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Two years of adjuvant trastuzumab yielded no extra benefit
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SAN ANTONIO — Extending trastuzumab therapy from 1 year to 2 years provided no additional survival benefit in a cohort of women with HER-2–positive early-stage disease, according to findings presented here.
Martine J. Piccart, MD, PhD, chief of the medicine department at the Jules Bordet Institute in Brussels, and president of the European Society for Medical Oncology and chair of the Breast International Group, discussed results for 5,102 women accrued worldwide.
“The trial design was a pragmatic one,” Piccart said, noting that patients were allowed to select their own chemotherapy regimen before being randomly assigned to 1 or 2 years of trastuzumab (Herceptin, Genentech) therapy.
Martine J. Piccart
Piccart said the DFS and OS among patients receiving the drug for 2 years was no different from that in patients receiving 1 year.
“The cumulative incidence of cardiac endpoints were also similar,” she said. “Serious events were rare, and there was no difference between the treatment durations.”
Also, the cardiac effects of trastuzumab were reversible. “Very few women experience any cardiac events after stopping trastuzumab,” Piccart said.
The trial also included an intention-to-treat analysis with 8 years of follow-up. “A significant proportion of patients treated with trastuzumab in the adjuvant setting are alive and free of disease recurrence after a median follow-up of 8 years,” she said.
She concluded that 1 year of adjuvant trastuzumab should remain the standard of care in women with HER-2–positive early breast cancer.
Piccart presented the findings from the HERA trial at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.
For more information:
Piccart-Gebhart MJ. #S5-2. Presented at: the 2012 CTRC-AACR San Antonio Breast Cancer Symposium; Dec. 4-8, 2012; San Antonio.
Disclosure: Piccart reports being a consultant for Roche.
Perspective
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C. Kent Osborne, MD
The HERA trial is an extremely important one because you can imagine the cost to the health care system if you had to give trastuzumab for 2 years rather than 1. I was happy to see that 1 year is just as good as 2. It sets the standard of therapy.
Perspective
Back to TopEdith A. Perez, MD
It was reported in 2005 that adjuvant trastuzumab significantly improved DFS, and it has consistently shown since then that it improved DFS and OS. Apart from the HERA trial, we also saw results of the PHARE study, which examined 6 months of trastuzumab. After these trials, we can confidently say that 1 year of trastuzumab is optimal. Now we can move on.
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