骨痛的存在与去势抵抗性前列腺癌患者总生存期 (OS) 较差显着相关。然而，关于转移性激素敏感性前列腺癌 (MHSPC) 背景下的骨痛和生存结果的数据很少。通过诊断时是否存在基线骨痛来比较 MHSPC 患者的生存结果。此事后次要研究这项分析于 2023 年 9 月 1 日至 12 月 31 日期间进行，使用了 SWOG-1216 的患者水平数据，这是一项 3 期前瞻性随机临床试验，从 3 月 1 日起从美国 248 个学术和社区中心入组了新诊断的 MHSPC 患者， 2013年至2017年7月15日。意向治疗人群中具有可用骨痛状态的所有患者均符合资格并纳入本次二次分析。在SWOG-1216试验中，患者被随机（1:1）接受雄激素剥夺疗法（ADT），奥特罗奈，300毫克，口服，每天两次（实验组），或比卡鲁胺，ADT，每天口服50毫克（对照组），直到疾病进展，不可接受的毒性作用，或患者退出。主要终点;无进展生存期（PFS）和前列腺特异性抗原（PSA）反应是次要终点。 Cox 比例风险回归模型用于单变量和多变量分析，调整年龄、治疗类型、格里森评分、疾病体积、Zubrod 表现状态和 PSA 水平。 在 1279 名男性研究参与者中，301 名 (23.5%) 患有基线骨痛896 人 (70.1%) 没有接受 MHSPC 诊断。 82 名患者 (6.4%) 无法获得骨痛状态。纳入本次二次分析的 1197 名患者的中位年龄为 67.6 岁（IQR，61.8-73.6 岁）。与未经历骨痛的患者相比，基线骨痛患者更年轻（中位年龄 66.0 [IQR，60.1-73.4] 岁 vs 68.2 [IQR，62.4-73.7] 岁；P = .02），且骨痛发生率更高高容量疾病的发生率（212 [70.4%] vs 373 [41.6%]；P < .001）。调整后，骨痛与较短的 PFS 和 OS 相关。中位随访 4.0 年（IQR，2.5-5.4 年）时，骨痛患者的中位 PFS 为 1.3 年（95% CI，1.1-1.7 年），而中位 PFS 为 3.7 年（95% CI，3.3-4.2 年） ）在没有初始骨痛的患者中（调整后的风险比 [AHR]，1.46；95% CI，1.22-1.74；P < .001）和 OS 为 3.9 年（95% CI，3.3-4.8 年）与未达到（NR ）（95% CI，6.6 年达到 NR），无初始骨痛的患者（AHR，1.66；95% CI，1.34-2.05；P < .001）。在 SWOG-1216 随机临床试验的事后二次分析中，在 MHSPC 诊断时有基线骨痛的患者比没有骨痛的患者生存结果更差。这些数据表明优先考虑这些患者参加临床试验，可能有助于患者咨询，并表明可能有必要将骨痛纳入 MHSPC 的预后模型中。ClinicalTrials.gov 标识符：NCT01809691。

The presence of bone pain is significantly associated with worse overall survival (OS) in patients with castration-resistant prostate cancer. However, there are few data regarding bone pain and survival outcomes in the context of metastatic, hormone-sensitive prostate cancer (MHSPC).To compare survival outcomes among patients with MHSPC by presence or absence of baseline bone pain at diagnosis.This post hoc secondary analysis, conducted from September 1 to December 31, 2023, used patient-level data from SWOG-1216, a phase 3, prospective randomized clinical trial that enrolled patients with newly diagnosed MHSPC from 248 academic and community centers across the US from March 1, 2013, to July 15, 2017. All patients in the intention-to-treat population who had available bone pain status were eligible and included in this secondary analysis.In the SWOG-1216 trial, patients were randomized (1:1) to receive either androgen deprivation therapy (ADT) with orteronel, 300 mg orally twice daily (experimental group), or ADT with bicalutamide, 50 mg orally daily (control group), until disease progression, unacceptable toxic effects, or patient withdrawal.Overall survival was the primary end point; progression-free survival (PFS) and prostate-specific antigen (PSA) response were secondary end points. Cox proportional hazards regression models were used for both univariable and multivariable analyses adjusting for age, treatment type, Gleason score, disease volume, Zubrod performance status, and PSA level.Of the 1279 male study participants, 301 (23.5%) had baseline bone pain at MHSPC diagnosis and 896 (70.1%) did not. Bone pain status was unavailable in 82 patients (6.4%). The median age of the 1197 patients eligible and included in this secondary analysis was 67.6 years (IQR, 61.8-73.6 years). Compared with patients who did not experience bone pain, those with baseline bone pain were younger (median age, 66.0 [IQR, 60.1-73.4] years vs 68.2 [IQR, 62.4-73.7] years; P = .02) and had a higher incidence of high-volume disease (212 [70.4%] vs 373 [41.6%]; P < .001). After adjustment, bone pain was associated with shorter PFS and OS. At a median follow-up of 4.0 years (IQR, 2.5-5.4 years), patients with bone pain had median PFS of 1.3 years (95% CI, 1.1-1.7 years) vs 3.7 years (95% CI, 3.3-4.2 years) in patients without initial bone pain (adjusted hazard ratio [AHR], 1.46; 95% CI, 1.22-1.74; P < .001) and OS of 3.9 years (95% CI, 3.3-4.8 years) vs not reached (NR) (95% CI, 6.6 years to NR) in patients without initial bone pain (AHR, 1.66; 95% CI, 1.34-2.05; P < .001).In this post hoc secondary analysis of the SWOG-1216 randomized clinical trial, patients with baseline bone pain at MHSPC diagnosis had worse survival outcomes than those without bone pain. These data suggest prioritizing these patients for enrollment in clinical trials, may aid patient counseling, and indicate that the inclusion of bone pain in prognostic models of MHSPC may be warranted.ClinicalTrials.gov Identifier: NCT01809691.