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Perioperative Morbidity of Radical Prostatectomy After Intensive Neoadjuvant Androgen Blockade in Men With High-Risk Prostate Cancer: Results of Phase II Trial Compared to a Control Group.
Ilario, Eder N; Bastos, Diogo A; Guglielmetti, Giuliano B; Murta, Claudio B; Cardili, Leonardo; Cordeiro, Mauricio D; Junior, Jose P; Coelho, Rafael F; Nahas, William C.
Afiliação
  • Ilario EN; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil. Electronic address: eder.nisi85@gmail.com.
  • Bastos DA; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Guglielmetti GB; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Murta CB; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Cardili L; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Cordeiro MD; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Junior JP; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Coelho RF; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Nahas WC; Faculdade de Medicina, Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
Clin Genitourin Cancer ; 21(1): 43-54, 2023 02.
Article em En | MEDLINE | ID: mdl-36428171
ABSTRACT

INTRODUCTION:

Recent studies about intense neoadjuvant therapy followed by Radical Prostatectomy (RP) lack standardized criteria regarding surgical complications and comparison to a group of patients who underwent RP without the use of neoadjuvant therapy. The aim of this study is to describe and compare the perioperative complication rates. MATERIALS AND

METHODS:

This was a prospective, single-center phase II trial in patients with high-risk prostate cancer (HRPCa). The control group included HRPCa patients who underwent RP outside the clinical trial during the same study recruitment period. The interventional group was randomized (11) to receive neoadjuvant androgen deprivation therapy plus abiraterone with or without apalutamide followed by RP. Complications observed up to 30 days of surgery were classified based on the Clavien-Dindo classification. Uni- and multivariate analyses were carried out to assess predictive factors associated with perioperative complications.

RESULTS:

In total, 124 patients with HRPCa were underwent to RP between May 27, 2019 and August 6, 2021, including 61 patients in the intervention group and 63 patients in the control group. The general and major complications in the intervention group reached 29.6% and 6.6%, respectively, and 39.7% and 7.9% in the control group, respectively. There was no significant difference between groups. We observed 4.9% of thromboembolic event in the neoadjuvant group.

CONCLUSIONS:

There was no significant increase in morbidity rate in RP after intense neoadjuvant therapy. The association of intense androgen deprivation neoadjuvant therapy with RP and extended pelvic lymphadenectomy may increase the risk of a perioperative thromboembolic events.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata / Terapia Neoadjuvante Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Humans / Male Idioma: En Revista: Clin Genitourin Cancer Assunto da revista: NEOPLASIAS / UROLOGIA Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata / Terapia Neoadjuvante Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Humans / Male Idioma: En Revista: Clin Genitourin Cancer Assunto da revista: NEOPLASIAS / UROLOGIA Ano de publicação: 2023 Tipo de documento: Article