Two randomized trials demonstrated a survival benefit of triplet therapy (androgen deprivation therapy [ADT]) plus androgen receptor pathway inhibitor [ARPI] plus docetaxel) over doublet therapy (ADT plus docetaxel), thus changing treatment strategies in metastatic hormonesensitive prostate cancer (mHSPC). We conducted the first real-world analysis comprising 97 mHSPC patients from 16 Austrian medical centers, among them 79.4% of patients received abiraterone and 17.5% darolutamide treatment. Baseline characteristics and clinical parameters during triplet therapy were documented. Mann-Whitney test for continuous or X²-test for categorical variables was used. Variables on progression were tested using logistic regression analysis and tabulated as hazard ratios (HR), 95% confidence interval (CI). Of 83.5% patients with synchronous and 16.5% with metachronous disease were included. 83.5% had high-volume disease diagnosed by conventional imaging (48.9%) or PSMA PET-CT (51.1%). While docetaxel and ARPI were administered consistent with pivotal trials, prednisolone, prophylactic gCSF and osteoprotective agents were not applied guideline conform in 32.5%, 37%, and 24.3% of patients, respectively. Importantly, a nonsimultaneous onset of chemotherapy and ARPI, performed in 44.3% of patients, was associated with significantly worse treatment response ( = .015, HR 0.245). Starting ARPI before chemotherapy was associated with significantly higher probability for progression ( = .023, HR 15.781) than vice versa. Strikingly, 15.6% (abiraterone) and 25.5% (darolutamide) low-volume patients as well as 14.4% (abiraterone) and 17.6% (darolutamide) metachronous patients received triplet therapy. Adverse events (AE) occurred in 61.9% with grade 3 to 5 in 15% of patient without age-related differences. All patients achieved a PSA decline of 99% and imaging response was confirmed in 88% of abiraterone and 75% of darolutamide patients. Triplet therapy arrived in clinical practice primarily for synchronous high-volume mHSPC. Regardless of selected therapy regimen, treatment is highly effective and tolerable. Preferably therapy should be administered simultaneously, however if not possible, chemotherapy should be started first.

中文翻译：

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转移性激素敏感前列腺癌三联疗法的真实世界证据：奥地利多中心研究

两项随。我们进行了首次真实世界分析，包括来自 16 个奥地利医疗中心的 97 名 mHSPC 患者，其中 79.4% 的患者接受阿比特龙治疗，17.5% 的患者接受达洛鲁胺治疗。记录三联疗法期间的基线特征和临床参数。使用连续的 Mann-Whitney 检验或分类变量的 X2 检验。使用逻辑回归分析测试进展变量，并将其制成危险比 (HR)、95% 置信区间 (CI)。 83.5% 的同步疾病患者和 16.5% 的异时疾病患者被纳入。 83.5% 的患者患有通过常规成像 (48.9%) 或 PSMA PET-CT (51.1%) 诊断的大量疾病。虽然多西紫杉醇和 ARPI 的给药与关键试验一致，但泼尼松龙、预防性 gCSF 和骨保护剂的使用分别有 32.5%、37% 和 24.3% 的患者未符合指南。重要的是，44.3% 的患者不同时进行化疗和 ARPI，治疗反应明显较差（= 0.015，HR 0.245）。在化疗前开始 ARPI 与进展概率显着较高 (= .023，HR 15.781) 相关，反之亦然。引人注目的是，15.6%（阿比特龙）和 25.5%（达洛鲁胺）低容量患者以及 14.4%（阿比特龙）和 17.6%（达洛鲁胺）异时患者接受了三联疗法。不良事件 (AE) 发生率为 61.9%，其中 15% 的患者发生 3 至 5 级不良事件，无年龄相关差异。所有患者的 PSA 下降了 99%，并且阿比特龙治疗组和达洛鲁胺治疗组分别有 88% 和 75% 的患者出现了影像学反应。三联疗法进入临床实践主要用于同步大容量 mHSPC。无论选择何种治疗方案，治疗都是非常有效且可耐受的。最好同时进行治疗，但如果不可能，则应首先开始化疗。