0000 0004 1936 8753grid.137628.9Department of MedicineNYU Langone Health New York NY USA
0000 0004 1936 8753grid.137628.9Interdisciplinary Melanoma Cooperative GroupNYU Langone Health New York NY USA.
J Immunother Cancer. 2018 May 18;6(1):38. doi: 10.1186/s40425-018-0345-7.
Cancer-testis antigen NY-ESO-1 is a highly immunogenic melanoma antigen which has been incorporated into adjuvant vaccine clinical trials. Three such early-phase trials were conducted at our center among patients with high-risk resected melanoma. We herein report on the pooled long-term survival outcomes of these patients in comparison to historical controls.
All melanoma patients treated at NYU Langone Health under any of three prospective adjuvant NY-ESO-1 vaccine trials were retrospectively pooled into a single cohort. All such patients with stage III melanoma were subsequently compared to historical control patients identified via a prospective institutional database with protocol-driven follow-up. Survival times were calculated using the Kaplan-Meier method, and Cox proportional hazard models were employed to identify significant prognostic factors and control for confounding variables.
A total of 91 patients were treated with an NY-ESO-1 vaccine for the treatment of high-risk resected melanoma. Of this group, 67 patients were stage III and were selected for comparative analysis with 123 historical control patients with resected stage III melanoma who received no adjuvant therapy. Among the pooled vaccine cohort (median follow-up 61 months), the estimated median recurrence-free survival was 45 months, while the median overall survival was not yet reached. In the control cohort of 123 patients (median follow-up 30 months), the estimated median recurrence-free and overall survival were 22 and 58 months, respectively. Within the retrospective stage III cohort, NY-ESO-1 vaccine was associated with decreased risk of recurrence (HR = 0.56, p < 0.01) and death (HR = 0.51, p = 0.01). Upon controlling for sub-stage, the adjuvant NY-ESO-1 clinical trial cohort continued to exhibit decreased risk of recurrence (HR = 0.45, p < 0.01) and death (HR = 0.40, p < 0.01).
In this small retrospective cohort of resected stage III melanoma patients, adjuvant NY-ESO-1 vaccine immunotherapy was associated with longer recurrence-free and overall survival relative to historical controls. These data support the continued investigation of adjuvant NY-ESO-1 based immunotherapy regimens in melanoma.
癌症睾丸抗原 NY-ESO-1 是一种高度免疫原性的黑色素瘤抗原，已被纳入佐剂疫苗临床试验。我们中心进行了三项此类早期临床试验，对象为高危可切除黑色素瘤患者。在此，我们报告了这些患者与历史对照相比的长期生存结果汇总。
在 NYU Langone Health 接受任何三种前瞻性 NY-ESO-1 疫苗试验治疗的所有黑色素瘤患者均被回顾性地归入单一队列。所有 III 期黑色素瘤患者随后与通过前瞻性机构数据库确定的历史对照患者进行比较，该数据库采用协议驱动的随访。使用 Kaplan-Meier 方法计算生存时间，并采用 Cox 比例风险模型识别显著的预后因素并控制混杂变量。
共有 91 例患者接受 NY-ESO-1 疫苗治疗高危可切除黑色素瘤。其中 67 例为 III 期，选择与 123 例接受无辅助治疗的 III 期黑色素瘤切除术的历史对照患者进行比较。在汇总的疫苗队列中（中位随访 61 个月），估计的中位无复发生存期为 45 个月，而总生存期尚未达到。在 123 例历史对照患者中（中位随访 30 个月），估计的中位无复发生存期和总生存期分别为 22 个月和 58 个月。在回顾性 III 期队列中，NY-ESO-1 疫苗与降低的复发风险相关（HR=0.56，p<0.01）和死亡风险（HR=0.51，p=0.01）。在控制亚分期后，辅助 NY-ESO-1 临床试验队列继续表现出降低的复发风险（HR=0.45，p<0.01）和死亡风险（HR=0.40，p<0.01）。
在这项 III 期黑色素瘤患者的小回顾性队列中，与历史对照相比，辅助 NY-ESO-1 疫苗免疫治疗与更长的无复发生存期和总生存期相关。这些数据支持在黑色素瘤中继续研究基于 NY-ESO-1 的辅助免疫治疗方案。
