Phase II Study of the Modified Weekly Nab-paclitaxel Regimen in Previously Treated Patients With Advanced Non?Small Cell Lung Cancer
Phase II Study of the Modified Weekly Nab-paclitaxel Regimen in Previously Treated Patients With Advanced Non?Small Cell Lung Cancer
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对既往接受过治疗的晚期非小细胞肺癌患者进行改良每周白蛋白结合型紫杉醇治疗方案的 II 期研究
DOI：
10.1097/coc.0000000000000876
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Hirata Kazuto
中科院分区：
文献类型：
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作者：
Yoshimura Naruo;Sawa Kenji;Nakai Toshiyuki;Matsumoto Yoshiya;Mitsuoka Shigeki;Kimura Tatsuo;Asai Kazuhisa;Yana Takashi;Kawaguchi Tomoya;Hirata Kazuto
目的：我们进行了一项临床 II 期研究，以评估改良的每周一次纳米颗粒白蛋白结合紫杉醇 (nab-paclitaxel) 方案对预先治疗的晚期非小细胞肺癌 (NSCLC) 患者的影响。 材料和方法：这项多中心单组 II 期研究纳入了既往接受过 > 1 种化疗方案的晚期 NSCLC 患者。患者在第1、8和15天（21天周期）接受80 mg/m 2 白蛋白结合型紫杉醇。主要终点是研究者评估的总体缓解率（ORR）。次要终点包括总生存期、无进展生存期（PFS）、疾病控制率和安全性。根据 Simon 2 阶段极小极大设计，计划入组 30 名患者。结果：2015 年 11 月至 2017 年 8 月期间入组 30 名患者。17 名患者 (56.7%) 接受了 > 2 种治疗方案。 ORR 为 23.3%（95% 置信区间 [CI]，8.2%-38.4%），满足研究的主要目标。中位 PFS 为 5.7 个月（95% CI，3.4-9.0 个月），中位总生存期为 12.6 个月（95% CI，8.7-20.8 个月）。整个研究期间的中位治疗周期数为 4 个（范围为 1 至 20 个），中位剂量强度为 63.6 mg/m 2/周（范围为 45.7 至 100.0 mg/m 2/周）。没有报告新的安全信号；最常见的≥3级不良事件是中性粒细胞减少症（56.7%）、白细胞减少症（23.3%）和感染（10.0%）。未观察到发热性中性粒细胞减少症病例。结论：针对既往接受过治疗的 NSCLC 患者，采用适合门诊患者的剂量和方案的白蛋白结合型紫杉醇单药治疗显示出高 ORR、长中位 PFS 和可接受的毒性。这种剂量方法可能对选定的患者有用。
Objectives:We conducted a clinical phase II study to evaluate the modified weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) regimen in pretreated patients with advanced non–small cell lung cancer (NSCLC).Materials and Methods:This multicenter single-arm phase II study enrolled patients with advanced NSCLC who had previously received> 1 chemotherapy regimen. Patients received nab-paclitaxel at 80 mg/m 2 on days 1, 8, and 15 (21-d cycle). The primary endpoint was the investigator-assessed overall response rate (ORR). Secondary endpoints included overall survival, progression-free survival (PFS), disease control rate, and safety. The planned enrollment was 30 patients according to a Simon 2-stage minimax design.Results:Thirty patients were enrolled between November 2015 and August 2017. Seventeen patients (56.7%) had received> 2 regimens. The ORR was 23.3%(95% confidence interval [CI], 8.2%-38.4%), meeting the primary objective of the study. Median PFS was 5.7 months (95% CI, 3.4-9.0 mo), and median overall survival was 12.6 months (95% CI, 8.7-20.8 mo). The median number of treatment cycles was 4 (range, 1 to 20) over the entire study period, and median dose intensity was 63.6 mg/m 2/wk (range, 45.7 to 100.0 mg/m 2/wk). No new safety signals were reported; the most common grade≥ 3 adverse events were neutropenia (56.7%), leukopenia (23.3%), and infection (10.0%). No cases of febrile neutropenia were observed.Conclusions:Nab-paclitaxel monotherapy with a dose and schedule suitable for outpatients showed high ORR, long median PFS, and acceptable toxicity for patients with previously treated NSCLC. This dosage method may be useful for selected patients.