Phase II randomised, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients (HCRN GI14-198).

Autor: Shaib WL; Winship Cancer Institute, Emory University, Atlanta, GA, USA. Electronic address: wshaib@emory.edu., Manali R; Department of Biostatistics, Emory University, Atlanta, GA, USA., Liu Y; Department of Biostatistics, Emory University, Atlanta, GA, USA., El-Rayes B; Winship Cancer Institute, Emory University, Atlanta, GA, USA., Loehrer P; Melvin and Bren Simon Comprehensive Cancer Center, Indiana University, Indianapolis, IN, USA., O'Neil B; Melvin and Bren Simon Comprehensive Cancer Center, Indiana University, Indianapolis, IN, USA., Cohen S; Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA, USA., Khair T; Gettysburg Cancer Center, Pennsylvania Cancer Specialists, PA, USA., Robin E; NorthShore University Health System-Metro Chicago, Evanston, IL, USA., Huyck T; Nebraska Cancer Specialists, Omaha, NE, USA., Bekaii-Saab T; Mayo Clinic, Scottsdale, AZ, USA.
Jazyk: angličtina
Zdroj: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2023 Aug; Vol. 189, pp. 112847. Date of Electronic Publication: 2023 Mar 11.
DOI: 10.1016/j.ejca.2023.02.030
Abstrakt: Background: Vascular endothelial growth factor receptor (VEGFR)-mediated signalling contributes to andgiogenesis and therapy resistance in pancreatic ductal adenocarcinoma (PDAC). Ramucirumab (RAM) is a VEGFR2 monoclonal antibody. We conducted a randomised phase II trial to compare progression-free survival (PFS) between mFOLFIRINOX with or without RAM in first line therapy of metastatic PDAC.
Methods: This phase II randomised, multi-centre, placebo controlled, double-blinded, trial randomly assigned to recurrent/metastatic PDAC patients to either mFOLFIRINOX/RAM (Arm A) or mFOLFIRINOX/placebo (Arm B). The primary endpoint is PFS at 9 months, and the secondary endpoints include overall survival (OS), response rate and toxicity evaluation.
Results: A total of 86 subjects enrolled, 82 eligible (42 in Arm A versus 40 in Arm B). The mean age was comparable (61.7 versus 63.0, respectively). Majority were White (N = 69) and males (N = 43). The median PFS was 5.6 compared to 6.7 months, for Arm A and B, respectively. At 9 months, the PFS rates were 25.1% and 35.0% for Arms A and B, respectively (p = 0.322). The median OS in Arm A was 10.3 compared to 9.7 months for Arm B (p = 0.094). The disease response rate for Arm A was 17.7% compared to Arm B of 22.6%. FOLFIRINOX/RAM combination was well tolerated.
Conclusions: The addition of RAM to FOLFIRINOX did not significantly impact PFS or OS. The combination was well tolerated (Funded by Eli Lilly; ClinicalTrials.gov number, NCT02581215).
Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Dr. Tomy Saab and Dr. Walid L. Shaib: The only relevant COI is the Eli Lily research support to the study that went to the respective institutions.
(Copyright © 2023 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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