Gastrointestinal symptoms & health-related quality of life among women with HR+/HER2– advanced or metastatic breast cancer treated in real-world settings in Italy and Germany

Abstract

Background: Gastrointestinal (GI) symptoms, including diarrhea and vomiting, are often reported by patients with advanced or metastatic breast cancer (ABC/mBC) and may affect patient care experience, health-related quality of life (HRQoL), and subsequent treatment decisions. This study characterizes the prevalence of GI symptoms and HRQoL among patients with HR+/HER2- ABC/mBC enrolled in the MARIA registry. Methods: MARIA is an ongoing prospective, multicenter, non-interventional study collecting clinical and patient-reported data from patients receiving 1st or 2nd line endocrine therapy or chemotherapy for HR+/HER2- ABC/MBC in Italy and Germany. Single-item responses from the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) were used to categorize patients into any/no symptom groups for both diarrhea and vomiting at baseline, 3-, and 6-months among patients with a visit and FACT-ES measurement. The FACT-General (FACT-G) measure was coadministered and scored to assess HRQoL at each visit. Independent t-tests examined differences in mean FACT-G scores between patients with and without symptoms for diarrhea or vomiting at baseline, 3-, and 6-months. Results: A total of 311 patients were included in the analysis. Diarrhea was reported among 17%, 28%, and 17% of patients at baseline, 3-, and 6-months, respectively. The prevalence of vomiting symptoms was 17%, 16%, and 17% at baseline, 3-, and 6- months, respectively. Mean differences [standard error] in FACT-G scores between patients reporting diarrhea and patients without were -5.0 [2.4] at baseline, -8.5 [3.7] at 3-months, -6.5 [2.9] at 6-months (all p-values <0.05). Mean FACT-G score differences [SE] between patients reporting vomiting and those who did not were -13.4 [2.3] at baseline, -17.6 [4.3] at 3-months, and -15.6 [2.6] at 6-months (all p-values <0.001). Conclusions: At least 1 in 6 patients with ABC/mBC reported diarrhea or vomiting at each point of follow-up. Group-level mean HRQoL scores were lower among patients reporting GI symptoms, regardless of the point in time. GI symptoms should be taken into consideration during treatment selection.