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.
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 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.
authors.affiliation: Department of Medical Oncology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Takeda
authors.affiliation: Department of Biostatistics, Yokohama City University, Yokohama, Japan.
authors.forename: Takeharu
authors.initials: T
authors.lastname: Yamanaka
authors.affiliation: Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.affiliation: Department of Medical Oncology, Kishiwada City Hospital, Osaka, Japan.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Hayashi
authors.affiliation: Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Azuma
authors.affiliation: Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan.
authors.forename: Morihito
authors.initials: M
authors.lastname: Okada
authors.affiliation: Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Sugawara
authors.affiliation: Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.
authors.forename: Haruko
authors.initials: H
authors.lastname: Daga
authors.affiliation: Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
authors.affiliation: Department of Medical Oncology, Izumi Municipal Hospital, Izumi, Japan.
authors.forename: Kimio
authors.initials: K
authors.lastname: Yonesaka
authors.affiliation: Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan.
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Urata
authors.affiliation: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Haruyasu
authors.initials: H
authors.lastname: Murakami
authors.affiliation: Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Haruhiro
authors.initials: H
authors.lastname: Saito
authors.affiliation: Division of Respiratory Medicine and Allergology, Aichi Medical University School of Medicine, Nagakute, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Kubo
authors.affiliation: Division of Respiratory Medicine, Gifu Municipal Hospital, Gifu, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Sawa
authors.affiliation: Department of Surgery, Saiseikai Hiroshima Hospital, Hiroshima, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Miyahara
authors.affiliation: Department of Thoracic Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.affiliation: Department of Medical Oncology, Faculty of Medicine, Kinki University, Osaka, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakanishi
authors.affiliation: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000068258:Bevacizumab / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000068258:Bevacizumab
keywords: bevacizumab; disease progression; docetaxel; non-small cell lung cancer; progression-free survival