Evidence map›Paper›PMID 39616817›Full record

SynthesisBreast (Edinburgh, Scotland)2025

Safety profile of sacituzumab govitecan in patients with breast cancer: A systematic review and meta-analysis.

Maria Inez Dacoregio, Isabella Michelon, Caio Ernesto do Rego Castro, Francisco Cezar Aquino de Moraes, Guilherme Rossato de Almeida, Lis Victória Ravani, Maysa Vilbert, Ricardo Lima Barros Costa

Abstract readSystematic ReviewMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Breast (Edinburgh, Scotland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Maria Inez DacoregioDepartment of Medicine, University of Centro Oeste, Guarapuava, Brazil. Electronic address: m.dacoregio2707@gmail.com.
Isabella MichelonDepartment of Medicine, Catholic University of Pelotas, Pelotas, Brazil. Electronic address: isabellafmichelon@gmail.com.
Caio Ernesto do Rego CastroDepartment of Medicine, Universidade de Brasília, DF, Brazil. Electronic address: caioernestorc@gmail.com.
Francisco Cezar Aquino de MoraesDepartment of Medicine, Federal University of Pará, Pará, Brazil. Electronic address: francisco.cezar2205@gmail.com.
Guilherme Rossato de AlmeidaAC Camargo Cancer Center, São Paulo, SP, Brazil. Electronic address: almguiro@gmail.com.
Lis Victória RavaniDepartment of Medicine, FMUSP Universidade de São Paulo, SP, Brazil. Electronic address: lis.ravani@fm.usp.br.
Maysa VilbertMassachusetts General Hospital Cancer Center, Division of Hematology/Oncology, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: maysavilbert@gmail.com.
Ricardo Lima Barros CostaDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. Electronic address: ricardo.costa@moffitt.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSacituzumab Govitecan (SG), a first-in-class anti-trophoblast cell surface antigen-2-directed antibody-drug conjugate (ADC), has shown clinically meaningful improvement in outcomes of patients with breast cancer (BC). However, it has also been accompanied by significant toxicity. Thus, we conducted a systematic review and meta-analysis to evaluate the safety and tolerability of SG in this patient population.

methodsWe comprehensively searched PubMed, Embase, and Cochrane databases, and ASCO and ESMO websites for clinical trials (CTs) assessing the safety of SG in BC patients. All analyses were performed in R software (v.4.2.2) using random effects models. Heterogeneity was assessed using I

resultsSeven studies - three randomized clinical trials (RCTs) and four single-arm phase I/II - were included, comprising 928 patients receiving SG and 576 on treatment of physician's choice (TPC). Most patients had triple negative BC (54.4 %, n = 505), metastatic disease (89.8 %, n = 833), and were heavily pretreated (at least two lines of prior therapy). Most common all-grade adverse events (AEs) were: neutropenia (70 %, 95 % CI, 64-76 %), followed by nausea (62 %, 95 % CI, 55-68 %), diarrhea (54 %, 95 % CI 47-60 %) and anemia (51 %, 95 % CI, 38-65 %). Regarding high-grade AEs, 46 % of patients developed grade ≥3 neutropenia. Compared to TPC, we observed a higher risk of neutropenia (OR 3.11, 95 % CI 1.62-5.99, I

conclusionThis systematic review and meta-analysis provides extensive data on the safety and management of SG toxicity in BC patients across clinical trials. Concerning rates of neutropenia, nausea diarrhea, and anemia were reported. We highlight the need for protocols establishing prophylactic measures and strategies to mitigate SG-related toxicity.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsCamptothecinImmunoconjugatesAdultFemaleHumansMiddle AgedRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCamptothecinImmunoconjugatessacituzumab govitecanAntibody-drug conjugatesBreast cancerIMMU-132Sacituzumab govitecanSafetyTROP-2

Identifiers

PMID39616817
PMCPMC11648803

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.