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Background <p>In late-line treatment for advanced gastric cancer (AGC), evidence supporting the use of irinotecan in older patients remains limited. We conducted a post-hoc age-subgroup analysis of the phase III RINDBeRG study, which randomized AGC patients previously treated with ramucirumab-based chemotherapy to receive ramucirumab plus irinotecan (RAM + IRI) or irinotecan alone (IRI).</p> Methods <p>Patients were classified as elderly (≥ 70&#xa0;years; n = 83 [RAM + IRI], 80 [IRI]) or non-elderly (&lt; 70&#xa0;years; n = 117, 113). Efficacy outcomes—including overall survival (OS), progression-free survival (PFS), and overall response rate (ORR)—and safety were compared. Prognostic factors for OS were explored via multivariable Cox regression.</p> Results <p>OS and PFS did not differ significantly between age groups. In the RAM + IRI group, median OS was 9.7 vs. 8.9&#xa0;months (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.63–1.15), and PFS was 4.0 vs. 3.6&#xa0;months (HR 0.84, CI 0.63–1.12). In the IRI group, OS was 8.5&#xa0;months in both groups (HR 0.99, CI 0.7–1.34), and PFS was 3.1 vs. 2.2&#xa0;months (HR 0.87, CI 0.65–1.17). ORRs were 20.5% vs. 14.5% (RAM + IRI) and 18.8% vs. 9.7% (IRI) in elderly vs. non-elderly patients. Grade ≥ 3 adverse events were comparable. Multivariable analysis identified ECOG PS 1, peritoneal metastasis, elevated LDH, modified Glasgow Prognostic Score ≥ 1, and low alkaline phosphatase as poor prognostic factors. Age was not prognostic.</p> Conclusions <p>Irinotecan-based therapy offers comparable efficacy and tolerability in older and younger patients with refractory AGC.</p>

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Efficacy and safety of irinotecan-based therapy in elderly patients with advanced gastric cancer receiving third-line or later chemotherapy: post-hoc age-subgroup analysis of the rindberg trial

  • 期刊论文

  • 发表日期：

    2025年12月4日

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  • Ryohei Kawabata,
  • Daisuke Sakai,
  • Toshio Shimokawa,
  • Rika Kizawa,
  • Toru Ishiguro,
  • Hiroki Yukami,
  • Shogen Boku,
  • Toshifumi Yamaguchi,
  • Shunji Endo,
  • Toshimasa Tsujinaka,
  • Taroh Satoh

摘要

Background

In late-line treatment for advanced gastric cancer (AGC), evidence supporting the use of irinotecan in older patients remains limited. We conducted a post-hoc age-subgroup analysis of the phase III RINDBeRG study, which randomized AGC patients previously treated with ramucirumab-based chemotherapy to receive ramucirumab plus irinotecan (RAM + IRI) or irinotecan alone (IRI).

Methods

Patients were classified as elderly (≥ 70 years; n = 83 [RAM + IRI], 80 [IRI]) or non-elderly (< 70 years; n = 117, 113). Efficacy outcomes—including overall survival (OS), progression-free survival (PFS), and overall response rate (ORR)—and safety were compared. Prognostic factors for OS were explored via multivariable Cox regression.

Results

OS and PFS did not differ significantly between age groups. In the RAM + IRI group, median OS was 9.7 vs. 8.9 months (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.63–1.15), and PFS was 4.0 vs. 3.6 months (HR 0.84, CI 0.63–1.12). In the IRI group, OS was 8.5 months in both groups (HR 0.99, CI 0.7–1.34), and PFS was 3.1 vs. 2.2 months (HR 0.87, CI 0.65–1.17). ORRs were 20.5% vs. 14.5% (RAM + IRI) and 18.8% vs. 9.7% (IRI) in elderly vs. non-elderly patients. Grade ≥ 3 adverse events were comparable. Multivariable analysis identified ECOG PS 1, peritoneal metastasis, elevated LDH, modified Glasgow Prognostic Score ≥ 1, and low alkaline phosphatase as poor prognostic factors. Age was not prognostic.

Conclusions

Irinotecan-based therapy offers comparable efficacy and tolerability in older and younger patients with refractory AGC.