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Multicenter Study
. 2024 Dec;29(12):1878-1886.
doi: 10.1007/s10147-024-02613-0. Epub 2024 Aug 28.

Real-world outcomes of FOLFOXIRI plus bevacizumab in patients with metastatic colorectal cancer: the JSCCR-TRIPON study

Yoshiyuki Yamamoto  1 , Hiroki Yukami  2   3 , Tatsuro Yamaguchi  4 , Hisatsugu Ohori  5 , Sachiko Nagasu  6 , Yoshinori Kagawa  7 , Naotoshi Sugimoto  8 , Hiromichi Sonoda  9 , Kentaro Yamazaki  10 , Atsuo Takashima  11 , Hiroyuki Okuyama  12 , Hiroko Hasegawa  13 , Chihiro Kondo  14 , Eishi Baba  15 , Toshihiko Matsumoto  16 , Yasuyuki Kawamoto  17 , Masato Kataoka  18 , Yoshiaki Shindo  19 , Toshiaki Ishikawa  20 , Taito Esaki  21 , Yosuke Kito  22 , Takeo Sato  23 , Taro Funakoshi  24 , Toshifumi Yamaguchi  3 , Yasuhiro Shimada  25 , Toshikazu Moriwaki  26
Affiliations
Multicenter Study

Real-world outcomes of FOLFOXIRI plus bevacizumab in patients with metastatic colorectal cancer: the JSCCR-TRIPON study

Yoshiyuki Yamamoto et al. Int J Clin Oncol. 2024 Dec.

Abstract

Background: FOLFOXIRI plus bevacizumab is a standard first-line chemotherapy for patients with metastatic colorectal cancer (mCRC). However, due to the severe toxicities, this regimen is not widely used. There is limited data on the real-world efficacy and safety.

Methods: We conducted a retrospective analysis of clinical data from mCRC patients who received FOLFOXIRI plus bevacizumab as first-line chemotherapy at 31 institutions. The initial dose was standardized according to the TRIBE regimen. Induction therapy was defined as a combination of oxaliplatin, irinotecan, and fluorouracil.

Results: Out of 104 patients who met the criteria, the median age was 58 years (range, 16-72). 81% of patients had an eastern cooperative oncology group performance status (PS) of 0. An initial dose reduction was observed in 63% of patients. The median number of preplanned induction therapy cycles was 12 (range, 4-12). The completion of scheduled induction therapy cycles was observed in 45% of patients, with treatment-related toxicities being the main reason for discontinuation (63%). The median progression-free survival and overall survival were 12.8 months (95% CI, 10.6-15.0) and 27.9 months (95% CI 21.6-34.2), respectively. The objective response rate and disease control rate were 63.7% and 98.9%, respectively. The R0 resection rate was 21.2%. The main grade 3 or higher toxicities were neutropenia (51%), febrile neutropenia (10%), and nausea/vomiting (5%). No treatment-related deaths were observed.

Conclusion: In a real-world clinical setting, FOLFOXIRI plus bevacizumab demonstrated efficacy and safety comparable to previous clinical trials.

Keywords: Bevacizumab; Colorectal cancer; FOLFOXIRI; Real-world outcome; Triplet.

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Conflict of interest statement

Declarations. Conflict of interest: Yoshinori Kagawa has received honoraria from Chugaim Ono, Merck Serono, Takeda, Eli Lilly, MSD, and Taiho. Naotoshi Sugimoto has received honoraria from Chugai, Cai-ichi Sankyo, Eli Lilly Japan, MSD, and Ono, reserch funding from Astellas, Ono, MSD, Pfizer, Chugai, Eizai and Seagen. Kentaro Yamazaki has received honoraria from Chugai, Takeda, Taiho, Eli Lilly, Merck Serono, MSD, and Ono, research funding from Taiho. Atsuo Takashima has received honoraria from Eli Lilly, Ono, Taiho, Chugai, Takeda, and Merck Serono, research funding from MSD, AstraZeneca, Amgen, Eisai, BMS, and Ono. Eishi Baba has received honoraria from Chugai, scholarship donation from Chugai and Taiho. Toshihiko Matsumoto has received honoraria from Chugai, research funding from Sanofi and Astellas. Taito Esaki has received research funding from MSD, Ono, Chugai, Amgen, ALX Oncology, Seagen, Taiho, Daiichi Sankyo, Pfyzer, Jazz Pharmaceuticals, Asahikasei Phama, Quintiles, Astellas Amgen Biopharm, Novartis, and Syneos Health Clinica. The other authors declare that they have no competing interests.

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