Background/Objectives:CAPTRANE evaluated the efficacy and tolerability of high-concentration capsaicin patch (HCCP) vs. oral pregabalin for the treatment of postsurgical neuropathic pain (PSNP) following breast cancer surgery. The study was designed with the aim of demonstrating noninferiority of one HCCP against daily pregabalin.Methods:This was a multicenter, randomized, parallel-arm, open-label study conducted across nine centers in France. The primary endpoint was a change from baseline in the Numeric Pain Rating Scale (NPRS) score after 2 months.Results:Recruitment challenges resulted in the randomization of 140 patients (versus 644 planned); the per-protocol population comprised 107 patients (HCCP: n = 65; pregabalin: n = 42). Baseline characteristics were similar between the two groups. In the per-protocol analysis, the mean (standard deviation) change versus baseline in NPRS score was −1.926 (2.554) with HCCP and −1.634 (2.498) with pregabalin. The prespecified analysis showed that HCCP was not inferior to pregabalin: the lower bound of the 90% confidence interval for the between-arm difference was −0.889 and the upper bound was +0.260 (i.e., below the predefined clinical threshold of +0.4). Patient-reported outcomes showed no statistically significant differences between treatments. The painful area size decreased significantly more with HCCP. Tolerability profiles differed, with HCCP mostly causing application-site reactions. While >50% of patients switched from pregabalin to HCCP, none switched from HCCP to pregabalin.Conclusions:This comparative study in PSNP post breast cancer surgery, evaluating a single treatment of HCCP, shows a noninferior reduction in pain intensity, a superior reduction in painful area size, and a patient preference for HCCP compared with pregabalin. Despite limitations, it contributes valuable initial data for PSNP management in breast cancer care.
背景/目的：CAPTRANE研究旨在评估高浓度辣椒素贴片（HCCP）与口服普瑞巴林治疗乳腺癌术后神经病理性疼痛（PSNP）的疗效和耐受性。本研究设计旨在证明单次HCCP治疗相对于每日口服普瑞巴林的非劣效性。 方法：本研究为一项在法国九家中心开展的多中心、随机、平行组、开放标签研究。主要终点为治疗2个月后数字疼痛评分量表（NPRS）评分相对于基线的变化。 结果：受招募困难影响，最终随机入组140例患者（原计划644例）；符合方案集人群包含107例患者（HCCP组：n = 65；普瑞巴林组：n = 42）。两组基线特征相似。符合方案集分析显示，NPRS评分相对于基线的平均变化值（标准差）在HCCP组为−1.926（2.554），普瑞巴林组为−1.634（2.498）。预设分析表明HCCP不劣于普瑞巴林：组间差异的90%置信区间下限为−0.889，上限为+0.260（即低于预设的临床界值+0.4）。患者报告结局显示两组间无统计学显著差异。HCCP组疼痛区域面积减少更显著。耐受性特征存在差异，HCCP主要引起用药部位反应。超过50%的患者从普瑞巴林转为使用HCCP，但无患者从HCCP转为使用普瑞巴林。 结论：这项针对乳腺癌术后PSNP的比较研究表明，与普瑞巴林相比，单次HCCP治疗在疼痛强度缓解方面呈非劣效性，在疼痛区域面积缩小方面更具优势，且患者更倾向于选择HCCP。尽管存在局限性，本研究为乳腺癌治疗中PSNP的管理提供了有价值的初步数据。
肿瘤(癌症)患者之家