Dr Llombart-Cussac on the Implications of Prophylaxis for Neutropenia and Diarrhea in Advanced Breast Cancer

Antonio Llombart-Cussac, MD, PhD, medical oncologist, chairman, Medical Oncology Service, University Hospital Arnau de Vilanova, discusses clinical implications from the phase 2 PRIMED trial (NCT05520723) that evaluated prophylactic measures for the prevention of neutropenia and diarrhea related to treatment with sacituzumab govitecan-hziy (Trodelvy) in patients with triple-negative (TNBC) or hormone receptor (HR)–positive, HER2-negative advanced breast cancer.

In PRIMED, patients being treated with sacituzumab govitecan also received granulocyte colony-stimulating factor (G-CSF) and loperamide during the first 2 cycles of treatment, and investigators sought to measure the incidence of grade 3 or higher neutropenia and grade 2 or higher diarrhea during the first 2 cycles.

Findings from the PRIMED trial presented at the 2024 ASCO Annual Meeting showed that after the first two cycles any-grade neutropenia occurred in 28% of patients, and 34% of patients experienced any-grade diarrhea. Grade 3 or higher neutropenia was reported in 16% of patients, meeting the study’s primary end point (P =.001). Notably, no patients experienced febrile neutropenia. Grade 2 or higher diarrhea was reported in 16.0% of patients (P = .084); 4% had grade 3 diarrhea, and no patients had grade 4 diarrhea.

Llombart-Cussac explains that the readout of findings from PRIMED have already influenced his clinical practice, where he has adopted of these prophylactic strategies for patients with advanced breast cancer receiving sacituzumab govitecan. From his experience, adding these agents to treatment with the antibody-drug conjugate has shown to be convenient for both patients and clinicians, he adds.

Although the PRIMED trial included a relatively small population of 50 patients, including 32 with TNBC and 18 with HR-positive/HER2-negative breast cancer, studies like this still have the ability to affect clinical practice, Llombart-Cussac emphasizes. By integrating prophylactic measures into standard treatment protocols, the trial offers a path to improve quality of life for patients and allow them to receive increased benefit from treatment, he explains. As the oncology field continues to evolve, the focus on preventing treatment-related adverse effects through proactive measures is likely to gain further traction, he concludes.