Development of a Prognostic Factor Index Among Women With HR+/HER2− Metastatic Breast Cancer in a Community Oncology Setting

Abstract

This analysis explored the impact of prognostic factors on clinical outcomes for patients with hormone receptor-positive/human epidermal growth factor 2-negative metastatic breast cancer. An index factor was created and included liver metastases, primary endocrine resistance, negative progesterone receptor status, and high tumor grade. The prognostic factor index may enable early identification of patients with a less favorable prognosis. Background: This study explored the impact of multiple prognostic factors on patient overall survival (OS) and realworld progression-free survival (rwPFS) for patients with hormone receptor-positive (HR þ )/human epidermal growth factor 2 negative (HER2 À ) metastatic breast cancer (MBC). Materials and Methods: This retrospective study used electronic health record data of patients in the United States from community oncology practices from January 1, 2008 to April 30, 2017. Eligibility included HR þ /HER2 À MBC diagnosis in 2008 or later and prior systemic therapy for MBC. An index variable was created to assess the effect of multiple clinical prognostic factors collectively, including liver metastases (LM), primary endocrine resistance (PER), negative progesterone receptor (PR À ) status, and high tumor grade (TG). Patients were grouped based on the number of prognostic factors present at MBC diagnosis: 0, 1, and 2þ. Differences in rwPFS and OS from start of first-line therapy were evaluated by the Kaplan-Meier method and multivariable Cox proportional hazards regression. Results: Approximately 29.1% of the 378 eligible patient sample had 0, 36.0% had 1, and 34.9% had 2þ prognostic factors. For the patients with 1 of the prognostic factors, 24.3% had high TG, 14.7% were LMþ, 39.7% had PER, and 21.3% were PR À . Univariate and multivariate results showed that rwPFS and OS were significantly (P < .05) shorter in patients with 1 and 2þ prognostic factors compared with patients with 0. Conclusions: The individual prognostic factors and the prognostic factor index may enable early identification of patients with a less favorable prognosis across the HR þ /HER2 À MBC population and help inform treatment decisions in difficult-to-treat populations.

Real-world clinical profile, treatment patterns and patient-reported outcomes in a subset of HR+/HER2- advanced breast cancer patients with poor prognostic factors: data from an international study

“…These findings aligned with a retrospective analysis of US patients with poor prognostic factors initiating treatment of advanced disease between 2008 and 2017. 57 The authors reported that 33% and 27% of the patient sample received an aromatase inhibitor- and chemotherapy-containing regimen, respectively. A higher proportion of those with liver metastases received chemotherapy.…”

Real-World Treatment Patterns and Outcomes in PD-L1-Positive Non-Small Cell Lung Cancer

“…For a combination regimen, all agents were required to start within 30 days of the start of the first agent, unless an agent was specifically planned to start after 30 days. In addition, it was required that the agent be discontinued and replaced by another agent within 30 days of the start of the first agent and that no agent be held and then resumed after an interval of more than 63 days [13,[17][18][19]. Accordingly, the addition of a new agent to an existing therapy more than 30 days after start of the first agent constituted a change of regimen, unless the record indicated a planned delay in the start of an agent.…”