Updated data show long-term benefit with pertuzumab regimen in early breast cancer
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Updated data from a randomized phase 3 study showed a pertuzumab-based regimen continued to provide durable benefit for people with HER2-positive early breast cancer, according to the agent’s manufacturer.
Researchers reported a 23% reduction in risk for recurrence or death at 8 years among patients assigned the regimen, results presented at a European Society for Medical Oncology Virtual Plenary session showed.
The benefit appeared even greater among those with lymph node-positive disease, who are at higher risk for recurrence.
The double-blind APHINITY study included 4,804 people with operable HER2-positive early breast cancer.
Researchers randomly assigned patients to adjuvant treatment with trastuzumab (Herceptin, Genentech/Roche) and chemotherapy plus either pertuzumab (Perjeta, Genentech/Roche) or placebo. Pertuzumab — a HER-2/neu receptor antagonist — works with trastuzumab and docetaxel to inhibit HER-2 dimerization.
Invasive DFS served as the primary endpoint. Secondary endpoints included overall and cardiac safety, DFS and health-related quality of life.
Results released in 2017 — based on median follow-up of 45.4 months — showed a significant reduction in risk for invasive breast cancer recurrence or death among patients assigned the pertuzumab regimen (HR = 0.82; 95% CI, 0.67-1).
Based on these findings, the FDA approved the regimen for adjuvant treatment of patients with HER2-positive early breast cancer at high risk for recurrence.
Updated results presented during the ESMO Virtual Plenary — based on median follow-up of 8.4 years — showed improved invasive DFS among pertuzumab-treated patients in the intent-to-treat population (HR = 0.77; 95% CI, 0.66-0.91). Researchers reported a greater benefit among patients with lymph node-positive disease (HR = 0.72; 95% CI, 0.6-0.87).
The benefits persisted regardless of hormone receptor status.
Investigators observed fewer deaths in the pertuzumab group than placebo group (7% vs. 8.4%); however, OS data remained immature and the numerical improvement in OS observed in the pertuzumab group had not reached statistical significance (HR = 0.83; 95% CI, 0.68-1.02).
The safety profile of the pertuzumab regimen appeared consistent with prior reports.
“The 8-year APHINITY results show the great progress made in treating this aggressive form of early breast cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Roche, said in a company-issued press release. “HER2-positive breast cancers are more likely than other subtypes to recur following surgery, so targeted treatment is critical to provide the best chance for a cure.”
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