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

被引：54

作者：

Ozaka, Masato ^{[1
,21
]}

Nakachi, Kohei ^{[2
]}

Kobayashi, Satoshi ^{[3
]}

Ohba, Akihiro ^{[4
]}

Imaoka, Hiroshi ^{[5
]}

Terashima, Takeshi ^{[6
]}

Ishii, Hiroshi ^{[7
]}

Mizusawa, Junki ^{[8
]}

Katayama, Hiroshi ^{[8
]}

Kataoka, Tomoko ^{[8
]}

Okusaka, Takuji ^{[4
]}

Ikeda, Masafumi ^{[5
]}

Sasahira, Naoki ^{[1
]}

Miwa, Haruo ^{[9
]}

Mizukoshi, Eishiro ^{[6
]}

Okano, Naohiro ^{[10
]}

Mizuno, Nobumasa ^{[11
]}

Yamamoto, Tomohisa ^{[12
]}

Komatsu, Yoshito ^{[13
]}

Todaka, Akiko ^{[14
,18
]}

Kamata, Ken ^{[15
]}

Furukawa, Masayuki ^{[16
]}

Fujimori, Nao ^{[17
]}

Katanuma, Akio ^{[18
]}

Takayama, Yukiko ^{[19
]}

Tsumura, Hidetaka ^{[20
]}

Fukuda, Haruhiko ^{[8
]}

Ueno, Makoto ^{[3
]}

Furuse, Junji ^{[3
,10
]}

机构：

[1] Japanese Fdn Canc Res, Gastroenterol Ctr, Dept Hepato Biliary Pancreat Med, Canc Inst Hosp, Tokyo, Japan

[2] Tochigi Canc Ctr, Dept Med Oncol, Utsunomiya, Japan

[3] Kanagawa Canc Ctr, Dept Gastroenterol, Yokohama, Japan

[4] Natl Canc Ctr, Dept Hepatobiliary & Pancreat Oncol, Tokyo, Japan

[5] Natl Canc Ctr Hosp East, Dept Hepatobiliary & Pancreat Oncol, Kashiwa, Japan

[6] Kanazawa Univ Hosp, Dept Gastroenterol, Kanazawa, Japan

[7] Clin Res Ctr, Chiba Canc Ctr, Chiba, Japan

[8] Natl Canc Ctr, Japan Clin Oncol Grp Data Ctr, Operat Off, Tokyo, Japan

[9] Yokohama City Univ, Dept Gastroenterol, Med Ctr, Yokohama, Japan

[10] Kyorin Univ, Dept Med Oncol, Fac Med, Tokyo, Japan

[11] Aichi Canc Ctr Hosp, Dept Gastroenterol, Nagoya, Japan

[12] Kansai Med Univ Hosp, Dept Surg, Osaka, Japan

[13] Hokkaido Univ Hosp, Dept Gastroenterol, Sapporo, Japan

[14] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, Shizuoka, Japan

[15] Kindai Univ, Dept Gastroenterol & Hepatol, Fac Med, Osaka, Japan

[16] Natl Hosp Org Kyushu Canc Ctr, Dept Hepato Biliary Pancreatol, Fukuoka, Japan

[17] Kyushu Univ, Grad Sch Med Sci, Dept Med & Bioregulatory Sci, Fukuoka, Japan

[18] Teine Keijinkai Hosp, Ctr Gastroenterol, Sapporo, Japan

[19] Tokyo Womens Med Univ, Dept Gastroenterol, Tokyo, Japan

[20] Hyogo Canc Ctr, Dept Gastroenterol Oncol, Akashi, Japan

[21] Japanese Fdn Canc Res, Hepatobiliary Pancreat Med Dept, Canc Inst Hosp, 3-8-31 Ariake,Koto Ku, Tokyo 1358550, Japan

来源：

EUROPEAN JOURNAL OF CANCER | 2023年 / 181卷

关键词：

Locally advanced pancreatic cancer; mFOLFIRINOX; Gemcitabine plus nab-paclitaxel; Phase II randomised Trial; First-line chemotherapy; CHEMOTHERAPY; SURVIVAL; CHEMORADIOTHERAPY; MULTICENTER; JAPAN;

D O I：

10.1016/j.ejca.2022.12.014

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 mFOLFIR-INOX or GnP. One-year overall survival (OS) was the primary endpoint. The major second-ary 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 hypoth-esis 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 mFOL-FIRINOX 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. 2022 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：135 / 144

页数：10

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