Umberto Vitolo, Marco Ladetto, Carola Boccomini, Barbara Botto, Annalisa Chiappella, Andrea Evangelista, Chiara Lobetti-Bodoni, and Giovannino Ciccone, Città della Salute e della Scienza Hospital and University, Turin; Luca Baldini, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Università di Milano, Milan; Federico De Angelis, Sapienza University, Rome; Alessandra Tucci and Giuseppe Rossi, Spedali Civili Hospital and University, Brescia; Annalisa Chiarenza, Ferrarotto Hospital, Catania; Antonello Pinto, National Institute for Study and Cure of Tumors, Pascale Foundation; Amalia De Renzo, Federico II University, Napoli; Francesco Zaja, Santa Maria della Misericordia Hospital and University, Udine; Claudia Castellino, Santa Croce and Carle Hospital, Cuneo; Alessia Bari, University of Modena and Reggio Emilia, Modena; Isabel Alvarez De Celis, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia; Guido Parvis, San Luigi Gonzaga Hospital and University, Orbassano; and Enrica Gamba, Roche Italia, Monza, Italy.
J Clin Oncol. 2013 Sep 20;31(27):3351-9. doi: 10.1200/JCO.2012.44.8290. Epub 2013 Aug 19.
To evaluate the efficacy of rituximab maintenance in 60- to 75-year-old patients with advanced follicular lymphoma responding to brief first-line chemoimmunotherapy followed by rituximab consolidation.
A total of 234 treatment-naive 60- to 75-year-old patients began chemoimmunotherapy with four monthly courses of rituximab, fludarabine, mitoxantrone, and dexamethasone (R-FND) followed by four weekly cycles of rituximab consolidation. Of these, 210 patients completed the planned treatment, and 202 responders were randomly assigned to rituximab maintenance (arm A) for 8 months, once every 2 months for a total of four doses, or to observation (arm B).
Median ages in arms A and B were 66 and 65 years, respectively. After induction and consolidation therapy, the overall response rate was 86%, with 69% complete remissions (CR). After a 42-month median follow-up from diagnosis, 3-year progression-free survival (PFS; the primary end point) and overall survival (OS) were 66% (95% CI, 59% to 72%) and 89% (95% CI, 85% to 93%), respectively. After randomization, 2-year PFS was 81% for rituximab maintenance versus 69% for observation, with a hazard ratio of 0.74 (95% CI, 0.45 to 1.21; P = .226), although this was not statistically significant. No differences between the two arms were detected for OS. Overall, the regimen was well-tolerated. The most frequent grade 3 to 4 toxicity was neutropenia (25% of treatment courses), with 13 infections. Two toxic deaths (0.8%) occurred during induction treatment.
A brief R-FND induction plus rituximab consolidation achieved excellent results with high CR and PFS rates, supporting the feasibility of this regimen in patients older than 60 years. A short rituximab maintenance did not achieve a statistically significant PFS improvement over observation.
评估利妥昔单抗维持治疗在接受简短一线化疗免疫治疗后缓解的 60-75 岁晚期滤泡淋巴瘤患者中的疗效，这些患者随后接受利妥昔单抗巩固治疗。
共有 234 名未经治疗的 60-75 岁初治患者接受化疗免疫治疗，方案为 4 个疗程的利妥昔单抗、氟达拉滨、米托蒽醌和地塞米松（R-FND），随后进行 4 个疗程的每周利妥昔单抗巩固治疗。其中 210 名患者完成了计划治疗，202 名缓解者被随机分配至利妥昔单抗维持治疗（A 组）8 个月，每 2 个月一次，共 4 个剂量，或观察（B 组）。
A 组和 B 组的中位年龄分别为 66 岁和 65 岁。诱导和巩固治疗后，总缓解率为 86%，完全缓解率为 69%。从诊断后中位随访 42 个月时，3 年无进展生存率（PFS；主要终点）和总生存率（OS）分别为 66%（95%CI，59%至 72%）和 89%（95%CI，85%至 93%）。随机分组后，利妥昔单抗维持治疗组的 2 年 PFS 为 81%，而观察组为 69%，风险比为 0.74（95%CI，0.45 至 1.21；P=0.226），但差异无统计学意义。两组之间 OS 无差异。总体而言，该方案耐受性良好。最常见的 3 级至 4 级毒性是中性粒细胞减少症（25%的治疗疗程），共发生 13 例感染。诱导治疗期间发生 2 例毒性死亡（0.8%）。
简短的 R-FND 诱导加利妥昔单抗巩固治疗取得了优异的结果，完全缓解率和 PFS 率均较高，支持该方案在 60 岁以上患者中的可行性。与观察组相比，短疗程利妥昔单抗维持治疗并未显著改善 PFS。
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