Masayuki Takeda1, Takeharu Yamanaka2, Takashi Seto3, Hidetoshi Hayashi4, Koichi Azuma5, Morihito Okada6, Shunichi Sugawara7, Haruko Daga8, Tomonori Hirashima9, Kimio Yonesaka10, Yoshiko Urata11, Haruyasu Murakami12, Haruhiro Saito13, Akihito Kubo14, Toshiyuki Sawa15, Eiji Miyahara16, Naoyuki Nogami17, Kazuhiko Nakagawa1, Yoichi Nakanishi18, Isamu Okamoto18. 1. Department of Medical Oncology, Faculty of Medicine, Kinki University, Osaka, Japan. 2. Department of Biostatistics, Yokohama City University, Yokohama, Japan. 3. Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan. 4. Department of Medical Oncology, Kishiwada City Hospital, Osaka, Japan. 5. Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan. 6. Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan. 7. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan. 8. Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan. 9. Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan. 10. Department of Medical Oncology, Izumi Municipal Hospital, Izumi, Japan. 11. Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan. 12. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. 13. Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan. 14. Division of Respiratory Medicine and Allergology, Aichi Medical University School of Medicine, Nagakute, Japan. 15. Division of Respiratory Medicine, Gifu Municipal Hospital, Gifu, Japan. 16. Department of Surgery, Saiseikai Hiroshima Hospital, Hiroshima, Japan. 17. Department of Thoracic Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan. 18. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Abstract
BACKGROUND:Bevacizumab combined with platinum-based chemotherapy has been established as a standard treatment option in the first-line setting for advanced nonsquamous non-small cell lung cancer (NSCLC). However, there has been no evidence to support the use of bevacizumab beyond disease progression in such patients. METHODS: West Japan Oncology Group 5910L was designed as a multicenter, open-label, randomized, phase 2 trial of docetaxel versus docetaxel plus bevacizumab every 3 weeks for patients with recurrent or metastatic nonsquamous NSCLC whose disease had progressed after first-line treatment withbevacizumab plus a platinum-based doublet. The primary endpoint was progression-free survival (PFS). RESULTS:One hundred patients were randomly assigned to receive docetaxel (n = 50) or docetaxel plus bevacizumab (n = 50), and this yielded median PFS times of 3.4 and 4.4 months, respectively, with a hazard ratio (HR) of 0.71 and a stratified log-rank P value of .058, which met the predefined criterion for statistical significance (P < .2). The median overall survival also tended to be longer in the docetaxel plus bevacizumab group (13.1 months; 95% confidence interval [CI], 10.6-21.4 months) versus the docetaxel group (11.0 months; 95% CI, 7.6-16.1 months) with an HR of 0.74 (95% CI, 0.46-1.19; stratified log-rank P = .11). No unexpected or severe adverse events were recorded. CONCLUSIONS: Further evaluation of bevacizumab beyond disease progression is warranted for patients with advanced NSCLC whose disease has progressed after treatment with bevacizumab plus a platinum-based doublet.
RCT Entities:
BACKGROUND:Bevacizumab combined with platinum-based chemotherapy has been established as a standard treatment option in the first-line setting for advanced nonsquamous non-small cell lung cancer (NSCLC). However, there has been no evidence to support the use of bevacizumab beyond disease progression in such patients. METHODS: West Japan Oncology Group 5910L was designed as a multicenter, open-label, randomized, phase 2 trial of docetaxel versus docetaxel plus bevacizumab every 3 weeks for patients with recurrent or metastatic nonsquamous NSCLC whose disease had progressed after first-line treatment with bevacizumab plus a platinum-based doublet. The primary endpoint was progression-free survival (PFS). RESULTS: One hundred patients were randomly assigned to receive docetaxel (n = 50) or docetaxel plus bevacizumab (n = 50), and this yielded median PFS times of 3.4 and 4.4 months, respectively, with a hazard ratio (HR) of 0.71 and a stratified log-rank P value of .058, which met the predefined criterion for statistical significance (P < .2). The median overall survival also tended to be longer in the docetaxel plus bevacizumab group (13.1 months; 95% confidence interval [CI], 10.6-21.4 months) versus the docetaxel group (11.0 months; 95% CI, 7.6-16.1 months) with an HR of 0.74 (95% CI, 0.46-1.19; stratified log-rank P = .11). No unexpected or severe adverse events were recorded. CONCLUSIONS: Further evaluation of bevacizumab beyond disease progression is warranted for patients with advanced NSCLC whose disease has progressed after treatment with bevacizumab plus a platinum-based doublet.