Future breast cancer care: ESMO Breast Cancer 2024
Transcript: ELEANOR: Diarrhoea manageable in real-world study of neratinib in EBC
Professor Rupert Bartsch
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What we present today, a poster on ELEANOR at the 2024 ESMO breast cancer meeting in Berlin. ELEANOR is a phase 4 trial, looking into neratinib, extended adjuvant treatment with neratinib in early stage, hormone receptor positive, HER2+ breast cancer in patients who had completed the prior standard therapy. Now, the approval for neratinib in this setting, that is based upon the ExteNet trial, and there are two things we need to mention here. One is that in ExteNet, the patients had received trastuzumab only, while today patients receive in the neo-adjuvant setting trastuzumab, pertuzumab and non-PCR T-DM1 and then of course, an issue with ExteNet was the high rate of grade three diarrhoea. That led to several patients doing early discontinuation of the neratinib treatment. So in order to improve outcomes, it's really required to reduce that high rate of grade three diarrhoea, and that is now achieved either with a mandatory loperamide prophylaxis or, and that's obviously even the more successful strategy with the dose escalation strategy. So you don't start at the 240 mix, but you start at lower doses and increase the dose gradually. The other thing was looking into a population that have received the standard treatment options today. And in general what you can say is that in extended neratinib, react reasonably well in patients who had received trastuzumab, pertuzumab and T-DM1, and in addition with the dose escalation strategy, we have seen much lower rates of grade three diarrhoea.
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