
NAPOLI 3, POUT, & Ivosidenib - Azole DDIs
Feb 15, 2024
Discover groundbreaking updates in oncology, starting with a potential new first-line treatment for metastatic pancreatic cancer, combining nalirifox's efficacy against previous standards. Dive into the positive results of the POUT trial, revealing significant improvements in disease-free and overall survival for upper tract urothelial cancer. Lastly, explore the critical drug interactions between ivosidenib and azole antifungals, highlighting the need for monitoring and adjustments to ensure therapeutic levels.
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Modest Survival Gain With Nalirifox
- NAPOLI‑3 showed nalirifox (liposomal irinotecan + 5‑FU + oxaliplatin) improved median OS to 11.1 vs 9.2 months versus gemcitabine+nab‑paclitaxel.
- The hazard ratio was 0.83, statistically significant but a modest clinical benefit with more diarrhea and high drug cost.
Check Doses Before Substituting Regimens
- Remember dosing differs: nalirifox uses lower oxaliplatin (60 mg/m2) and lower liposomal irinotecan (50 mg/m2) than earlier combinations.
- Adjust expectations and toxicity management because the regimen isn't interchangeable with prior irinotecan formulations.
Statistical Significance ≠ Clinical Importance
- Trials can be 'overpowered' to detect small differences that are statistically significant but of limited clinical importance.
- Large sample sizes may make modest survival gains appear meaningful despite marginal absolute benefit.
