Feasibility study of first-line chemotherapy using Pemetrexed and Bevacizumab for advanced or recurrent nonsquamous non-small cell lung cancer in elderly patients: TORG1015. Issue 1 (December 2016)

• Record Type: Journal Article
• Authors: Kozuki, Toshiyuki; Nogami, Naoyuki; Kitajima, Hiromoto; Iwasawa, Shunichiro; Sakaida, Emiko; Takiguchi, Yuichi; Ikeda, Satoshi; Yoshida, Masahiro; Kato, Terufumi; Miyamoto, Shingo; Sakamaki, Kentaro; Shinkai, Tetsu; Watanabe, Koshiro
• Is Part Of: BMC cancer. Volume 16:Issue 1(2016)
• Page Start: 1
• Page End: 7
• Publication Date: 2016-12
• Subjects: Non-small cell lung cancer -- Bevacizumab -- Pemetrexed -- Elderly -- Feasibility study; Cancer -- Periodicals; 616.994005
• DOI: 10.1186/s12885-016-2338-6
• Languages: English
• ISSNs: 1471-2407

Abstract

Abstract Background The addition of bevacizumab to cytotoxic agents prolongs survival in patients with nonsquamous non-small cell lung cancer (NSCLC). To date, there is no evidence to suggest that treatment with a cytotoxic agent plus bevacizumab is more effective than a cytotoxic agent alone for nonsquamous NSCLC in elderly patients. We conducted a feasibility study of pemetrexed plus bevacizumab as a first-line treatment for advanced or recurrent nonsquamous NSCLC in elderly patients. Methods Major eligibility and exclusion criteria included: chemotherapy-naive status; non-fitness for bolus combination chemotherapy; stage III/IV or relapsed nonsquamous NSCLC; age ≥70; performance status 0–1; absence of brain metastasis; and no history of hemoptysis and thoracic irradiation. Pemetrexed (500 mg/m2 ) and bevacizumab (15 mg/kg) were administered intravenously on day 1, and repeated every 3 weeks thereafter. The primary endpoint was safety, and the secondary endpoints were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and the percentage of patients who completed ≥3 cycles. Results From October 2010 to April 2012, a total of 12 patients were enrolled. No dose-limiting toxicity or treatment-related deaths were observed. Three patients achieved PR, and the ORR was 25 %. The median PFS and OS were 5.4 months (95 % CI 1.1–8.8 months) and 13.6 months (95 % CI 5.3–15.6 months), respectively. Seven of 12 patients (58 %) received ≥3 cycles. Conclusions Pemetrexed plus bevacizumab in the treatment of elderly patients with nonsquamous NSCLC was well tolerated and shows promise as first-line treatment. Trial registration UMIN Clinical Trial Registry;UMIN000004263 . Registered on 25 September, 2010.