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.
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 co-administered 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.
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).
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.
Pfizer Inc.
Pfizer Inc.
E.H. Law, D. Mitra: Employee, stock ownership: Pfizer. M. Ajmera, K. Davis: Employee: RTI Health Solutions, who were paid consultants to Pfizer in connection with the development of this abstract. N. Harbeck: Honoraria: Pfizer, Lilly, Novartis; Consulting Pfizer, Lilly, Novartis. M. De Laurentiis: Honoraria: Pfizer, Novartis, Roche, Celgene, AstraZeneca, Eisai, Eli Lilly. All other authors have declared no conflicts of interest.