title: Feasibility study of first-line chemotherapy using Pemetrexed and Bevacizumab for advanced or recurrent nonsquamous non-small cell lung cancer in elderly patients: TORG1015.
abstract: 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.
  
  
  
  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/m(2)) 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.
  
  
  
  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.
  
  
  
  Pemetrexed plus bevacizumab in the treatment of elderly patients with nonsquamous NSCLC was well tolerated and shows promise as first-line treatment.
  
  
  
  UMIN Clinical Trial Registry; UMIN000004263 . Registered on 25 September, 2010.
authors.affiliation: Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, 160 Kou Minamiumemoto, Matsuyama, Ehime, 791-0280, Japan. tokozuki@shikoku-cc.go.jp.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.affiliation: Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, 160 Kou Minamiumemoto, Matsuyama, Ehime, 791-0280, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.affiliation: Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, 160 Kou Minamiumemoto, Matsuyama, Ehime, 791-0280, Japan.
authors.forename: Hiromoto
authors.initials: H
authors.lastname: Kitajima
authors.affiliation: Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
authors.forename: Shunichiro
authors.initials: S
authors.lastname: Iwasawa
authors.affiliation: Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
authors.forename: Emiko
authors.initials: E
authors.lastname: Sakaida
authors.affiliation: Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takiguchi
authors.affiliation: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ikeda
authors.affiliation: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
authors.forename: Terufumi
authors.initials: T
authors.lastname: Kato
authors.affiliation: Department of Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Miyamoto
authors.affiliation: Department of Biostatistics, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sakamaki
authors.affiliation: Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, 160 Kou Minamiumemoto, Matsuyama, Ehime, 791-0280, Japan.
authors.forename: Tetsu
authors.initials: T
authors.lastname: Shinkai
authors.affiliation: Thoracic Oncology Research Group, Yokohama, Japan.
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D000068437:Pemetrexed / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate
chemical_list: D000068437:Pemetrexed; D000068258:Bevacizumab
keywords: Bevacizumab; Elderly; Feasibility study; Non-small cell lung cancer; Pemetrexed