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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Thursday, January 11, 2024
The PD-L1 inhibitor atezolizumab may not improve clinical outcomes when added to standard chemotherapy for patients with stage II and III triple-negative breast cancer, according to Michail Ignatiadis, MD, PhD, of the Université Libre de Bruxelles, Belgium, and colleagues. The findings of this global, randomized, open-label, phase III study, ALEXANDRA/IMPassion030, were presented at the 2023 San Antonio Breast Cancer Symposium (SABCS; Abstract GS01-03).
“Adjuvant atezolizumab is very unlikely to improve invasive disease–free survival when added to adjuvant anthracycline and taxane-based chemotherapy in patients with stage II to III triple-negative breast cancer. With longer treatment exposure in the atezolizumab arm, adverse events were more frequent but consistent with the atezolizumab safety profile,” stated the study investigators.
Patients with stage II and III resectable triple-negative breast cancer were enrolled (n = 2,199) and stratified by nodal stage and central PD-L1 status. Patients were randomly assigned to receive adjuvant atezolizumab (840 mg every 2 weeks) plus standard chemotherapy (paclitaxel, epirubicin or doxorubicin, and cyclophosphamide; n = 1,101) or the same chemotherapy regimen alone (n = 1,098). Study accrual was stopped in November 2022 to perform an early interim analysis, and a hazard ratio of < 1 was set as the futility boundary. The primary endpoint of invasive disease–free survival crossed the futility boundary, and therefore treatment was permanently discontinued in March 2023.
At the median follow-up of 25.3 months, 127 and 112 invasive disease–free survival events were observed in the atezolizumab and chemotherapy-alone arms, respectively. There were no significant differences across either arm in invasive disease–free survival events when stratified by nodal status or PD-L1 status. Grade 3 or higher adverse events were 58.0% and 48.2% in the atezolizumab arm vs the chemotherapy-alone arm, respectively, and no new safety signals were observed.
Disclosure: For full disclosures of the other study authors, visit atgproductions.net.
2023 San Antonio Breast Cancer Symposium
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