A TARGETED LITERATURE REVIEW TO IDENTIFY PATIENT-REPORTED SYMPTOMS ASSOCIATED WITH BREAST CANCER DISEASE PROGRESSION
Author(s)
Diana Lüftner, MD, PhD1, Selin Yurdakul, MD2, Sandhya Mehta, PhD, MS3, Allison Martin Nguyen, BS, MHA, MS4, Peter Kaskel, MBA, MD5, Esther Pang, PharmD3, Magnus Lutz, MSc6, Debayan Purkait, PhD7, Obinna Onwude, MSc2.
1Immanuel Klinik Märkische Schweiz and Immanuel Klinik Rüdersdorf, Medical University of Brandenburg, Brandenburg, Germany, 2IQVIA London, London, United Kingdom, 3Daiichi Sankyo, Inc., Basking Ridge, NJ, USA, 4Merck & Co., Inc., Rahway, NJ, USA, 5Merck Sharp & Dohme GmbH, Munich, Germany, 6Daiichi Sankyo Europe GmbH, Munich, Germany, 7IQVIA Bangalore, Bangalore, India.
1Immanuel Klinik Märkische Schweiz and Immanuel Klinik Rüdersdorf, Medical University of Brandenburg, Brandenburg, Germany, 2IQVIA London, London, United Kingdom, 3Daiichi Sankyo, Inc., Basking Ridge, NJ, USA, 4Merck & Co., Inc., Rahway, NJ, USA, 5Merck Sharp & Dohme GmbH, Munich, Germany, 6Daiichi Sankyo Europe GmbH, Munich, Germany, 7IQVIA Bangalore, Bangalore, India.
OBJECTIVES: As more treatments for breast cancer (BC) emerge, leading to longer survival, earlier patient-relevant endpoints are needed to evaluate efficacy and support regulatory and health technology assessment submissions. Patient-relevant endpoints, such as time to symptomatic disease progression (DP), may provide earlier insights into treatment efficacy. As a first step, this targeted literature review synthesized qualitative insights about patient-reported symptoms associated with DP in patients with BC.
METHODS: The PubMed, ESMO, Embase, and ASCO databases were searched for publications reporting signs and symptoms associated with BC progression over the past 15 years; the Patient, Intervention, Comparison, Outcome, Study Design (PICOS) framework was used to identify patient-reported symptoms across BC stages. Insights were qualitatively assessed to clarify symptoms relevant to DP and severity.
RESULTS: Ten of 723 articles met the full extraction criteria (patient-reported data from BC populations), including 8 primary research and 2 review articles. Most common disease-related symptoms in advanced BC were fatigue (range, 80%-100%), pain (13%-100%), dyspnea (6%-75%), and appetite loss (6%-75%). In patients with triple-negative or HR+/HER2− BC, fatigue (80%-100%) and pain (47%-59%) were the most prevalent and burdensome symptoms of advanced BC. Eighteen symptoms were identified from stage II-IV BC, with increasing burden associated with advanced BC, but were not indicative of DP. Four studies provided metastatic site-specific symptoms, such as brain (headache/focal seizure), lung (cough/dyspnea), and liver (abdominal pain); however, symptoms generally aligned with those reported by all patients with BC.
CONCLUSIONS: The current literature provides key insights on symptoms related to BC, demonstrating higher burden with advanced BC. However, an evidence gap remains regarding symptom evolution with DP, especially for subpopulations such as HR+/HER2− BC, and across treatment lines for advanced BC. Given the clinical and patient-centered relevance of symptomatic DP, further research is needed to inform clinical practice and trial endpoints.
METHODS: The PubMed, ESMO, Embase, and ASCO databases were searched for publications reporting signs and symptoms associated with BC progression over the past 15 years; the Patient, Intervention, Comparison, Outcome, Study Design (PICOS) framework was used to identify patient-reported symptoms across BC stages. Insights were qualitatively assessed to clarify symptoms relevant to DP and severity.
RESULTS: Ten of 723 articles met the full extraction criteria (patient-reported data from BC populations), including 8 primary research and 2 review articles. Most common disease-related symptoms in advanced BC were fatigue (range, 80%-100%), pain (13%-100%), dyspnea (6%-75%), and appetite loss (6%-75%). In patients with triple-negative or HR+/HER2− BC, fatigue (80%-100%) and pain (47%-59%) were the most prevalent and burdensome symptoms of advanced BC. Eighteen symptoms were identified from stage II-IV BC, with increasing burden associated with advanced BC, but were not indicative of DP. Four studies provided metastatic site-specific symptoms, such as brain (headache/focal seizure), lung (cough/dyspnea), and liver (abdominal pain); however, symptoms generally aligned with those reported by all patients with BC.
CONCLUSIONS: The current literature provides key insights on symptoms related to BC, demonstrating higher burden with advanced BC. However, an evidence gap remains regarding symptom evolution with DP, especially for subpopulations such as HR+/HER2− BC, and across treatment lines for advanced BC. Given the clinical and patient-centered relevance of symptomatic DP, further research is needed to inform clinical practice and trial endpoints.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO126
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology