Chemotherapy (doublet or triplet) plus targeted therapy by RAS status as conversion therapy in colorectal cancer patients with initially unresectable liver-only metastases. The UNICANCER PRODIGE-14 randomised clinical trial

被引：26

作者：

Ychou, Marc ^{[1
]}

Rivoire, Michel ^{[2
]}

Thezenas, Simon ^{[3
]}

Guimbaud, Rosine ^{[4
]}

Ghiringhelli, Francois ^{[5
]}

Mercier-Blas, Anne ^{[6
]}

Mineur, Laurent ^{[7
]}

Francois, Eric ^{[8
]}

Khemissa, Faiza ^{[9
]}

Chauvenet, Marion ^{[10
]}

Kianmanesh, Reza ^{[11
]}

Fonck, Marianne ^{[12
]}

Houyau, Philippe ^{[13
]}

Aparicio, Thomas ^{[14
]}

Galais, Marie-Pierre ^{[15
]}

Audemar, Franck ^{[16
]}

Assenat, Eric ^{[17
]}

Lopez-Crapez, Evelyne ^{[18
,19
]}

Jouffroy, Claire ^{[20
]}

Adenis, Antoine ^{[1
]}

Adam, Rene ^{[21
]}

Bouche, Olivier ^{[22
]}

机构：

[1] Inst Canc Montpellier, Dept Digest Oncol, Montpellier, France

[2] Leon Berard Canc Ctr, Dept Surg Oncol, Lyon, France

[3] Inst Canc Montpellier, Biometr Unit, Montpellier, France

[4] CHU Toulouse, Dept Digest Oncol IUCT Rangueil Larrey, Toulouse, France

[5] Ctr Georges Francois Leclerc, Dept Med Oncol, Dijon, France

[6] Ctr Hosp Prive St Gregoire, Dept Med Oncol, St Gregoire, France

[7] Inst St Catherine, Dept Digest Oncol, Avignon, France

[8] Ctr Antoine Lacassagne, Dept Med Oncol, Nice, France

[9] Ctr Hosp St Jean, Gastroenterol Unit, Perpignan, France

[10] Hop Lyon Sud, Dept Hepatogastroenterol & Digest Oncol, Lyon, France

[11] Hop Robert Debre, Dept Digest & Endocrine Surg, Reims, France

[12] Inst Bergonie, Dept Digest Oncol, Bordeaux, France

[13] Clin Claude Bernard, Dept Med Oncol, Albi, France

[14] Hop St Louis, AP HP, Dept Gastroenterol & Digest Oncol, Paris, France

[15] Ctr Francois Baclesse, Dept Med Oncol, Caen, France

[16] Ctr Hosp Cote Basque, Gastroenterol Unit, Bayonne, France

[17] CHU St Eloi, Dept Digest Oncol, Montpellier, France

[18] Inst Canc Montpellier, Translat Res Unit, Montpellier, France

[19] Univ Montpellier, Inst Rech Cancerol Montpellier, IRCM, INSERM U1194, Montpellier, France

[20] R&D Unicanc, Paris, France

[21] Hop Paul Brousse, AP HP, Hepatobiliary Ctr, Villejuif, France

[22] Hop Robert Debre, Dept Hepatogastroenterol & Digest Oncol, Reims, France

来源：

BRITISH JOURNAL OF CANCER | 2022年 / 126卷 / 09期

关键词：

1ST-LINE TREATMENT; PHASE-II; OPEN-LABEL; BEVACIZUMAB; FOLFOXIRI; CETUXIMAB; OXALIPLATIN; FOLFIRINOX; SURVIVAL; CAPECITABINE;

D O I：

10.1038/s41416-021-01644-y

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background Colorectal cancer (CRC) patients have a better prognosis if metastases are resectable. Initially, unresectable liver-only metastases can be converted to resectable with chemotherapy plus a targeted therapy. We assessed which of chemotherapy doublet (2-CTx) or triplet (3-CTx), combined with targeted therapy by RAS status, would be better in this setting. Methods PRODIGE 14 was an open-label, multicenter, randomised Phase 2 trial. CRC patients with initially defined unresectable liver-only metastases received either, 2-CTx (FOLFOX or FOLFIRI) or 3-CTx (FOLFIRINOX), plus bevacizumab/cetuximab by RAS status. The primary endpoint was to increase the R0/R1 liver-resection rate from 50 to 70% with the 3-CTx. Results Patients (n = 256) were mainly men with an ECOG PS of 0, and a median age of 60 years. In total, 109 patients (42.6%) had RAS-mutated tumours. After a median follow-up of 45.6 months, the R0/R1 liver-resection rate was 56.9% (95% CI: 48-66) with the 3-CTx versus 48.4% (95% CI: 39-57) with the 2-CTx (P = 0.17). Median overall survival was 43.4 months with 3-CTx versus 40 months with 2-CTx. Conclusion We failed to increase from 50 to 70% the R0/R1 liver-resection rate with the use of 3-CTx combined with bevacizumab or cetuximab by RAS status in CRC patients with initially unresectable liver metastases.

引用

页码：1264 / 1270

页数：7

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