A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407)

医学 吉西他滨 内科学 奥沙利铂 叶黄素 伊立替康 临床终点 胃肠病学 养生 临床研究阶段 胰腺癌 无进展生存期 不利影响 外科 随机对照试验 癌症 化疗 结直肠癌
作者
Masato Ozaka,Kohei Nakachi,Satoshi Kobayashi,Akihiro Ohba,Hiroshi Imaoka,Takeshi Terashima,Hiroshi Ishii,Junki Mizusawa,Hiroshi Katayama,Tomoko Kataoka,Takuji Okusaka,Masafumi Ikeda,Naoki Sasahira,Haruo Miwa,Eishiro Mizukoshi,Naohiro Okano,Nobumasa Mizuno,Tomohisa Yamamoto,Yoshito Komatsu,Akiko Todaka
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:181: 135-144 被引量:50
标识
DOI:10.1016/j.ejca.2022.12.014
摘要

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).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%.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.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.
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