title: Combination chemotherapy with bevacizumab and S-1 for elderly patients with metastatic colorectal cancer (BASIC trial).
abstract: BACKGROUND
  Chemotherapeutic regimens for elderly patients with metastatic colorectal cancer (mCRC), such as bevacizumab combined with 5-fluorouracil (5-FU) and leucovorin, often exclude oxaliplatin and irinotecan owing to the risk of toxicity. However, treatment with infusional 5-fluorouracil and leucovorin requires percutaneous port-catheter placement and other precautions, causing unnecessary stress for patients as well as healthcare workers.
  
  
  METHODS
  We conducted a phase II study to evaluate the efficacy and safety of bevacizumab plus S-1 in elderly patients with previously untreated mCRC. Bevacizumab was given intravenously every two weeks, and S-1 was administered orally on days 1-28 of a 42-day cycle. The primary end-point was progression-free survival (PFS). The secondary end-points were time to treatment failure, response rate (RR), overall survival (OS), treatment completion status and safety.
  
  
  RESULTS
  From October 2007 through March 2010, 56 patients were enroled. The median PFS was 9.9months, the median OS was 25.0months, and the RR was 57%. The main adverse events of grade 3 or higher were hypertension (11%), diarrhoea (9%) and neutropenia (7%).
  
  
  CONCLUSIONS
  Our results suggest that combination chemotherapy with S-1 and bevacizumab can be administered safely and continuously on an outpatient basis and is therapeutically effective in elderly patients with mCRC.
authors.affiliation: Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7 Daigakumachi, Takatsuki, Osaka 569-8686, Japan. Electronic address: ctc004@poh.osaka-med.ac.jp.
authors.forename: M
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Muro
authors.affiliation: Department of Medical Oncology, Kochi Health Sciences Hospital, 2125-1 Ike, Kochi 781-8555, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Tsuji
authors.affiliation: Department of Medical Oncology, Tochigi Cancer Center, Utsunomiya, 4-9-13 Yonan, Utsunomiya, Tochigi 320-0834, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Hamamoto
authors.affiliation: Department of Gastrointestinal Oncology/Gastroenterology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yoshino
authors.affiliation: Department of Surgical Oncology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, Gifu 501-1194, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: Department of Medical Oncology, Oita University Faculty of Medicine, 1-1, Idaigaoka, Hasamacho, Yufu, Oita 879-5543, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Shirao
authors.affiliation: Department of Gastroenterology, Saku Central Hospital, 197 Usuda, Saku, Nagano 384-0393, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Miyata
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan.
authors.forename: D
authors.initials: D
authors.lastname: Takahari
authors.affiliation: Department of Surgical Oncology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, Gifu 501-1194, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Department of Gastrointestinal Oncology/Gastroenterology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Ohtsu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D000068258:Bevacizumab; D010094:Oxonic Acid
keywords: Bevacizumab; Colorectal cancer; Elderly; S-1