Presented by Dr Kevin Punie (Ziekenhuis aan de Stroom, Belgium)
In this video, Dr Kevin Punie presents patient-reported outcomes (PROs) from the phase III ASCENT-03 trial, comparing sacituzumab govitecan (SG) with physician’s choice chemotherapy in patients with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors.
PROs were assessed using the EORTC QLQ-C30 questionnaire to evaluate quality of life (QoL), symptom burden, and functional status during treatment. The key endpoints included change from baseline in physical functioning at week 25 and time to first deterioration in fatigue.
Results for the key endpoints showed that physical functioning was maintained more effectively with SG, while a gradual worsening was observed in the chemotherapy arm. Time to first deterioration in fatigue was similar between both treatment groups.
Across additional exploratory endpoints, patients treated with SG showed greater improvements in pain and less worsening of role functioning, global health status/QoL, fatigue and dyspnoea compared with chemotherapy. Gastrointestinal symptoms such as diarrhoea and nausea/vomiting favoured chemotherapy, consistent with the known safety profile of SG, but did not negatively impact overall QoL scores.
Time to first improvement was also explored in domains where more than half of patients’ baseline scores could improve. Time to first improvement was shorter in the SG group for physical, role and social functioning, as well as for fatigue and insomnia compared to the chemotherapy group. These results suggest that patients starting with poorer QoL may experience faster benefit with SG
Overall, these PRO findings complement the efficacy results from ASCENT-03 and support SG as a potential new standard of care for this population.
References:
Punie K, SABCS 2025, Abstract RF6-05