Carrión-Madroñal, Isabel María, Díaz-Acedo, Rocío, Lora-Escobar, Santiago José, Naranjo-Llamas, Eloisa, Jaramillo-Ruiz, Didiana, Artacho-Criado, Silvia, and Prado-Mel, Elena
Aim: Sacituzumab-govitecan (Sgov) is a new antibody-drug conjugate recently approved for metastatic triple negative breast cancer (mTNBC), so there are still few data published in the real-world setting. Materials & methods: This study was to analyze the effectiveness and safety of Sgov in mTNBC of patients from the three main hospitals of a city and to compare with the pivotal ASCENT-trial. A total of 46 patients were included, all women diagnosed with mTNBC, with a median age of 52 years and Eastern Cooperative Oncology Group performance status 0–1 71.8% of patients. Results: Sgov effectiveness data seem to be slightly inferior than expected. Furthermore, it is observed that patients with an Eastern Cooperative Oncology Group of two or higher benefit significantly less from treatment with the drug. Safety profile of Sgov is acceptable. Plain Language Summary What is this article about? Sacituzumab-govitecan (Sgov) is a new drug recently approved for metastatic triple negative breast cancer, so there is still little data on patients receiving treatment outside of a clinical trial. What were the results? At the cut-off date, 33 patients (71.7%) had withdrawn from treatment with Sgov, and 21 patients (45.7%) had died. Disease remained stable or shrank in 23.9% of patients (n = 11). Median time to disease progression was 4.1 months (IC 95%: 2.6–5.6) and median overall survival 11.0 months (95% CI: 6.1–15.9), with a median duration of follow-up of 6.6 months (interquartile range: 2.1–10.5). Patients with ECOG 0–1 (better performance status) show a higher overall survival than patients with higher ECOG (Not reached [95% CI: NR-NR] vs 3.8 [95% CI: 2.7–4.9]; p = 0.009). No patients stopped treatment due to side effects and almost two thirds of patients did not have to have their dose reduced or delayed due to adverse events (AE). Asthenia (71.7%) and anemia (60.9%) were the most frequent AE. No patient characteristics were identified that predicted less or worse toxicity. What do the results of the study mean? This suggests that sacituzumab-govitecan effectiveness data seem to be slightly worse than expected, even more when performance status before starting Sgov is poor (ECOG 2). AE profile of Sgov is acceptable. Article highlights Sacituzumab-govitecan (Sgov) overall response rate for pretreated metastatic triple negative breast cancer was lower than in the pivotal ASCENT clinical trial. Patients with an ECOG ≥2 seem to benefit less from Sgov in our study population. Asthenia and anemia were the most frequent adverse events with 30,4% of patients receiving growth-factor support. Neutropenia was the most frequently AEs of grade 3 or higher reported, as in the pivotal study. About 61% of patients experienced treatment delays or dose reductions due to toxicity. Overall response rate was 23,9% and disease control rate 41,3% in patients treated with Sgov. Future studies would involve this patient profile to confirm the benefit of Sgov. Drug safety shown in real-world safety profiles appears to be acceptable. [ABSTRACT FROM AUTHOR]