![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
Background. After approval of bevacizumab in Germany in 2005 for the treatment of unresectable advanced or refractory colorectal cancer (CRC), this observational cohort study was initiated to assess the efficacy and safety of bevacizumab with various chemotherapy regimen in patients with metastatic CRC (mCRC).
Material and methods. To facilitate enrolment of a typical mCRC population, eligibility criteria were minimised. Choice of chemotherapy regimen was at the physicians’ discretion, but influenced by current registration status. Predefined endpoints were treatment characteristics, response rate, progression-free survival (PFS), overall survival (OS) and adverse events assessed as potentially related to bevacizumab treatment. Patients were followed for up to four years.
Results. In total 1777 eligible patients were enrolled at 261 sites from January 2005 to June 2008. Median age: 64 years (range 19–100); male 62%; ECOG performance status 0–1/≥ 2 89%/11%. Chemotherapy choice was fluoropyrimidine (FU) 12%, FU/oxaliplatin 18%, FU/irinotecan 64%, no chemotherapy concurrent to bevacizumab 2% and other 4%. Best investigator-assessed response rate was 60% (complete response 10%, partial response 51%). Median PFS was 10.2 months and median OS was 24.8 months.
Conclusions. The efficacy and safety profile of bevacizumab in this population of mCRC patients with different chemotherapy regimens is consistent with that observed in other patient registries/non-randomised trials and also corresponds well with data from similar treatment arms of phase III trials.
Declaration of interest: This work was sponsored by F. Hoffman La-Roche. Support for third-party writing assistance was provided by F. Hoffman La-Roche. Alexander Stein has received research funding from Roche and Sanofi, honoraria from Sanofi, Roche, Bayer, Amgen, and Merck Serono; Barbara Leutgeb has been employed by Roche and Dirk Arnold has received research funding from Roche, honoraria from Roche, Merck Serono, Amgen, Bayer, and Sanofi, and is on the scientific advisory board of Roche, Merck Serono, and Amgen. The remaining authors report no conflicts of interest.
Supplementary material available online
Supplementary Table I available online at http://informahealthcare.com/doi/abs/10.3109/0284186X.2014.961649