Molly M Greenwade1, Kathleen N Moore2, Jessica M Gillen3, Kai Ding4, Michelle R Rowland5, Aleia K Crim6, Bailey Kleis7, Camille C Gunderson8. 1. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: molly-greenwade@ouhsc.edu. 2. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: kathleen-moore@ouhsc.edu. 3. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: jessica-gillen@ouhsc.edu. 4. Department of Biostatistics and Epidemiology, University of Oklahoma HSC, Oklahoma City, OK, United States. Electronic address: kai-ding@ouhsc.edu. 5. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: michelle-rowland@ouhsc.edu. 6. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: aleia-crim@ouhsc.edu. 7. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: bailey-kleis@ouhsc.edu. 8. Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: camille-gunderson@ouhsc.edu.
Abstract
OBJECTIVE: To characterize patients who did not enroll on a clinical trial and identify barriers that may limit enrollment among patients with advanced epithelial ovarian cancer (EOC) presenting for first-line chemotherapy. METHODS: We conducted a retrospective review of patients diagnosed with stage II-IV EOC from 10/2009-4/2013, a time period during which multiple trials were available to all EOC patients, including optimally debulked, suboptimally debulked, or undergoing neoadjuvant chemotherapy. Enrollment status, demographics, tumor characteristics, and treatment details were recorded. SAS version 9.3 was used for all analyses. RESULTS: 144 patients met study criteria; 67% were enrolled on a trial. Enrolled patients were significantly younger (median 61 vs 68years, p=0.002). Stage (p=0.30), race (p=0.75), and performance status (p=0.38) were similar between enrolled and non-enrolled patients. Distance did not impact enrollment, as nearly half of patients in both groups lived >50miles from the treatment center (39.0% vs 47.8%, p=0.36). Mode of chemotherapy administration significantly differed based on participation (all p<0.05). Despite similar residual disease status (p=1.00) and number of chemotherapy regimens received (p=0.59), patients treated on trial had a higher 3-year survival rate (70.7% vs 51.7%, p=0.031). The difference in median progression-free survival approached significance (20.2 vs 9.2months, p=0.091). CONCLUSION: In an institution where the culture is to offer clinical trials to all eligible patients, 33% of front-line EOC patients did not participate. Increasing age was associated with non-participation. Modifiable barriers must be overcome so that trial enrollment can better reflect true EOC demographics.
OBJECTIVE: To characterize patients who did not enroll on a clinical trial and identify barriers that may limit enrollment among patients with advanced epithelial ovarian cancer (EOC) presenting for first-line chemotherapy. METHODS: We conducted a retrospective review of patients diagnosed with stage II-IV EOC from 10/2009-4/2013, a time period during which multiple trials were available to all EOC patients, including optimally debulked, suboptimally debulked, or undergoing neoadjuvant chemotherapy. Enrollment status, demographics, tumor characteristics, and treatment details were recorded. SAS version 9.3 was used for all analyses. RESULTS: 144 patients met study criteria; 67% were enrolled on a trial. Enrolled patients were significantly younger (median 61 vs 68years, p=0.002). Stage (p=0.30), race (p=0.75), and performance status (p=0.38) were similar between enrolled and non-enrolled patients. Distance did not impact enrollment, as nearly half of patients in both groups lived >50miles from the treatment center (39.0% vs 47.8%, p=0.36). Mode of chemotherapy administration significantly differed based on participation (all p<0.05). Despite similar residual disease status (p=1.00) and number of chemotherapy regimens received (p=0.59), patients treated on trial had a higher 3-year survival rate (70.7% vs 51.7%, p=0.031). The difference in median progression-free survival approached significance (20.2 vs 9.2months, p=0.091). CONCLUSION: In an institution where the culture is to offer clinical trials to all eligible patients, 33% of front-line EOC patients did not participate. Increasing age was associated with non-participation. Modifiable barriers must be overcome so that trial enrollment can better reflect true EOC demographics.
Authors: Laura M Chambers; Meng Yao; Molly Morton; Morgan Gruner; Anna Chichura; Anthony B Costales; Max Horowitz; Peter G Rose; Chad M Michener; Robert Debernardo Journal: Gynecol Oncol Rep Date: 2022-02-28
Authors: Joseph M Unger; Dawn L Hershman; Cathee Till; Lori M Minasian; Raymond U Osarogiagbon; Mark E Fleury; Riha Vaidya Journal: J Natl Cancer Inst Date: 2021-03-01 Impact factor: 13.506