Gunter von Minckwitz, MD, PhD
Adding pertuzumab (Perjeta) to trastuzumab (Herceptin) and chemotherapy reduced the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in patients with HER2-positive early breast cancer in the phase III APHINITY study, according to Genentech, the manufacturer of the monoclonal antibody.
The 5-year progression-free survival (PFS) rate was 86% with the pertuzumab, trastuzumab, and docetaxel regimen (95% CI, 77-91) compared with 81% (95% CI, 71-87), 73% (95% CI, 64-81), and 73% (95% CI, 63-81), for groups A, C, and D, respectively. The hazard ratio for PFS for arm A versus B was 0.69 (95% CI, 0.34-1.00).
The 5-year DFS findings were 81%, 84%, 80%, and 75%, in the A, B, C, and D arms, respectively. The DFS hazard ratio for arm A versus B was 0.60 (95% CI, 0.28-1.27).
The most common severe grade ≥3 adverse events (AEs) for pertuzumab, trastuzumab, and docetaxel were neutropenia (44.9%), febrile neutropenia (8.4%), leukopenia (4.7%) and diarrhea (5.6%). Left ventricular dysfunction (LVD) was higher in the pertuzumab containing arms. Across all arms, all-grade LVD and congestive heart failure rates were 1.9%, 8.4%, 3.7%, and 7.4% in arms A, B, C, and D, respectively.
The FDA initially approved pertuzumab in June 2012 for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Gianni L, Pienkowski T, Im Y-H, et al. Five-year analysis of the phase II NeoSphere trial evaluating four cycles of neoadjuvant docetaxel (D) and/or trastuzumab (T) and/or pertuzumab (P). J Clin Oncol. 2015;33 (suppl; abstr 505). The Lancet Oncology. 2017;18(2):241-250. doi:10.1016/s1470-2045(16)30632-5.
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