412P - Sacituzumab govitecan versus chemotherapy for metastatic breast cancer: A meta-analysis on safety outcomes

Background

Although Sacituzumab Govitecan (SG) had a manageable safety profile across clinical trials, this antibody-drug conjugate (ADC) has a specific set of treatment-related adverse events, which may limit adherence to treatment. However, few data are available regarding the comparison of SG versus chemotherapy in breast cancer (BC) patients. Herein, we performed a systematic review and meta-analysis aimed to systematically compare the safety profile of SG versus chemotherapy in phase II and III metastatic BC (mBC) clinical trials.

Methods

Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, all phase II and III randomized clinical trials that compared SG versus chemotherapy in mBC patients were retrieved. The outcomes of interest were grade 3-4, and all grade neutropenia, leukopenia, anemia, nausea, diarrhea, and fatigue in clinical trials comparing SG versus chemotherapy for mBC patients. The risk of alopecia, febrile neutropenia, and treatment discontinuation rate were also assessed.

Results

Two eligible trials were selected in this meta-analysis, encompassing a total of 999 patients (SG=526; chemotherapy=473). The pooled Odds Ratios (ORs) for outcomes such as grade 3-4 and all grade neutropenia, leukopenia, anemia and other nonhematological adverse events showed a higher risk for patients receiving SG versus chemotherapy. No statistically significant differences were observed in grade 3-4 fatigue, all grade nausea, febrile neutropenia and treatment discontinuation due to adverse events.

Conclusions

Despite our research revealing the presence of a higher risk of some adverse events in patients receiving SG than those treated with chemotherapy (e.g., diarrhea), our pooled results suggested no statistically significant differences in terms of treatment discontinuation and febrile neutropenia, which is commonly considered an important and often life-threatening event. Our data, coupled with a statistically significant and clinically meaningful survival benefit, support the use of SG as an important therapeutic option for mBC. Further analysis is needed in the future, and real-world evidence is required to better explore this topic.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.