| Autor: |
Juan Fita MJ; Fundación Instituto Valenciano de Oncología, Carrer del Professor Beltrán Báguena, 8, 46009 Valencia, Spain., Anido Herranz U; Medical Oncology, Complejo Hospitalario Universitario de Santiago, 15706 Santiago de Compostela, Spain., Mendez-Vidal MJ; Medical Oncology, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Hospital Universitario Reina Sofía (HURS), 14004 Córdoba, Spain., Gironés-Sarrió R; Medical Oncology, Hospital Universitari i Politècnic la Fe, 46026 Valencia, Spain., Muñoz-Langa J; Medical Oncology, Hospital Arnau de Vilanova, 46015 Valencia, Spain., Sepúlveda-Sánchez J; Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación 12 de Octubre, 28041 Madrid, Spain., Mellado B; Medical Oncology, Hospital Clinic of Barcelona, 08036 Barcelona, Spain.; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), 08036 Barcelona, Spain., Alvarez-Fernandez C; Medical Oncology, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias, 33011 Oviedo, Spain., Heras López L; Servicio de Oncología Médica, Unidad de Sarcomas, Melanoma y Genitourinario, Institut Català d'Oncologia, 08908 L'Hospitalet de Llobregat, Spain., López-Guerrero JA; Laboratory of Molecuar Biology, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain.; Department of Pathology, Catholic University of València, 46001 Valencia, Spain., García-Casado Z; Laboratory of Molecuar Biology, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain., Calatrava A; Servicio Anatomía Patológica, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain., Ángel Climent M; Fundación Instituto Valenciano de Oncología, Carrer del Professor Beltrán Báguena, 8, 46009 Valencia, Spain. |
| Abstrakt: |
The SOGUG-IMANOL trial was a phase 2, uncontrolled, Spanish multicenter study to assess the effect of maintenance treatment with olaparib on radiographic progression-free survival (PFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) who achieved partial or complete response or disease stabilization on docetaxel treatment and had a documented germline/somatic mutation in any of the homologous recombination repair (HRR) genes. Patients received olaparib 300 mg orally twice daily. From the screened population ( n = 134), 26 (19.4%) somatic mutations were found, and 14 patients were included in the study. The median radiographic PFS was 11.1 (95%CI, 5.7 to 16.5) months. The median PSA-PFS was 3.5 (95%CI, 1.0 to 6.0) months, and the median clinical PFS was 14.7 (95%CI, 1.8 to 27.5 months). Clinical benefit was observed in 12 patients (85.7%, 95%CI 67.4% to 100%), including two patients with partial response and 10 with stable disease. Six patients reported grade 3-5 adverse events: asthenia ( n = 3), anemia ( n = 2) and neutropenia ( n = 1). In this setting, olaparib has been shown to be an efficacious maintenance treatment in terms of radiographic PFS and clinical benefit, becoming a therapeutic option for some patients harboring an HRR gene mutation and in scenarios where further investigation is needed. |
