IRINOTECAN LIPOSOMAL Muestra una Eficacia Comparable a la del TOPOTECAN Que es el Único Tratamiento Que Cuenta Con FULL APPROVAL de la FDA en el SMALL CELL LUNG CANCER RECIDIVANTE ( Segunda Línea ) .

 

Este Nivel de Actividad, Junto con una Mejor Tolerabilidad  Respalda las Investigaciones Sobre Terapias Combinatorias con IRINOTECAN LIPOSOMAL .

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

At a median follow-up of 18.4 months, the median OS was 7.9 months in the LIPOSOMAL IRINOTECAN arm vs 8.3 months in the TOPOTECAN arm (HR, 1.11; 95% CI, 0.90-1.37; P =.31), missing the primary end point of the study . 

Among those given LIPOSOMAL IRINOTECAN, the median PFS per blinded independent central review (BICR) was 4.0 months compared with 3.3 months for those treated with TOPOTECAN (HR, 0.96; 95% CI, 0.77-1.20; nominal P =.71) .

The OVERALL Response Rate (ORR) per BICR was 44.1% (95% CI, 37.6%-50.8%) and 21.6% (range, 16.4%-27.4%), with LIPOSOMAL IRINOTECAN vs TOPOTECAN, Respectively .

LIPOSOMAL IRINOTECAN demonstrated similar PFS, a doubling of ORR, and reduced incidence of grade ≥3 related TEAEs and TEAE-related discontinuations compared with TOPOTECAN .

 This level of activity together with improved tolerability will support future combinatorial therapy research with LIPOSOMAL IRINOTECAN,” concluded the study authors . ...