Clinical trial enrollment during first course of gynecologic cancer treatment and survival.

Autor: Khadraoui W; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center, Arthur G James Cancer Center, Columbus, OH, USA., Sinnott JA; Department of Statistics, College of Arts and Sciences, The Ohio State University, Columbus, OH, USA., Meade CE; Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA., Plascak J; Division of Cancer Prevention and Control, Department of Internal Medicine College of Medicine, The Ohio State University, Columbus, OH, USA., Carey A; Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA., Backes FJ; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center, Arthur G James Cancer Center, Columbus, OH, USA., Dood RL; Department of Obstetrics and Gynecology, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, USA; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA., Trabert B; Department of Obstetrics and Gynecology, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, USA; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA., Felix AS; Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA. Electronic address: Ashley.Felix@osumc.edu.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2024 Nov 14; Vol. 192, pp. 59-64. Date of Electronic Publication: 2024 Nov 14.
DOI: 10.1016/j.ygyno.2024.11.003
Abstrakt: Objective: Among gynecologic cancer patients, it is unclear whether participation in clinical trials impacts survival outcomes. In addition, given the known racial and ethnic disparities in gynecologic cancer trial enrollment, it is important to assess whether clinical trial enrollment is similarly related to overall survival among racial and ethnic minorities. Therefore, we examined associations between clinical trial enrollment and overall survival and potential effect modification by race/ethnicity and cancer site among gynecologic cancer patients.
Methods: We used the National Cancer Database to identify women diagnosed with a cervical, ovarian, or uterine cancer from 2004 to 2020 (N = 861,817). Race/ethnicity categories included American Indian/Alaska Native, Asian, Black, Hispanic (any race), Native Hawaiian/Pacific Islander, and White. We used stratified Cox proportional hazards regression to estimate univariable and multivariable-adjusted hazard ratios and 95% confidence intervals for associations of clinical trial enrollment and overall survival. Effect modification by race/ethnicity and cancer site was assessed with multiplicative interaction terms in separate models.
Results: Median follow-up was 56.0 months (range 0.03-229.4 months). Clinical trial enrollment was related to improved overall survival among gynecologic cancer patients in the overall study population (hazard ratio = 0.90, 95% confidence interval = 0.82-0.99). Neither race/ethnicity (p = 0.34) nor cancer site (p = 0.09) modified the association.
Conclusion: Clinical trial enrollment was associated with improved outcomes for gynecologic cancer patients. These findings are important in demonstrating that participation in clinical trials, regardless of therapeutic treatment assignment, is related to better outcomes.
Competing Interests: Declaration of competing interest Dr. Plascak reports honoraria payments from National Comprehensive Cancer Network, North American Association of Central Cancer Registries, and MJH Life Sciences. Dr. Backes reports personal fees from UptoDate, Agenus, Clovis, Clinical Care Options, Medscape/WebMD, Med Learning, I3Health, CMR Institute, Global Learning Initiative/Prova, OncLive, Targeted Oncology, Research to Practice, GOG Foundation, CEC Oncology, Clovis, Eisai, Merck, AstraZeneca, GSK, ImmunoGen, BioNTech, Daiichi Sankyo, EMD Serono, and Myriad, research funding from Clovis, Eisai, Immunogen, Merck, Beigene, Tempus, Natera, and AstraZeneca, and unpaid leadership roles with Society of Gynecologic Oncology, NRG Oncology Developmental therapeutics committee, and IGCS Education360. All other authors have no conflicts of interest to disclose.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: