Phase III randomized trial comparing systemic versus intra-arterial oxaliplatin, combined with LV5FU2+/- irinotecan and a targeted therapy, in the first-line treatment of metastatic colorectal cancer restricted to the liver (OSCAR): PRODIGE 49

被引：7

作者：

Pernot, Simon ^{[1
]}

Pellerin, Olivier ^{[2
]}

Mineur, Laurent ^{[3
]}

Monterymard, Carole ^{[4
]}

Smith, Denis ^{[5
]}

Lapuyade, Bruno ^{[6
]}

Gallois, Claire ^{[7
]}

Tougeron, David ^{[10
]}

Thirot-Bidault, Anne ^{[11
]}

Audemar, Franck ^{[12
]}

Simon, Mireille ^{[13
]}

Lecaille, Cedric ^{[14
]}

Louafi, Sami ^{[15
]}

Lepage, Come ^{[4
,5
,6
,7
,8
,9
,10
,11
,12
,13
,14
,15
,16
]}

Ducreux, Michel ^{[17
]}

Taieb, Julien ^{[7
]}

Akouz, Faiza Khemissa ^{[8
]}

De Baere, Thierry ^{[9
]}

机构：

[1] Inst Bergonie, Dept Med Oncol, 229 Cours Argonne, F-33076 Bordeaux, France

[2] Univ Paris, Hop Europeen Georges Pompidou, Dept Intervent Radiol, SIRIC CARPEM, Paris, France

[3] Inst St Catherine, Dept Med Oncol, Avignon, France

[4] Univ Burgundy & Franche Comte, Federat Francophone Cancerol Digest FFCD, EPICAD INSERM LNC UMR 1231, Dijon, France

[5] Univ Bordeaux, Dept Gastroenterol & GI Oncol, CHU Haut Leveque, Pessac, France

[6] Univ Bordeaux, Dept Intervent Radiol, CHU Haut Leveque, Pessac, France

[7] Univ Paris, Hop Europeen Georges Pompidou, Dept Gastroenterol & GI Oncol, SIRIC CARPEM, Paris, France

[8] CH St Jean, Dept Gastroenterol & GI Oncol, Perpignan, France

[9] Univ Paris Saclay, Dept Intervent Radiol, Gustave Roussy, BIOTHERIS, Villejuif, France

[10] Univ Poitiers, Dept Gastroenterol & Hepatol, CHU Mil, Poitiers, France

[11] Hop Prive Antony, Dept Med Oncol, Antony, France

[12] CH Cote Basque, Dept Gastroenterol & GI Oncol, Bayonne, France

[13] CH Pau, Dept Gastroenterol & GI Oncol, Pau, France

[14] Polyclin Bordeaux Nord Aquitaine, Dept Gastroenterol & GI Oncol, Bordeaux, France

[15] CH Corbeille Essonne, Dept Med Oncol, Corbeille Essonne, France

[16] Univ Burgundy & Franche Comte, Dept Gastroenterol & GI oncol, CHU Bocage, Dijon, France

[17] Univ Paris Saclay, Dept Med Oncol, Gustave Roussy, Inserm U1279, Villejuif, France

来源：

DIGESTIVE AND LIVER DISEASE | 2022年 / 54卷 / 03期

关键词：

Colorectal neoplasm; Liver metastases; Hepatic arterial infusion; Randomized controlled trial; HEPATIC ARTERIAL INFUSION; FOLFOXIRI PLUS BEVACIZUMAB; EARLY TUMOR SHRINKAGE; PUMP CHEMOTHERAPY; OPEN-LABEL; FOLFIRI; 5-FLUOROURACIL; MULTICENTER; LEUCOVORIN; CONVERSION;

D O I：

10.1016/j.dld.2021.12.012

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Introduction: In patients with unresectable liver metastases from colorectal cancer (CRCLM), systemic doublet or triplet chemotherapy and targeted therapy is considered a standard first-line treatment. Hepatic arterial infusion of oxaliplatin (HAI-ox) generates a high response rate, but this still needs to be confirmed in a randomized trial. We incorporated HAI-ox in doublet or triplet + targeted therapy to validate its efficacy. Aim: The OSCAR study is an ongoing randomized phase III trial comparing FOLFOX + targeted therapy according to RAS status, or FOLFOXIRI + bevacizumab in patients eligible for triplet therapy, with the same regimen but with HAI-ox instead of IV-ox as the first-line treatment for CRCLM. Materials and methods: Main eligibility criteria are colorectal cancer, unresectable liver metastasis, no extra-hepatic metastases except pulmonary nodules if <= 3 and < 10 mm, ECOG performance status 0 or 1. Endpoint: The primary endpoint is progression-free survival (PFS). A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73). Secondary endpoints include overall survival, overall response rate, secondary liver resection, safety, and quality of life. Conclusion: This study is planned to include 348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753). (c) 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

引用

页码：324 / 330

页数：7

共 21 条

[21] Combination therapy of bevacizumab with either S-1 and irinotecan or mFOLFOX6/CapeOX as first-line treatment of metastatic colorectal cancer (TRICOLORE): Exploratory analysis of RAS status and primary tumour location in a randomised, open-label, phase III, non-inferiority trial [J].

Denda, Tadamichi ;

Takashima, Atsuo ;

Gamoh, Makio ;

Iwanaga, Ichiro ;

Komatsu, Yoshito ;

Takahashi, Masanobu ;

Nakamura, Masato ;

Ohori, Hisatsugu ;

Sakashita, Akiko ;

Tsuda, Masahiro ;

Kobayashi, Yoshimitsu ;

Baba, Hideo ;

Kotake, Masanori ;

Ishioka, Chikashi ;

Yamada, Yasuhide ;

Sato, Atsushi ;

Yuki, Satoshi ;

Morita, Satoshi ;

Takahashi, Shin ;

Yamaguchi, Tatsuro ;

Shimada, Ken .

EUROPEAN JOURNAL OF CANCER, 2021, 154 :296-306

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