Shoji Satoshi, Miura Satoru, Watanabe Satoshi, Ohtsubo Aya, Nozaki Koichiro, Saida Yu, Ichikawa Kosuke, Kondo Rie, Tanaka Tomohiro, Koyama Kenichi, Tanaka Hiroshi, Okajima Masaaki, Abe Tetsuya, Ota Takeshi, Ishida Takashi, Makino Masato, Iwashima Akira, Sato Kazuhiro, Matsumoto Naoya, Yoshizawa Hirohisa, Kikuchi Toshiaki
Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
Transl Lung Cancer Res. 2022 Jul;11(7):1359-1368. doi: 10.21037/tlcr-22-89.
This multicenter, open-label, single-arm phase II study [Niigata Lung Cancer Treatment Group (NLCTG) 1302] was conducted to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) monotherapy for previously treated patients with advanced non-small cell lung cancer (NSCLC). We also investigated chemotherapy-induced peripheral neuropathy (CIPN) to evaluate the quality of life (QOL).
Sixty-five patients with advanced NSCLC from 14 participating institutions who had previously undergone one or two cytotoxic chemotherapy regimens were enrolled in this study. The patients received 100 mg/m nab-paclitaxel intravenously on days 1, 8, and 15, every 4 weeks. The primary endpoint was overall objective response rate. CIPN symptoms were prospectively assessed using the Patient Neurotoxicity Questionnaire (PNQ) and Common Terminology Criteria for Adverse Events (CTCAE).
The overall response rate (ORR) was 18.5% [95% confidence interval (CI): 10.9-29.6%], and the median progression-free survival (PFS) was 3.4 (95% CI: 2.5-4.3) months. Median overall survival (OS) was 8.6 (95% CI: 7.1-10.2) months. The most common non-hematologic grade ≥3 adverse events were infection (7.7%) and hyponatremia (4.6%). Neutropenia was the most common grade 3 or 4 adverse event (30.8%), and febrile neutropenia developed in 6.2% patients. The PNQ and CTCAE scores for motor peripheral neuropathy were low (kappa =0.10).
The primary endpoint was achieved. Nab-paclitaxel was well tolerated and showed anti-tumor activity in patients with previously treated NSCLC. This study demonstrates a low degree of concordance in CIPN grading between physicians and patients.
University hospital Medical Information Network Clinical Trial Registry (ID: UMIN000012343).
本多中心、开放标签、单臂II期研究[新潟肺癌治疗组（NLCTG）1302]旨在评估纳米白蛋白结合型紫杉醇（nab-紫杉醇）单药治疗既往接受过治疗的晚期非小细胞肺癌（NSCLC）患者的疗效和安全性。我们还对化疗引起的周围神经病变（CIPN）进行了调查，以评估生活质量（QOL）。
本研究纳入了来自14个参与机构的65例晚期NSCLC患者，这些患者既往接受过一或两种细胞毒性化疗方案。患者每4周在第1、8和15天静脉注射100mg/m² nab-紫杉醇。主要终点为总体客观缓解率。使用患者神经毒性问卷（PNQ）和不良事件通用术语标准（CTCAE）对CIPN症状进行前瞻性评估。
总体缓解率（ORR）为18.5%[95%置信区间（CI）：10.9 - 29.6%]，中位无进展生存期（PFS）为3.4（95%CI：2.5 - 4.3）个月。中位总生存期（OS）为8.6（95%CI：7.1 - 10.2）个月。最常见的非血液学≥3级不良事件为感染（7.7%）和低钠血症（4.6%）。中性粒细胞减少是最常见的3或4级不良事件（30.8%），6.2%的患者发生发热性中性粒细胞减少。运动性周围神经病变的PNQ和CTCAE评分较低（kappa = 0.10）。
达到了主要终点。Nab-紫杉醇耐受性良好，在既往接受过治疗的NSCLC患者中显示出抗肿瘤活性。本研究表明医生和患者之间CIPN分级的一致性程度较低。
大学医院医学信息网络临床试验注册中心（ID：UMIN000012343）。
