaplan-Meier EstimateLymphoma, B-CellLymphoma, Mantle-CellMaleMiddle AgedNauseaNeoplasm Recurrence, LocalNitrogen Mustard CompoundsRemission InductionRituximab