By: Greg Laub
At the European Society for Medical Oncology (ESMO) virtual meeting, new data from the phase III ASCENT study was presented showing that patients with treatment-resistant metastatic triple-negative breast cancer (TNBC) who received sacituzumab govitecan (Trodelvy) had significant and clinically meaningful improvements in health-related quality of life (QOL).
In this exclusive MedPage Today video, co-investigator Kevin Punie, MD, from University Hospitals Leuven in Belgium, describes the background of the study and the clinical implications.
Following is a transcript of his remarks:
The study presented that ESMO this year was a subgroup analyzes from the phase III ASCENT study, so it was a predefined analysis to evaluate the impact of the treatment on the health-related quality of life of the patients treated with sacituzumab as compared to the effects of the control arm on their health-related quality-of-life outcomes. So the primary aim of the trial was to evaluate potential differences in quality of life according to the treatment arms in the trial.
So, the primary aim was actually to show that there was improvement in global quality of life, and when we looked to some primary health-related quality-of-life domains we effectively saw that there was a significant and a clinically meaningful improvement in health-related quality-of-life scores for those patients treated with sacituzumab as compared to those treated in the control arm with a single-agent chemotherapy of treatment of physician’s choice.
So we saw significant improvements for global health status, but also for physical functioning and emotional functioning. And these were all significantly better when we compared these results with those randomized in the [physician’s choice] arm.
So there was also less symptomatic impact of fatigue, of pain, and of dyspnea in the patients treated with sacituzumab compared to those in the [control] arm. The only symptom burden which was higher was diarrhea, and diarrhea is a known side effect of sacituzumab govitecan. This was significantly, but also meaningfully, worse for patients treated with Trodelvy. However, this did not appear to translate in an adverse effect on the patient’s global functioning, on the patient’s global health score, so this is actually a reassuring finding.
I think that the implications of this research is that it increases the value of Trodelvy in the specific treatment setting. So, when we have a new drug that improves outcomes, usually in the beginning we are lacking data, patient-reported outcomes on quality of life and of course in the incurable setting of metastatic triple-negative breast cancer, patients are frequently confronted with the high symptomatic burden of disease. And therefore, the effect and the evolution of the quality of life in different treatment arms is an important factor to consider when we prioritize treatments. And given these positive results this does not only show that we improve the outcome, but we also improve the quality of life while prolonging the disease scores of those patients. And that is an important takeaway, which is also validated into some clinical skills, used to assess the value of new anti-cancer treatments. And taking into account a specific example for Trodelvy, we anticipate that these positive results of health-related quality of life will actually result in an upgrade of the value of Trodelvy, for example in the ESMO magnitude of clinical benefit scale.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.