Posted by Michael Wonder on 01 Oct 2018
Pertuzumab in early breast cancer: no proof of an additional benefit despite exemplary surrogate validation
1 October 2018 - Effect on disease-free survival too small to conclude on overall survival.
For the third time since 2013, the IQWiG has investigated the added benefit of the active substance pertuzumab for the treatment of patients with HER2- positive breast cancer as part of an early benefit assessment. The monoclonal antibody is used in combination with trastuzumab and chemotherapy. While the first two benefit assessments focused on the treatment of advanced breast cancer and neo-adjuvant therapy, this time the advantages and disadvantages in the adjuvant setting, thus supporting therapy of early breast cancer with high risk of recurrence, should be evaluated.
The conclusion: for patients under the age of 65 years, the combination therapy with pertuzumab, trastuzumab, a taxane and possibly an anthracycline does not fare better than the comparator. At the age of 65, there is even a hint of lesser benefit . The methodologically sound validation of the surrogate outcome of disease-free survival as well as the long follow-up of symptoms and health-related quality of life are to be emphasised positively.
