1. A Phase I/II Study of Biweekly Carboplatin and Nab-paclitaxel With Concurrent Radiotherapy for Patients With Locally Advanced Unresectable Stage III Non–small-cell Lung Cancer
- Author
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Tomonori Makiguchi, Masamichi Itoga, Yoshiomi Hatayama, Hisashi Tanaka, Kageaki Taima, Junichi Yokouchi, Yoshiko Ishioka, Fumihiko Okumura, Yukihiro Hasegawa, Toshihiro Shiratori, Chiori Tabe, Sadatomo Tasaka, and Masahiko Aoki
- Subjects
Adult ,Male ,0301 basic medicine ,Pulmonary and Respiratory Medicine ,Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,Maximum Tolerated Dose ,Paclitaxel ,medicine.medical_treatment ,Urology ,Adenocarcinoma of Lung ,Neutropenia ,Carboplatin ,Young Adult ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Albumins ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Clinical endpoint ,Humans ,Lung cancer ,Aged ,Retrospective Studies ,Pneumonitis ,business.industry ,Standard treatment ,Chemoradiotherapy ,Middle Aged ,Prognosis ,medicine.disease ,Confidence interval ,Survival Rate ,Radiation therapy ,030104 developmental biology ,Oncology ,chemistry ,030220 oncology & carcinogenesis ,Carcinoma, Squamous Cell ,Female ,business ,Follow-Up Studies - Abstract
Background Concurrent chemoradiotherapy (CCRT) is the standard treatment for patients with locally advanced non–small-cell lung cell cancer (LA-NSCLC). We conducted a phase I/II study of biweekly carboplatin and nab-paclitaxel (nab-PTX) with radiotherapy (RT). Materials and Methods In the phase I part, patients with inoperable stage IIIA/IIIB NSCLC were treated with carboplatin (area under the time-concentration curve, 4) and nab-PTX (60-100 mg/m2) on days 1, 15, and 29. Thoracic RT was administered from day 1 to a total dose of 60 Gy in 30 fractions. In the phase II part, patients were administered carboplatin and nab-PTX on days 1, 15, and 29 at the recommended dose (RD). The primary endpoint of the phase I part was to determine the maximum tolerated dose and the RD. In the phase II part, the primary endpoint was 2-year overall survival (OS) rate, and secondary endpoints were the objective response rate, progression-free survival, OS, and safety profile. Results In the phase I part, although maximum tolerated dose was not obtained, the RD was carboplatin (area under the time-concentration curve, 4) and nab-PTX (100 mg/m2). Of the evaluable 28 patients, the rate of 2-year OS was 67.8% (95% confidence interval, 49.3%-82.1%). The objective response rate was 96.4%, and the median follow-up time was 33.2 months. The median progression-free survival was 18.2 months (95% confidence interval, 13.1 months to not reached). The most common toxicities of grade 3 or higher were neutropenia (60.5%), anemia (14.2%), thrombocytopenia (7.2%), and pneumonitis (3.6%). Conclusions This study achieved the primary endpoint. Biweekly carboplatin and nab-PTX with concurrent RT was well-tolerated and exerted promising antitumor activity.
- Published
- 2021