Phase II Trial Evaluating Olaparib Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer Responsive or Stabilized on Docetaxel Treatment: SOGUG-IMANOL Study.

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.

Cancers. 2023 Oct 31*** epublish ***

María José Juan Fita, Urbano Anido Herranz, María José Mendez-Vidal, Regina Gironés-Sarrió, José Muñoz-Langa, Juan Sepúlveda-Sánchez, Begoña Mellado, Carlos Alvarez-Fernandez, Lucía Heras López, José Antonio López-Guerrero, Zaida García-Casado, Ana Calatrava, Miguel Ángel Climent

Fundación Instituto Valenciano de Oncología, Carrer del Professor Beltrán Báguena, 8, 46009 Valencia, Spain., Medical Oncology, Complejo Hospitalario Universitario de Santiago, 15706 Santiago de Compostela, Spain., Medical Oncology, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Hospital Universitario Reina Sofía (HURS), 14004 Córdoba, Spain., Medical Oncology, Hospital Universitari i Politècnic la Fe, 46026 Valencia, Spain., Medical Oncology, Hospital Arnau de Vilanova, 46015 Valencia, Spain., Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación 12 de Octubre, 28041 Madrid, Spain., Medical Oncology, Hospital Clinic of Barcelona, 08036 Barcelona, Spain., Medical Oncology, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias, 33011 Oviedo, Spain., Servicio de Oncología Médica, Unidad de Sarcomas, Melanoma y Genitourinario, Institut Català d'Oncologia, 08908 L'Hospitalet de Llobregat, Spain., Laboratory of Molecuar Biology, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain., Servicio Anatomía Patológica, Fundación Instituto Valenciano de Oncología, 46009 Valencia, Spain.