Humanistic Burden in Metastatic Triple-Negative Breast Cancer (mTNBC): A Systematic Literature Review (SLR)
Author(s)
Yuanhui Zhang, PhD1, Iwona Pustulka, MS2, Anandaroop Dasgupta, PhD1, Marissa Betts, MS3, Ryan Thaliffdeen, BS, MS, PharmD1, Sonya Egodage, MD4, Henry Ogden, PhD, MRes5, Manali A. Bhave, MD6;
1Gilead Sciences, Inc, Foster City, CA, USA, 2Evidera Inc., Poland Domaniewska, Warsaw, Poland, 3Evidera Inc., Waltham, MA, USA, 4Evidera Ltd, Bethesda, MD, USA, 5Evidera Ltd. The Ark, London, United Kingdom, 6Winship Cancer Institute, Emory University, Atlanta, GA, USA
1Gilead Sciences, Inc, Foster City, CA, USA, 2Evidera Inc., Poland Domaniewska, Warsaw, Poland, 3Evidera Inc., Waltham, MA, USA, 4Evidera Ltd, Bethesda, MD, USA, 5Evidera Ltd. The Ark, London, United Kingdom, 6Winship Cancer Institute, Emory University, Atlanta, GA, USA
Presentation Documents
OBJECTIVES: To conduct an SLR on health-related quality of life (HRQOL) and utility/disutility values in patients with mTNBC by PD-(L)1 status.
METHODS: The SLR followed Cochrane methodologies. Literature searches were conducted across MEDLINE, Embase, Cochrane Library (CENTRAL), CINAHL, and PsycInfo, covering data from the inception of each database to June 2024. Only English-language studies on mTNBC or mixed stages were included.
RESULTS: From 765 screened abstracts and 56 full-texts, 20 publications from 13 primary studies were included (7 randomized clinical trials with secondary or exploratory patient-reported endpoints, 5 observational, 1 vignette-based). Twelve studies reported on HRQOL, 5 on health utilities, and 1 on treatment satisfaction. Four studies examined patients eligible for anti-PD-(L)1 therapy, and the remaining 9 studies examined all-comers (PD-(L)1 status unclear/mixed).
Studies in anti-PD-(L)1 therapy eligible patients: These 4 studies compared atezolizumab+nab-paclitaxel versus placebo+nab-paclitaxel, pembrolizumab+chemotherapy versus placebo+chemotherapy, pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab+olaparib versus pembrolizumab+chemotherapy. All studies showed either decreased or no change in HRQOL from baseline for each intervention measured by EORTC-QLQ-C30 GHS/HRQOL or EQ-5D VAS, and no statistically significant between-group difference.
All-comers studies: One study reported improved HRQOL from baseline for olaparib versus decreased/no change with TPC for those with germline BRCA mutations. One study showed HRQOL improvement and utility gains in later-line mTNBC for sacituzumab govitecan versus placebo/TPC. An observational study showed that both HRQOL (measured by EORTC-QLQ-C30 GHS/QOL domain) and patients’ satisfaction on treatment (measured by CTSQ) decreased from 1L to 2L to 3L+. Another study found that nausea and vomiting were associated with greater reductions in HRQOL compared to neutropenia.
CONCLUSIONS: Newer therapies for mTNBC, including immunotherapy, showed no detriment or modest HRQOL benefit over comparators via exploratory analyses. More data are needed to better understand the humanistic burden of mTNBC on patient HRQOL, especially in the advanced/metastatic setting.
METHODS: The SLR followed Cochrane methodologies. Literature searches were conducted across MEDLINE, Embase, Cochrane Library (CENTRAL), CINAHL, and PsycInfo, covering data from the inception of each database to June 2024. Only English-language studies on mTNBC or mixed stages were included.
RESULTS: From 765 screened abstracts and 56 full-texts, 20 publications from 13 primary studies were included (7 randomized clinical trials with secondary or exploratory patient-reported endpoints, 5 observational, 1 vignette-based). Twelve studies reported on HRQOL, 5 on health utilities, and 1 on treatment satisfaction. Four studies examined patients eligible for anti-PD-(L)1 therapy, and the remaining 9 studies examined all-comers (PD-(L)1 status unclear/mixed).
Studies in anti-PD-(L)1 therapy eligible patients: These 4 studies compared atezolizumab+nab-paclitaxel versus placebo+nab-paclitaxel, pembrolizumab+chemotherapy versus placebo+chemotherapy, pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab+olaparib versus pembrolizumab+chemotherapy. All studies showed either decreased or no change in HRQOL from baseline for each intervention measured by EORTC-QLQ-C30 GHS/HRQOL or EQ-5D VAS, and no statistically significant between-group difference.
All-comers studies: One study reported improved HRQOL from baseline for olaparib versus decreased/no change with TPC for those with germline BRCA mutations. One study showed HRQOL improvement and utility gains in later-line mTNBC for sacituzumab govitecan versus placebo/TPC. An observational study showed that both HRQOL (measured by EORTC-QLQ-C30 GHS/QOL domain) and patients’ satisfaction on treatment (measured by CTSQ) decreased from 1L to 2L to 3L+. Another study found that nausea and vomiting were associated with greater reductions in HRQOL compared to neutropenia.
CONCLUSIONS: Newer therapies for mTNBC, including immunotherapy, showed no detriment or modest HRQOL benefit over comparators via exploratory analyses. More data are needed to better understand the humanistic burden of mTNBC on patient HRQOL, especially in the advanced/metastatic setting.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR258
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology