Quality-adjusted survival with combination nal-IRI+5-FU/LV vs 5-FU/LV alone in metastatic pancreatic cancer patients previously treated with gemcitabine-based therapy: a Q-TWiST analysis
A partir des données d'un essai de phase III incluant 236 patients atteints d'un cancer du pancréas de stade métastatique et évaluant l'efficacité de l'ajout de l'irinotécan nanoliposomal (nal-IRI) à un traitement combinant 5-fluorouracile et leucovorine (5-FU/LV) après l'échec d'une thérapie à base de gemcitabine, cette étude évalue l'efficacité de cet ajout du point de vue de la survie ajustée sur la qualité de vie
Background: In the NAPOLI-1 Phase 3 trial, nal-IRI+5-fluorouracil and leucovorin (5-FU/LV) significantly improved median overall survival (6.1 vs 4.2 months, P=0.012) and progression-free survival (3.1 vs 1.5 months, P=0.0001) vs 5-FU/LV alone in metastatic pancreatic adenocarcinoma patients previously treated with gemcitabine-based therapy. This analysis evaluated between treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST). Methods: Overall survival was partitioned into time with grade greater than or equal to3 toxicity (TOX), disease progression (REL), and time without disease progression symptoms or grade greater than or equal to3 toxicity (TWiST). Mean Q-TWiST was calculated by weighting time spent by a utility of 1.0 for TWiST and 0.5 for TOX and REL. In threshold analyses, utility for TOX and REL were varied from 0.0 to 1.0. Results: Patients in nal-IRI+5-FU/LV (n=117) vs 5-FU/LV (n=119) had significantly more mean time in TWiST (3.4 vs 2.4 months) and TOX (1.0 vs 0.3 months) but similar REL (2.5 vs 2.7 months). In the base case, nal-IRI+5-FU/LV patients had 1.3 months (95% CI, 0.4–2.1; 5.1 vs 3.9) greater Q-TWiST (threshold analyses range: 0.9–1.6 months). Conclusions: Within NAPOLI-1, nal-IRI+5-FU/LV resulted in statistically significant and clinically meaningful gains in quality-adjusted survival vs 5-FU/LV alone.