A phase II study of modified FOLFIRINOX for chemotherapy-na⟨ve patients with metastatic pancreatic cancer

被引：110

作者：

Ozaka, Masato ^{[1
]}

Ishii, Hiroshi ^{[2
]}

Sato, Tosiya ^{[3
]}

Ueno, Makoto ^{[4
]}

Ikeda, Masafumi ^{[5
]}

Uesugi, Kazuhiro ^{[2
]}

Sata, Naohiro ^{[6
]}

Miyashita, Kouichirou ^{[7
]}

Mizuno, Nobumasa ^{[8
]}

Tsuji, Kunihiro ^{[9
]}

Okusaka, Takuji ^{[10
]}

Furuse, Junji ^{[11
]}

机构：

[1] Japanese Fdn Canc Res, Canc Inst Hosp, Dept Gastroenterol, Koto Ku, 3-8-31 Ariake, Tokyo 1358550, Japan

[2] Natl Hosp Org, Shikoku Canc Ctr, 160 Kou, Matsuyama, Ehime 7910280, Japan

[3] Kyoto Univ, Sch Publ Hlth, Dept Biostat, Sakyo Ku, Kyoto 6068501, Japan

[4] Kanagawa Canc Ctr, Div Hepatobiliary & Pancreat Oncol, Asahi Ku, 2-3-2 Nakao, Yokohama, Kanagawa 2418515, Japan

[5] Natl Canc Ctr Hosp East, Dept Hepatobiliary & Pancreat Oncol, 6-5-1 Kashiwanoha, Kashiwa, Chiba 2778577, Japan

[6] Jichi Med Univ, Sch Med, Dept Surg, 3311-1 Yakushiji, Shimotsuke, Tochigi 3290498, Japan

[7] Showa Univ, Northern Yokohama Hosp, Internal Med Gastroenterol, Chigasakityuo 35-1, Yokohama, Kanagawa 2248503, Japan

[8] Aichi Canc Ctr Hosp, Dept Gastroenterol, Chikusa Ku, 1-1 Kanokoden, Nagoya, Aichi 4648681, Japan

[9] Ishikawa Prefectural Cent Hosp, Dept Gastroenterol, Kuratsukihigashi 2-1, Kanazawa, Ishikawa 9208530, Japan

[10] Natl Canc Ctr, Dept Hepatobiliary & Pancreat Oncol, Chuo Ku, 5-1-1 Tsukiji, Tokyo 1040045, Japan

[11] Kyorin Univ, Sch Med, Dept Med Oncol, 6-20-2 Shinkawa, Mitaka, Tokyo 1818611, Japan

来源：

CANCER CHEMOTHERAPY AND PHARMACOLOGY | 2018年 / 81卷 / 06期

关键词：

Metastatic; Pancreatic cancer; Chemotherapy; FOLFIRINOX; Modified FOLFIRINOX; RESISTANT PROSTATE-CANCER; COLORECTAL-CANCER; JAPANESE PATIENTS; BREAST-CANCER; TRIAL; CHEMOTHERAPY; OXALIPLATIN; CABAZITAXEL; GEMCITABINE; LEUCOVORIN;

D O I：

10.1007/s00280-018-3577-9

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-na < ve patients with metastatic pancreatic cancer. Patients with untreated metastatic pancreatic cancer (MPC) received modified FOLFIRINOX (intravenous oxaliplatin 85 mg/m(2), irinotecan 150 mg/m(2), 5-FU infusion 2400 mg/m(2) over 46 h, no bolus 5-FU). The primary endpoints were overall survival and the incidence of grade 3 or higher neutropenia. No patients received prophylactic pegfilgrastim. Sixty-nine pts. were enrolled from 39 institutions in Japan. The median overall survival was 11.2 months [95% confidence interval (CI) 9.0-]. The median progression-free survival was 5.5 months (95% CI 4.1-6.7). The response rate was 37.7% (95% CI 26.3-50.2), and the disease control rate was 78.3% (95% CI 66.7-87.3). The incidence of grade 3 or higher neutropenia was 47.8%. Serious adverse events occurred in six patients (8.7%). All AE proportions were less than those in the previous Japanese full-dose phase II study. One patient died due to interstitial pneumonia related to treatment. This is the first prospective study of modified FOLFIRINOX in Asia. Modified FOLFIRINOX in this study has an improved safety profile with maintained efficacy in MPC without prophylactic pegfilgrastim.

引用

页码：1017 / 1023

页数：7

共 12 条

[1] 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

[2] Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial [J].

de Bono, Johann Sebastian ;

Oudard, Stephane ;

Ozguroglu, Mustafa ;

Hansen, Steinbjorn ;

Machiels, Jean-Pascal ;

Kocak, Ivo ;

Gravis, Gwenaelle ;

Bodrogi, Istvan ;

Mackenzie, Mary J. ;

Shen, Liji ;

Roessner, Martin ;

Gupta, Sunil ;

Sartor, A. Oliver .

LANCET, 2010, 376 (9747) :1147-1154

[3] Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer:: The Gruppo Oncologico Nord Ovest [J].

Falcone, Alfredo ;

Ricci, Sergio ;

Brunetti, Isa ;

Pfanner, Elisabetta ;

Allegrini, Giacomo ;

Barbara, Cecilia ;

Crino, Lucio ;

Benedetti, Giovanni ;

Evangelista, Walter ;

Fanchini, Laura ;

Cortesi, Enrico ;

Picone, Vincenzo ;

Vitello, Stefano ;

Chiara, Silvana ;

Granetto, Cristina ;

Porcile, Gianfranco ;

Fioretto, Luisa ;

Orlandini, Cinzia ;

Andreuccetti, Michele ;

Masi, Gianluca .

JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (13) :1670-1676

[4] Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer [J].

Jones, Stephen E. ;

Savin, Michael A. ;

Holmes, Frankie Ann ;

O'Shaughnessy, Joyce A. ;

Blum, Joanne L. ;

Vukelja, Svetislava ;

McIntyre, Kristi J. ;

Pippen, John E. ;

Bordelon, James H. ;

Kirby, Robert ;

Sandbach, John ;

Hyman, William J. ;

Khandelwal, Pankaj ;

Negron, Angel G. ;

Richards, Donald A. ;

Anthony, Stephen P. ;

Mennel, Robert G. ;

Boehm, Kristi A. ;

Meyer, Walter G. ;

Asmar, Lina .

JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (34) :5381-5387

[5] Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy [J].

Kosaka, Yoshimasa ;

Rai, Yoshiaki ;

Masuda, Norikazu ;

Takano, Toshimi ;

Saeki, Toshiaki ;

Nakamura, Seigo ;

Shimazaki, Ryutaro ;

Ito, Yoshinori ;

Tokuda, Yutaka ;

Tamura, Kazuo .

SUPPORTIVE CARE IN CANCER, 2015, 23 (04) :1137-1143

[6]

Mahaseth H, 2013, PANCREAS, V42, P1311, DOI 10.1097/MPA.0b013e31829e2006

[7] Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer [J].

Nozawa, Masahiro ;

Mukai, Hirofumi ;

Takahashi, Shunji ;

Uemura, Hiroji ;

Kosaka, Takeo ;

Onozawa, Yusuke ;

Miyazaki, Jun ;

Suzuki, Kazuhiro ;

Okihara, Koji ;

Arai, Yoichi ;

Kamba, Tomomi ;

Kato, Masashi ;

Nakai, Yasutomo ;

Furuse, Hiroshi ;

Kume, Haruki ;

Ide, Hisamitsu ;

Kitamura, Hiroshi ;

Yokomizo, Akira ;

Kimura, Takahiro ;

Tomita, Yoshihiko ;

Ohno, Keiji ;

Kakehi, Yoshiyuki .

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 2015, 20 (05) :1026-1034

[8] Phase II study of FOLFIRINOX for chemotherapy-naive Japanese patients with metastatic pancreatic cancer [J].

Okusaka, Takuji ;

Ikeda, Masafumi ;

Fukutomi, Akira ;

Ioka, Tatsuya ;

Furuse, Junji ;

Ohkawa, Shinichi ;

Isayama, Hiroyuki ;

Boku, Narikazu .

CANCER SCIENCE, 2014, 105 (10) :1321-1326

[9] FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC):: a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG) [J].

Souglakos, J ;

Androulakis, N ;

Syrigos, K ;

Polyzos, A ;

Ziras, N ;

Athanasiadis, A ;

Kakolyris, S ;

Tsousis, S ;

Kouroussis, C ;

Vamvakas, L ;

Kalykaki, A ;

Samonis, G ;

Mavroudis, D ;

Georgoulias, V .

BRITISH JOURNAL OF CANCER, 2006, 94 (06) :798-805

[10] Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer [J].

Stein, Stacey M. ;

James, Edward S. ;

Deng, Yanhong ;

Cong, Xiangyu ;

Kortmansky, Jeremy S. ;

Li, Jia ;

Staugaard, Carol ;

Indukala, Doddamane ;

Boustani, Ann Marie ;

Patel, Vatsal ;

Cha, Charles H. ;

Salem, Ronald R. ;

Chang, Bryan ;

Hochster, Howard S. ;

Lacy, Jill .

BRITISH JOURNAL OF CANCER, 2016, 114 (07) :737-743

← 1 2 →