Halabi Susan, Vogelzang Nicholas J, Kornblith Alice B, Ou San-San, Kantoff Philip W, Dawson Nancy A, Small Eric J
Department of Biostatistics and Bioinformatics, Duke University, and Cancer and Leukemia Group B Statistical Center, Durham, NC, USA.
J Clin Oncol. 2008 May 20;26(15):2544-9. doi: 10.1200/JCO.2007.15.0367.
Pain from castration-refractory prostate cancer (CRPC) bone metastases is a common event. Although it is assumed that pain represents an adverse prognostic factor, this variable has not been extensively evaluated. The objective of this study was to determine whether men with CRPC who had higher pain interference scores at baseline had worse clinical outcomes compared with men who had lower pain scores.
Data from three randomized phase III multicenter trials conducted by the Cancer and Leukemia Group B from 1992 to 1998 were combined. Eligible patients had progressive CRPC adenocarcinoma of the prostate, an Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate hematologic, renal, and hepatic functions. Seven items from the Brief Pain Inventory were used to assess the impact of pain on a range of daily activities and quality of life, each rated on a scale from 0 to 10.
In 599 men, the median pain interference scores was 17 (interquartile range, 4 to 34), and 38% of the men had opioid analgesic use at baseline. There was a statistically significant association between pain interference scores and risk of death. The median survival times were 17.6 months (95% CI, 16.1 to 19.1 months) and 10.2 months (95% CI, 8.6 to 11.3 months; P < .001) in men with low (< 17) and high (>or= 17) pain scores, respectively. Pain was inversely associated with likelihood of prostate-specific antigen decline, objective response, and time to bone progression.
This analysis demonstrates that pain is a statistically significant predictor of overall survival in men with metastatic CRPC. These results need to be validated prospectively in future phase III trials.
去势抵抗性前列腺癌（CRPC）骨转移引起的疼痛很常见。尽管人们认为疼痛是一个不良预后因素，但这一变量尚未得到广泛评估。本研究的目的是确定与疼痛评分较低的男性相比，基线时疼痛干扰评分较高的CRPC男性是否具有更差的临床结局。
合并了癌症与白血病B组在1992年至1998年进行的三项随机III期多中心试验的数据。符合条件的患者患有进展性CRPC前列腺腺癌，东部肿瘤协作组体能状态为0至2，且血液学、肾脏和肝脏功能良好。使用简明疼痛问卷中的七个项目来评估疼痛对一系列日常活动和生活质量的影响，每项评分范围为0至10分。
在599名男性中，疼痛干扰评分的中位数为17（四分位间距，4至34），38%的男性在基线时使用阿片类镇痛药。疼痛干扰评分与死亡风险之间存在统计学显著关联。疼痛评分低（<17）和高（≥17）的男性的中位生存时间分别为17.6个月（95%CI，16.1至19.1个月）和10.2个月（95%CI，8.6至11.3个月；P<.001）。疼痛与前列腺特异性抗原下降的可能性、客观缓解以及骨进展时间呈负相关。
该分析表明，疼痛是转移性CRPC男性总生存的统计学显著预测因素。这些结果需要在未来的III期试验中进行前瞻性验证。
