Wenzel Mike, Koll Florestan, Hoeh Benedikt, Humke Clara, Siech Carolin, Mader Nicolai, Sabet Amir, Groener Daniel, Steuber Thomas, Graefen Markus, Maurer Tobias, Brandts Christian, Banek Severine, Chun Felix K H, Mandel Philipp
Department of Urology, University Hospital Frankfurt, Goethe University Frankfurt am Main, Frankfurt, Germany;
Department of Urology, University Hospital Frankfurt, Goethe University Frankfurt am Main, Frankfurt, Germany.
J Nucl Med. 2025 Jan 3;66(1):61-66. doi: 10.2967/jnumed.124.268807.
Lu-vipivotide tetraxetan prostate-specific membrane antigen (Lu-PSMA) therapy is under current scientific investigation and aims to become established in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, real-world evidence in treatment comparison is scant. We relied on the FRAMCAP database and compared cabazitaxel versus Lu-PSMA therapy in mCRPC patients regarding progression-free survival (PFS) and overall survival (OS). Sensitivity analyses addressed second- to fourth-line mCRPC treatment to approximate current phase III patient selection criteria. Of 373 patients, 14% received cabazitaxel, 65% received Lu-PSMA, and 21% received both. Patients undergoing Lu-PSMA therapy were significantly older than cabazitaxel patients (median, 72 y vs. 66 y; < 0.01), and a higher proportion had an Eastern Cooperative Oncology Group score of 2 or more (12% vs. 5.0%, = 0.1). Rates of a prostate-specific antigen decline of at least 50% were 32% versus 0% for Lu-PSMA versus cabazitaxel. In outcome analyses, significant superior median PFS was observed for Lu-PSMA versus cabazitaxel (13.4 mo vs. 7.1 mo, < 0.001), even after multivariable adjustment (hazard ratio, 0.38; < 0.001). Regarding OS, rates also significantly differed, with median OS of 14.7 mo versus 16.5 mo versus 29.6 mo for cabazitaxel versus Lu-PSMA versus both treatments ( < 0.01). In sensitivity analyses of second- to fourth-line mCRPC treatment, PFS rates and median OS rates for cabazitaxel versus Lu-PSMA versus both therapies qualitatively remained the same as for the entire cohort. In a real-world setting, Lu-PSMA provides significantly better PFS and qualitatively better OS rates than does cabazitaxel chemotherapy and should therefore be considered a valuable treatment option for advanced mCRPC patients according to the European Medicines Agency approval.
镥-维泊妥珠单抗四乙酸前列腺特异性膜抗原（Lu-PSMA）疗法目前正在进行科学研究，旨在确立其在转移性去势抵抗性前列腺癌（mCRPC）治疗中的地位。然而，治疗对比的真实世界证据却很少。我们依托FRAMCAP数据库，比较了卡巴他赛与Lu-PSMA疗法在mCRPC患者中的无进展生存期（PFS）和总生存期（OS）。敏感性分析针对二线至四线mCRPC治疗，以近似当前III期患者选择标准。在373例患者中，14%接受了卡巴他赛治疗，65%接受了Lu-PSMA治疗，21%接受了两种治疗。接受Lu-PSMA治疗的患者显著比接受卡巴他赛治疗的患者年龄大（中位数，72岁对66岁；<0.01），且东部肿瘤协作组评分为2分或更高的比例更高（12%对5.0%，=0.1）。前列腺特异性抗原下降至少50%的比例，Lu-PSMA治疗组为32%，而卡巴他赛治疗组为0%。在疗效分析中，观察到Lu-PSMA治疗组的中位PFS显著优于卡巴他赛治疗组（13.4个月对7.1个月，<0.001），即使在多变量调整后也是如此（风险比，0.38；<0.001）。关于OS，其发生率也有显著差异，卡巴他赛、Lu-PSMA及两种治疗的中位OS分别为14.7个月、16.5个月和29.6个月（<0.01）。在二线至四线mCRPC治疗的敏感性分析中，卡巴他赛、Lu-PSMA及两种疗法的PFS率和中位OS率在定性上与整个队列相同。在真实世界环境中，与卡巴他赛化疗相比，Lu-PSMA提供了显著更好 的PFS和定性上更好的OS率，因此根据欧洲药品管理局的批准，应被视为晚期mCRPC患者的一种有价值的治疗选择。
