Nanoliposomal irinotecan combined with fluorouracil/leucovorin improved overall survival in metastatic pancreatic cancer patients who have already been treated with gemcitabine.
Nanoliposomal irinotecan combined with fluorouracil/leucovorin improved overall survival in metastatic pancreatic cancer patients who have already been treated with gemcitabine, according to updated results of the NAPOLI-1 phase III clinical trial presented at the 2016 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, held January 21–23 in San Francisco (abstract 417).
“With a significant improvement in the 12-month overall survival rate and a well-defined safety and tolerability profile, the [nanoliposomal irinotecan] combination regimen is well-positioned to become the standard of care in the post-gemcitabine setting,” said Andrea Wang-Gillam, MD, PhD, of the Washington University School of Medicine in St. Louis, in a statement. “This new therapy offers hope for extended life expectancy in a patient population with limited options.”
About one in four patients in the nanoliposomal irinotecan combination arm survived at least 1 year. The 12-month overall survival rate was 26% in the nanoliposomal irinotecan plus fluorouracil/leucovorin arm compared with 16% in the fluorouracil/leucovorin arm.
The global, open label NAPOLI-1 trial randomized 417 previously treated metastatic pancreatic cancer patients to either nanoliposomal irinotecan, fluorouracil/leucovorin, or nanoliposomal irinotecan plus fluorouracil/leucovorin.
Six-month survival estimates were 53% (95% CI, 44%–62%) for the nanoliposomal irinotecan combination vs 38% (95% CI, 29%–47%) for fluorouracil/leucovorin alone. Twelve-month survival estimates were 26% (95% CI, 18%–35%) for the nanoliposomal irinotecan combination vs 16% (95% CI, 10%–24%) for fluorouracil/leucovorin alone.
Addition of nanoliposomal irinotecan to fluorouracil/leucovorin resulted in a median overall survival of 6.2 months compared with 4.2 months with fluorouracil/leucovorin alone (hazard ratio [HR], 0.75; P = .0417).
There was no survival advantage with nanoliposomal irinotecan monotherapy compared with fluorouracil/leucovorin (4.9 vs 4.2 months; HR, 1.08; P = 0.5).
These results were also published last year in Lancet.
The most common high grade adverse events in the nanoliposomal irinotecan arm were neutropenia, diarrhea, vomiting, and fatigue.
Nanoliposomal irinotecan in combination with fluorouracil/leucovorin for was approved last year by the US Food and Drug Administration for gemcitabine-treated metastatic pancreatic cancer.