Yasuto Yoneshima1, Satoshi Morita2, Masahiko Ando3, Atsushi Nakamura4, Shunichiro Iwasawa5, Hiroshige Yoshioka6, Yasuhiro Goto7, Masafumi Takeshita8, Toshiyuki Harada9, Katsuya Hirano10, Tetsuya Oguri11, Masashi Kondo7, Satoru Miura12, Yukio Hosomi13, Terufumi Kato14, Toshio Kubo15, Junji Kishimoto16, Nobuyuki Yamamoto17, Yoichi Nakanishi18, Isamu Okamoto19. 1. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 2. Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 3. Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan. 4. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan. 5. Department of Respirology, Chiba University Hospital, Chiba, Japan. 6. Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan. 7. Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Japan. 8. Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 9. Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan. 10. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. 11. Department of Education and Research Center for Community Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 12. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. 13. Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan. 14. Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan. 15. Center for Clinical Oncology, Okayama University Hospital, Okayama, Japan. 16. Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan. 17. Internal Medicine III, Wakayama Medical University, Wakayama, Japan. 18. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan. 19. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: okamotoi@kokyu.med.kyushu-u.ac.jp.
Abstract
INTRODUCTION: We aimed to evaluate the efficacy and safety of nanoparticle albumin-bound (nab-) paclitaxel for previously treated patients with advanced NSCLC. METHODS: In this randomized, open-label, noninferiority phase 3 trial, we enrolled patients with advanced NSCLC previously treated withcytotoxic chemotherapy. Patients were randomly allocated (1:1) to receive docetaxel (60 mg/m2) on day 1 or nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle. The primary end point was overall survival (OS) analyzed on an intention-to-treat basis. RESULTS:Between May 22, 2015, and March 12, 2018, a total of 503 patients were randomly allocated to the treatment. Median OS was 16.2 months (95% confidence interval [CI]: 14.4-19.0) for the 252 patients allocated to nab-paclitaxel and 13.6 months (95% CI: 10.9-16.5) for the 251 patients allocated to docetaxel (hazard ratio = 0.85, 95.2% CI: 0.68-1.07). Median progression-free survival was 4.2 months (95% CI: 3.9-5.0) for the nab-paclitaxel group versus 3.4 months (95% CI: 2.9-4.1) for the docetaxel group (hazard ratio = 0.76, 95% CI: 0.63-0.92, p = 0.0042). The objective response rate was 29.9% (95% CI: 24.0-36.2) for the nab-paclitaxel group and 15.4% (95% CI: 10.9-20.7) for the docetaxel group (p = 0.0002). Adverse events of grade greater than or equal to 3 included febrile neutropenia (5 of 245 patients [2%] in the nab-paclitaxel group versus 55 of 249 patients [22%] in the docetaxel group) and peripheral sensory neuropathy (24 [10%] versus 2 [1%], respectively). CONCLUSIONS:Nab-paclitaxel was noninferior to docetaxel in terms of OS. It should, thus, be considered a standard treatment option for previously treated patients with advanced NSCLC.
RCT Entities:
INTRODUCTION: We aimed to evaluate the efficacy and safety of nanoparticle albumin-bound (nab-) paclitaxel for previously treated patients with advanced NSCLC. METHODS: In this randomized, open-label, noninferiority phase 3 trial, we enrolled patients with advanced NSCLC previously treated with cytotoxic chemotherapy. Patients were randomly allocated (1:1) to receive docetaxel (60 mg/m2) on day 1 or nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle. The primary end point was overall survival (OS) analyzed on an intention-to-treat basis. RESULTS: Between May 22, 2015, and March 12, 2018, a total of 503 patients were randomly allocated to the treatment. Median OS was 16.2 months (95% confidence interval [CI]: 14.4-19.0) for the 252 patients allocated to nab-paclitaxel and 13.6 months (95% CI: 10.9-16.5) for the 251 patients allocated to docetaxel (hazard ratio = 0.85, 95.2% CI: 0.68-1.07). Median progression-free survival was 4.2 months (95% CI: 3.9-5.0) for the nab-paclitaxel group versus 3.4 months (95% CI: 2.9-4.1) for the docetaxel group (hazard ratio = 0.76, 95% CI: 0.63-0.92, p = 0.0042). The objective response rate was 29.9% (95% CI: 24.0-36.2) for the nab-paclitaxel group and 15.4% (95% CI: 10.9-20.7) for the docetaxel group (p = 0.0002). Adverse events of grade greater than or equal to 3 included febrile neutropenia (5 of 245 patients [2%] in the nab-paclitaxel group versus 55 of 249 patients [22%] in the docetaxel group) and peripheral sensory neuropathy (24 [10%] versus 2 [1%], respectively). CONCLUSIONS:Nab-paclitaxel was noninferior to docetaxel in terms of OS. It should, thus, be considered a standard treatment option for previously treated patients with advanced NSCLC.