Dr Llombart-Cussac on Preventing Neutropenia and Diarrhea in HR+/HER2– Advanced Breast Cancer

Antonio Llombart-Cussac, MD, PhD, medical oncologist, chairman, Medical Oncology Service, University Hospital Arnau de Vilanova, discusses preventing neutropenia and diarrhea in patients with triple-negative or hormone receptor (HR)–positive, HER2-negative advanced breast cancer receiving sacituzumab govitecan-hziy (Trodelvy).

The phase 2 PRIMED trial (NCT05520723) focused on the prevention of sacituzumab govitecan–related neutropenia and diarrhea. The study evaluated the efficacy of prophylactic treatments administered after each dose of sacituzumab govitecan, Llombart-Cussac says. The study demonstrated that prophylactic treatment with granulocyte colony-stimulating factor was highly effective in preventing neutropenia. This regimen significantly reduced the incidence of neutropenia, eliminating the need for more complex interventions, Llombart-Cussac reports.

After the first two cycles, the incidence of any-grade neutropenia and diarrhea was 28% and 34%, respectively. Eight patients (16%) experienced grade 3 or higher neutropenia, meeting the primary end point (P =.0002). Additionally, eight patients (16%) had grade 2 or higher diarrhea, with 4% experiencing grade 3 diarrhea, indicating a numerical benefit from prophylactic loperamide (P =.084). Importantly, no patients developed febrile neutropenia, Llombart-Cussac reports. Regarding diarrhea, although the primary end point was not met, the use of loperamide prophylaxis resulted in a notable reduction in diarrhea events. However, this was accompanied by constipation in some patients, an adverse effect (AE) related to loperamide, Llombart-Cussac notes. Llombart-Cussac suggests that although loperamide is effective, alternative strategies may need to be explored to manage diarrhea without causing constipation.

Overall, the PRIMED trial findings indicate that prophylactic interventions can significantly mitigate the risk of neutropenia and diarrhea in patients receiving sacituzumab govitecan. The straightforward administration schedule for neutropenia prevention proved effective and well tolerated, Llombart-Cussac says. The findings for diarrhea underscore the need to balance efficacy with proper AE management.