文章：

奥法木单抗维持治疗延长复发性慢性淋巴细胞白血病无进展生存期：PROLONG研究最终分析

Ofatumumab maintenance prolongs progression-free survival in relapsed chronic lymphocytic leukemia: final analysis of the PROLONG study

原文发布日期：2019-12-04

DOI: 10.1038/s41408-019-0260-2

类型: Article

开放获取: 是

英文摘要：

We report the final analysis of the PROLONG study on ofatumumab maintenance in relapsed chronic lymphocytic leukemia (CLL). In all, 480 patients with CLL in complete or partial remission after second- or third-line treatment were randomized 1:1 to ofatumumab (300 mg first week, followed by 1000 mg every 8 weeks for up to 2 years) or observation. Median follow-up duration was 40.9 months. Median progression-free survival was 34.2 and 16.9 months for ofatumumab and observation arms, respectively, (hazard ratio, 0.55 [95% confidence interval, 0.43–0.70]; P < 0.0001). Median time to next treatment for ofatumumab and observation arms, respectively, was 37.4 and 27.6 months (0.72 [0.57–0.91]; P = 0.0044). Overall survival was similar in both arms; median was not reached (0.99 [0.72–1.37]). Grade ≥ 3 adverse events occurred in 62% and 51% of patients in ofatumumab and observation arms, respectively, the most common being neutropenia (23% and 10%), pneumonia (13% and 12%) and febrile neutropenia (6% and 4%). Up to 60 days after the last treatment, four deaths were reported in the ofatumumab arm versus six in the observation arm, none considered related to ofatumumab. Ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.
 

摘要翻译： 

本文报告PROLONG研究中关于奥法木单抗维持治疗复发型慢性淋巴细胞白血病（CLL）的最终分析结果。该研究共纳入480例经二线或三线治疗后达到完全或部分缓解的CLL患者，按1:1随机分配至奥法木单抗组（首周300mg，随后每8周1000mg，最长治疗2年）或观察组。中位随访时间为40.9个月。奥法木单抗组与观察组的中位无进展生存期分别为34.2个月和16.9个月（风险比0.55[95%置信区间0.43-0.70]；P＜0.0001）；中位至下次治疗时间分别为37.4个月和27.6个月（0.72[0.57-0.91]；P=0.0044）。两组总生存期相近，均未达到中位值（0.99[0.72-1.37]）。奥法木单抗组与观察组分别有62%和51%患者发生≥3级不良事件，最常见包括中性粒细胞减少症（23% vs 10%）、肺炎（13% vs 12%）和发热性中性粒细胞减少症（6% vs 4%）。末次治疗60天内，奥法木单抗组报告4例死亡，观察组6例，均评估为与奥法木单抗无关。奥法木单抗维持治疗能显著延长复发型CLL患者的无进展生存期，且耐受性良好。

原文链接：

Ofatumumab maintenance prolongs progression-free survival in relapsed chronic lymphocytic leukemia: final analysis of the PROLONG study