Clinical Oncology Letters
https://www.clinicaloncologyletters.com/article/5c7008530e8825e64d8e6fd5
Clinical Oncology Letters
Artigo Original

Perfil dos pacientes portadores de câncer de próstata metastático resistente a castração incluídos no Programa de Acesso Expandido de uma instituição Brasileira

Enzalutamide in castration resistant metastatic prostate cancer: an institutional experience of patients treated in an expanded access program

Rocha JA, , Cruz FJ

Downloads: 1
Views: 1134

Resumo

Introdução: A Enzalutamida (ENZ) é um potente inibidor da sinalização do receptor de andrógenos que bloqueia várias vias de sinalização do receptor. Desenvolvemos um estudo para analisar o perfil dos pacientes incluídos no Programa de Acesso Expandido (PAE) do Instituto Brasileiro de Combate ao Câncer (IBCC) beneficiados pelo uso da Enzalutamida no tratamento de CPRC, após falha de tratamento com docetaxel. Métodos: Trata-se de um estudo observacional restrospectivo que incluiu pacientes com CPRC com doença progressiva inscritos no PAE do IBCC para ENZ. Resultados: Um declínio máximo do PSA ≥30% foi observada em 4 pacientes (23,52% dos pacientes), uma queda do PSA ≥50% foi observada em 7 pacientes (41,76% dos pacientes), e um declínio do PSA ≥90% foi observada em 4 pacientes (23,52% dos pacientes). A sobrevida livre de progressão do PSA foi de 4 meses (3,7-7,2) e a sobrevida livre de progressão clinica/radiológica foi de 7 meses (4,9-9,2). Foram considerados fatores preditores de resposta EGOG, numero de sítios de metástases, linhas de tratamentos hormonal previas e número de quimioterapias previas. Conclusão: Os resultados sugerem boas taxas de resposta do PSA e bom controle clinico da doença atrasando assim o tempo de início de quimioterapia

Palavras-chave

Câncer de Próstata, Enzalutamida, Neoplasias de Próstata Resistentes à Castração, Programa de Acesso Expandido, Estudo Observacional

Abstract

Introduction: Enzalutamide (ENZ) is a potent inhibitor of androgen receptor signaling that blocks multiple receptor signaling pathways. We performed a study to analyze the profile of patients included in the Expanded Access Program (EAP) of the Instituto Brasileiro de Controle do Cancer (IBCC) benefited from the use of ENZ in the treatment of CRPC after failure of treatment with docetaxel. Methods: This is a restrospective observational study that included patients with CRPC with progressive disease enrolled in the IBCC PAE for ENZ. Results: A maximum of PSA decline ≥30% was observed in 4 patients (23.52% of patients), a decline ≥50% PSA was observed in 7 patients (41.76% of patients), and a decline in PSA ≥90% was observed in 4 patients (23.52% of patients). The progression-free survival of PSA was 4 months (3.7 to 7.2) and the free survival clinical / radiological progression was 7 months (4.9 to 9.2). Were considered predictors of response EGOG, number of metastatic sites, lines of prior hormonal treatments and number of chemotherapies look ahead. Conclusion: The results suggest good response rates of PSA and good clinical management of the disease thus delaying the time to start chemotherapy.

Keywords

Prostate Cancer, Enzalutamide, Prostatic Neoplasms, CastrationResistant, Expanded Access Program, Observational Study

Referências

1. Instituto Nacional do Cancer Jose Alencar Gomes da Silva. Disponivel em: <http://www. inca.gov.br/estimativa/2016/sintese-de-resultados-comentarios.asp>.

2. Feldman BJ, et al. The development of androgen independent prostate cancer. Nat Rev Cancer. 2001;1:34-45.

3. Grossmann, et al. Androgen receptor signaling in androgen-refractory prostate cancer. Journal of National Cancer Institute. Volume 93, No 22, November 21, 2001.

4. Scher, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. N Engl J Med 2012; 367:1187-1197.

5. Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group.Am J Clin Oncol. 1982;5:649-655.

6. Saad ED, et al. Critérios comuns de toxicidade do Instituto Nacional de Câncer dos Estados Unidos / Common toxicity criteria of the National Cancer Institute Rev. bras. cancerol; 48(1): 63-96, jan.-mar. 2002.

7. Scher, et al. Design and End Points of Clinical Trials for Patients With Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. JCO, March 1, 2008 vol. 26 no. 7 1148-1159.

8. Joshua, et al. Safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Expanded access in North America. The Prostate, Volume 75, Issue 8, pages 836–844, June 1, 2015.

9. Badrising, et al. Clinical activity and tolerability of enzalutamide (MDV3100) in patients with metastatic, castration-resistant prostate cancer who progress after docetaxel and abiraterone treatment. Cancer, Volume 120, Issue 7, pages 968–975, 1 April 2014.

10. Bianchine, et al. Antitumour activity of enzalutamide (MDV3100) in patients with metastatic castration-resistant prostate cancer (CRPC) pre-treated with docetaxel and abiraterone. EJC, January 2014, Volume 50, Issue 1, Pages 78-8.

11. Beer, et al. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. N Engl J Med 2014; 371:424-433.

5c7008530e8825e64d8e6fd5 col Articles
Links & Downloads

Clin Onc Let

Share this page
Page Sections