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- Title
Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L): An open-label, randomized, phase 2 trial.
- Authors
Takeda, Masayuki; Yamanaka, Takeharu; Seto, Takashi; Hayashi, Hidetoshi; Azuma, Koichi; Okada, Morihito; Sugawara, Shunichi; Daga, Haruko; Hirashima, Tomonori; Yonesaka, Kimio; Urata, Yoshiko; Murakami, Haruyasu; Saito, Haruhiro; Kubo, Akihito; Sawa, Toshiyuki; Miyahara, Eiji; Nogami, Naoyuki; Nakagawa, Kazuhiko; Nakanishi, Yoichi; Okamoto, Isamu
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
JAPAN; BEVACIZUMAB; LUNG cancer treatment; DOCETAXEL; DISEASE progression; CANCER chemotherapy; ANTINEOPLASTIC agents; COMPARATIVE studies; HYDROCARBONS; LUNG cancer; LUNG tumors; RESEARCH methodology; MEDICAL cooperation; PROGNOSIS; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; PROPORTIONAL hazards models; KAPLAN-Meier estimator
- Publication
Cancer (0008543X), 2016, Vol 122, Issue 7, p1050
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.29893