Ⅱ期研究：每周应用纳米白蛋白结合紫杉醇作为二线或三线治疗晚期非小细胞肺癌。

Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel as Second- or Third-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer.

机构信息

Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan,

Department of Respiratory Medicine, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan,

出版信息

Chemotherapy. 2020;65(1-2):21-28. doi: 10.1159/000508715. Epub 2020 Jul 16.

DOI:10.1159/000508715

PMID:32674095

Abstract

INTRODUCTION

Treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) are poor due to limited treatment options.

OBJECTIVE

We conducted a multicenter, single-arm phase II study to prospectively assess the efficacy and safety of weekly nab-PTX in patients with advanced NSCLC with failed cytotoxic chemotherapy.

METHODS

Patients with advanced NSCLC having adequate organ functions with a performance status of 0-1 were enrolled. A 100 mg/m2 dose of nab-paclitaxel was administered on days 1, 8, and 15 of a 28-day cycle. Primary endpoint was the objective response rate (ORR). Secondary endpoints were disease control rate (DCR), toxicity profile, progression-free survival (PFS), and overall survival (OS).

RESULTS

Between September 2013 and May 2016, 35 patients were enrolled. The ORR was 31.4%, and the DCR was 74.3%. The median PFS was 3.6 months, and the median OS was 11.4 months. The most common grade 3 or 4 toxicities included neutropenia (54.3%), leukopenia (42.9%), and anemia (11.4%). Two patients discontinued chemotherapy due to pneumonitis.

CONCLUSIONS

Nab-PTX may be a later-line chemotherapeutic option for previously treated advanced NSCLC.

摘要

简介

由于治疗选择有限，晚期非小细胞肺癌（NSCLC）患者的治疗效果不佳。

目的

我们进行了一项多中心、单臂 II 期研究，前瞻性评估每周 nab-PTX 在接受细胞毒性化疗失败的晚期 NSCLC 患者中的疗效和安全性。

方法

招募了具有足够器官功能且表现状态为 0-1 的晚期 NSCLC 患者。在 28 天周期的第 1、8 和 15 天给予 100mg/m2 的 nab-紫杉醇。主要终点是客观缓解率（ORR）。次要终点是疾病控制率（DCR）、毒性谱、无进展生存期（PFS）和总生存期（OS）。

结果

2013 年 9 月至 2016 年 5 月期间，共纳入 35 例患者。ORR 为 31.4%，DCR 为 74.3%。中位 PFS 为 3.6 个月，中位 OS 为 11.4 个月。最常见的 3 级或 4 级毒性包括中性粒细胞减少症（54.3%）、白细胞减少症（42.9%）和贫血（11.4%）。两名患者因肺炎而停止化疗。