A randomized phase II study of bevacizumab in combination with docetaxel or S-1 in patients with non-squamous non-small-cell lung cancer previously treated with platinum based chemotherapy (HANSHIN Oncology Group 0110). Issue 2 (August 2015)

• Record Type: Journal Article
• Authors: Nishino, Kazumi; Imamura, Fumio; Kumagai, Toru; Katakami, Nobuyuki; Hata, Akito; Okuda, Chiyuki; Urata, Yoshiko; Hattori, Yosihihiro; Tachihara, Motoko; Yokota, Souichirou; Nishimura, Takashi; Kaneda, Toshihiko; Satouchi, Miyako; Morita, Satoshi; Negoro, Shunichi
• Is Part Of: Lung cancer. Volume 89:Issue 2(2015:Aug.)
• Page Start: 146
• Page End: 153
• Publication Date: 2015-08
• Subjects: Non-squamous non-small-cell lung cancer -- Bevacizumab -- Docetaxel -- S-1 -- Second-line -- Phase II; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2015.05.022
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: We examined bevacizumab in combination with docetaxel or S-1 in pretreated NSCLC. Docetaxel plus bevacizumab and S-1 plus bevacizumab produced modest PFS benefits. Docetaxel plus bevacizumab was promising in bevacizumab-naïve patients. 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 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.