タカヤマ　ユキコ   TAKAYAMA Yukiko   高山　敬子    所属   医学部 医学科（東京女子医科大学病院）    職種   講師
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407).
掲載誌名	正式名：European journal of cancer (Oxford, England : 1990) 略　 称：Eur J Cancer ISSNコード：18790852/09598049
掲載区分	国外
巻・号・頁	181,pp.135-144
著者・共著者	OZAKA Masato, NAKACHI Kohei, KOBAYASHI Satoshi, OHBA Akihiro, IMAOKA Hiroshi, TERASHIMA Takeshi, ISHII Hiroshi, MIZUSAWA Junki, KITAYAMA Hiroshi, TAKAOKA Tomoko, OKUSAKA Takuji, IKEDA Masafumi, SASAHIRA Naoki, MIWA Haruo, MIZUKOSHI Eishiro, OKANO Naohiro, MIZUNO Nobumasa, YAMAMOYO Tomohisa, KOMATSU Yoshito, TODAKA Akiko, KAMATA Ken, FURUKAWA Masayuki, FUJIMORI Nao, KATANUMA Akio, TAKAYAMA Yukiko, TSUMURA Hidetaka, FUKUDA Haruhiko, UENO Makoto, FURUSE Junji,
発行年月	2023/03
概要	AIM:We compared the efficacy of modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) with that of gemcitabine plus nab-paclitaxel (GnP) for locally advanced pancreatic cancer (LAPC).METHODS:Patients with untreated LAPC were randomly assigned (1:1) to receive mFOLFIRINOX or GnP. One-year overall survival (OS) was the primary endpoint. The major secondary end-points included progression-free survival (PFS), response rate (RR), carbohydrate antigen 19-9 (CA19-9) response, and adverse events. The sample size was 124 patients to select a more effective regimen with a minimum probability of 0.85 and to examine the null hypothesis of the 1-year OS <53%.RESULTS:Of the 126 patients enrolled from 29 institutions, 125 were deemed eligible. The 1-year OS was 77.4% (95% CI, 64.9-86.0) and 82.5% (95% CI, 70.7-89.9) in the mFOLFIRINOX and GnP arms, respectively. The median PFS was 11.2 (95% CI, 9.9-15.9) and 9.4 months (95% CI, 7.4-12.8) in the mFOLFIRINOX and GnP arms, respectively. The RR and CA19-9 response rate were 30.9% (95% CI, 19.1-44.8) and 57.1% (95% CI, 41.0-72.3) and 42.1% (95% CI 29.1-55.9) and 85.0% (95% CI, 70.2-94.3) in the mFOLFIRINOX and GnP arms, respectively. Grade 3-4 diarrhoea and anorexia were predominant in the mFOLFIRINOX arm.CONCLUSION:GnP was considered the candidate for a subsequent phase III trial because of its better RR, CA19-9 response, and mild gastrointestinal toxicities. Both regimens displayed higher efficacy in the 1-year survival than in the historical data of gemcitabine monotherapy.
DOI	10.1016/j.ejca.2022.12.014
PMID	36652891