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Background <p>The addition of bevacizumab to trifluridine–tipiracil (FTD/TPI) therapy improves outcomes in patients with refractory metastatic colorectal cancer (CRC). However, predictive factors of efficacy for FTD/TPI when used in combination with bevacizumab are not yet fully recognized.</p> Methods <p>Patients included in the Spanish cohort of the SUNLIGHT trial were evaluated. The primary endpoint of this post-hoc exploratory subanalysis was overall survival (OS). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), safety and the assessment of potential predictive factors of efficacy for FTD/TPI plus bevacizumab, such as age, <i>KRAS</i> mutational status, the incidence of neutropenia, patient prognosis, and prior administration of bevacizumab.</p> Results <p>A total of 115 patients were analysed, 58 receiving FTD/TPI and 57 FTD/TPI plus bevacizumab. The median OS was 8.5 vs. 10.6&#xa0;months (<i>p</i> = 0.254), respectively, and the median PFS was 2.4 vs. 4.7&#xa0;months (<i>p</i> &lt; 0.0001), respectively. Severe neutropenia affected 20% more patients in the experimental arm than in the control arm (51% vs. 31%, respectively). The univariate analysis showed that a benefit of adding bevacizumab to FTD/TPI in terms of PFS was observed in all previously defined patient subgroups and was accompanied by DCR of 69% for FTD/TPI plus bevacizumab vs. 45% in arm of FTD/TPI alone.</p> Conclusions <p>The addition of bevacizumab to FTD/TPI tends to improve OS probably due to the reduced number of patients included in this cohort and significantly improved PFS in all patient subgroups with metastatic CRC. Prospective studies are needed to confirm these results and to find out additional predictive factors that help us to discriminate which patients would benefit most from FTD/TPI plus bevacizumab.</p>

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Predictive factors of efficacy for FTD/TPI plus bevacizumab in refractory metastatic colorectal cancer patients: a subanalysis of the Spanish cohort from the SUNLIGHT phase III trial

  • 期刊论文

  • 发表日期：

    2025年5月8日

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  • Gemma Soler,
  • Cristina Grávalos,
  • Fernando Rivera,
  • María José Safont,
  • Anna C. Virgili,
  • Manuel Valladares-Ayerbes,
  • Reyes Ferreiro-Monteagudo,
  • María José Ortiz-Morales,
  • Eduardo Polo-Marques,
  • Irina Kornusova-Bersheva,
  • Elsa Soustre,
  • Weiyu Yao,
  • Elena Élez

摘要

Background

The addition of bevacizumab to trifluridine–tipiracil (FTD/TPI) therapy improves outcomes in patients with refractory metastatic colorectal cancer (CRC). However, predictive factors of efficacy for FTD/TPI when used in combination with bevacizumab are not yet fully recognized.

Methods

Patients included in the Spanish cohort of the SUNLIGHT trial were evaluated. The primary endpoint of this post-hoc exploratory subanalysis was overall survival (OS). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), safety and the assessment of potential predictive factors of efficacy for FTD/TPI plus bevacizumab, such as age, KRAS mutational status, the incidence of neutropenia, patient prognosis, and prior administration of bevacizumab.

Results

A total of 115 patients were analysed, 58 receiving FTD/TPI and 57 FTD/TPI plus bevacizumab. The median OS was 8.5 vs. 10.6 months (p = 0.254), respectively, and the median PFS was 2.4 vs. 4.7 months (p < 0.0001), respectively. Severe neutropenia affected 20% more patients in the experimental arm than in the control arm (51% vs. 31%, respectively). The univariate analysis showed that a benefit of adding bevacizumab to FTD/TPI in terms of PFS was observed in all previously defined patient subgroups and was accompanied by DCR of 69% for FTD/TPI plus bevacizumab vs. 45% in arm of FTD/TPI alone.

Conclusions

The addition of bevacizumab to FTD/TPI tends to improve OS probably due to the reduced number of patients included in this cohort and significantly improved PFS in all patient subgroups with metastatic CRC. Prospective studies are needed to confirm these results and to find out additional predictive factors that help us to discriminate which patients would benefit most from FTD/TPI plus bevacizumab.