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Comparing the efficacy of regorafenib and 5-fluorouracil-based rechallenge chemotherapy in the third-line treatment of metastatic colorectal cancer

  • Elif Şenocak Taşçı,
  • Başak Oyan,
  • Özlem Sönmez,
  • Arda Ulaş Mutlu,
  • Muhammed Mustafa Atcı,
  • Abdullah Sakin,
  • İrem Öner,
  • Havva Yeşil Çınkır,
  • Melek Karakurt Eryılmaz,
  • Dilek Çağlayan,
  • Onur Yazdan Balçık,
  • Nail Paksoy,
  • Senem Karabulut,
  • Derya Kıvrak Salim,
  • Cemil Bilir,
  • Miraç Özen,
  • Melike Özçelik,
  • Ali Arıcan,
  • Baran Akagündüz,
  • Ali İnal,
  • Dinçer Aydın,
  • Leyla Özer,
  • Ahmet Gülmez,
  • Nazım Serdar Turhal,
  • Selin Aktürk Esen,
  • Efnan Algın,
  • Sinem Akbaş,
  • Yakup İriağaç,
  • Teoman Şakalar,
  • Çağlar Ünal,
  • Özlem Er,
  • Şaban Seçmeler,
  • Mustafa Bozkurt

摘要

Background

The optimal treatment for metastatic colorectal cancer (mCRC) after the second line is still controversial. Regorafenib has been the standard of care in this setting as it improved overall survival (OS) compared to placebo. In real-world practice chemotherapy rechallenge is also a preferred option even though supporting evidence is not enough. We aim to compare the efficacy of regorafenib and 5-fluorouracil-based (5-FU) rechallenge treatment in the third line setting of mCRC.

Methods

In this retrospective multi-institutional trial, mCRC patients from 21 oncology centers who progressed after 2 lines of chemotherapy were analyzed. Patients who were treated with regorafenib or rechallenge therapy in the third-line setting were eligible. Rechallenge chemotherapy was identified as the re-use of the 5-FU based regimen which was administered in one of the previous treatment lines. OS, disease control rate (DCR), progression free survival (PFS) and toxicity were analyzed.

Results

Three hundred ninety-four mCRC patients were included in the study. 128 (32.5%) were in the rechallenge, and 266 (67.5%) were in the regorafenib group. Median PFS was 5.82 months in rechallenge and 4 months in regorafenib arms (hazard ratio:1.45,95% CI, p = 0.167). DCR was higher in the rechallenge group than regorafenib (77% vs 49.5%, respectively, p =  < 0.001). Median OS after the third-line treatment was 11.99 (95% CI, 9.49–14.49) and 8.08 months (95% CI, 6.88–9.29) for rechallenge and regorafenib groups, respectively (hazard ratio:1.51, 95% CI, p < 0.001). More adverse effects and discontinuation were seen with regorafenib treatment.

Conclusion

Our study revealed that higher disease control and OS rates were achieved with rechallenge treatment compared to regorafenib, especially in patients who achieved disease control in one of the first two lines of therapy.