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Multicenter phase II study of second-line cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type metastatic colorectal cancer: the FLIER study.
- Source :
-
Anticancer research [Anticancer Res] 2014 Apr; Vol. 34 (4), pp. 1967-73. - Publication Year :
- 2014
-
Abstract
- Background: This study was the first multicenter phase II study of cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type mCRC as a second-line treatment in Japan including BRAF and PIK3CA genotyping.<br />Patients and Methods: Tumors of 112 pre-registered patients were genotyped for KRAS, BRAF, and PIK3CA. The primary study end-point was response rate, and secondary end-points were progression-free survival (PFS), overall survival (OS), and safety.<br />Results: Sixty-seven patients (59.8%) were EGFR-positive and KRAS wild-type. The mean age of the enrolled patients (n=60) was 62.6 years (range=37-82 years). The response rate was 31.7% and stable disease was observed in 53.3%. No objective response was observed in patients with BRAF or PIK3CA mutations. The median PFS and OS were 7.4 and 18.2 months, respectively. Grade-3/4 adverse events were leucopenia (26.7%), neutropenia (43.3%), paronychia (10.0%), fissure (10.0%) and acne-like rash (5.0%).<br />Conclusion: Second-line cetuximab plus FOLFIRI was effective and well-tolerated.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Camptothecin administration & dosage
Camptothecin analogs & derivatives
Cetuximab
Chemotherapy, Adjuvant
Colorectal Neoplasms genetics
Colorectal Neoplasms mortality
Female
Fluorouracil administration & dosage
Genes, ras
Genotype
Humans
Irinotecan
Leucovorin administration & dosage
Male
Middle Aged
Neoplasm Metastasis
Treatment Outcome
Tumor Burden
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Colorectal Neoplasms drug therapy
Colorectal Neoplasms pathology
Subjects
Details
- Language :
- English
- ISSN :
- 1791-7530
- Volume :
- 34
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Anticancer research
- Publication Type :
- Academic Journal
- Accession number :
- 24692733