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Longer trastuzumab treatment failed to improve outcomes in HER-2–positive breast cancer
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Women with HER-2–positive breast cancer who underwent 2 years of treatment with trastuzumab received no additional benefit than women who underwent 1 year of treatment, according to study results presented at the 2012 Congress of the European Society for Medical Oncology in Vienna.
“The key message for 2012 is that 1 year of treatment with trastuzumab remains the standard of care for HER-2–positive early breast cancer patients,” Richard D. Gelber, PhD, a professor of biostatistics at Harvard Medical School and Dana-Farber Cancer Institute in Boston, said in a press release.
Richard D. Gelber
“These results show that the benefit of adjuvant trastuzumab remains over time and it is not lost after some years,” Gelber said. “Patients can be reassured that 1-year trastuzumab is a very effective treatment, reducing the risk of disease recurrence and death by one-quarter compared to not using trastuzumab.”
Previous studies identified that 1 year of treatment with trastuzumab (Herceptin, Genentech) significantly improved disease-free survival and OS in patients with HER-2–positive early breast cancer. Gelber and colleagues investigated whether extending trastuzumab treatment to 2 years would offer additional benefit.
The researchers launched the HERA trial, an international, multicenter, randomized phase 3 study that involved 5,102 women with early HER-2–positive breast cancer.
All patients underwent chemotherapy, surgery and/or radiotherapy. The researchers then randomly assigned patients to one of three treatment regimens: trastuzumab every 3 weeks for 1 year (n=1,552); trastuzumab every 3 weeks for 2 years (n=1,553); or observation (n= 1,997).
DFS served as the primary endpoint. Secondary endpoints included OS and time to distant recurrence.
The unadjusted HR for an event in the 2-year treatment group vs. the 1-year treatment group was 0.99 (95% CI, 0.85-1.14; P=0.8588). Researchers observed comparable OS between the two groups (HR=1.05; 95% CI, 0.86-1.28; P=0.6333).
The time to distant recurrence also was similar between the two study arms, the researchers said.
“While extending the duration of trastuzumab administration to 2 years did not significantly improve outcome compared with 1-year trastuzumab, ongoing trials are testing whether combining trastuzumab with other anti-HER–2 agents — for example pertuzumab (Perjeta, Genentech) or lapatinib (Tykerb, GlaxoSmithKline) — might further benefit patients with HER-2–positive early breast cancer,” Gelber said.
The findings clearly show that prolongation of treatment to 2 years does not result in improved outcomes, Christoph Zielinski, MD, PhD, director of the clinical division of oncology and chairman of the department of medicine at the Medical University of Vienna in Austria, said in a press release.
Christoph Zielinski
“The present trial … strongly supports the correctness of adjuvant treatment duration delivered to patients with HER2/neu over-expressing early breast cancer,” Zielinski said. “We can be assured that patients are being treated in the best possible and most cost-effective way, by weighing benefit versus costs for the health care system. The latter aspect is quite important, as the recurrence of disease in a patient leads not only to suffering and death, but also to an immensely increased burden for the society. The current data thus add to the evidence how the latter aspects can be avoided by the delivery of an optimal duration of treatment for a selected patient population.”
For more information:
Goldhirsch A. Abstract #LBA6. Presented at: 2012 European Society for Medical Oncology Congress; Sept. 28 – Oct. 2, 2012; Vienna, Austria.
Disclosure: The researchers report honoraria, consulting relationships, employment relationships and advisory board memberships with GlaxoSmithKline, Genentech and Roche.