Tomsitz Dirk, Ruf Theresa, Heppt Markus, Staeger Ramon, Ramelyte Egle, Dummer Reinhard, Garzarolli Marlene, Meier Friedegund, Meier Eileen, Richly Heike, Gromke Tanja, Siveke Jens T, Franklin Cindy, Klespe Kai-Christian, Mauch Cornelia, Kilian Teresa, Seegräber Marlene, Schilling Bastian, French Lars E, Berking Carola, Heinzerling Lucie
Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University (LMU) Munich, 80337 Munich, Germany.
Department of Dermatology, Uniklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), 91054 Erlangen, Germany.
Cancers (Basel). 2023 Jun 30;15(13):3430. doi: 10.3390/cancers15133430.
Tebentafusp has recently been approved for the treatment of metastatic uveal melanoma (mUM) after proving to have survival benefits in a first-line setting.
This retrospective, multicenter study analyzed the outcomes and safety of tebentafusp therapy in 78 patients with mUM.
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, = 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.
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.
在一线治疗中被证明具有生存获益后，替贝福司普最近被批准用于治疗转移性葡萄膜黑色素瘤（mUM）。
这项回顾性多中心研究分析了78例mUM患者接受替贝福司普治疗的疗效和安全性。
接受替贝福司普治疗的患者中位无进展生存期（PFS）为3个月（95%置信区间2.7至3.3），中位总生存期（OS）为22个月（95%置信区间10.6至33.4）。与已发表的3期研究相比，我们的队列中乳酸脱氢酶（LDH）升高的患者比例更高（65.4%对35.7%），并且纳入了既往接受过全身和局部消融治疗的患者。在接受免疫检查点抑制剂（ICI）治疗后再接受替贝福司普治疗的患者中，与相反治疗顺序相比，中位OS有延长趋势（28个月，95%置信区间26.9至29.1）（相反治疗顺序为24个月，95%置信区间13.0至35.0，P = 0.257）。最常见的治疗相关不良事件是71.2%的患者发生细胞因子释放综合征，53.8%的患者发生皮肤毒性。1例患者发生肿瘤溶解综合征。
来自这个真实队列的数据显示，中位PFS/OS与已发表的3期试验数据相似。与相反治疗顺序相比，ICI序贯替贝福司普治疗可能导致更长的PFS/OS。
