Randomised phase II trial of trifluridine/tipiracil (FTD/TPI) plus ramucirumab (RAM) versus trifluridine/tipiracil for previously treated patients with advanced gastric or esophagogastric junction adenocarcinoma (RETRIEVE study, WJOG15822G).
Humans
Young Adult
Adult
Trifluridine
/ adverse effects
Prospective Studies
Frontotemporal Dementia
/ drug therapy
Adenocarcinoma
/ drug therapy
Stomach Neoplasms
/ drug therapy
Drug Combinations
Esophagogastric Junction
/ pathology
Colorectal Neoplasms
/ pathology
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Ramucirumab
Angiogenesis inhibitor
Esophagogastric Junction adenocarcinoma
Gastric cancer
Ramucirumab
Trifluridine/tipiracil
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
05 Aug 2023
05 Aug 2023
Historique:
received:
09
04
2023
accepted:
20
07
2023
medline:
7
8
2023
pubmed:
6
8
2023
entrez:
5
8
2023
Statut:
epublish
Résumé
Trifluridine/tipiracil (FTD/TPI) prolongs survival in the third- or later-line treatment for advanced gastric cancer (GC), esophagogastric junction (EGJ) adenocarcinoma, and colorectal cancer. While single-arm phase II trials showed promising outcomes of FTD/TPI plus ramucirumab (RAM) as third- or later-line treatments for advanced GC or EGJ cancer, there have been no clinical trials to directly compare FTD/TPI plus RAM with FTD/TPI monotherapy. Therefore, we have started a randomised phase II trial to evaluate the efficacy and safety of FTD/TPI plus RAM compared with FTD/TPI monotherapy as third- or later-line treatments in patients with advanced GC and EGJ adenocarcinoma. This RETREVE trial (WJOG15822G) is a prospective, open-label, randomised, multicentre phase II trial comparing FTD/TPI plus RAM versus FTD/TPI monotherapy in a third- or later-line setting. Eligibility criteria include age of > 20 years; performance status of 0 or 1; unresectable or recurrent gastric or EGJ adenocarcinoma; confirmed HER2 status; refractory or intolerant to fluoropyrimidine, taxane or irinotecan; refractory to RAM (not intolerant); and at least a measurable lesion per RECIST 1.1. FTD/TPI (35 mg/m This study will clarify the additional effect of RAM continuation beyond disease progression on FTD/TPI in the third- or later-line setting for patients with advanced GC or EGJ cancer. jRCTs041220120.
Sections du résumé
BACKGROUND
BACKGROUND
Trifluridine/tipiracil (FTD/TPI) prolongs survival in the third- or later-line treatment for advanced gastric cancer (GC), esophagogastric junction (EGJ) adenocarcinoma, and colorectal cancer. While single-arm phase II trials showed promising outcomes of FTD/TPI plus ramucirumab (RAM) as third- or later-line treatments for advanced GC or EGJ cancer, there have been no clinical trials to directly compare FTD/TPI plus RAM with FTD/TPI monotherapy. Therefore, we have started a randomised phase II trial to evaluate the efficacy and safety of FTD/TPI plus RAM compared with FTD/TPI monotherapy as third- or later-line treatments in patients with advanced GC and EGJ adenocarcinoma.
METHODS
METHODS
This RETREVE trial (WJOG15822G) is a prospective, open-label, randomised, multicentre phase II trial comparing FTD/TPI plus RAM versus FTD/TPI monotherapy in a third- or later-line setting. Eligibility criteria include age of > 20 years; performance status of 0 or 1; unresectable or recurrent gastric or EGJ adenocarcinoma; confirmed HER2 status; refractory or intolerant to fluoropyrimidine, taxane or irinotecan; refractory to RAM (not intolerant); and at least a measurable lesion per RECIST 1.1. FTD/TPI (35 mg/m
DISCUSSION
CONCLUSIONS
This study will clarify the additional effect of RAM continuation beyond disease progression on FTD/TPI in the third- or later-line setting for patients with advanced GC or EGJ cancer.
TRIAL REGISTRATION
BACKGROUND
jRCTs041220120.
Identifiants
pubmed: 37543568
doi: 10.1186/s12885-023-11199-1
pii: 10.1186/s12885-023-11199-1
pmc: PMC10403909
doi:
Substances chimiques
tipiracil
NGO10K751P
Trifluridine
RMW9V5RW38
Drug Combinations
0
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
726Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
PLoS One. 2019 Feb 27;14(2):e0212513
pubmed: 30811474
Lancet Oncol. 2020 Mar;21(3):412-420
pubmed: 31999946
BMC Cancer. 2023 Feb 22;23(1):180
pubmed: 36814222
Lancet Oncol. 2015 May;16(5):499-508
pubmed: 25877855
Thorac Cancer. 2019 Apr;10(4):775-781
pubmed: 30809973
Cancer Chemother Pharmacol. 2016 Oct;78(4):809-14
pubmed: 27566700
Oncologist. 2018 Jul;23(7):840-843
pubmed: 29674442
Ann Oncol. 2018 Oct 1;29(10):2052-2060
pubmed: 30052729
Lancet Oncol. 2014 Oct;15(11):1224-35
pubmed: 25240821
Gastric Cancer. 2017 Jul;20(4):655-662
pubmed: 27858180
Br J Cancer. 2023 May;128(10):1897-1905
pubmed: 36871043
J Immunother Cancer. 2018 Oct 11;6(1):106
pubmed: 30314524
Lancet Gastroenterol Hepatol. 2021 Mar;6(3):209-217
pubmed: 33508242
ESMO Open. 2020 Jul;4(Suppl 2):
pubmed: 32719002
J Clin Med. 2020 Dec 15;9(12):
pubmed: 33333866
Lancet Oncol. 2018 Nov;19(11):1437-1448
pubmed: 30355453
CA Cancer J Clin. 2021 May;71(3):209-249
pubmed: 33538338
J Clin Oncol. 2008 Nov 20;26(33):5326-34
pubmed: 18854571
Oncol Rep. 2015 May;33(5):2135-42
pubmed: 25812794
Gastric Cancer. 2018 May;21(3):464-472
pubmed: 28799048
Lancet Oncol. 2013 Jan;14(1):29-37
pubmed: 23168366
Lancet. 2017 Dec 2;390(10111):2461-2471
pubmed: 28993052
Lancet. 2021 Jul 3;398(10294):27-40
pubmed: 34102137
Future Oncol. 2021 Mar;17(8):869-875
pubmed: 32954810