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NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors

European Journal of Cancer Feb 10, 2019

Wang-Gillam A, et al. - Researchers report the final survival analysis and baseline characteristics related to long-term survivors (survival of ≥1 year) in the NAPOLI-1 trial, wherein a significantly improved median overall survival with liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) vs 5-FU/LV alone (6.1 vs 4.2 months; hazard ratio [HR], 0.67) has already been reported in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). For the first 4 weeks of 6-week cycles, nal-IRI + 5-FU/LV (n = 117), nal-IRI (n = 151), or 5-FU/LV (n = 149), was randomly administered to patients with mPDAC. They compared the baseline features and efficacy in the overall population vs in patients who survived ≥1 year. They found that, over an extended follow-up, survival benefits of nal-IRI+5-FU/LV vs 5-FU/LV were maintained. In addition, nal-IRI+5-FU/LV vs 5-FU/LV offered 26% and 16% of one-year overall survival rates, respectively. Karnofsky performance status ≥90, age ≤65 years, lower CA19-9 levels, neutrophil-to-lymphocyte ratio ≤5 and no liver metastases constituted the baseline characteristics that were related to long-term survival. There were no new safety concerns.
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