背景：Tebentafusp最近被批准用于治疗转移性葡萄膜黑色素瘤（mUM），因为它在一线治疗中具有生存益处。
方法：本回顾性研究，多中心研究分析了78例mUM患者tebentafusp治疗的结果和安全性。
结果：接受tebentafusp治疗的患者的中位PFS为3个月（95％CI2.7至3.3），中位OS为22个月（95％CI10.6至33.4）。与已发表的第三阶段研究相反，我们的队列中LDH升高的患者比例较高(65.4%vs.35.7%），并包括先前接受过全身和局部消融治疗的患者。在ICI后接受tebentafusp治疗的患者中，中位OS有更长的趋势(28个月，95%CI26.9至29.1)与反向治疗序列(24个月，95%CI13.0至35.0，p=0.257）。最常见的治疗相关不良事件是71.2%的患者的细胞因子释放综合征和53.8%的患者的皮肤毒性。1例患者发生肿瘤溶解综合征。
结论：来自该真实队列的数据显示，PFS/OS中位数与已发表的3期试验数据相似。与反向治疗顺序相比，用ICI和tebentafusp治疗可能会导致更长的PFS/OS。
BACKGROUND: Tebentafusp has recently been approved for the treatment of metastatic uveal melanoma (mUM) after proving to have survival benefits in a first-line setting.
METHODS: This retrospective, multicenter
study analyzed the outcomes and safety of
tebentafusp therapy in 78 patients with mUM.
RESULTS: Patients treated with
tebentafusp had a median PFS of 3 months (95% CI 2.7 to 3.3) and a median OS of 22 months (95% CI 10.6 to 33.4). In contrast to a published Phase 3
study, our cohort had a higher rate of patients with elevated LDH (65.4% vs. 35.7%) and included patients with prior systemic and local ablative therapies. In patients treated with tebentafusp following ICI, there was a trend for a longer median OS (28 months, 95% CI 26.9 to 29.1) compared to the inverse treatment sequence (24 months, 95% CI 13.0 to 35.0, p = 0.257). The most common treatment-related adverse events were cytokine release syndrome in 71.2% and skin toxicity in 53.8% of patients. Tumor lysis syndrome occurred in one patient.
CONCLUSIONS: Data from this real-life cohort showed a median PFS/OS similar to published Phase 3
trial data. Treatment with ICI followed by tebentafusp may result in longer PFS/OS compared to the inverse treatment sequence.
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