Zinzani Pier Luigi, Tani Monica, Fanti Stefano, Stefoni Vittorio, Musuraca Gerardo, Vitolo Umberto, Perrotti Alessio, Fina Mariapaola, Derenzini Enrico, Baccarani Michele
Institute of Hematology and Medical Oncology L&A Seragnoli, University of Bologna, Bologna, Italy.
Cancer. 2008 Feb 15;112(4):856-62. doi: 10.1002/cncr.23236.
A prospective, single-arm, open-label, nonrandomized Phase 2 study of combined fludarabine and mitoxantrone (FM) plus radioimmunotherapy was conducted to evaluate efficacy and safety in patients with untreated, indolent, nonfollicular non-Hodgkin lymphoma (NHL).
Between February 2005 and June 2006, at their institute, the authors treated 26 eligible patients with previously untreated, indolent, nonfollicular NHL (10 marginal zone lymphomas, 8 lymphoplasmacytic lymphomas, and 8 small lymphocytic lymphomas) using a novel regimen that consisted of 6 cycles of FM chemotherapy followed 6 to 10 weeks later by yttrium-90 (90Y) ibritumomab tiuxetan.
After FM chemotherapy, the overall response rate was 80.5% and included a 50% complete remission (CR) rate (13 patients) and a 30.5% partial remission (PR) rate (8 patients). Of the 20 patients (13 with CR and 7 with PR) who were evaluable (at least a PR with normal platelet counts and bone marrow infiltration <25%) for subsequent 90Y ibritumomab tiuxetan, 100% obtained a CR at the end of the entire treatment regimen. At a median follow-up of 20 months, the estimated 3-year progression-free survival rate was 89.5%, and the estimated 3-year overall survival rate was 100%. The 90Y ibritumomab tiuxetan toxicity included grade >or=3 hematologic toxicity in 16 of 20 patients; the most common grade >or=3 toxicities were neutropenia (11 patients) and thrombocytopenia (16 patients) (adverse events were graded according to the World Health Organization criteria for toxicity). Transfusions of erythrocytes and/or platelets were given to 5 patients.
The current study established the feasibility, tolerability, and efficacy of the FM plus 90Y ibritumomab tiuxetan regimen for the treatment of patients with untreated, indolent, nonfollicular NHL.
开展了一项前瞻性、单臂、开放标签、非随机的2期研究，评估氟达拉滨与米托蒽醌联合方案（FM）加放射免疫疗法治疗未经治疗的惰性非滤泡性非霍奇金淋巴瘤（NHL）患者的疗效和安全性。
2005年2月至2006年6月期间，作者在其机构使用一种新方案治疗了26例符合条件的先前未经治疗的惰性非滤泡性NHL患者（10例边缘区淋巴瘤、8例淋巴浆细胞性淋巴瘤和8例小淋巴细胞性淋巴瘤），该方案包括6个周期的FM化疗，6至10周后给予钇-90（90Y）替伊莫单抗。
FM化疗后，总体缓解率为80.5%，包括50%的完全缓解（CR）率（13例患者）和30.5%的部分缓解（PR）率（8例患者）。在可评估后续90Y替伊莫单抗治疗的20例患者（13例CR和7例PR）中（至少为PR，血小板计数正常且骨髓浸润<25%），100%在整个治疗方案结束时获得CR。中位随访20个月时，估计3年无进展生存率为89.5%，估计3年总生存率为100%。90Y替伊莫单抗毒性包括20例患者中有16例出现≥3级血液学毒性；最常见的≥3级毒性是中性粒细胞减少（11例患者）和血小板减少（16例患者）（不良事件根据世界卫生组织毒性标准分级）。5例患者接受了红细胞和/或血小板输注。
本研究证实了FM加90Y替伊莫单抗方案治疗未经治疗的惰性非滤泡性NHL患者的可行性、耐受性和疗效。
