Outcomes research examining treatments, quality of life and costs in HER2 -negative and triple-negative metastatic breast cancer: a systematic literature review

Abstract

Aim:With the aggregation of real-world data in healthcare, opportunities for outcomes research are growing. In this study, we summarize published literature examining comparative effectiveness research (CER), treatment patterns, quality of life (QoL) and costs in HER2-negative and triple-negative (TN) metastatic breast cancer (mBC). Methods: PubMed (2010-January 2016) and four conferences (2013-January 2016) were searched using MeSH/keywords, including mBC, QoL, morbidity and therapeutics. Studies relating to CER, treatment patterns, QoL, costs or treatment appropriateness in US patients with HER2-negative/TN mBC were included in the review. Results: Of 1782 identified records, 33 studies met full inclusion criteria: seven related to CER, 18 to treatment patterns, one to treatment appropriateness/navigation, two to QoL and five to costs. Studies varied in objectives, designs and outcomes. Study designs included retrospective chart reviews (52%), retrospective secondary database analyses (27%), economic models (12%), physician surveys (6%) and patient surveys (3%). 25 studies reported results on HER2-negative mBC, six on TN mBC and two on both subtypes. The most common end points examined were treatment patterns, overall survival and progression-free survival. Conclusion: Outcomes research in HER2-negative mBC in the USA was limited, specifically among TN patients, indicating an opportunity for further research in this high unmet need population. Endpoints and treatment options varied, thus, it is difficult to draw summary conclusions about these studies. Outcomes research examining real-world data in mBC has increased in recent years, and may continue to grow with the implementation of new policy programs. Breast cancer is the most common cancer type among women in the USA. 29% of incident cancer cases are attributable to breast cancer alone [1]. About 66% of women with breast cancer have HER2-negative and 10-17% have HER2-negative, estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative) cancer, referred to as triple-negative breast cancer (TNBC) [2,3]. In 2016, an estimated 246,660 women were newly diagnosed with breast cancer, of which approximately 6% had metastatic or stage IV disease at the time of diagnosis [1,4,5]. About 30% of women initially diagnosed with early-stage breast cancer develop recurrent advanced or metastatic disease [6,7]. The 5-year survival rate with stage IV breast cancer is only 26.3% [4,5].Tumor markers in breast cancer impact prognosis, treatment and survival [8]. Prognosis has improved significantly for patients with metastatic HER2-positive breast cancer with emergence of trastuzumab and other anti-HER2 agents but has lagged for patients with advanced HER2-negative breast cancer since the emergence of effective new targeted therapies such as everolimus is only beginning [9]. Moreover, an important minority of these patients, those with triple-negative (TN) disease, has a relatively poor prognosis given the lack of targeted therapies, leaving cytoto...

Atypical Presentation of Triple-Negative Breast Cancer

“…An example of this situation is a study of 222 women diagnosed with breast cancer, where 18% were triple negative, with a 5-year survival rate of 96% in early stages, and only 2 women were diagnosed in late stages, with no 5-year survival [8]. In a Systematic Review, 6% had metastatic disease, with a 5-year survival rate of only 26.4% [39]. Here lies the importance of its detection, since mortality is related to late diagnosis and an advancement of the tumor stage, in addition to being able to apply preventive measures already mentioned that can improve the overall survival of patients.…”

Introducing Volume 7 of the Journal of Comparative Effectiveness Research

“…This issue is completed with a protocol paper describing the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study [7] and a Systematic Review article examining treatments, quality of life and costs in metastatic breast cancer [8].…”

“…Real-world evidence has become an important discussion point, and source of data, in recent times (as shown by some of our most read articles in 2017, see more below). This issue includes an interview from Dr Marc Berger, discussing the reports published by the joint ISPOR-ISPE Special Task Force on real-world evidence in healthcare decision making, with the goal of establishing good procedural practices for real-world data studies and ultimately increase trust in this type of research [1].In his Editorial, Skip Olson discusses the development of an integrated strategy for evidence generation, bringing together both randomized clinical trial and real-world evidence-based approaches [2].In a new White Paper, Hampson et al discuss the outcomes of an Institute for Clinical and Economic Review policy forum, exploring the challenges presented by gene therapies, discussing potential solutions and presenting policy recommendations [3].Also in this issue is a range of research and review content, including a Methodology paper discussing the Platform for Haematology in EMEA: Data for Real World Analysis (PHEDRA) [4]; and research on hemophilia B [5] and hemorrhage following cesarean delivery [6].This issue is completed with a protocol paper describing the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study [7] and a Systematic Review article examining treatments, quality of life and costs in metastatic breast cancer [8]. …”

Disparities in Guideline-Concordant Initial Systemic Treatment in Women with HER2-Negative Metastatic Breast Cancer: A SEER-Medicare Analysis

“…6,9 Still, the literature regarding MBC, particularly in patients with HER2-negative cancers, is extremely limited. 10 A study by Poorvu et al was conducted using the SEER-Medicare data for women diagnosed with MBC during 2010-2011 and reported that 24% of HER2-negative patients did not receive any systemic therapy in the first 6 months following cancer diagnosis. 9 However, the predictors of guideline-concordant care among HER2-negative cases were not identified in the study.…”