One year of trastuzumab treatment just as effective as 2 years of treatment
For patients with HER2-postive early-stage breast cancer, 1 year of adjuvant trastuzumab should remain the standard of care, according to data presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.
“Giving trastuzumab for a longer duration (2 years) did not improve disease-free or overall survival compared with 1 year of trastuzumab treatment,” said Martine J. Piccart, MD, PhD, chief of the medicine department at the Jules Bordet Institute in Brussels, Belgium.
Piccart and colleagues took part in the HERA trial, an international, multicenter, phase 3, randomized trial that spanned several countries. In an effort to compare the efficacy and safety of 1 and 2 years of treatment, researchers followed 5102 women with HER2-positive early-stage breast cancer randomly assigned to trastuzumab every 3 weeks for 1 or 2 years, or to observation. Surgery, chemotherapy, and radiotherapy were completed previously, as indicated, for all participants.
Overall survival rates and disease-free status were comparable between the 1- and 2-year trastuzumab arms. In addition, the primary cardiac end point of symptomatic congestive heart failure was comparable in the 2 arms. However, the secondary cardiac end point of asymptomatic cardiac dysfunction was higher in the 2-year arm compared with the 1-year arm (7.2% and 4.1%, respectively). Cardiac events occurred mostly during trastuzumab administration, and the majority were reversible when trastuzumab was discontinued.
“The HERA trial showed the sustainability of the efficacy of trastuzumab, proving that 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,” Piccart said. “It is also reassuring with regard to the low cardiac toxicity of trastuzumab when given after adjuvant chemotherapy. Finally, it confirms that 1 year of adjuvant trastuzumab should remain the standard of care in women with HER2-positive early breast cancer.”
Source: AACR.