title: Retrospective cohort study on the safety and efficacy of bevacizumab with chemotherapy for metastatic colorectal cancer patients: the HGCSG0801 study.
abstract: OBJECTIVE
  After approval of bevacizumab in Japan, post-marketing surveillance studies reported on safety. However, few reports have shown the efficacy of bevacizumab as used in daily practice. We evaluated the efficacy and safety of bevacizumab for metastatic colorectal cancer patients in daily practice.
  
  
  METHODS
  All unresectable metastatic colorectal cancer patients who began receiving bevacizumab in participating facilities from June 2007 to October 2008 were retrospectively analyzed for safety and efficacy. Adverse events were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events. Response Evaluation in Solid Tumors criteria, version 1.0, was used for the tumor response rate.
  
  
  RESULTS
  A total of 212 patients from 17 institutions were assessed. Grade 3 or higher adverse events related to bevacizumab included gastrointestinal perforation in 3, thrombosis in 7, hypertension in 30 and gastrointestinal bleeding in 2. Response rates were 62.5, 30.1 and 11.8% overall among patients receiving bevacizumab as first-, second- and third-line or greater therapy. Median progression-free survival was 14.4 [95% confidence interval (CI): 10.8-18.1], 7.8 (95% CI: 6.5-9.1) and 6.0 (95% CI: 4.6-7.3) months, and median overall survival was 32.5 (95% CI: 24.6-40.3), 16.4 (95% CI: 14.4-18.5) and 11.8 (95% CI: 8.6-15.0) months, respectively.
  
  
  CONCLUSIONS
  The general cohort of patients in HGCSG0801 showed a similar efficacy and safety profile of bevacizumab as seen in clinical trials. Although the sample size was small and there were several study limitations, these results suggest that colorectal cancer patients in Japan might safely receive and benefit from bevacizumab in combination with chemotherapy in daily practice, as is seen in patients in other countries.
authors.affiliation: Department of Gastroenterology, Hokkaido University Graduate School of Medicine, North 14, West 5, Kita-ku, Sapporo, Hokkaido 060-8648, Japan. susu-my@hotmail.co.jp
authors.forename: Susumu
authors.initials: S
authors.lastname: Sogabe
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yuki
authors.forename: Takaya
authors.initials: T
authors.lastname: Kusumi
authors.forename: Kazuteru
authors.initials: K
authors.lastname: Hatanaka
authors.forename: Michio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Takashi
authors.initials: T
authors.lastname: Kato
authors.forename: Takuto
authors.initials: T
authors.lastname: Miyagishima
authors.forename: Ayumu
authors.initials: A
authors.lastname: Hosokawa
authors.forename: Ichiro
authors.initials: I
authors.lastname: Iwanaga
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
authors.forename: Masahiro
authors.initials: M
authors.lastname: Asaka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016001:Confidence Intervals; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004844:Epistaxis / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D000077146:Irinotecan; D007564:Japan; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000556:secondary / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010094:Oxonic Acid / Q000008:administration & dosage; D011507:Proteinuria / Q000139:chemically induced; D012189:Retrospective Studies; D005641:Tegafur / Q000008:administration & dosage; D013927:Thrombosis / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D004338:Drug Combinations; D009944:Organoplatinum Compounds; C079198:S 1 (combination); D005641:Tegafur; D000068258:Bevacizumab; D010094:Oxonic Acid; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin