By Jacqueline Reinhard, SHARE, New York, NY
The international, multicenter Herceptin Adjuvant (HERA) clinical trial involving 5,102 patients was a focus of presentations at the 2012 San Antonio Breast Cancer Symposium held in early December. The study was conducted to determine the efficacy and safety of adjuvant trastuzumab (Herceptin) — after surgery, radiation and chemotherapy — for patients with early stage HER2-positive breast cancer. Dr. Martine J. Piccart-Gebhart reported on a secondary objective of the HERA clinical trial: to see if 2 years of treatment with Herceptin produced a better patient outcome than 1 year of treatment.
After undergoing their initial surgery, patients were treated with chemotherapy and/or radiation and then with Herceptin every three weeks. Only those patients with good heart function were permitted to participate. The two study cohorts were well balanced by disease characteristics. Data were reviewed 4 years and 8 years after the study. At 4-year follow-up, there appeared to be a possible advantage for the patients who received Cialis Herceptin for 2 years, but after 8 years there was no significant difference (which illustrates the importance of having long-term follow-up), and cardiac adverse events remained low at 8-year follow-up. Further, 20% of participants in the 2-year cohort had adverse events, compared with 16% in the 1-year group, providing additional evidence that 2 years of treatment with Herceptin was not an improvement over treatment for 1 year. Hence, 1 year of treatment remains the gold standard. However, there was a slight indication that longer treatment with Herceptin may have an advantage for the subgroup of estrogen-receptor-negative patients, and further studies may reveal a benefit for them.
Goldhirsch A, Piccart-Gebhart MJ, Procter M, et al. HERA TRIAL: Results of the analysis of 1 year versus 2 years trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer. Oral presentation at the 35th annual San Antonio Breast Cancer Symposium, December 4-8, 2012. San Antonio, TX. Abstract S5-2.