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1-year trastuzumab remains standard in HER-2–positive breast cancer
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One year of adjuvant trastuzumab should remain the standard of care for patients with HER-2–positive early-stage breast cancer, even though the incidence of cardiac events is higher with a 12-month regimen than a 6-month regimen, according to results of a randomized phase 3 trial.
One year of adjuvant trastuzumab (Herceptin, Genentech) has been the standard treatment for patients with HER-2–positive early-stage breast cancer since 2005. However, the optimum duration of treatment has been the subject of debate, according to background information in the study.
The open-label PHARE trial included 3,380 women who underwent treatment at 156 centers in France. Researchers assigned half of the women to the standard 12-month regimen, while the other half received treatment for 6 months.
After a median follow-up was 42.5 months, researchers reported 175 DFS events in the 1-year arm and 219 DFS events in the 6-month arm.
At 2 years, the DFS rate was 93.8% in the 12-month arm vs. 91.1% in the 6-month arm (HR=1.28; 95% CI, 1.05–1.56).
The rate of cardiac events was significantly higher in the 12-month arm (5.7% vs. 1.9%; P<.0001).
Longer follow-up is needed to reach a conclusion regarding non-inferiority of the 6-month regimen among specific subgroups of patients, as the trial was not powered to answer that question, researchers said.
“These results will need to be validated in other ongoing similar trials investigating trastuzumab duration through a pooled analysis,” the researchers wrote. “Several trials are currently assessing a shorter duration of trastuzumab … However, on the basis of the results presented here, 12 months of adjuvant trastuzumab should remain the standard of care for women with HER-2–positive early breast cancer.”
Disclosure: The study was funded by the French National Cancer Institute. The researchers report research funding and honoraria from Aventis, Celgene, GlaxoSmithKline, Johnson & Johnson and Roche.
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Adam M. Brufsky, MD, PhD, FACP
This trial is important in our efforts to define the optimal length of time to administer adjuvant trastuzumab. The HERA trial (Piccart-Gebhart MJ. Abstract #S5-2. Presented at: San Antonio Breast Cancer Symposium; Dec. 4-8, 2012; San Antonio) is fairly clear that there does not appear to be a benefit of 2 years of trastuzumab compared with one, but there is additional cardiotoxicity. In the PHARE trial, 6 months of adjuvant trastuzumab was not shown to be noninferior in terms of DFS to 12 months, with a median follow-up of about 3 years. Perhaps with longer follow-up we may have an answer. For now, the evidence-based length is 12 months of adjuvant trastuzumab for the therapy of early-stage, HER-2–positive breast cancer. It will be interesting to see if the length of adjuvant therapy will be affected by the introduction of new drugs such as lapatinib (Tykerb, GlaxoSmithKline), pertuzumab (Perjeta, Genentech), or ado-trastuzumab emtansine (Kadcyla, Genentech) into the adjuvant setting.
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