Rummel Mathias J, Al-Batran Salah E, Kim Soo-Z, Welslau Manfred, Hecker Ralf, Kofahl-Krause Dorothea, Josten Klaus-M, Dürk Heinz, Rost Andreas, Neise Michael, von Grünhagen Ulrich, Chow Kai U, Hansmann Martin-L, Hoelzer Dieter, Mitrou Paris S
Med. Klinik II, Johann Wolfgang Goethe-Universitätsklinik, Frankfurt/Main, Germany.
J Clin Oncol. 2005 May 20;23(15):3383-9. doi: 10.1200/JCO.2005.08.100.
The aim of this multicenter-study was to evaluate the progression-free survival, response rate and toxicity of the combination of bendamustine and rituximab (BR) in patients with mantle cell or low-grade lymphomas in first to third relapse or refractory to previous treatment.
A total of 245 courses (median, four courses per patient) were administered to 63 patients. Bendamustine was given at a dose of 90 mg/m2 as a 30-minute infusion on days 1 and 2, combined with 375 mg/m2 rituximab on day 1, for a maximum of four cycles every 4 weeks. Histologies were 24 follicular, 16 mantle cell, 17 lymphoplasmacytoid, and six marginal zone lymphoma.
Fifty-seven of 63 patients responded to BR, corresponding to an overall response rate of 90% (95% CI, 80% to 96%) with a complete remission rate (CR) of 60% (95% CI, 47% to 72%). The median time of progression-free survival was 24 months (range, 5 to 44+ months), and the median duration of overall survival has not yet been reached. In mantle cell lymphomas, BR showed a considerable activity, achieving a response rate of 75% (95% CI, 48% to 93%) with a CR rate of 50%. Myelosuppression was the major toxicity, with 16% grade 3 and 4 leukocytopenia. Thrombocytopenia was rare, with only 3% grade 3 and 4.
These results demonstrate that the BR combination is a highly active regimen in the treatment of low-grade lymphomas and mantle cell lymphomas.
这项多中心研究旨在评估苯达莫司汀与利妥昔单抗联合用药(BR)对处于首次至第三次复发或对先前治疗耐药的套细胞淋巴瘤或低度淋巴瘤患者的无进展生存期、缓解率及毒性。
共对63例患者给予了245个疗程(中位数,每位患者4个疗程)的治疗。苯达莫司汀剂量为90mg/m²,于第1天和第2天静脉输注30分钟,第1天联合375mg/m²利妥昔单抗,每4周最多进行4个周期。组织学类型包括24例滤泡性淋巴瘤、16例套细胞淋巴瘤、17例淋巴浆细胞样淋巴瘤和6例边缘区淋巴瘤。
63例患者中有57例对BR有反应,总缓解率为90%(95%CI,80%至96%),完全缓解率(CR)为60%(95%CI,47%至72%)。无进展生存期的中位数为24个月(范围,5至44 +个月),总生存期的中位数尚未达到。在套细胞淋巴瘤中,BR显示出相当的活性,缓解率为75%(95%CI,48%至93%),CR率为50%。骨髓抑制是主要毒性,16%为3级和4级白细胞减少。血小板减少罕见,仅3%为3级和4级。
这些结果表明,BR联合方案在治疗低度淋巴瘤和套细胞淋巴瘤方面是一种高活性的治疗方案。