Aleix Prat: The Katherine phase III updated results are out
Aleix Prat, Director of the Cancer Institute at the Hospital Clinic of Barcelona, shared a post on LinkedIn:
“The Katherine phase III updated results are out! previous report in NEJM was in 2019.
Overall great benefit of adjuvant T-DM1 in HER2+ residual disease after neoadjuvant therapy.
But…please check the HER2 2+ vs 3+ result in the article and supplemental. The interaction test is significant, the absolute benefit in HER2 2+ in terms of iDFS is small (3.6 points), and there is not OS benefit at all in this group (check supplemental).
This is a predictive biomarker (done in a central lab!), and clinical guidelines should acknowledge that.
Article states: ‘The 7-year invasive disease–free survival in the IHC 3+ cohorts (total, 1132 patients) was 82.8% with T-DM1 and 66.5% with trastuzumab (hazard ratio for invasive disease or death, 0.47; 95% CI, 0.37 to 0.60; absolute difference, 16.3 percentage points) and in the IHC 2+ cohorts (total, 326 patients) was 72.4% and 68.8%, respectively (hazard ratio, 0.84; 95% CI, 0.56 to 1.25; absolute difference, 3.6 percentage points).
An exploratory assessment of the interaction between the IHC status and the treatment effect yielded an interaction term (hazard ratio, 0.55; 95% CI, 0.35 to 0.88) that suggested a different magnitude of benefit of T-DM1 in the two subgroups.’’
Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer.
Authors: Charles E. Geyer, Jr., Michael Untch, Chiun-Sheng Huang, Max S. Mano, Eleftherios P. Mamounas, Norman Wolmark, Priya Rastogi, Andreas Schneeweiss, Andres Redondo, Hans H. Fischer, Véronique D’Hondt, Alison K. Conlin, Valentina Guarneri, Irene L. Wapnir, Christian Jackisch, Claudia Arce-Salinas, Peter A. Fasching, Michael P. DiGiovanna, John P. Crown, Pia Wuelfing, Zhimin Shao, Elena Rota Caremoli, Hervé R. Bonnefoi, Bryan T. Hennessy, Ljiljana Stamatovic, Hugo Castro-Salguero, Adam M. Brufsky, Adam Knott, Asna Siddiqui, Chiara Lambertini, Thomas Boulet, Beatrice Nyawira, Eleonora Restuccia, Sibylle Loibl
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