Resultados de FASE III, Aleatorizado y Abierto, de IRINOTECAN LIPOSOMAL Versus TOPOTECAN en Adultos con Cáncer de Pulmón de Células Pequeñas de Segunda Línea ( Recidivante ) .

 

A Randomized, Open-Label Phase III Study Of Liposomal Irinotecan Versus Topotecan In Adults With Relapsed Small Cell Lung Cancer .

JOURNAL Of CLINICAL ONCOLOGY , 22 APRIL 2024 .

Results :

Among 461 randomly assigned patients, 229 received liposomal IRINOTECAN and 232 received TOPOTECAN .

The median follow-up was 18.4 months .

 The median OS was 7.9 months with liposomal IRINOTECAN versus 8.3 months with TOPOTECAN (hazard ratio [HR], 1.11 [95% CI, 0.90 to 1.37]; P = .31). 

The median PFS per blinded independent central review (BICR) was 4.0 months with liposomal IRINOTECAN and 3.3 months with TOPOTECAN (HR, 0.96 [95% CI, 0.77 to 1.20]; nominal P = .71); ORR per BICR was 44.1% (95% CI, 37.6 to 50.8) and 21.6% (16.4 to 27.4), respectively .

 

Overall, 42.0% and 83.4% of patients receiving liposomal IRINOTECAN and TOPOTECAN, respectively, experienced grade ≥3 related treatment-emergent adverse events (TEAEs) .

The most common grade ≥3 related TEAEs were diarrhea (13.7%), neutropenia (8.0%), and decreased neutrophil count (4.4%) with liposomal IRINOTECAN and neutropenia (51.6%), anemia (30.9%), and leukopenia (29.1%) with TOPOTECAN . ...