106P - Toxicity profile antibody-drug conjugates (ADCs) in metastatic breast cancer patients: A systematic review and meta-analysis based on studies’ design

Background

Antibody-drug conjugates (ADCs) have improved survival in metastatic breast cancer (MBC). Despite ADCs having a better safety profile than chemotherapy, treatment-related adverse events (TRAE) have been widely reported in clinical trials. Assessing the prevalence of TRAEs is essential for handling symptom burden. Therefore, based on the studies' design, we conducted a meta-analysis to estimate the prevalence of the TRAEs related to currently approved ADCs in individuals with MBC.

Methods

We searched the PubMed, Embase, Scopus, CINAHL, and Cochrane databases up to December 2023. We estimated proportions with 95% confidence intervals, using both exact binomial and score test-based confidence intervals. We applied the Freeman-Tukey double arcsine transformation to stabilize variances within random-effects models performed using the Metaprop command in Stata. Subsequently, we quantitatively assembled the pooled effect sizes for each TRAE to ascertain the proportion of the TRAEs using a random effect model.

Results

Ten randomised controlled trials (RCTs) and 13 cohort studies were included, with 3266 and 1945 subjects, respectively. Gastrointestinal disorders were highly prevalent during T-DXd (39%, 95% CI: 16-62%; 39%, 95% CI: 21-56%), general disorders (i.e., fatigue) were extremely common during TDM-1 therapy (23%, 95% CI: 14-31%; 26%, 95% CI: 16-37%) and blood system disorders (i.e., neutropenia) were the most prevalent (49%, 95% CI: 17-82%; 31%, 95% CI: 5-58%) along with gastrointestinal disorders (37%, 95% CI: 19-56%; 37%, 95% CI: 19-55%) during sacituzumab govitecan treatment. The highest percentage was reached by nausea (77%; 95% CI: 72-81%; 73%, 95% CI: 70-75%) during T-DXd therapy.

Conclusions

Despite nausea being the most prevalent symptom overall, each treatment has a specific toxicity profile that should be considered when planning treatment care pathways in MBC. This approach may pave the groundwork for developing personalised risk-stratified cancer care treatments.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.