PURPOSE: The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma. METHODS: A total of 164 patients with follicular lymphoma (grade 1/2), mantle cell lymphoma or lymphoplasmacytic lymphoma (immunocytoma) was randomised to treatment with vincristine 2 mg (day 1) and prednisone 100 mg/m2 (days 1-5) + bendamustine 60 mg/m2 (days 1-5) or + cyclophosphamide 400 mg/m2 (days 1-5) for a total of eight 21-day cycles. RESULTS: The rate of complete remission was 22% with BOP and 20% with COP. The projected 5-year survival rate was 61% with BOP and 46% with COP. The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy (74% vs. 56%; P = 0.05), and did reach significance in responders who did not receive interferon maintenance therapy (70% vs. 47%; P = 0.03). Toxicity was acceptable in both treatment groups, although alopecia and leucopenia were more severe with COP. CONCLUSIONS:Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.
RCT Entities:
PURPOSE: The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma. METHODS: A total of 164 patients with follicular lymphoma (grade 1/2), mantle cell lymphoma or lymphoplasmacytic lymphoma (immunocytoma) was randomised to treatment with vincristine 2 mg (day 1) and prednisone 100 mg/m2 (days 1-5) + bendamustine 60 mg/m2 (days 1-5) or + cyclophosphamide 400 mg/m2 (days 1-5) for a total of eight 21-day cycles. RESULTS: The rate of complete remission was 22% with BOP and 20% with COP. The projected 5-year survival rate was 61% with BOP and 46% with COP. The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy (74% vs. 56%; P = 0.05), and did reach significance in responders who did not receive interferon maintenance therapy (70% vs. 47%; P = 0.03). Toxicity was acceptable in both treatment groups, although alopecia and leucopenia were more severe with COP. CONCLUSIONS:Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.
Authors: D O Dixon; P McLaughlin; F B Hagemeister; E J Freireich; L M Fuller; F F Cabanillas; E A Gehan Journal: J Clin Oncol Date: 1987-10 Impact factor: 44.544
Authors: Kai Uwe Chow; Daniel Nowak; Simone Boehrer; Martin Ruthardt; Andrea Knau; Dieter Hoelzer; Paris S Mitrou; Eckhart Weidmann Journal: Biochem Pharmacol Date: 2003-09-01 Impact factor: 5.858
Authors: N L Harris; E S Jaffe; H Stein; P M Banks; J K Chan; M L Cleary; G Delsol; C De Wolf-Peeters; B Falini; K C Gatter Journal: Blood Date: 1994-09-01 Impact factor: 22.113
Authors: Wolfram Pönisch; Barbara Moll; Malvina Bourgeois; Marc Andrea; Thomas Schliwa; Simone Heyn; Marion Schmalfeld; Thomas Edelmann; Cornelia Becker; Franz Albert Hoffmann; Andreas Schwarzer; Ute Kreibich; Matthias Egert; Runa Stiegler; Rainer Krahl; Yvonne Remane; Anette Bachmann; Tom Lindner; Lorenz Weidhase; Sirak Petros; Stefan Fricke; Vladan Vucinic; Haifa Al Ali; Dietger Niederwieser Journal: J Cancer Res Clin Oncol Date: 2013-09-18 Impact factor: 4.553
Authors: Brad S Kahl; Nancy L Bartlett; John P Leonard; Ling Chen; Kristen Ganjoo; Michael E Williams; Myron S Czuczman; K Sue Robinson; Robin Joyce; Richard H van der Jagt; Bruce D Cheson Journal: Cancer Date: 2010-01-01 Impact factor: 6.860