Affiliation:
1. Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany
2. Department of Obstetrics and Gynecology, University of Freiburg, Freiburg, Germany
3. Department of Women's Health, Tübingen University, Tübingen, Germany
Abstract
AbstractThe third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.This retrospective, multicentric study evaluated real-world tolerability, feasibility and efficacy in a pre-treated, real-world cohort at three major German breast cancer centers.125 patients treated with T-DXd or SG from November 2020 to June 2023 were included (T-DXd: 77 patients; SG: 48 patients). The median treatment duration was 6.0 months for T-DXd and 3.5 months for SG therapy, with a median follow-up duration of 10.4 months for T-DXd (95% CI: 8.4–11.6) and 11.8 months for SG (95% CI: 8.0–14.4). Severe neutropenia (CTC ≥ III°) occurred in 33.3% during SG therapy, with a numerical reduction observed following primary, prophylactic use of G-CSF. T-DXd-associated pneumonitis occurred in 8 out of 77 patients (10.4 %). Median progression-free survival (mPFS) was 8.6 months (95% CI: 5.8–12.4) with T-DXd (HER2+: 10.8; HER2-low: 4.7) and 4.9 months (95% CI: 2.8–6.3) with SG (TNBC 4.9; HR+/HER2−: not reached). Median overall survival (OS) was 23.8 months (95% CI: 16.1–not estimable) with T-DXd (HER2+: 27.1; HER2-low: not reached), and 12.4 months (95% CI: 8.7–not estimable) with SG therapy (TNBC: 12.4, HR+/HER2−: not reached). 95.7% of the
protocol-specified, therapeutic dose was administered for T-DXd and 89.6% for SG.Overall, this indicates good feasibility, tolerability, and effectiveness of ADC therapies in the real-world setting.