Phase II study of nanoparticle albumin-bound paclitaxel monotherapy for relapsed non-small cell lung cancer with patient-reported outcomes (NLCTG1302).

Abstract

Background:

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).

Methods:

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/m2 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).

Results:

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).

Conclusions:

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.

Trial Registration:

University hospital Medical Information Network Clinical Trial Registry (ID: UMIN000012343).

• Authors: Satoshi Shoji, Satoru Miura, Satoshi Watanabe, Aya Ohtsubo, Koichiro Nozaki, Yu Saida, Kosuke Ichikawa, Rie Kondo, Tomohiro Tanaka, Kenichi Koyama, Hiroshi Tanaka, Masaaki Okajima, Tetsuya Abe, Takeshi Ota, Takashi Ishida, Masato Makino, Akira Iwashima, Kazuhiro Sato, Naoya Matsumoto, Hirohisa Yoshizawa, Toshiaki Kikuchi
• Journal: Translational lung cancer research (Transl Lung Cancer Res) Vol. 11 Issue 7 Pg. 1359-1368 (Jul 2022) ISSN: 2218-6751 [Print] China
• PMID: 35958345 (Publication Type: Journal Article)
• Copyright: 2022 Translational Lung Cancer Research. All rights reserved.