Kazumi Nishino1, Fumio Imamura2, Toru Kumagai2, Nobuyuki Katakami3, Akito Hata3, Chiyuki Okuda3, Yoshiko Urata4, Yosihihiro Hattori4, Motoko Tachihara5, Souichirou Yokota6, Takashi Nishimura7, Toshihiko Kaneda8, Miyako Satouchi4, Satoshi Morita9, Shunichi Negoro10. 1. Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan. Electronic address: nishinishipptruth@yahoo.co.jp. 2. Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan. 3. Division of Integrated Oncology, Institute of Biomedical Research and Innovation, 2-2, Minatojima Minamimachi Chuo-ku, Kobe, Hyogo 650-0047, Japan. 4. Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan. 5. Department of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. 6. Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka, Japan. 7. Department of Respiratory Medicine, Kyoto Katsura Hospital, Kyoto, Japan. 8. Department of Respiratory Medicine, Kobe City Medical Center, West Hospital, Kobe, Japan. 9. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 10. Department of Medical Oncology, Hyogo Cancer Center, Akashi, Japan.
Abstract
OBJECTIVES: This randomized phase II trial investigated the efficacy and safety of docetaxel plus bevacizumab and S-1 plus bevacizumab in the second-line treatment of non-squamous (non-Sq) non-small-cell lung cancer (NSCLC). MATERIALS AND METHODS:Patients with non-Sq NSCLC who experienced disease progression after prior platinum-based chemotherapy with or withoutbevacizumab were randomly assigned to receive docetaxel plus bevacizumab (DB) once every 3 weeks or S-1 orally twice daily on days 1-14 plus bevacizumab (SB) on day 1 every 3 weeks until disease progression. RESULTS:Ninety patients were randomized. The median progression-free survival (PFS) was 3.9 months (95% confidence interval [CI]=3.0-6.5) in DB and 3.5 months (95% CI=2.9-5.9) in SB. The objective response rate was significantly higher in DB than in SB (22.2% vs. 2.2%; P=0.004), whereas the disease control rates of the arms were identical (62.2% vs. 62.2%; P=1.00). Patients receiving DB were more likely to have ≥grade 3 neutropenia (93.4% vs. 4.4%) and febrile neutropenia (33.3% vs. 0%) than SB. In DB, PFS and overall survival (OS) were significantly longer among bevacizumab-naïve patients than among bevacizumab-experienced patients (median PFS: 7.2 vs. 2.9 months; P=0.004; and median OS: 21.3 vs. 14.1 months; P=0.012). CONCLUSION:DB and SB produced modest PFS benefits in the second-line treatment of patients with advanced non-Sq NSCLC. Because of the toxicity of DB and the low response rate of SB, neither regimen warrants further investigation, excluding DB in bevacizumab-naïve patients with advanced non-Sq NSCLC.
RCT Entities:
OBJECTIVES: This randomized phase II trial investigated the efficacy and safety of docetaxel plus bevacizumab and S-1 plus bevacizumab in the second-line treatment of non-squamous (non-Sq) non-small-cell lung cancer (NSCLC). MATERIALS AND METHODS:Patients with non-Sq NSCLC who experienced disease progression after prior platinum-based chemotherapy with or without bevacizumab were randomly assigned to receive docetaxel plus bevacizumab (DB) once every 3 weeks or S-1 orally twice daily on days 1-14 plus bevacizumab (SB) on day 1 every 3 weeks until disease progression. RESULTS: Ninety patients were randomized. The median progression-free survival (PFS) was 3.9 months (95% confidence interval [CI]=3.0-6.5) in DB and 3.5 months (95% CI=2.9-5.9) in SB. The objective response rate was significantly higher in DB than in SB (22.2% vs. 2.2%; P=0.004), whereas the disease control rates of the arms were identical (62.2% vs. 62.2%; P=1.00). Patients receiving DB were more likely to have ≥grade 3 neutropenia (93.4% vs. 4.4%) and febrile neutropenia (33.3% vs. 0%) than SB. In DB, PFS and overall survival (OS) were significantly longer among bevacizumab-naïve patients than among bevacizumab-experienced patients (median PFS: 7.2 vs. 2.9 months; P=0.004; and median OS: 21.3 vs. 14.1 months; P=0.012). CONCLUSION:DB and SB produced modest PFS benefits in the second-line treatment of patients with advanced non-Sq NSCLC. Because of the toxicity of DB and the low response rate of SB, neither regimen warrants further investigation, excluding DB in bevacizumab-naïve patients with advanced non-Sq NSCLC.
Authors: Adrian D Vickers; Katherine B Winfree; Gebra Cuyun Carter; Urpo Kiiskinen; Min-Hua Jen; Donald Stull; James A Kaye; David P Carbone Journal: BMC Cancer Date: 2019-04-15 Impact factor: 4.430