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Adjuvant Pertuzumab Succeeds in Phase III HER2+ Breast Cancer Trial

Jason M. Broderick @jasoncology
Published: Thursday, Mar 02, 2017

Gunter von Minckwitz, MD, PhD

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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