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

被引：5

作者：

Iwamoto, Shigeyoshi ^{[1
]}

Hazama, Shoichi ^{[2
]}

Kato, Takeshi ^{[3
]}

Miyake, Yasuhiro ^{[4
]}

Fukunaga, Mutsumi ^{[5
]}

Matsuda, Chu ^{[6
]}

Bando, Hiroyuki ^{[7
]}

Sakamoto, Junichi ^{[8
]}

Oba, Koh ^{[9
]}

Mishima, Hideyuki ^{[10
]}

机构：

[1] Kansai Med Univ, Takii Hosp, Dept Surg, Moriguchi, Osaka 5708507, Japan

[2] Yamaguchi Univ, Dept Digest Surg & Surg Oncol, Grad Sch Med, Ube, Yamaguchi 755, Japan

[3] Kansai Rosai Hosp, Dept Surg, Amagasaki, Hyogo, Japan

[4] Nishinomiya Municipal Cent Hosp, Dept Surg, Nishinomiya, Hyogo, Japan

[5] Sakai Municipal Hosp, Dept Surg, Sakai, Osaka, Japan

[6] Osaka Gen Med Ctr, Dept Surg, Osaka, Japan

[7] Ishikawa Prefectural Gen Hosp, Dept Gastrointestinal Surg, Kanazawa, Ishikawa, Japan

[8] Tokai Cent Hosp, Kakamigahara, Japan

[9] Hokkado Univ Hosp, Translat Res & Clin Trial Ctr, Sapporo, Hokkaido, Japan

[10] Aichi Med Univ Hosp, Oncol Ctr, Nagakute, Aichi, Japan

来源：

ANTICANCER RESEARCH | 2014年 / 34卷 / 04期

关键词：

Colorectal cancer; KRAS; FOLFIRI; cetuximab; Japanese; 1ST-LINE TREATMENT; RANDOMIZED-TRIAL; MUTATION STATUS; RAS MUTATIONS; OPEN-LABEL; IRINOTECAN; THERAPY; FLUOROURACIL; BEVACIZUMAB; LEUCOVORIN;

D O I：

暂无

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1967 / 1973

页数：7

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