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Bevacizumab beyond disease progression after first‐line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non–small cell lung cancer ( W est J apan O ncology G roup 5910L): An open‐label, randomized, phase 2 trial
Author(s) -
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
Publication year - 2016
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.29893
Subject(s) - bevacizumab , medicine , docetaxel , hazard ratio , lung cancer , oncology , clinical endpoint , chemotherapy , progression free survival , randomized controlled trial , confidence interval , surgery
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. Cancer 2016;122:1050–1059. © 2016 American Cancer Society