Advanced PDAC: SOXIRI regimen does well in phase 2 trial

  • Akahori T & al.
  • Oncologist
  • 24 Jan 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • S-1/oxaliplatin/irinotecan (SOXIRI) is effective in patients with previously untreated, unresectable pancreatic ductal adenocarcinoma (PDAC), and the regimen appeared to be better tolerated than FOLFIRINOX.

Why this matters

  • FOLFIRINOX is effective in this population but can be difficult to tolerate and is not suitable for all patients.

Study design

  • Open-label, single-arm, phase 2 study (n=35).
  • Statistical analysis: the threshold for SOXIRI was 10%, at which a sample size of 29 would lead to a power of 80%.
  • Funding: None.

Key results

  • Overall response rate (ORR) was 22.8% (95% CI, 10.4%-40.1%), exceeding the 10% threshold.
  • Disease control rate was 74.0%, which was similar to that of FOLFIRINOX found in a phase 2/3 study (70.2%) and a phase 2 study in Japanese patients (69.4%).
  • Median OS was 17.7 months.
  • Median PFS was 7.4 months.
  • Incidence of grade 3-4 neutropenia and febrile neutropenia was lower than in the phase 2 study in Japanese patients, and similar to that observed in the FOLFIRINOX phase 2/3 study.
  • Incidence of grade 3-4 fatigue, nausea, and neuropathy was similar to the FOLFIRINOX phase 2 study in Japanese patients and lower than in the FOLFIRINOX phase 2/3 study.

Limitations

  • Small study population.
  • No placebo control.

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