nal‐IRI+5‐FU/LV versus 5‐FU/LV in post‐gemcitabine metastatic pancreatic cancer: Randomized phase 2 trial in Japanese patients

Background In the NAPOLI‐1 phase 3 trial, liposomal irinotecan (nal‐IRI) +5‐fluorouracil/leucovorin (5‐FU/LV) significantly increased mPFS versus 5‐FU/LV (3.1 vs. 1.5 months [unstratified HR = 0.56, p = 0.0001]) in patients with mPAC that progressed on prior gemcitabine‐based therapy. This randomize...

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Bibliographic Details
Published in:Cancer medicine (Malden, MA) MA), 2020-12, Vol.9 (24), p.9396-9408
Main Authors: Ueno, Makoto, Nakamori, Shoji, Sugimori, Kazuya, Kanai, Masashi, Ikeda, Masafumi, Ozaka, Masato, Furukawa, Masayuki, Okusaka, Takuji, Kawabe, Ken, Furuse, Junji, Komatsu, Yoshito, Ishii, Hiroshi, Sato, Atsushi, Shimizu, Satoshi, Chugh, Priti, Tang, Rui, Ioka, Tatsuya
Format: Article
Language:English
Subjects:
5-Fluorouracil
Adult
Aged
Aged, 80 and over
Angina pectoris
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer therapies
Chemotherapy
Clinical Cancer Research
clinical trials
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Diarrhea
Drug Resistance, Neoplasm
Female
Fluorouracil - administration & dosage
Gemcitabine
Humans
Irinotecan
Irinotecan - administration & dosage
Japan
Leucovorin - administration & dosage
Liposomes - administration & dosage
Male
medical oncology
Metastases
Metastasis
Middle Aged
Mortality
Neoplasm Metastasis
Neoplasm Staging
Original Research
Pancreatic cancer
pancreatic ductal adenocarcinoma
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - pathology
Patients
Quality of life
Statistical analysis
Survival Rate
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Summary:Background In the NAPOLI‐1 phase 3 trial, liposomal irinotecan (nal‐IRI) +5‐fluorouracil/leucovorin (5‐FU/LV) significantly increased mPFS versus 5‐FU/LV (3.1 vs. 1.5 months [unstratified HR = 0.56, p = 0.0001]) in patients with mPAC that progressed on prior gemcitabine‐based therapy. This randomized phase 2 trial evaluated nal‐IRI+5‐FU/LV tolerability (Part 1), safety, and efficacy (Part 2; outcomes reported here) in Japanese patients with mPAC that progressed on gemcitabine‐based therapy. Methods Patients were randomized 1:1 and stratified by KPS (70 and 80 vs. ≥90) and baseline albumin (≥4.0 g/dl vs.
ISSN:2045-7634
2045-7634
DOI:10.1002/cam4.3558