In a phase 1b trial, researchers evaluated the safety and efficacy profiles of combined S-1, irinotecan, and oxaliplatin (S-IROX) for first-line chemotherapy in patients with advanced pancreatic cancer. According to the study’s lead author, Akihiro Ohba, the combination regimen had a promising efficacy and manageable safety profile. The findings were published in the European Journal of Cancer.
This trial enrolled 47 patients with advanced prostate cancer aged 20 to 75 years of age, of which 45 were eligible for analysis. Doses included escalating S-1 at 60 or 80 mg/m2 per day on days 1 to 7, fixed oxaliplatin at 85 mg/m2 biweekly, and escalating irinotecan at 150, 165, or 180 mg/m2 once every 2 weeks. A 3 + 3 dose-expansion structure was constructed to identify the maximum-tolerated (MTD) and recommended doses (RD).
First-Line S-IROX Improves Pancreatic Cancer in Phase 1 Trial
According to the authors, the 45 patients had an overall response rate of 51.1% (95% CI, 35.8-66.3%), median progression-free survival of 6.9 months (95% CI, 5.1-8.8), and median overall survival of 15.8 months (95% CI, 9.8-20.8). The authors noted that both survival outcomes were superior to historical FOLFIRINOX data.
Additionally, the most commonly reported adverse events with S-IROX included neutropenia, elevated liver enzyme levels, diarrhea, and nausea. The authors noted that the MTD was not identified during the study, but the RD was established at the level 1 dose of S-1 80 mg/m2, irinotecan 150 mg/m2, and oxaliplatin 85 mg/m2.
The authors ultimately suggested S-IROX was potentially effective with manageable safety for patients with advanced prostate cancer. The article noted that a phase 2/3 trial comparing S-IROX, mFOLFIRINOX, and gemcitabine plus nab-paclitaxel is ongoing at the time of writing.