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Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer

par Rugo, Hope H.S.;Tolaney, Sara S.M.;Loirat, Delphine;Punie, Kevin;Bardia, Aditya;Hurvitz, Sara;O'Shaughnessy, Joyce;Cortes, Javier;Diéras, Veronique;Carey, Lisa L.A.;Gianni, Luca;Piccart-Gebhart, Martine ;Loibl, Sibylle;Goldenberg, David D.M.;Hong, Quan;Olivo, Martin M.S.;Itri, Loretta Marie;Kalinsky, Kevin
Référence NPJ breast cancer, 8, 1, 98
Publication Publié, 2022-12

Article révisé par les pairs

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Résumé :

Sacituzumab govitecan (SG) is an anti-Trop-2 antibody-drug conjugate with an SN-38 payload. In the ASCENT study, patients with metastatic triple-negative breast cancer (mTNBC) relapsed/refractory to ≥2 prior chemotherapy regimens (≥1 in the metastatic setting), received SG or single-agent treatment of physician’s choice (eribulin, vinorelbine, capecitabine, or gemcitabine). This ASCENT safety analysis includes the impact of age and UGT1A1 polymorphisms, which hinder SN-38 detoxification. SG demonstrated a manageable safety profile in patients with mTNBC, including those ≥65 years; neutropenia/diarrhea are key adverse events (AE). Patients with UGT1A1 *28/*28 genotype versus those with 1/*28 and *1/*1 genotypes had higher rates of grade ≥3 SG-related neutropenia (59% vs 47% and 53%), febrile neutropenia (18% vs 5% and 3%), anemia (15% vs 6% and 4%), and diarrhea (15% vs 9% and 10%), respectively. Individuals with UGT1A1 *28/*28 genotype should be monitored closely; active monitoring and routine AE management allow optimal therapeutic exposure of SG.