5PSQ-022 Follow-up the effectiveness and safety of sacituzumab-govitecan in a cohort of patients with triple-negative metastatic breast cancer: a multicentre study

Le résumé fourni par la source

Background and Importance Sacituzumab-govitecan (SG) is an antibody-drug conjugate approved for unresectable/metastatic triple-negative breast cancer (TNBC), available in the Spanish public health system since late 2022. Real-life data remains scarce. Aim and Objectives This update, based on more mature data after a longer follow-up period, aims to analyse the effectiveness and safety of SG in TNBC patients from the three main university hospitals in the city. Material and Methods Retrospective, observational, and multicentre study was conducted, including all patients treated with SG until November 2023, with a median follow-up of 10.3 months. Data were obtained from medical records and analysed with SPSS Statistics v.21. Variables collected: sex, age, body mass index (BMI), hormone receptor (HR), human epidermal growth receptor-2 (HER2) status, primary granulocyte-colony-stimulating factor(G-CSF) prophylaxis, location of metastases, breast-cancer-gene (BRCA) mutational status, Eastern Cooperative Oncology Group (ECOG) score, treatment duration, objective response rate (ORR) according to RECIST-v1.1 criteria, progression-free survival (PFS), overall survival (OS), treatment discontinuation, cycles received, previous chemotherapy (CT) lines, and adverse effects (AEs) according to Common Terminology Criteria for Adverse Events-v5 (CTCAE). Results Forty-six patients were included (100% female); median age 52 (Interquartile range (IQR)=45–61). Mean BMI 26 (standard deviation (SD) =4.4). 100% HR-negative and 100% HER2-negative. 32.6% received primary prophylaxis with G-CSF. Lung metastases were the most frequent (56.5%), followed by bone (43.5%), hepatic (25.5%) and ganglionic (21.3%). 56.5% BRCA-negative, 6.5% BRCA2 and 34.8% not available. Most of the patients had a baseline ECOG 0–1 (72%). Median duration of treatment was 3.1 months (IQR=1.5–7.0). To date, two patients were still on treatment. Median follow-up: 10.3 months (IQR=3.5–15.5). ORR 32.6% (30.4% RP and 2.2% RC), stable disease in 21.7% and progression in the rest. Median PFS was 3.8 months (IC 95%: 2.5–5.1) and OS 10.1 months (IC 95%: 5.9–14.3). 81.8% of patients discontinued treatment due to disease progression and 15.9% exitus. Median total of cycles received was five (IQR=2.5–8.0) and a median of two (IQR=1–3) previous CT-lines in metastatic-stage. 97.8% of the patients had some AE during treatment. Most frequents: asthenia (80% (G3–4:6.7%)), anaemia (66.7% (G3–4:8.9%)), neutropenia (51% (G3–4:17.7%)), diarrhoea (46.7% (G3–4:6.7%)), alopecia (42.2% (G3–4:4.4%)). 69.6% had any reduction or delay of dose because of toxicity and no patient discontinued treatment due to AEs. Conclusion and Relevance Median PFS and OS were lower than in the pivotal ASCENT trial. While most patients experienced AEs, none led to treatment discontinuation. Further studies with a larger sample size are needed to confirm these results. References and/or Acknowledgements Conflict of Interest No conflict of interest

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.