Long-Term Follow-Up of Patients With Follicular Lymphoma Receiving Single-Agent Rituximab at Two Different Schedules in Trial SAKK 35/98
Long-Term Follow-Up of Patients With Follicular Lymphoma Receiving Single-Agent Rituximab at Two Different Schedules in Trial SAKK 35/98
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DOI：
10.1200/jco.2010.28.4786
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发表时间：
2010-10-10
影响因子：
45.3
通讯作者：
Ghielmini, Michele
中科院分区：
文献类型：
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作者：
Martinelli, Giovanni;Schmitz, Shu-Fang Hsu;Ghielmini, Michele
目的 我们报告了一项随机临床试验的长期结果，该试验比较了滤泡性淋巴瘤患者每周一次、持续 4 周的单药利妥昔单抗诱导治疗与诱导后每 2 个月进行 4 个周期的维持治疗。 患者和方法 患者（之前接受过化疗 138 例；未接受过化疗 64 例）接受了单药利妥昔单抗治疗，如果病情没有进展，则被随机分配接受不进一步治疗（观察）或额外接受 4 剂治疗。间隔 2 个月给予利妥昔单抗（延长暴露）。 结果 在中位随访 9.5 年且所有活着的患者均已观察至少 5 年时，观察组的中位无事件生存期 (EFS) 为 13 个月，延长暴露组为 24 个月 (P
Purpose We report the long-term results of a randomized clinical trial comparing induction therapy with once per week for 4 weeks single-agent rituximab alone versus induction followed by 4 cycles of maintenance therapy every 2 months in patients with follicular lymphoma.Patients and Methods Patients (prior chemotherapy 138; chemotherapy-naive 64) received single-agent rituximab and if nonprogressive, were randomly assigned to no further treatment (observation) or four additional doses of rituximab given at 2-month intervals (prolonged exposure).Results At a median follow-up of 9.5 years and with all living patients having been observed for at least 5 years, the median event-free survival (EFS) was 13 months for the observation and 24 months for the prolonged exposure arm (P