1. Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402
- Author
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Toshiyuki Harada, Daisuke Jingu, Mami Morita, Akira Inoue, Hisashi Tanaka, Atsushi Nakamura, Shunichi Gamou, Taku Nakagawa, Eisaku Miyauchi, Ryota Saito, and Tomoya Kuda
- Subjects
Pulmonary and Respiratory Medicine ,Male ,non‐small cell lung cancer ,medicine.medical_specialty ,Lung Neoplasms ,Paclitaxel ,phase I/II trial ,Gastroenterology ,chemistry.chemical_compound ,Internal medicine ,Albumins ,Carcinoma, Non-Small-Cell Lung ,nab‐PTX monotherapy ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Clinical endpoint ,Humans ,In patient ,Lung cancer ,Adverse effect ,RC254-282 ,Nab-paclitaxel ,Aged ,Platinum ,Aged, 80 and over ,business.industry ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,General Medicine ,Original Articles ,Middle Aged ,medicine.disease ,Progression-Free Survival ,Phase i ii ,Oncology ,chemistry ,Original Article ,Female ,Non small cell ,business - Abstract
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/m2) 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/m2) and 12 patients in phase II were treated with 150 mg/m2. In the phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, 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., We conducted the first prospective multicenter phase I/II trial to evaluate the efficacy and safety of biweekly nab‐PTX treatment in patients with previously treated advanced NSCLC. In phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, the objective response rate was 22%; median progression‐free and overall survival was 3.6 and 11.2 months, respectively.
- Published
- 2021