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.
SOGUG-IMANOL试验是一项II期、非对照、西班牙多中心研究，旨在评估奥拉帕利维持治疗对转移性去势抵抗性前列腺癌（mCRPC）患者影像学无进展生存期（PFS）的影响。入组患者需满足以下条件：在多西他赛治疗后达到部分或完全缓解或疾病稳定，且经证实携带同源重组修复（HRR）基因中任一基因的胚系/体细胞突变。患者接受奥拉帕利300 mg口服给药，每日两次。在筛选人群（n=134）中，发现26例（19.4%）体细胞突变，最终14例患者纳入研究。中位影像学PFS为11.1个月（95%CI：5.7-16.5）。中位PSA-PFS为3.5个月（95%CI：1.0-6.0），中位临床PFS为14.7个月（95%CI：1.8-27.5）。12例患者（85.7%，95%CI：67.4%-100%）观察到临床获益，其中2例达到部分缓解，10例疾病稳定。6例患者报告了3-5级不良事件：乏力（3例）、贫血（2例）和中性粒细胞减少症（1例）。在此背景下，奥拉帕利在影像学PFS和临床获益方面被证明是一种有效的维持治疗方案，为携带HRR基因突变的患者提供了一种治疗选择，但该方案仍需进一步研究验证。
肿瘤(癌症)患者之家