TY - JOUR
T1 - Efficacy and safety of bevacizumab-based combination regimens in patients with previously untreated metastatic colorectal cancer
T2 - Final results from a randomised phase ii study of bevacizumab plus 5-fluorouracil, leucovorin plus irinotecan versus bevacizumab plus capecitabine plus irinotecan (FNCLCC ACCORD 13/0503 study)
AU - Ducreux, M.
AU - Adenis, A.
AU - Pignon, J. P.
AU - François, E.
AU - Chauffert, B.
AU - Ichanté, J. L.
AU - Boucher, E.
AU - Ychou, M.
AU - Pierga, J. Y.
AU - Montoto-Grillot, C.
AU - Conroy, T.
N1 - Funding Information:
This study was supported by grants from Roche, Pfizer, and Chugai. Support for third-party writing assistance for this manuscript was provided by F. Hoffmann-La Roche.
PY - 2013/4/1
Y1 - 2013/4/1
N2 - Background: The combination of bevacizumab and bolus 5-fluorouracil, leucovorin and irinotecan is highly effective in patients with metastatic colorectal cancer (mCRC). This randomised, multicenter, non-comparative phase II trial assessed the efficacy and safety of bevacizumab plus oral capecitabine plus irinotecan (XELIRI) or infusional 5-fluorouracil, leucovorin plus irinotecan (FOLFIRI) as first-line therapy for patients with mCRC. Patients and Methods: Patients received bevacizumab 7.5 mg/kg on day 1 plus XELIRI (irinotecan 200 mg/m2 on day 1 and oral capecitabine 1000 mg/m 2 bid on days 1-14) every 3 weeks or bevacizumab 5 mg/kg on day 1 plus FOLFIRI (5-fluorouracil 400 mg/m2 on day 1 plus 2400 mg/m 2 as a 46-h infusion, leucovorin 400 mg/m2 on day 1, and irinotecan 180 mg/m2 on day 1) every 2 weeks. Patients aged ≥65 years received a lower dose of capecitabine (800 mg/m2 twice daily). The primary endpoint was 6-month progression-free survival (PFS) rate. Results: A total of 145 patients were enrolled (bevacizumab-XELIRI, n = 72; bevacizumab-FOLFIRI, n = 73). The 6-month PFS rate was 82% (95% confidence intervals (CI) 71-90%) in the bevacizumab-XELIRI arm and 85% (95% CI 75-92%) in the bevacizumab-FOLFIRI arm. In both the bevacizumab-XELIRI and bevacizumab-FOLFIRI arms, median PFS and overall survival (OS) were 9 and 23 months, respectively. The most frequent toxicities were grade 3/4 neutropenia (bevacizumab-XELIRI 18%; bevacizumab-FOLFIRI 26%) and grade 3 diarrhoea (12% and 5%, respectively). Conclusions: This randomised non-comparative study demonstrates that bevacizumab-XELIRI and bevacizumab-FOLFIRI are effective regimens for the first-line treatment of patients with mCRC with manageable toxicity profiles.
AB - Background: The combination of bevacizumab and bolus 5-fluorouracil, leucovorin and irinotecan is highly effective in patients with metastatic colorectal cancer (mCRC). This randomised, multicenter, non-comparative phase II trial assessed the efficacy and safety of bevacizumab plus oral capecitabine plus irinotecan (XELIRI) or infusional 5-fluorouracil, leucovorin plus irinotecan (FOLFIRI) as first-line therapy for patients with mCRC. Patients and Methods: Patients received bevacizumab 7.5 mg/kg on day 1 plus XELIRI (irinotecan 200 mg/m2 on day 1 and oral capecitabine 1000 mg/m 2 bid on days 1-14) every 3 weeks or bevacizumab 5 mg/kg on day 1 plus FOLFIRI (5-fluorouracil 400 mg/m2 on day 1 plus 2400 mg/m 2 as a 46-h infusion, leucovorin 400 mg/m2 on day 1, and irinotecan 180 mg/m2 on day 1) every 2 weeks. Patients aged ≥65 years received a lower dose of capecitabine (800 mg/m2 twice daily). The primary endpoint was 6-month progression-free survival (PFS) rate. Results: A total of 145 patients were enrolled (bevacizumab-XELIRI, n = 72; bevacizumab-FOLFIRI, n = 73). The 6-month PFS rate was 82% (95% confidence intervals (CI) 71-90%) in the bevacizumab-XELIRI arm and 85% (95% CI 75-92%) in the bevacizumab-FOLFIRI arm. In both the bevacizumab-XELIRI and bevacizumab-FOLFIRI arms, median PFS and overall survival (OS) were 9 and 23 months, respectively. The most frequent toxicities were grade 3/4 neutropenia (bevacizumab-XELIRI 18%; bevacizumab-FOLFIRI 26%) and grade 3 diarrhoea (12% and 5%, respectively). Conclusions: This randomised non-comparative study demonstrates that bevacizumab-XELIRI and bevacizumab-FOLFIRI are effective regimens for the first-line treatment of patients with mCRC with manageable toxicity profiles.
KW - Bevacizumab
KW - Capecitabine
KW - Colorectal neoplasms
KW - Fluorouracil
KW - Irinotecan
KW - Quality of life
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=84875727313&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2012.12.011
DO - 10.1016/j.ejca.2012.12.011
M3 - Article
C2 - 23352604
AN - SCOPUS:84875727313
SN - 0959-8049
VL - 49
SP - 1236
EP - 1245
JO - European Journal of Cancer
JF - European Journal of Cancer
IS - 6
ER -