Presenting Author: Jennifer Hutchinson, PharmD, BCOP, Massachusetts General Hospital, Boston, MA
BACKGROUND: Sacituzumab govitecan is a Trop-2–directed antibody–drug conjugate approved for the treatment of metastatic breast cancer. In clinical trials, infusion-related reactions (IRRs) occurred in 35% of patients, with 2% having grade 3 or 4 adverse events. Accordingly, the prescribing information recommends administering the first infusions over 180 minutes and subsequent infusions over 60 to 120 minutes, each followed by a 30-minute observation period. Premedication with antipyretics and H1/H2 antagonists are required, with corticosteroids added if previous infusion reactions occurred. Despite notable trial-reported IRR rates, real-world data on incidence and timing are limited, and guidance for premedication de-escalation is lacking.
OBJECTIVES: To characterize the incidence and presentation of IRRs in patients receiving sacituzumab govitecan compared with clinical trial data and to evaluate the feasibility of premedication de-escalation.
METHODS: We conducted a retrospective chart review of patients aged ≥18 years with breast cancer who received at least the first dose of sacituzumab govitecan at Mass General Brigham Cancer Institute between April 2020 and May 2025. The primary outcome was the incidence of IRRs. The secondary outcomes included the timing and severity of IRRs per the Common Terminology Criteria of Adverse Events, version 5.0 and the tolerability of standard premedication de-escalation.
RESULTS: A total of 85 patients were included in this observational analysis. The median age was 61 years (range, 25-82 years), and 90.6% received ≥2 previous lines of therapy. Patients received a median of 7 doses of sacituzumab govitecan (range, 1-112 doses) over a median of 70 days (range, 1-1216 days). None of the patients had IRRs while receiving treatment. All the patients received medication per the FDA-recommended initial infusion rate of 180 minutes. For subsequent doses, the median infusion time was 120 minutes (range, 60-180 minutes), with 98.7% of patients receiving an infusion in ≤120 minutes. At no point were the infusion rates extended for better tolerability. Most patients also received the appropriate premedications, including diphenhydramine (98.8%), famotidine (97.6%), and acetaminophen (97.6%), along with dexamethasone (98.8%) already included in their antiemetic regimen. During treatment, 8.2% of patients discontinued famotidine, 5.9% discontinued acetaminophen, 4.7% discontinued diphenhydramine, and 2.4% discontinued dexamethasone. The median number of doses to premedication de-escalation was 3 (range, 1-14).
CONCLUSION: In this real-world cohort, no IRRs were observed with sacituzumab govitecan, which suggests greater tolerability than in clinical trials. Some patients tolerated premedication de-escalation, with de-escalation occurring as early as dose 3. Given the low incidences of IRRs, these findings support further investigation into developing protocols to safely reduce premedication requirements and potentially shorten observation times.
- Trodelvy (sacituzumab govitecan-hziy) injection, for intravenous use [prescribing information]. Gilead Sciences; March 2025. Accessed September 22, 2025. www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
- Spring LM, Nakajima E, Hutchinson J, et al. Sacituzumab govitecan for metastatic triple-negative breast cancer: clinical overview and management of potential toxicities. Oncologist. 2021;26:827-834.