目的:随着III期黑色素瘤患者免疫治疗的良好结果,切除和完全淋巴结清扫后辅助放疗的作用必须重新评估.我们评估了辅助放疗和免疫治疗与仅在切除的III期黑色素瘤患者中的免疫治疗相比的结果和安全性。
方法:这项回顾性和单机构研究包括2019年1月至2022年12月接受完全淋巴结清扫和辅助免疫治疗的III期黑色素瘤患者。与免疫治疗相关的放疗组定义为淋巴结清扫区完成免疫治疗和辅助放疗。主要终点是无病生存期。次要终点是局部进展,局部复发高危患者的3级或以上不良事件发生率和无病生存率.
结果:纳入33例患者。其中,12人接受辅助淋巴结野放疗。中位随访时间为17个月(范围:8-45个月)。接受放射治疗和免疫治疗的患者的疾病分期明显更高,囊外延伸更为频繁。12个月时,仅接受免疫治疗的患者的无病生存率为66.7%(95%CI:42.5~82.5%),接受放疗和免疫治疗的患者的无病生存率为83.3%(95%CI:48.2~95.6%;P=0.131).接受免疫治疗的患者局部区域进展率为24%,接受免疫治疗和放疗的患者为8%(P=0.379)。辅助治疗后,6%的患者发生3级或以上的免疫治疗相关事件,没有发生3级或以上的放射相关不良事件。
结论:在III期黑色素瘤患者中,辅助淋巴结野放疗联合免疫疗法似乎与更长的无病生存期相关,具有可接受的公差。然而,这些结果需要长期和前瞻性研究的证实.
OBJECTIVE: With the promising results of immunotherapy in patients with stage III melanoma, the role of adjuvant radiotherapy after resection and complete lymph-node dissection must be reassessed. We evaluate the outcomes and safety of adjuvant radiotherapy and immunotherapy compared to immunotherapy only in patients with resected stage III melanoma.
METHODS: This retrospective and single institution study included patients treated for a stage III melanoma with complete lymph-node dissection and adjuvant immunotherapy from January 2019 to December 2022. The radiotherapy associated with immunotherapy group was defined by completion of immunotherapy and adjuvant radiotherapy in the lymph-node dissection area. The primary endpoint was disease-free survival. The secondary endpoints were locoregional progression, incidence of adverse events grade 3 or above and disease-free survival rate in patients with high risk of locoregional recurrence.
RESULTS: Thirty-three patients were included. Among them, twelve received adjuvant lymph-node field radiotherapy. The median duration of follow-up was 17months (range: 8-45months). Patients receiving radiotherapy and immunotherapy had a significantly higher disease stage and more frequent extracapsular extension. At 12months, the disease-free survival rate was 66.7% for the patients receiving immunotherapy alone (95% CI: 42.5-82.5%) and 83.3% for those receiving radiotherapy and immunotherapy (95% CI: 48.2-95.6%; P=0.131). The locoregional progression rate was 24% in patients receiving immunotherapy and 8% in patients receiving immunotherapy and radiotherapy (P=0.379). After adjuvant treatment, 6% of patients developed grade 3 or above immunotherapy-related events and none developed grade 3 or above radiation-related adverse events.
CONCLUSIONS: In patients with stage III melanoma, adjuvant lymph-node field radiotherapy combined with immunotherapy seems to be associated with longer disease-free survival, with acceptable tolerance. However, these results need to be confirmed by long-term and prospective studies.