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

期刊论文
发表日期：

2024年8月28日

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Yoshiyuki Yamamoto,
Hiroki Yukami,
Tatsuro Yamaguchi,
Hisatsugu Ohori,
Sachiko Nagasu,
Yoshinori Kagawa,
Naotoshi Sugimoto,
Hiromichi Sonoda,
Kentaro Yamazaki,
Atsuo Takashima,
Hiroyuki Okuyama,
Hiroko Hasegawa,
Chihiro Kondo,
Eishi Baba,
Toshihiko Matsumoto,
Yasuyuki Kawamoto,
Masato Kataoka,
Yoshiaki Shindo,
Toshiaki Ishikawa,
Taito Esaki,
Yosuke Kito,
Takeo Sato,
Taro Funakoshi,
Toshifumi Yamaguchi,
Yasuhiro Shimada,
Toshikazu Moriwaki

摘要

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.