一项随机III期研究，比较磷酸氟达拉滨与环磷酰胺、长春新碱和泼尼松用于既往接受过烷化剂或含烷化剂方案治疗的复发性低度非霍奇金淋巴瘤患者。

Randomized phase III study of fludarabine phosphate versus cyclophosphamide, vincristine, and prednisone in patients with recurrent low-grade non-Hodgkin's lymphoma previously treated with an alkylating agent or alkylator-containing regimen.

作者信息

Klasa Richard J, Meyer Ralph M, Shustik Chaim, Sawka Carol A, Smith Anne, Guévin Raymond, Maksymiuk Andrew, Rubinger Morel, Samosh Martin, Laplante Suzanne, Grenier Jean-François

机构信息

Division of Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada.

出版信息

J Clin Oncol. 2002 Dec 15;20(24):4649-54. doi: 10.1200/JCO.2002.11.068.

DOI:10.1200/JCO.2002.11.068

PMID:12488409

Abstract

PURPOSE

To compare in a phase III study the safety and efficacy of fludarabine to that of cyclophosphamide, vincristine, and prednisone (CVP) in recurrent, low-grade, non-Hodgkin's lymphoma after previous response to systemic treatment.

PATIENTS AND METHODS

Patients were randomized to fludarabine (25 mg/m(2) intravenously on days 1 to 5, every 28 days) or CVP (cyclophosphamide 750 mg/m(2) and vincristine 1.2 mg/m(2) both intravenously on day 1 and prednisone 40 mg/m(2) orally on days 1 to 5, every 21 days). The primary outcome assessed was progression-free survival (PFS); secondary outcomes included treatment-free survival (TFS), overall survival (OS), treatment-related toxicity, and quality of life (QoL) according to the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 version 1.0 instrument.

RESULTS

Ninety-one patients were randomized, 47 to fludarabine and 44 to CVP. There was no difference in response rates, with 64% (complete response [CR], 9%) for fludarabine versus 52% (CR, 7%) for CVP (P =.72). With a median follow-up of 42 months, median PFS (11 months v 9.1 months; P =.03) and TFS (15 months v 11 months; P =.02) were superior in patients receiving fludarabine. No difference in median overall survival was detected (57 months for fludarabine v 44 months for CVP; P =.95). Three patients receiving fludarabine died of treatment-related toxicity compared with none of the patients receiving CVP. Peripheral neuropathy and alopecia were more common with CVP. Patients receiving fludarabine had higher scores for social function (P =.008); no other differences in QoL were detected.

CONCLUSION

In recurrent low-grade lymphoma, fludarabine improves PFS, TFS, and social function scores in comparison with CVP but does not improve OS.

摘要

目的

在一项III期研究中，比较氟达拉滨与环磷酰胺、长春新碱和泼尼松（CVP）用于既往接受全身治疗有反应的复发性、低度非霍奇金淋巴瘤的安全性和疗效。

患者与方法

患者被随机分为氟达拉滨组（第1至5天静脉注射25mg/m²，每28天一次）或CVP组（第1天静脉注射环磷酰胺750mg/m²和长春新碱1.2mg/m²，第1至5天口服泼尼松40mg/m²，每21天一次）。评估的主要结局为无进展生存期（PFS）；次要结局包括无治疗生存期（TFS）、总生存期（OS）、治疗相关毒性以及根据欧洲癌症研究与治疗组织生活质量问卷C-30第1.0版工具评估的生活质量（QoL）。

结果

91例患者被随机分组，47例接受氟达拉滨治疗，44例接受CVP治疗。缓解率无差异，氟达拉滨组为64%（完全缓解[CR]，9%），CVP组为52%（CR，7%）（P = 0.72）。中位随访42个月，接受氟达拉滨治疗的患者中位PFS（11个月对9.1个月；P = 0.03）和TFS（15个月对11个月；P = 0.02）更优。未检测到中位总生存期有差异（氟达拉滨组为57个月，CVP组为44个月；P = 0.95）。3例接受氟达拉滨治疗的患者死于治疗相关毒性，而接受CVP治疗的患者无死亡。CVP组周围神经病变和脱发更常见。接受氟达拉滨治疗的患者社会功能评分更高（P = 0.008）；未检测到QoL的其他差异。