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First-line FOLFOXIRI-based Chemotherapy for Unresectable Metastatic Colorectal Cancer: Real-world Outcomes, Safety,

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First-line FOLFOXIRI chemotherapy in Japan shows significant effectiveness and manageable safety for metastatic colorectal cancer, enabling conversion surgery in some patients for improved survival.

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Area of Science:

  • Oncology
  • Gastroenterology
  • Clinical Pharmacology

Background:

  • Limited real-world data exists on first-line FOLFOXIRI chemotherapy for unresectable metastatic colorectal cancer (mCRC) in Japan.
  • Evaluating effectiveness, safety, conversion feasibility, and long-term outcomes is crucial for this patient population.

Purpose of the Study:

  • To assess the real-world efficacy and safety of first-line FOLFOXIRI-based chemotherapy in Japanese patients with mCRC.
  • To identify factors associated with successful conversion surgery after induction chemotherapy.
  • To analyze long-term survival outcomes and treatment-related toxicities.

Main Methods:

  • Retrospective single-center cohort study of 59 patients receiving first-line FOLFOXIRI (± targeted agent).
  • Progression-free survival (PFS) and overall survival (OS) analyzed using Kaplan-Meier and Cox models.
  • Adverse events (AEs) graded per CTCAE v5.0.

Main Results:

  • Objective response rate (66.1%) and disease control rate (88.1%) were high.
  • Conversion surgery (R0 resection) achieved in 23.7% of patients, associated with longer PFS and OS.
  • High rates of Grade ≥3 neutropenia (72.9%) and febrile neutropenia (25.4%), but severe non-hematological AEs and treatment-related deaths were rare.
  • RAS-mutant tumors showed shorter OS compared to RAS-wildtype.

Conclusions:

  • First-line FOLFOXIRI provides substantial disease control and survival benefits with manageable toxicity in Japanese mCRC patients.
  • Conversion surgery in a subset of patients leads to improved long-term survival.
  • A conversion-focused triplet induction strategy is a viable option for rectal cancer without peritoneal metastasis, regardless of RAS mutation status.