FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer-subgroup analysis of patients with KRAS: mutated tumours in the randomised German AIO study KRK-0306.
Ann Oncol
; 23(7): 1693-9, 2012 Jul.
Article
in En
| MEDLINE
| ID: mdl-22219013
ABSTRACT
BACKGROUND:
The AIO KRK-0306 trial compares the efficacy of infusional 5-fluorouracil, folinic acid, irinotecan (FOLFIRI) plus cetuximab with FOLFIRI plus bevacizumab in first-line treatment of metastatic colorectal cancer (mCRC). In October 2008, an amendment terminated the inclusion of patients with KRAS-mutated tumours. This subgroup of patients is evaluated in the present analysis, while the study is ongoing for patients with KRAS wild-type tumours.METHODS:
Patients were randomly assigned to FOLFIRI (Tournigand regimen) every 2 weeks plus cetuximab (400 mg/m2 day 1, followed by 250 mg/m2 weekly=arm A) or bevacizumab (5 mg/kg every 2 weeks=arm B). Among 336 randomised patients, KRAS mutation was demonstrated in 100 assessable patients. The primary study end point was objective response rate (ORR).RESULTS:
ORR was 44% [95% confidence interval (CI) 29% to 59%] in arm A versus 48% (95% CI, 33% to 62%) in arm B. Progression-free survival was 7.5 versus 8.9 months (hazard ratio 1.0) and overall survival was 22.7 versus 18.7 months (hazard ratio 0.86) in arms A versus B, respectively.CONCLUSIONS:
This is the first head to head comparison of cetuximab versus bevacizumab in first-line treatment of mCRC. In the present evaluation of patients with KRAS-mutated tumours, neither strategy demonstrated a clearly superior outcome.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Colorectal Neoplasms
/
Adenocarcinoma
/
Antineoplastic Combined Chemotherapy Protocols
/
Proto-Oncogene Proteins
/
Ras Proteins
Type of study:
Clinical_trials
Country/Region as subject:
Europa
Language:
En
Journal:
Ann Oncol
Journal subject:
NEOPLASIAS
Year:
2012
Document type:
Article
Affiliation country:
Germany