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

共 50 条

[1] A Comparison of Folinic Acid, Fluorouracil and Irinotecan (FOLFIRI) plus Bevacizumab and FOLFIRI plus Aflibercept as Second-line Treatment for Metastatic Colorectal Cancer [J].

Jo, H. ;

Lee, M-S ;

Lee, Y-P ;

Kim, H. ;

Hong, J. Y. ;

Lee, J. ;

Park, S. H. ;

Park, J. O. ;

Park, Y. S. ;

Lim, H. Y. ;

Kang, W. K. ;

Kim, S. T. .

CLINICAL ONCOLOGY, 2022, 34 (08) :E323-E328

[2] Bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as the second-line therapy for patients with metastatic colorectal cancer, a multicenter study [J].

Deng, Ting ;

Zhang, Le ;

Liu, Xiao-jian ;

Xu, Jian-ming ;

Bai, Yu-xian ;

Wang, Yan ;

Han, Yu ;

Li, Yu-hong ;

Ba, Yi .

MEDICAL ONCOLOGY, 2013, 30 (04)

[3] Second-line cetuximab/irinotecan versus oxaliplatin/fluoropyrimidines for metastatic colorectal cancer with wild-type KRAS [J].

Hong, Yong Sang ;

Kim, Hwa Jung ;

Park, Seong Joon ;

Kim, Kyu-Pyo ;

Lee, Jae-Lyun ;

Park, Jin Hong ;

Kim, Jong Hoon ;

Lim, Seok-Byung ;

Yu, Chang Sik ;

Kim, Jin Cheon ;

Baek, Ji Yeon ;

Kim, Sun Young ;

Kim, Tae Won .

CANCER SCIENCE, 2013, 104 (04) :473-480

[4] Phase IB/II Study of Second-Line Therapy with Panitumumab, Irinotecan, and Everolimus (PIE) in KRAS Wild-Type Metastatic Colorectal Cancer [J].

Townsend, Amanda ;

Tebbutt, Niall ;

Karapetis, Christos ;

Cooper, Pamela ;

Singhal, Nimit ;

Yeend, Susan ;

Pirc, Louise ;

Joshi, Rohit ;

Hardingham, Jennifer ;

Price, Timothy .

CLINICAL CANCER RESEARCH, 2018, 24 (16) :3838-3844

[5] Safety and efficacy of second-line treatment with folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) in combination of panitumumab and bevacizumab for patients with metastatic colorectal cancer [J].

Xie, Song ;

Han, Guoping ;

Fan, Zhikun ;

He, Lifeng ;

Xu, Wenbing ;

Qin, Zhen .

MEDICAL ONCOLOGY, 2014, 31 (07)

[6] Multicenter open-label randomized phase II study of second-line panitumumab and irinotecan with or without fluoropyrimidines in patients with KRAS wild-type metastatic colorectal cancer (PACIFIC study) [J].

Nagata, Naoki ;

Maeda, Hiromichi ;

Ishibashi, Keiichiro ;

Hirata, Keiji ;

Makiyama, Akitaka ;

Iwamoto, Shigeyoshi ;

Takemoto, Hiroyoshi ;

Imasato, Mitsunobu ;

Yoshida, Yoichiro ;

Munemoto, Yoshinori ;

Tanaka, Chihiro ;

Morita, Yoshitaka ;

Hotta, Yoshihiro ;

Toyofuku, Atsushi ;

Nagasaka, Takeshi ;

Morita, Satoshi ;

Sakamoto, Junichi ;

Mishima, Hideyuki .

MEDICAL ONCOLOGY, 2019, 36 (06)

[7] Bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as the second-line therapy for patients with metastatic colorectal cancer, a multicenter study [J].

Ting Deng ;

Le Zhang ;

Xiao-jian Liu ;

Jian-ming Xu ;

Yu-xian Bai ;

Yan Wang ;

Yu Han ;

Yu-hong Li ;

Yi Ba .

Medical Oncology, 2013, 30

[8] Phase II study of cetuximab with irinotecan for KRAS wild-type colorectal cancer in Japanese patients [J].

Terazawa, Tetsuji ;

Nishitani, Hitoshi ;

Kato, Ken ;

Hashimoto, Hironobu ;

Akiyoshi, Kohei ;

Ito, Yuriko ;

Nakamoto, Akihiro ;

Iwasa, Satoru ;

Nakajima, Takako Eguchi ;

Hamaguchi, Tetsuya ;

Yamada, Yasuhide ;

Shimada, Yasuhiro .

ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2017, 13 (02) :E132-E137

[9] A randomized Phase II clinical study of combining panitumumab and bevacizumab, plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) compared with FOLFIRI alone as second-line treatment for patients with metastatic colorectal cancer and KRAS mutation [J].

Liu, Yuguo ;

Luan, Lijuan ;

Wang, Xingli .

ONCOTARGETS AND THERAPY, 2015, 8 :1061-1068

[10] Comparison of Panitumumab Plus Irinotecan and Cetuximab Plus Irinotecan for KRAS Wild-type Metastatic Colorectal Cancer [J].

Yamaguchi, Toshifumi ;

Iwasa, Satoru ;

Nagashima, Kengo ;

Ikezawa, Nobuaki ;

Hamaguchi, Tetsuya ;

Shoji, Hirokazu ;

Honma, Yoshitaka ;

Takashima, Atsuo ;

Okita, Natsuko ;

Kato, Ken ;

Yamada, Yasuhide ;

Shimada, Yasuhiro .

ANTICANCER RESEARCH, 2016, 36 (07) :3531-3536

← 1 2 3 4 5 →