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Comparison of safety and efficacy of fluorouracil + oxaliplatin + irinotecan (FOLFOXIRI) and modified FOLFOXIRI with bevacizumab for metastatic colorectal cancer: data from clinical practice

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Abstract

Purpose

The efficacy of fluorouracil + oxaliplatin + irinotecan with bevacizumab (FOLFOXIRI + BV) has been verified for metastatic colorectal cancer (mCRC). In clinical practice, the original (O-FOLFOXIRI + BV) and modified dose settings (M-FOLFOXIRI + BV) are adopted for Asian patients. We aimed to compare the real-world efficacy and safety of these two regimens.

Methods

This retrospective cohort study reviewed clinical data of all consecutive mCRC patients treated with FOLFOXIRI + BV at a cancer centre in Japan. One hundred patients were divided into two groups: one that received O-FOLFOXIRI + BV (group O, n = 30) and another that received M-FOLFOXIRI + BV (group M, n = 70). Progression-free survival (PFS) was set as the primary endpoint, with overall survival (OS), overall response rate (ORR), and safety as secondary endpoints.

Results

PFS was superior in group M (median PFS; 8.7 vs. 11.5 months, P = 0.098). The use of O-FOLFOXIRI + BV emerged as an independent risk factor of poor PFS (hazard ratio = 2.155, P = 0.012). Both ORR (43.3 vs. 65.7%, P = 0.047) and OS (median OS; 17.9 vs. 27.0 months, P = 0.127) were more favourable in group M. Grade ≥ 3 adverse events were more frequently observed in group O (90 vs. 74.3%, P = 0.108), whereas dose intensity was higher in group M because a shorter duration was required for cytotoxic drug administration (2.9 vs. 2.6 weeks/course, P = 0.051) in the induction term.

Conclusion

We found that M-FOLFOXIRI + BV had more favourable efficacy and safety than O-FOLFOXIRI + BV, which may be a better fit for Asian patients and can be potentially used as an alternative for upfront chemotherapy for mCRC.

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Change history

  • 29 November 2021

    The entries of column 1 of the Table 1 has been correctly aligned.

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Acknowledgements

We would like to thank Editage for their English editing services.

Funding

This study was partially supported by Ryuji Tominaga (Wajiro Hospital), Masumi Kamachi (Shinagawa Hospital), and Nobuko Yoshiki (Yoshiki Dermatology Clinic).

Author information

Authors and Affiliations

  1. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan

    Keisuke Kazama, Manabu Shiozawa, Nobuhiro Sugano, Sumito Sato, Mamoru Uchiyama, Maho Sato & Takashi Oshima

  2. Department of Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

    Keisuke Kazama, Masakatsu Numata, Toru Aoyama, Hiroshi Tamagawa, Norio Yukawa & Yasushi Rino

Authors
  1. Keisuke Kazama
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Contributions

Keisuke Kazama: Conceptualisation, methodology, writing of original draft, review and editing, formal analysis, investigation. Manabu Shiozawa: Conceptualisation, methodology, writing of review and editing, formal analysis, investigation.　Masakatsu Numata: Conceptualisation, methodology, writing of review and editing. Nobuhiro Sugano: Formal analysis, investigation. Sumito Sato: Formal analysis, investigation. Mamoru Uchiyama: Formal analysis, investigation. Maho Sato: Formal analysis, investigation. Toru Aoyama: Methodology, writing of review. Hiroshi Tamagawa: Methodology, writing of review. Takashi Oshima: Methodology, writing of review. Norio Yukawa: Methodology, writing of review. Yasushi Rino: Methodology, writing of review and editing. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Keisuke Kazama.

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Ethics approval

The study protocols were approved by the institutional review board of the Kanagawa Cancer Centre (approval no. 2020-EKI01).

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Patients were informed of study protocols on a notice board or the website of each hospital.

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The authors declare no competing interests.

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Kazama, K., Shiozawa, M., Numata, M. et al. Comparison of safety and efficacy of fluorouracil + oxaliplatin + irinotecan (FOLFOXIRI) and modified FOLFOXIRI with bevacizumab for metastatic colorectal cancer: data from clinical practice. Int J Colorectal Dis 37, 337–348 (2022). https://doi.org/10.1007/s00384-021-04064-9

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