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Capecitabine/irinotecan or capecitabine/oxaliplatin in combination with bevacizumab is effective and safe as first-line therapy for metastatic colorectal cancer: a randomized phase II study of the AIO colorectal study group.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2013 Jun; Vol. 24 (6), pp. 1580-7. Date of Electronic Publication: 2013 Mar 04. - Publication Year :
- 2013
-
Abstract
- Background: This randomized phase II trial investigated the efficacy and safety of capecitabine/oxaliplatin (CapOx) plus bevacizumab and dose-modified capecitabine/irinotecan (mCapIri) plus bevacizumab as first-line therapy in patients with metastatic colorectal cancer (mCRC).<br />Patients and Methods: Patients received bevacizumab 7.5 mg/kg with oxaliplatin 130 mg/m(2)/day 1 plus capecitabine 1000 mg/m(2) bid/days 1-14 or with irinotecan 200 mg/m(2)/day 1 plus capecitabine 800 mg/m(2) bid/days 1-14 both every 21 days. The primary end point was 6 months progression-free survival (PFS).<br />Results: A total of 255 patients were enrolled. The intent-to-treat population comprised 247 patients (CapOx-bevacizumab: n = 127; mCapIri-bevacizumab: n = 120). The six-month PFS rates were 76% (95% CI, 69%-84%) and 84% (95% CI, 77%-90%). Median PFS and OS were 10.4 months (95% CI, 9.0-12.0) and 24.4 months (95% CI, 19.3-30.7) with CapOx-bevacizumab, and 12.1 months (95% CI, 10.8-13.2) and 25.5 months (95% CI, 21.0-31.0) with mCapIri-bevacizumab. Grade 3/4 diarrhea as predominant toxic effect occurred in 22% of patients with CapOx-bevacizumab and in 16% with mCapIri-bevacizumab.<br />Conclusions: Both, CapOx-bevacizumab and mCapIri-bevacizumab, show promising activity and an excellent toxic effect profile. Efficacy is in the range of other bevacizumab-containing combination regimen although lower doses of irinotecan and capecitabine were selected for mCapIri.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized administration & dosage
Antibodies, Monoclonal, Humanized adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bevacizumab
Camptothecin administration & dosage
Camptothecin adverse effects
Camptothecin analogs & derivatives
Capecitabine
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Deoxycytidine analogs & derivatives
Diarrhea chemically induced
Diarrhea diagnosis
Disease-Free Survival
Female
Fluorouracil administration & dosage
Fluorouracil adverse effects
Fluorouracil analogs & derivatives
Humans
Irinotecan
Male
Middle Aged
Organoplatinum Compounds administration & dosage
Organoplatinum Compounds adverse effects
Oxaliplatin
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Colorectal Neoplasms drug therapy
Colorectal Neoplasms pathology
Subjects
Details
- Language :
- English
- ISSN :
- 1569-8041
- Volume :
- 24
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 23463625
- Full Text :
- https://doi.org/10.1093/annonc/mdt028