Background Advanced breast cancer (ABC) is a heterogeneous disease with several well-defined subtypes, among which, HR+, HER2- is the most prevalent. While clinical factors and genomic signatures have clear prognostic significance in the early breast cancer setting, this is less clear in the advanced disease setting. The aim of this systematic literature review was to identify the strength and consistency of evidence for prognostic factors in HR+, HER2-, ABC patients. Methods A comprehensive search was conducted of the major electronic databases (MEDLINE, EMBASE and Cochrane Controlled Register of Trials) in November 2018 for primary research clinical studies published since 2010 in HR+, HER2- ABC patients. Endpoints of interest were tumor response, progression-free survival (PFS), overall survival (OS), and breast-cancer specific survival (BCSS). Studies were screened by two independent reviewers for eligibility. Results Seventy-nine studies (72 full-text publications and 7 conference abstracts) were included wherein all patients were diagnosed with ABC and ≥50% of the population were HR+, HER2-. The majority were observational studies (n=71). Among the four endpoints, OS was the most commonly (n=67) assessed. Negative progesterone receptor (PR) status, higher tumor grade, higher CTC count, higher Ki67 level, number of metastatic sites (multiple vs. single) and sites of metastases (e.g., presence of liver metastases vs. absence), patients with relapsed BC compared with de novo metastatic BC, shorter time to recurrence or progression to ABC, poor performance status, prior therapy attributes in the early or metastatic setting (type of therapy, treatment line, response of prior therapy), and race (black vs. white) were consistently (>50% of studies found significant association) associated with worse OS; the relationship was inconsistent for tumor size, histological type (lobular vs. ductal), lymph node involvement and age. Directionality of relationship was consistent for all factors except lymph node involvement. Strength of association with OS was moderate [hazard ratio (HR) between 1.5-2.9] for PR status, tumor grade, CTC count, and Ki67 level, number and site (e.g., bone, liver, lung) of metastases, time to recurrence or progression to ABC, performance status, prior therapy attributes, and weak (HR<1.5) for de novo metastatic BC and race. Heterogeneity was observed across the studies in the composition of the patient population, definition and categorization for a few prognostic factors (e.g., number and sites of metastases, prior therapy, age). Similar results from fewer number of studies were observed for tumor response, PFS, BCSS. Conclusions Based on consistency and strength of the data PR status, tumor grade, CTC count, number and sites metastases, time to recurrence or progression to ABC, performance status, and prior therapy attributes were identified as the prognostic factors that had the strongest evidence. The application of these factors may be able to inform future research and clinical decision-making to improve outcomes in patients with HR+/HER2- ABC. Association between prognostic factors and overall survivalPrognostic factor Total no. of studies that assessed associationTotal no. of studies reporting significant association No. studies with significant multivariate analysis PR status1085Tumor Grade211411CTC count1097Ki67542No. of metastatic sites262313Site of metastasis332117De novo metastatic BC543Tumor size1255Lymph node1141Histological type 511Time to disease recurrence or progression18138Performance status14118Prior therapy352720Age371713Race1376 Citation Format: Gebra C Carter, Keri Stenger, Maitreyee Mohanty, Amy L Chong, Pradeep Basa, Shivaprasad Singuru, Sheena Singh, Vanita Tongbram, Sherko Kümmel, Valentina Guarneri, Sara M Tolaney. Prognostic factors associated with clinical outcomes in HR+, HER2- advanced breast cancer: Systematic literature review [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-08-40.
Background:Glioblastoma (GB) treatment remains challenging because of recurrence and poorly defined treatment options after first-line therapy. To better understand real-world application of treatment paradigms and their impact on outcomes, we describe patterns of treatment, outcomes, and use of cancer-related healthcare resource for glioblastoma in the USA.Methods:A retrospective, online chart-abstraction study was conducted; each participating oncologist contributed ≤5 charts. Patients were ≥18 years with biopsy-confirmed primary or secondary newly diagnosed GB on or after 1 January 2010, had received first- and second-line therapies, and had information collected for ≥3 months after initiation of second-line therapy or until death. Assessments were descriptive and included Kaplan– Meier analyses from initiation to end of second-line therapy, disease progression, or death.Results:One hundred sixty physicians contributed information on 503 patient charts. During first-line therapy, patients most commonly underwent temozolomide monotherapy (76.5%). During second-line therapy, patients most commonly underwent bevacizumab monotherapy (58.1%). Median duration of second-line therapy was 130 days; median time to disease progression was 113 days. Median survival was 153 days. Use of supportive care was observed to be numerically higher in first- compared with second-line therapy except for anti-depressants, growth factors, and stimulants. Frequently used resources included corticosteroids (78.8% of patients in first-line and 62.6% in second-line therapies), anti-epileptics (45.8% and 41.5%) and narcotic opioids (45.3% and 41.4%).Conclusions:Most GB patients received temozolomide during first-line therapy and bevacizumab monotherapy or combination therapy during second-line therapy. Use of supportive care appeared to be higher in first- compared with second-line therapy for some agents.
Introduction: Racial and ethnic minority enrollment in clinical trials is still a challenge and current recruitment planning has failed to improve diverse representation in clinical trials. The following literature review identified common barriers to diverse trial enrollment resulting in suggested tactics to address these barriers for breast cancer clinical trials. Methods: A literature review was conducted to identify barriers to oncology clinical trial enrollment for African American, Hispanic, Asian American, and Native American populations. A targeted review of barriers for patients in the lower socioeconomic status (SES) bracket was also performed. An advisory board of study coordinators was consulted to assess site–level awareness, barriers, and resources needed from the pharmaceutical industry. Additionally, ongoing initiatives were assessed including use of a Latino toolkit, patient navigators, and community outreach strategies. Results: The number of evidence based recruitment strategies targeting ethnic minorities was found to be lacking. There are four key aspects that influence diverse patients' decisions to participate in trials: family/friends, finances, faith, and physicians/staff. Barriers identified affected a majority of the analyzed patient populations. These included: protocol inclusion/exclusion criteria; logistical concerns; few incentives for participating; and cultural factors. The informed consent form and process were cumbersome and not patient-centric; costs related to travel and co-pays, and mistrust of medical research and the pharmaceutical industry were also identified as common barriers. The primary barriers were lack of invitations and lack of awareness at multiple levels within medical institutions, health care professionals, communities, and the pharmaceutical industry. Suggestions to address enrollment barriers include education to increase awareness, a patient-centric approach to consent and trial discussions, and tailoring site selection strategies. Other suggestions are immersion into communities, patient reimbursement, cultural competency training, pro-active translations, early recruitment planning, and identifying processes for approaching non-English speaking patients. Epidemiology data should also be incorporated in planning to establish baseline and enrollment goals. Conclusion: Although each of the analyzed populations is unique, common themes emerged. A patient-centric approach to increasing diversity in clinical trials should include considering a patient's key influences, addressing common concerns, conducting a properly informed consent process, and empowering a patient's decision making process. Gaps in current recruitment practices do still exist and further research on evidence based diverse recruitment strategies is also needed. Citation Format: Kelly R. Kirsch, Gebra C. Carter, Jacqueline M. Cole, Allicia C. Girvan, Coleman K. Obasaju. Recommendations to address common barriers to diversity in oncology clinical trials: An industry perspective. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A66. doi:10.1158/1538-7755.DISP13-A66
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.