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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Veröffentlicht in:	Cancer medicine (Malden, MA) MA), 2020-12, Vol.9 (24), p.9396-9408
Hauptverfasser:	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:	Artikel
Sprache:	eng
Schlagworte:	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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Zusammenfassung:	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