Background <p>Fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus ramucirumab is a well-established second-line treatment for metastatic colorectal cancer (mCRC) following bevacizumab-based chemotherapy. However, its efficacy after other first-line regimens, including anti-EGFR antibody-based and triplet chemotherapy, remains insufficiently characterized. The aim of this study was to compare the efficacy and safety of FOLFIRI plus ramucirumab between patients treated with different first-line treatment regimens.</p> Methods <p>This retrospective multicenter study included 186 mCRC patients who received second-line FOLFIRI plus ramucirumab between 2016–2025. Patients were classified into three groups based on their first-line regimens: Bmab (bevacizumab-based), EGFR (anti-EGFR antibody-based), and Triplet (triplet chemotherapy). The primary endpoint was progression-free survival (PFS). Survival outcomes were evaluated using the Kaplan–Meier method and a propensity score-stratified Cox proportional hazards model.</p> Results <p>The incidence of grade ≥ 3 adverse events, the median PFS and overall survival (OS) in the Bmab, EGFR, and Triplet groups were comparable (adverse events; 33.8%, 33.3%, 37.3%; PFS: 8.2, 8.6, and 8.7&#xa0;months; and OS: 18.9, 23.0, and 17.8&#xa0;months, respectively). In the propensity score-adjusted model using the Bmab group as the reference, no evidence of a difference was detected in PFS (adjusted hazard ratio [95% CI]: 1.84 [0.88–3.83] and 0.97 [0.66–1.45] in the EGFR and Triplet groups, respectively) or OS (1.26 [0.64–2.47] and 0.84 [0.55–1.29] in the EGFR and Triplet groups, respectively).</p> Conclusions <p>In this retrospective real-world cohort, FOLFIRI plus ramucirumab appeared feasible after anti-EGFR antibody–based or triplet chemotherapy, with no clear signal of markedly different outcomes across prior first-line regimens.</p>

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Efficacy and safety of second-line fluorouracil, leucovorin, and irinotecan plus ramucirumab according to prior first-line regimens in metastatic colorectal cancer: a multicenter retrospective study

  • Toshinori Yanagawa,
  • Kozo Kataoka,
  • Hiroki Osumi,
  • Mitsuhiro Furuta,
  • Zhenxin Rao,
  • Ayako Imada,
  • Yuko Fukumoto,
  • Jihyung Song,
  • Kazuma Ito,
  • Kei Kimura,
  • Manabu Shiozawa,
  • Masataka Ikeda

摘要

Background

Fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus ramucirumab is a well-established second-line treatment for metastatic colorectal cancer (mCRC) following bevacizumab-based chemotherapy. However, its efficacy after other first-line regimens, including anti-EGFR antibody-based and triplet chemotherapy, remains insufficiently characterized. The aim of this study was to compare the efficacy and safety of FOLFIRI plus ramucirumab between patients treated with different first-line treatment regimens.

Methods

This retrospective multicenter study included 186 mCRC patients who received second-line FOLFIRI plus ramucirumab between 2016–2025. Patients were classified into three groups based on their first-line regimens: Bmab (bevacizumab-based), EGFR (anti-EGFR antibody-based), and Triplet (triplet chemotherapy). The primary endpoint was progression-free survival (PFS). Survival outcomes were evaluated using the Kaplan–Meier method and a propensity score-stratified Cox proportional hazards model.

Results

The incidence of grade ≥ 3 adverse events, the median PFS and overall survival (OS) in the Bmab, EGFR, and Triplet groups were comparable (adverse events; 33.8%, 33.3%, 37.3%; PFS: 8.2, 8.6, and 8.7 months; and OS: 18.9, 23.0, and 17.8 months, respectively). In the propensity score-adjusted model using the Bmab group as the reference, no evidence of a difference was detected in PFS (adjusted hazard ratio [95% CI]: 1.84 [0.88–3.83] and 0.97 [0.66–1.45] in the EGFR and Triplet groups, respectively) or OS (1.26 [0.64–2.47] and 0.84 [0.55–1.29] in the EGFR and Triplet groups, respectively).

Conclusions

In this retrospective real-world cohort, FOLFIRI plus ramucirumab appeared feasible after anti-EGFR antibody–based or triplet chemotherapy, with no clear signal of markedly different outcomes across prior first-line regimens.