Phase I/II Study of Cisplatin plus Nab-Paclitaxel with Concurrent Thoracic Radiotherapy for Patients with Locally Advanced Non-Small Cell Lung Cancer

The oncologist

article

Hidetoshi Hayashi¹  Yasuhito Fujisaka²  Kaoru Tanaka¹  Yoshikazu Hasegawa³  Keita Kudo⁴  Yasutaka Chiba⁵  Kazuhiko Nakagawa¹  Masakazu Ogura⁶  Takashi Niwa⁷  Toshihide Yokoyama⁷  Junko Tanizaki⁸  Tomohiro Ozaki⁸  Hiroshige Yoshioka⁹  Takayasu Kurata⁹  Yosuke Tamura^1,10 

[1] Department of Medical Oncology, Faculty of Medicine, Kindai University;Clinical Research Center, Osaka Medical College Hospital;Department of Medical Oncology, Izumi City General Hospital;Department of Thoracic Medical Oncology, National Hospital Organization Osaka Minami Medical Center;Clinical Research Center, Kindai University Hospital;Department of Radiation Oncology, Kishiwada City Hospital;Department of Respiratory Medicine, Kurashiki Central Hospital;Department of Medical Oncology, Kishiwada City Hospital;Department of Thoracic Oncology, Kansai Medical University Hospital;Department of Respiratory Medicine and Thoracic Oncology, Osaka Medical College Hospital

关键词: Cisplatin;    Dose-limiting toxicity;    nab-Paclitaxel;    Radiotherapy;    Non-small cell lung cancer;   

DOI  :  10.1002/ONCO.13524

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background. We conducted a phase I/II trial of cisplatin plus nab-paclitaxel with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (NSCLC) to determine the recommended dose (RD) of nab-paclitaxel and to evaluate the safety and efficacy of this regimen. Methods. In the phase I study, escalating doses of weekly nab-paclitaxel were administered together with cisplatin at 75 mg/m2 every 3 weeks and concurrent radiotherapy. In the phase II study, nab-paclitaxel was administered at the RD. Results. In the phase I study, whereas no dose-limiting toxicity (DLT) was observed with nab-paclitaxel at 50 or 60 mg/m2 , one of six patients experienced DLT (esophagitis of grade 3) at 70 mg/m2 , determined as the RD. Twenty-four patients at RD were evaluable for safety and efficacy in phase II. Common toxicities included esophagitis (87.5%) and leukopenia (79.2%). Pneumonitis and treatment-related deaths were not observed, but 20 patients (83.3%) experienced radiation pneumonitis, with one case of grade 3 and four of grade 2, after completion of concurrent chemoradiotherapy. The 2-year overall survival and progression-free survival rates were 73.9% and 56.5% (95% confidence interval [CI], 34.3%–74.7%), respectively. Conclusion. Concurrent chemoradiation with nab-paclitaxel at 70 mg/m2 and cisplatin at 75 mg/m2 every 3 weeks showed encouraging feasibility and activity for locally advanced NSCLC.

【 授权许可】

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