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Immune microenvironment of premenopausal estrogen receptor-positive/HER2-negative advanced breast cancer in response to treatment of Pembrolizumab, exemestane, and leuprolide

ABSTRACT: Immune microenvironment of premenopausal estrogen receptor-positive/HER2-negative advanced breast cancer in response to treatment of Pembrolizumab, exemestane, and leuprolide

PROVIDER: PRJNA1089137 | ENA |

REPOSITORIES: ENA

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Project description:Importance:Everolimus plus exemestane and capecitabine are approved second-line therapies for advanced breast cancer. Objective:A postapproval commitment to health authorities to estimate the clinical benefit of everolimus plus exemestane vs everolimus or capecitabine monotherapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Design:Open-label, randomized, phase 2 trial of treatment effects in postmenopausal women with advanced breast cancer that had progressed during treatment with nonsteroidal aromatase inhibitors. Interventions:Patients were randomized to 3 treatment regimens: (1) everolimus (10 mg/d) plus exemestane (25 mg/d); (2) everolimus alone (10 mg/d); and (3) capecitabine alone (1250 mg/m2 twice daily). Main Outcomes and Measures:Estimated hazard ratios (HRs) of progression-free survival (PFS) for everolimus plus exemestane vs everolimus alone (primary objective) or capecitabine alone (key secondary objective). Safety was a secondary objective. No formal statistical comparisons were planned. Results:A total of 309 postmenopausal women were enrolled, median age, 61 years (range, 32-88 years). Of these, 104 received everolimus plus exemestane; 103, everolimus alone; and 102, capecitabine alone. Median follow-up from randomization to the analysis cutoff (June 1, 2017) was 37.6 months. Estimated HR of PFS was 0.74 (90% CI, 0.57-0.97) for the primary objective of everolimus plus exemestane vs everolimus alone and 1.26 (90% CI, 0.96-1.66) for everolimus plus exemestane vs capecitabine alone. Between treatment arms, potential informative censoring was noted, and a stratified multivariate Cox regression model was used to account for imbalances in baseline characteristics; a consistent HR was observed for everolimus plus exemestane vs everolimus (0.73; 90% CI, 0.56-0.97), but the HR was closer to 1 for everolimus plus exemestane vs capecitabine (1.15; 90% CI, 0.86-1.52). Grade 3 to 4 adverse events were more frequent with capecitabine (74%; n?=?75) vs everolimus plus exemestane (70%; n?=?73) or everolimus alone (59%; n?=?61). Serious adverse events were more frequent with everolimus plus exemestane (36%; n?=?37) vs everolimus alone (29%; n?=?30) or capecitabine (29%; n?=?30). Conclusions and Relevance:These findings suggest that everolimus plus exemestane combination therapy offers a PFS benefit vs everolimus alone, and they support continued use of this therapy in this setting. A numerical PFS difference with capecitabine vs everolimus plus exemestane should be interpreted cautiously owing to imbalances among baseline characteristics and potential informative censoring. Trial Registration:ClinicalTrials.gov identifier: NCT01783444.

Dataset Information

Immune microenvironment of premenopausal estrogen receptor-positive/HER2-negative advanced breast cancer in response to treatment of Pembrolizumab, exemestane, and leuprolide

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