@article {IWAMOTO1967, author = {SHIGEYOSHI IWAMOTO and SHOICHI HAZAMA and TAKESHI KATO and YASUHIRO MIYAKE and MUTSUMI FUKUNAGA and CHU MATSUDA and HIROYUKI BANDO and JUNICHI SAKAMOTO and KOJI OBA and HIDEYUKI MISHIMA}, title = {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}, volume = {34}, number = {4}, pages = {1967--1973}, year = {2014}, publisher = {International Institute of Anticancer Research}, 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. 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. 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\%). Conclusion: Second-line cetuximab plus FOLFIRI was effective and well-tolerated.}, issn = {0250-7005}, URL = {https://ar.iiarjournals.org/content/34/4/1967}, eprint = {https://ar.iiarjournals.org/content/34/4/1967.full.pdf}, journal = {Anticancer Research} }