Open AccessPhase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402
Author(s) -
Miyauchi Eisaku,
Tanaka Hisashi,
Nakamura Atsushi,
Harada Toshiyuki,
Nakagawa Taku,
Morita Mami,
Jingu Daisuke,
Kuda Tomoya,
Gamou Shunichi,
Saito Ryota,
Inoue Akira
Publication year - 2021
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.14149
Subject(s) - medicine , clinical endpoint , lung cancer , paclitaxel , nab paclitaxel , phases of clinical research , gastroenterology , adverse effect , oncology , chemotherapy , surgery , clinical trial
Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin‐bound paclitaxel (nab‐PTX) in patients with advanced non‐small cell lung cancer (NSCLC). Methods The study included patients aged ≥20 years with previously treated NSCLC. Nab‐PTX (100–150 mg/m 2 ) was administered biweekly in a 28‐day cycle. The phase I portion was performed to determine the recommended phase II dose of nab‐PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression‐free survival, overall survival, and safety. Results A total of 15 patients received biweekly nab‐PTX (100–150 mg/m 2 ) and 12 patients in phase II were treated with 150 mg/m 2 . In the phase I portion, 150 mg/m 2 was determined as the recommended dose. Among those treated with 150 mg/m 2 , the objective response rate was 22%, and the median progression‐free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients. Conclusions Biweekly nab‐PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.