Assessing Real-World Racial Differences Among Patients With Metastatic Triple-Negative Breast Cancer in US Community Practices.

Objective: Real-world data characterizing differences between African American (AA) and White women with metastatic triple-negative breast cancer (mTNBC) are limited. Using 9 years of data collected from community practices throughout the United States, we assessed racial differences in the proportion of patients with mTNBC, and their characteristics, treatment, and overall survival (OS). Methods: This retrospective study analyzed de-identified data from 2,116 patients with mTNBC in the Flatiron Health database (January 2011 to March 2020). Characteristics and treatment patterns between AA and White patients with mTNBC were compared using descriptive statistics. OS was examined using Kaplan-Meier analysis and a multivariate Cox proportional hazards regression model. Results: Among patients with metastatic breast cancer, more AA patients (23%) had mTNBC than White patients (12%). This difference was particularly pronounced in patients who lived in the Northeast, were aged 45-65, had commercial insurance, and had initial diagnosis at stage II. AA patients were younger and more likely to have Medicaid. Clinical characteristics and first-line treatments were similar between AA and White patients. Unadjusted median OS (months) was shorter in AA (10.3; 95% confidence interval [CI]: 9.1, 11.7) vs. White patients (11.9; 95% CI: 10.9, 12.8) but not significantly different. After adjusting for potential confounders, the hazard ratio for OS was 1.09 (95% CI: 0.95, 1.25) for AA vs. White patients. Conclusions: The proportion of patients with mTNBC was higher in AA than White mBC patients treated in community practices. Race did not show an association with OS. Both AA and White patients with mTNBC received similar treatments. OS was similarly poor in both groups, particularly in patients who had not received any documented anti-cancer treatment. Effective treatment remains a substantial unmet need for all patients with mTNBC.

Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study.

Maraviroc is a first-in-class chemokine coreceptor type-5 (CCR5) antagonist with demonstrated immunovirologic activity in treatment-experienced (TE) patients with CCR5 (R5)-tropic HIV-1; however, experience in regimens containing newer antiretroviral agents is limited. The primary objective of this 96-week open-label, noncomparative, multicenter Phase 3b study (NCT00478231) was to assess the safety of maraviroc in combination with optimized background therapy (OBT), which could include recently introduced agents such as darunavir and raltegravir in TE patients in Brazil with R5 HIV-1 and limited therapeutic options. Immunovirologic activity was a secondary endpoint. Of 638 patients screened, 206 were treated and 125 completed the study. Approximately 70% were male; the mean age was 43.2 years. Most patients (65.0%) received an OBT combination of protease inhibitor plus nucleoside reverse transcriptase inhibitor. Adverse event (AE) and treatment-related AE incidence was 91.3% and 36.9%, respectively. The most common AEs were diarrhea, nasopharyngitis, and headache. Serious AEs and treatment-related serious AEs occurred in 16.5% and 4.4% of patients. Only eight patients (3.9%) discontinued due to AEs. Few AIDS-defining events were observed (4.9%). The proportion of patients with viral load <400 copies/ml increased from 2.4% at baseline to 43.9% at week 8, remaining >40% until week 48. At the end of treatment, 26.7% of patients had a viral load <400 copies/ml. Median CD4(+) cell count increased throughout the study; the mean change from baseline to end of treatment was 174.1 cells/µl. In conclusion, maraviroc, combined with different agents from multiple classes, was well tolerated in highly TE patients. Maraviroc plus OBT was associated with an immunovirologic response in this population.