Abstract 266P
Background
Combination of chemotherapy plus immune checkpoint inhibitors (ICIs) has recently shown efficacy in triple-negative breast cancer (TNBC), and thus, has been introduced in clinical practice in both the advanced and early disease stage. However, few data are available regarding the extent and the potential consequences of discontinuation rate and serious adverse events of these treatments, especially in the neoadjuvant setting. Herein, we performed a comprehensive systematic review and meta-analysis to assess discontinuation rate and serious adverse events of chemoimmunotherapy compared to chemotherapy alone in phase II and III neoadjuvant clinical trials in TNBC.
Methods
Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, EMBASE, Cochrane Library, and PubMed/ Medline were searched for articles published from June 2008 to March 2023. The outcomes of interest were discontinuation rate, serious adverse events, and grade 3-4 adverse events.
Results
Overall, 4 studies were included in the analysis. The pooled Odds Ratios (ORs) for discontinuation rate and serious adverse events were 1.26 (95% CI, 0.78-2.06) and 1.79 (95% CI, 1.4-2.28), respectively, in patients receiving chemoimmunotherapy versus chemotherapy alone as neoadjuvant treatment for TNBC. A higher risk of grade 3-4 adverse events was reported in the chemoimmunotherapy group (OR 1.30; 95% CI, 1.07-1.59). The analysis was associated with substantial heterogeneity and the risk of discontinuation rate was strongly conditioned by the KEYNOTE-522 trial.
Conclusions
Our findings support the design of clinical trials which could be specifically focused on safety and treatment adherence, as well as the potential impact on outcome and quality of life in TNBC patients receiving neoadjuvant treatment. Careful monitoring of tolerability remains a crucial need in this clinical setting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
M. Giuliano.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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