SABCS 2025 | I-SPY 2: early treatment symptoms predict pCR in high-risk breast cancer
Amrita Basu, PhD, University of California San Francisco, San Francisco, CA, presents findings from an I-SPY 2 (NCT01042379) analysis of patients with high-risk early breast cancer receiving immunotherapy or antibody-drug conjugate (ADC)-based neoadjuvant therapy. Analysis of electronic patient-reported symptoms (PROs) identified that moderate to severe muscle and joint pain, headache, mouth/throat sores, and limb swelling during the first 1–3 weeks were associated with higher odds of achieving pathologic complete response (pCR). This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2025 Meeting in San Antonio, TX.
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Transcript
So we looked at symptoms, early symptoms, and we looked at whether they were associated with our primary endpoint, which is pathologic complete response. And what we learned is that there were a group of symptoms, a cluster of symptoms that were predictive of PCR within the first three weeks of treatment. And then when we looked beyond three weeks, we didn’t see the significance anymore...
So we looked at symptoms, early symptoms, and we looked at whether they were associated with our primary endpoint, which is pathologic complete response. And what we learned is that there were a group of symptoms, a cluster of symptoms that were predictive of PCR within the first three weeks of treatment. And then when we looked beyond three weeks, we didn’t see the significance anymore. So these symptoms included joint pain, muscle pain, mouth and throat sores, and headache. And in summary, we were doing further validation of these symptoms and we are hoping that we can combine this information with other types of data that we currently collect so that the risk prediction becomes much more accurate and we have a stronger prediction of who’s going to respond favorably in the trial. I think patients are very anxious during the entire process and understanding in that very early phase when sometimes they’re probably the most anxious that there are going to be symptoms not all symptoms mean that there’s something you know negative that’s going to happen or there’s a negative consequence and so I think that you know doing this research and doing the extended work we’re doing on not just looking at symptoms with efficacy but also symptoms with adverse events and the prediction of these early symptoms sometimes is a later indication of something that may be developing later. It’s just more knowledge and for the patient to be aware that there’s multiple directions, there’s multiple things happening, and multiple different outcomes.
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