Talimogenelaherparepvec(T-VEC;IMLYGIC®,AmgenInc.)是一种溶瘤免疫疗法,在欧洲被批准用于治疗不可切除的转移性黑色素瘤(IIIB-IVM1a期)。这项研究描述了四个欧洲国家对T-VEC的实际使用情况。
人口统计数据,治疗模式,安全,和临床有效性在回顾性图表审查中检查了IIIB-IVM1a期不可切除的黑色素瘤患者在外科手术(荷兰)和医学(奥地利,德国,英国)肿瘤学设置。
总的来说,纳入66例患者(荷兰:n=31;奥地利,德国,英国:n=35)。中位年龄为69岁,59.1%为女性。T-VEC启动时,47例患者(71.2%)患有IIIB/C期疾病;其中,30人来自荷兰。尽管72.7%的患者接受T-VEC作为一线治疗,荷兰的这一比例高于其他国家(93.5%vs54.3%)。在停止T-VEC的47例患者中,26(55.3%)没有剩余的可注射病变(可能表明完全缓解);这些患者中有20/26来自荷兰。一名患者因毒性而停用T-VEC。
这项研究是在欧洲的实际临床实践中首次对T-VEC治疗无法切除的IIIB/C-IVM1a期黑色素瘤的综合性跨国评估。欧洲国家之间的差异很明显,与其他国家相比,荷兰的医生在疾病早期晚期和一线患者中使用T-VEC。
Talimogene laherparepvec (T-VEC; IMLYGIC®, Amgen Inc.) is an oncolytic immunotherapy approved in Europe for the treatment of unresectable metastatic melanoma (stage IIIB-IVM1a). This study characterised real-world use of T-VEC in four European countries.
Data on demographics, treatment pattern, safety, and clinical effectiveness were examined in a retrospective chart
review of patients with stage IIIB-IVM1a unresectable melanoma treated with T-VEC in surgical (the Netherlands) and medical (Austria, Germany, UK) oncology settings.
Overall, 66 patients were included (the Netherlands: n = 31; Austria, Germany, UK: n = 35). The median age was 69 years and 59.1% were female. At the time of T-VEC initiation, 47 patients (71.2%) had stage IIIB/C disease; of these, 30 were from the Netherlands. Although 72.7% patients overall received T-VEC as first-line therapy, this was higher in the Netherlands than the other countries (93.5% vs 54.3%). Of the 47 patients who discontinued T-VEC, 26 (55.3%) had no remaining injectable lesions (potentially indicating complete response); 20/26 of these patients were from the Netherlands. One patient discontinued T-VEC due to toxicity.
This study is the first comprehensive multinational evaluation of the use of T-VEC to treat unresectable stage IIIB/C-IVM1a melanoma in real-world clinical practice in Europe. The differences between European countries were apparent, with physicians in the Netherlands using T-VEC in patients with earlier advanced disease stage and in the first-line setting compared with other countries.