PDF(Pubmed)
Abstract：
UNASSIGNED: 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).
UNASSIGNED: To compare survival outcomes among patients with MHSPC by presence or absence of baseline bone pain at diagnosis.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT01809691.
UNASSIGNED: To compare survival outcomes among patients with MHSPC by presence or absence of baseline bone pain at diagnosis.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT01809691.
摘要：
■在去势抵抗性前列腺癌患者中，骨痛的存在与更差的总生存期(OS)显著相关。然而,在转移性骨痛和生存结局方面的数据很少，激素敏感型前列腺癌（MHSPC）。
■通过诊断时是否存在基线骨痛来比较MHSPC患者的生存结果。
■这是事后二次分析，在2023年9月1日至12月31日进行,使用了SWOG-1216的患者水平数据,该研究是一项3期前瞻性随机临床试验,纳入了2013年3月1日至2017年7月15日美国248个学术和社区中心新诊断的MHSPC患者.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，并纳入该二级分析。
■在SWOG-1216试验中，患者被随机(1:1)接受奥特龙的雄激素剥夺治疗(ADT)，300毫克，每天两次口服（实验组），或ADT与比卡鲁胺，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,或患者戒断。
■总生存期是主要终点；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,格里森得分,疾病体积,Zubrod性能状态,PSA水平。
■在1279名男性研究参与者中，301（23.5％）在MHSPC诊断时具有基线骨痛，896（70.1％）没有。82例患者（6.4%）骨疼痛状态不可用。符合资格并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年）。与没有经历骨痛的患者相比，那些有基线骨痛的人更年轻(中位年龄，66.0[IQR,60.1-73.4]年vs68.2[IQR，62.4-73.7]年；P=.02），高容量疾病的发病率更高（212[70.4％]vs373[41.6％]；P<.001）。调整后,骨痛与较短的PFS和OS相关.在4.0年的中位随访时间(IQR，2.5-5.4年），骨痛患者的中位PFS为1.3年(95%CI,1.1-1.7年),而无初始骨痛患者的中位PFS为3.7年(95%CI,3.3-4.2年)(调整后的风险比[AHR],1.46;95％CI，1.22-1.74;P<.001），OS为3.9年（95％CI，3.3-4.8年）与未达到（NR）（95％CI，6.6年至NR）的患者（AHR，1.66；95%CI，1.34-2.05；P<.001）。
■在对SWOG-1216随机临床试验的事后二次分析中，在MHSPC诊断时出现基线骨痛的患者的生存结局比没有骨痛的患者更差.这些数据表明，这些患者优先参加临床试验，可以帮助病人咨询，并表明将骨痛纳入MHSPC的预后模型可能是有必要的。
■ClinicalTrials.gov标识符：NCT01809691。
■通过诊断时是否存在基线骨痛来比较MHSPC患者的生存结果。
■这是事后二次分析，在2023年9月1日至12月31日进行,使用了SWOG-1216的患者水平数据,该研究是一项3期前瞻性随机临床试验,纳入了2013年3月1日至2017年7月15日美国248个学术和社区中心新诊断的MHSPC患者.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，并纳入该二级分析。
■在SWOG-1216试验中，患者被随机(1:1)接受奥特龙的雄激素剥夺治疗(ADT)，300毫克，每天两次口服（实验组），或ADT与比卡鲁胺，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,或患者戒断。
■总生存期是主要终点；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,格里森得分,疾病体积,Zubrod性能状态,PSA水平。
■在1279名男性研究参与者中，301（23.5％）在MHSPC诊断时具有基线骨痛，896（70.1％）没有。82例患者（6.4%）骨疼痛状态不可用。符合资格并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年）。与没有经历骨痛的患者相比，那些有基线骨痛的人更年轻(中位年龄，66.0[IQR,60.1-73.4]年vs68.2[IQR，62.4-73.7]年；P=.02），高容量疾病的发病率更高（212[70.4％]vs373[41.6％]；P<.001）。调整后,骨痛与较短的PFS和OS相关.在4.0年的中位随访时间(IQR，2.5-5.4年），骨痛患者的中位PFS为1.3年(95%CI,1.1-1.7年),而无初始骨痛患者的中位PFS为3.7年(95%CI,3.3-4.2年)(调整后的风险比[AHR],1.46;95％CI，1.22-1.74;P<.001），OS为3.9年（95％CI，3.3-4.8年）与未达到（NR）（95％CI，6.6年至NR）的患者（AHR，1.66；95%CI，1.34-2.05；P<.001）。
■在对SWOG-1216随机临床试验的事后二次分析中，在MHSPC诊断时出现基线骨痛的患者的生存结局比没有骨痛的患者更差.这些数据表明，这些患者优先参加临床试验，可以帮助病人咨询，并表明将骨痛纳入MHSPC的预后模型可能是有必要的。
■ClinicalTrials.gov标识符：NCT01809691。
