Maintenance Perjeta and Affinity trial, pro

Results for the Aphinity trial were very recently published in the New England Journal of Medicine. The study met its primary endpoint and showed that adjuvant treatment with the combination of pertuzumab (Perjeta), trastuzumab (Herceptin), and chemotherapy (the pertuzumab-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive diseasefree survival) in patients with HER2-positive early breast cancer compared to trastuzumab and chemotherapy alone. The safety profile of the pertuzumab-based regimen was consistent with that seen in previous studies, and no new safety signals were identified. However, there was no OS benefit, which one would like to see for maintenance therapy. Inital comments by Key Opinion Leaders were lukewarm, making the point that thousands were randomizedto Perhjeta at a great cost to demonstrate a truly modest difference in outcomes and that  if the new therapy becomes a standard-of-care approach, then we will clearly be overtreating the vast majority of patients. Until guidelines adopt this therapy as standard it should be considered not medically necessary.

 

Gunter von Minckwitz, M.D., Marion Procter, Ph.D., Evandro de Azambuja, M.D., Dimitrios Zardavas, M.D., Mark Benyunes, M.D., Giuseppe Viale, M.D., Thomas Suter, M.D., Amal Arahmani, Ph.D., Nathalie Rouchet, M.Sc., Emma Clark, M.Sc., Adam Knott, Ph.D., Istvan Lang, M.D., Christelle Levy, M.D., Denise A. Yardley, M.D., Jose Bines, M.D., Richard D. Gelber, Ph.D., Martine Piccart, M.D., and Jose Baselga, M.D., for the APHINITY Steering Committee and Investigators*Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cance.
N Engl J Med 2017; 377:122-131July 13, 2017

NCCN Breast Cancer 2017

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