Experts Support Broader Pertuzumab Use in HER2-Positive Breast Cancer
Published Online: Monday, April 14, 2014
Adam Brufsky, MD, PhD
In September 2013, the FDA approved pertuzumab in combination with trastuzumab (Herceptin) and chemotherapy for patients with HER2-positive locally advanced or early-stage breast cancer, marking the first neoadjuvant indication in that disease setting. This accelerated approval was based on results from the phase II NeoSphere trial,1 which showed that pertuzumab, a HER dimerization inhibitor, combined with the HER2 inhibitor trastuzumab and the chemotherapy docetaxel, significantly improved pathologic complete response (pCR) when compared with three other neoadjuvant regimens. In the study, pCR was defined as the absence of invasive cancer in the breast and lymph nodes.
In a recent OncLive Peer Exchange roundtable entitled “Practical Considerations in Breast Cancer,” moderator Adam M. Brufsky, MD, PhD, Medical Director, Women’s Cancer Center, Magee-Womens Hospital of UPMC, University of Pittsburgh Cancer Institute, asked panelists which patients they would consider for neoadjuvant therapy in HER2-positive breast cancer, based on the recent approval.
Denise A. Yardley, MD
NeoSphere TrialIn the phase II NeoSphere trial,1 417 patients with newly diagnosed HER2-positive early-stage breast cancer were evenly randomized to one of four treatment arms: trastuzumab plus docetaxel (n = 107, group A), pertuzumab and trastuzumab plus docetaxel (n = 107, group B), pertuzumab plus trastuzumab (n = 107, group C), or pertuzumab plus docetaxel (n = 96, group D).
Patients who received pertuzumab/trastuzumab/ docetaxel experienced a significant improvement in pCR of 45.8% (95% CI, 36.1-55.7), compared with 29% (95% CI, 20.6-38.5), 24% (95% CI, 15.8-33.7), and 16.8% (95% CI, 10.3-25.3) for groups A, D, and C, respectively.
The most common grade 3 severity or higher adverse events (AEs) observed in the pertuzumab/ trastuzumab/docetaxel arm were neutropenia (48 of 107), febrile neutropenia (9 of 107), and leukopenia (5 of 107). The number of serious AEs was similar in groups A, B, and D, but was much lower in group C, which did not receive chemotherapy.
Joyce A. O’Shaughnessy, MD
“What I’ve been doing in my practice is trying to get people on it because that pathologic CR rate is so important, particularly in the ER [estrogen receptor]–negative, where we know it does translate into benefit,” explained Joyce A. O’Shaughnessy, MD, Chair, Breast Cancer Research, Baylor Charles A. Sammons Cancer Center, Texas Oncology and US Oncology. “I think if they meet the label, T2 N0 or node positive clinically by however you get there, they should pertuzumab preoperative.”
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