دورية أكاديمية

Factors influencing clinical trial enrollment among ovarian cancer patients.

التفاصيل البيبلوغرافية
العنوان: Factors influencing clinical trial enrollment among ovarian cancer patients.
المؤلفون: Greenwade MM; 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., Moore KN; 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., Gillen JM; 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., Ding K; Department of Biostatistics and Epidemiology, University of Oklahoma HSC, Oklahoma City, OK, United States. Electronic address: kai-ding@ouhsc.edu., Rowland MR; 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., Crim AK; 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., Kleis B; 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., Gunderson CC; 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.
المصدر: Gynecologic oncology [Gynecol Oncol] 2017 Sep; Vol. 146 (3), pp. 465-469. Date of Electronic Publication: 2017 Jul 06.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Academic Press Country of Publication: United States NLM ID: 0365304 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-6859 (Electronic) Linking ISSN: 00908258 NLM ISO Abbreviation: Gynecol Oncol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York, Academic Press.
مواضيع طبية MeSH: Clinical Trials as Topic* , Patient Participation* , Patient Selection*, Neoplasms, Glandular and Epithelial/*therapy , Ovarian Neoplasms/*therapy, Adult ; Age Factors ; Aged ; Aged, 80 and over ; Antineoplastic Agents/administration & dosage ; Carcinoma, Ovarian Epithelial ; Chemotherapy, Adjuvant ; Cytoreduction Surgical Procedures ; Disease-Free Survival ; Female ; Humans ; Middle Aged ; Neoadjuvant Therapy ; Neoplasms, Glandular and Epithelial/pathology ; Ovarian Neoplasms/pathology ; Retrospective Studies ; Survival Rate
مستخلص: 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.
(Copyright © 2017 Elsevier Inc. All rights reserved.)
فهرسة مساهمة: Keywords: Chemotherapy; Clinical trial; Eligibility; Enrollment; Ovarian cancer
المشرفين على المادة: 0 (Antineoplastic Agents)
تواريخ الأحداث: Date Created: 20170711 Date Completed: 20170919 Latest Revision: 20190221
رمز التحديث: 20231215
DOI: 10.1016/j.ygyno.2017.06.035
PMID: 28689668
قاعدة البيانات: MEDLINE
الوصف
تدمد:1095-6859
DOI:10.1016/j.ygyno.2017.06.035