Sacchi Stefano, Pozzi Samantha, Marcheselli Raffaella, Federico Massimo, Tucci Alessandra, Merli Francesco, Orsucci Loretta, Liberati Marina, Vallisa Daniele, Brugiatelli Maura
Department of Oncology and Hematology, University of Modena, Modena, Italy.
Cancer. 2007 Jul 1;110(1):121-8. doi: 10.1002/cncr.22740.
The current study was conducted to asses the safety profile and clinical activity of rituximab in combination with fludarabine and cyclophosphamide in patients with recurrent follicular lymphoma (FL).
This study was a noncomparative, multicenter, phase II study. Between March 2000 and December 2002, 54 patients with recurrent FL were enrolled in the FC+R trial. Patients received fludarabine at a dose of 25 mg/m(2) and cyclophosphamide at a dose of 300 mg/m(2) daily for 3 consecutive days, every 3 weeks for 4 cycles. Rituximab was administered at a dose of 375 mg/m(2) beginning 2 weeks after the first course of fludarabine and cyclophosphamide and then on Day 1 of each cycle thereafter. The planned treatment duration was 10 weeks.
Overall, 92% of patients completed the planned therapy in 10 to 14 weeks and 74% achieved a complete response (CR). Among patients with BCL2-positive bone marrow, 86% obtained a molecular disease remission (MR). The median survival from treatment (SFT), the duration of disease remission (DR), and time to disease progression (TTP) had not been reached after a median follow-up of 45 months. Of the baseline characteristics, >2 previous treatments, BCL2-positive bone marrow, and low Follicular Lymphoma International Prognostic Index (FLIPI) score were found to be associated with better DR and/or TTP. Hematologic toxicity was transient and reversible, with the exception of 3 patients with severe and prolonged neutropenia. Three patients presented with infections, 1 of whom died of bronchopneumonia.
The FC+R scheme, a nonanthracycline-containing regimen lasting up to 10 weeks, was found to be relatively well-tolerated and demonstrated significant antilymphoma activity with excellent clinical CR and molecular response rates.
本研究旨在评估利妥昔单抗联合氟达拉滨和环磷酰胺治疗复发性滤泡性淋巴瘤（FL）患者的安全性和临床活性。
本研究为非对照、多中心、II期研究。2000年3月至2002年12月，54例复发性FL患者入组FC+R试验。患者接受剂量为25mg/m²的氟达拉滨和剂量为300mg/m²的环磷酰胺，连续3天每日给药，每3周1次，共4个周期。利妥昔单抗在第一个疗程的氟达拉滨和环磷酰胺治疗开始2周后以375mg/m²的剂量给药，此后在每个周期的第1天给药。计划治疗持续时间为10周。
总体而言，92%的患者在10至14周内完成了计划治疗，74%达到完全缓解（CR）。在BCL2阳性骨髓患者中，86%获得分子疾病缓解（MR）。中位随访45个月后，治疗后中位生存期（SFT）、疾病缓解持续时间（DR）和疾病进展时间（TTP）均未达到。在基线特征中，既往接受过>2次治疗、BCL2阳性骨髓和低滤泡性淋巴瘤国际预后指数（FLIPI）评分与更好的DR和/或TTP相关。血液学毒性是短暂且可逆的，但有3例患者出现严重且持续时间长的中性粒细胞减少。3例患者出现感染，其中1例死于支气管肺炎。
FC+R方案是一种不含蒽环类药物的方案，持续时间长达10周，耐受性相对良好，具有显著的抗淋巴瘤活性，临床CR和分子反应率优异。
