Benefício clínico e segurança do denosumabe no tumor de células gigantes do osso: revisão sistemática e meta-análise de braço único

Francisco Wellington Lopes Guimarães Filho; Marcelo  de Toledo Petrilli; Jairo  Greco Garcia; Reynaldo  Jesus-Garcia Filho; Caio Falk Giannotti; Ariane  Butke Brandt; Rafael  Muller dos Santos

doi:10.61411/rsc2026126519

Autores

Dr. Francisco Wellington Lopes Guimarães Filho Escola Paulista de Medicina - EPM/UNIFESP Autor https://orcid.org/0009-0006-4410-492X
Dr. Marcelo de Toledo Petrilli Escola Paulista de Medicina - EPM/UNIFESP Autor https://orcid.org/0000-0001-7217-5799
Dr. Jairo Greco Garcia Escola Paulista de Medicina - EPM/UNIFESP Autor https://orcid.org/0000-0002-5720-8617
Dr. Reynaldo Jesus-Garcia Filho Escola Paulista de Medicina - EPM/UNIFESP Autor https://orcid.org/0000-0001-7895-5729
Dr. Caio Falk Giannotti Escola Paulista de Medicina - EPM/UNIFESP Autor https://orcid.org/0000-0002-8409-5582
Dra. Ariane Butke Brandt Universidade de São Paulo Autor https://orcid.org/0000-0001-6526-884X
Dr. Rafael Muller dos Santos Escola Paulista de Medicina - EPM/UNIFESP Autor https://orcid.org/0009-0001-3889-5853

DOI:

https://doi.org/10.61411/rsc2026126519

Resumo

O tumor de células gigantes do osso é uma neoplasia osteolítica localmente agressiva na qual o denosumabe se tornou uma opção sistêmica importante, porém ainda há incerteza quanto à durabilidade do controle e à segurança em esquemas do mundo real. Este estudo teve como objetivo sintetizar a efetividade e a segurança do tratamento baseado em denosumabe em pacientes com TCGO com maturidade esquelética. Realizou-se busca nas bases PubMed, EMBASE, Scopus e Cochrane Library estudos clínicos em texto completo e em língua inglesa que avaliaram denosumabe em pacientes com maturidade esquelética e tumor de células gigantes do osso até janeiro de 2026. Os desfechos primários foram benefício clínico e eventos adversos, e os desfechos secundários foram resposta por imagem, recidiva local e falha do tratamento. Uma meta-análise de braço único com modelo de efeitos aleatórios foi realizada, com estabilização de variância e ponderação pelo inverso da variância. A heterogeneidade foi quantificada pelo I², e intervalos preditivos e análises leave-one-out foram utilizados para avaliar a robustez. As análises de subgrupo foram limitadas ao desenho do estudo. Foram analisados 22 estudos, incluindo 1.170 pacientes. A taxa combinada de benefício clínico foi de 79,94% (IC 95% 74,21–85,02; I² 85,8%), e a taxa combinada de resposta por imagem foi de 72,72% (IC 95% 59,46–84,04; I² 97,2%). A recidiva local ocorreu em 24,49% dos pacientes (IC 95% 14,30–36,54; I² 96,5%) e a falha do tratamento em 10,36% (IC 95% 6,74–14,69; I² 57,0%). A taxa combinada de eventos adversos foi de 31,16% (IC 95% 6,76–63,08; I² 98,5%). A análise de subgrupo por desenho do estudo não reduziu de forma consistente a heterogeneidade, os intervalos preditivos foram amplos para a maioria dos desfechos e a meta-regressão utilizando idade média e a proporção de pacientes do sexo feminino não identificou moderadores significativos das estimativas combinadas. Observou-se que o denosumabe esteve associado a benefício clínico significativo e resposta radiológica em pacientes com maturidade esquelética e TCGO, porém, a durabilidade do controle e as estimativas de segurança variaram amplamente entre os estudos, ressaltando a necessidade de desfechos padronizados e de evidência prospectiva comparativa.

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