Nationwide Multicenter Observational Study of FOLFIRINOX Chemotherapy in 399 Patients With Unresectable or Recurrent Pancreatic Cancer in Japan

被引：15

作者：

Todaka, Akiko ^{[1
]}

Mizuno, Nobumasa ^{[2
]}

Ozaka, Masato ^{[3
]}

Ueno, Hideki ^{[4
]}

Kobayashi, Satoshi ^{[5
]}

Uesugi, Kazuhiro ^{[6
]}

Kobayashi, Noritoshi ^{[7
]}

Hayashi, Hideyuki ^{[8
]}

Sudo, Kentaro ^{[9
]}

Okano, Naohiro ^{[10
]}

Horita, Yosuke ^{[11
]}

Kamei, Keiko ^{[12
]}

Yukisawa, Seigo ^{[13
]}

Nakamori, Shoji ^{[14
]}

Yachi, Yutaka ^{[15
]}

Henmi, Toshiyuki ^{[16
]}

Kobayashi, Marina ^{[17
]}

Boku, Narikazu ^{[18
]}

Mori, Keita ^{[19
]}

Fukutomi, Akira ^{[1
]}

机构：

[1] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, 1007 Shimonagakubo, Nagaizumi, Shizuoka 4118777, Japan

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

[3] Japanese Fdn Canc Res, Dept Gastroenterol, Canc Inst Hosp, Tokyo, Japan

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

[5] Kanagawa Canc Ctr, Div Hepatobiliary & Pancreat Med Oncol, Yokohama, Kanagawa, Japan

[6] Natl Hosp Org Shikoku Canc Ctr, Dept Gastroenterol, Matsuyama, Ehime, Japan

[7] Yokohama City Univ Med, Dept Oncol, Yokohama, Kanagawa, Japan

[8] Hokkaido Univ Hosp, Dept Gastroenterol & Hepatol, Sapporo, Hokkaido, Japan

[9] Chiba Canc Ctr, Div Gastroenterol, Chiba, Japan

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

[11] Toyama Prefectural Cent Hosp, Dept Chemotherapy & Internal Med, Toyama, Japan

[12] Kindai Univ, Fac Med, Dept Surg, Osaka, Japan

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

[14] Osaka Natl Hosp, Dept Hepatobiliary & Pancreat Surg, Osaka, Japan

[15] Daiichi Sankyo Co Ltd, Pharmacovigilance Dept, Tokyo, Japan

[16] Yakult Honsha Co Ltd, Postmkt Surveillance Pharmacovigilance Dept, Tokyo, Japan

[17] Shizuoka Ind Fdn Pharma Valley Ctr, Clin Trial Promot Sect, Shizuoka, Japan

[18] Natl Canc Ctr, Div Gastrointestinal Med Oncol, Tokyo, Japan

[19] Shizuoka Canc Ctr, Clin Res Ctr, Clin Res Promot Unit, Shizuoka, Japan

来源：

PANCREAS | 2018年 / 47卷 / 05期

关键词：

pancreatic cancer; chemotherapy; oxaliplatin; irinotecan; 5-fluorouracil; FOLFIRINOX; AMERICAN SOCIETY; PHASE-III; GEMCITABINE; ERLOTINIB; SURVIVAL; THERAPY;

D O I：

10.1097/MPA.0000000000001049

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Objectives FOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin) is the standard therapy worldwide for unresectable pancreatic cancer; however, clinical data for Japanese patients are limited. Therefore, the observational study of FOLFIRINOX for patients with pancreatic cancer was conducted. Methods The study included 399 patients with unresectable or recurrent pancreatic cancer, from 27 institutions in Japan, treated with FOLFIRINOX and surveyed until December 2015. Results The median age was 63 years; in most patients, the Eastern Cooperative Oncology Group performance status was 1 or lower. The initial dose was reduced in 270 patients (68%). The main grade 3/4 toxicities were neutropenia (64%), anorexia (14%), and febrile neutropenia (13%). Fatal adverse events occurred in 5 patients, 4 of whom did not satisfy the main inclusion criteria of a previous Japanese phase II FOLFIRINOX study. The median overall survival and progression-free survival times were 10.8, and 4.5 months, respectively. The objective response rate was 21%, and the disease control rate was 61%. The median overall survival times were 11.1, 18.5, and 4.9 months in chemotherapy-naive patients with metastatic, locally advanced, and recurrent disease, respectively. Conclusion When carefully managed, FOLFIRINOX is acceptably safe and efficacious in Japanese patients with unresectable pancreatic cancer.

引用

页码：631 / 636

页数：6

共 19 条

[1]

[Anonymous], 2017, CLIN PRACTICE GUIDEL

[2]

[Anonymous], 2016, VIT STAT JAP

[3]

[Anonymous], 2016, NCCN Clinical Practice Guidelines in Oncology for Prostate Cancer, V3

[4] Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline [J].

Balaban, Edward P. ;

Mangu, Pamela B. ;

Khorana, Alok A. ;

Shah, Manish A. ;

Mukherjee, Somnath ;

Crane, Christopher H. ;

Javle, Milind M. ;

Eads, Jennifer R. ;

Allen, Peter ;

Ko, Andrew H. ;

Engebretson, Anitra ;

Herman, Joseph M. ;

Strickler, John H. ;

Benson, Al B., III ;

Urba, Susan ;

Yee, Nelson S. .

JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (22) :2654-U169

[5] Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial [J].

Burris, HA ;

Moore, MJ ;

Andersen, J ;

Green, MR ;

Rothenberg, ML ;

Madiano, MR ;

Cripps, MC ;

Portenoy, RK ;

Storniolo, AM ;

Tarassoff, P ;

Nelson, R ;

Dorr, FA ;

Stephens, CD ;

VanHoff, DD .

JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (06) :2403-2413

[6] FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer [J].

Conroy, Thierry ;

Desseigne, Francoise ;

Ychou, Marc ;

Bouche, Olivier ;

Guimbaud, Rosine ;

Becouarn, Yves ;

Adenis, Antoine ;

Raoul, Jean-Luc ;

Gourgou-Bourgade, Sophie ;

de la Fouchardiere, Christelle ;

Bennouna, Jaafar ;

Bachet, Jean-Baptiste ;

Khemissa-Akouz, Faiza ;

Pere-Verge, Denis ;

Delbaldo, Catherine ;

Assenat, Eric ;

Chauffert, Bruno ;

Michel, Pierre ;

Montoto-Grillot, Christine ;

Ducreux, Michel .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (19) :1817-1825

[7] New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].

Eisenhauer, E. A. ;

Therasse, P. ;

Bogaerts, J. ;

Schwartz, L. H. ;

Sargent, D. ;

Ford, R. ;

Dancey, J. ;

Arbuck, S. ;

Gwyther, S. ;

Mooney, M. ;

Rubinstein, L. ;

Shankar, L. ;

Dodd, L. ;

Kaplan, R. ;

Lacombe, D. ;

Verweij, J. .

EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247

[8] Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib The LAP07 Randomized Clinical Trial [J].

Hammel, Pascal ;

Huguet, Florence ;

van Laethem, Jean-Luc ;

Goldstein, David ;

Glimelius, Bengt ;

Artru, Pascal ;

Borbath, Ivan ;

Bouche, Olivier ;

Shannon, Jenny ;

Andre, Thierry ;

Mineur, Laurent ;

Chibaudel, Benoist ;

Bonnetain, Franck ;

Louvet, Christophe .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 315 (17) :1844-1853

[9] Modified-FOLFIRINOX in metastatic pancreatic cancer: A prospective study in Chinese population [J].

Li, Xiang ;

Ma, Tao ;

Zhang, Qi ;

Chen, Yi-Gang ;

Guo, Cheng-Xiang ;

Shen, Yi-Nan ;

Sun, Pei-Wei ;

Li, Guo-Gang ;

Gao, Shun-Liang ;

Que, Ri-Sheng ;

Lou, Jian-Ying ;

Yu, Ri-Sheng ;

Yuan, Ying ;

Wei, Qi-Chun ;

Wei, Shu-Mei ;

Zhang, Yun ;

Zheng, Lei ;

Bai, Xue-Li ;

Liang, Ting-Bo .

CANCER LETTERS, 2017, 406 :22-26

[10] European cancer mortality predictions for the year 2015: does lung cancer have the highest death rate in EU women? [J].

Malvezzi, M. ;

Bertuccio, P. ;

Rosso, T. ;

Rota, M. ;

Levi, F. ;

La Vecchia, C. ;

Negri, E. .

ANNALS OF ONCOLOGY, 2015, 26 (04) :779-786

← 1 2 →