Division of Medical Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada.
University of Nevada School of Medicine, Reno.
Melanoma Res. 2024 Aug 1;34(4):326-334. doi: 10.1097/CMR.0000000000000962. Epub 2024 May 27.
Long follow-up time is needed for overall survival (OS) data to mature for early-stage melanoma. This retrospective study aimed to describe the relationships between OS and two intermediate endpoints - real-world recurrence-free survival (rwRFS) and real-world distant metastasis-free survival (rwDMFS) - for patients with stage IIB or IIC melanoma that was completely resected from 1 January 2008 to 31 December 2017, with follow-up to 31 December 2020. We used three different approaches to describe the relationships: estimates of correlation using Kendall τ rank correlation; comparisons of all-cause survival with/without recurrence or distant metastasis using adjusted Cox proportional hazard models; and landmark analyses of all-cause survival stratified by recurrence status at 1-5 years. During a 39-month median follow-up from surgical resection, 223/567 patients (39%) experienced recurrence, among whom 171/567 patients (30%) developed distant metastasis. Median OS from surgical resection was 117.6 months [95% confidence interval (CI), 104.7-not reached], median rwRFS was 49.8 months (95% CI, 39.6-61.0), and median rwDMFS was 70.9 months (95% CI, 58.4-89.1). We observed strong correlations between rwRFS and OS, and between rwDMFS and OS (Kendall τ of 0.73 and 0.82, respectively). Risk of death was significantly greater after recurrence (all-cause survival adjusted hazard ratio [HR], 7.48; 95% CI, 4.55-12.29) or distant metastasis (adjusted HR, 11.00; 95% CI, 6.92-17.49). Risk of death remained significantly elevated with recurrence or distant metastasis by landmark years 1, 3, and 5 after surgical resection. These findings support the use of recurrence/rwRFS and distant metastasis/rwDMFS as surrogate endpoints for OS after complete resection of stage IIB or IIC melanoma.
对于早期黑色素瘤，总生存（OS）数据需要长期随访才能成熟。本回顾性研究旨在描述 2008 年 1 月 1 日至 2017 年 12 月 31 日期间完全切除的 IIB 期或 IIC 期黑色素瘤患者的 OS 与两个中间终点（真实世界无复发生存率 [rwRFS]和真实世界无远处转移生存率 [rwDMFS]）之间的关系，并随访至 2020 年 12 月 31 日。我们使用三种不同的方法来描述关系：使用 Kendall τ秩相关估计相关性；使用调整后的 Cox 比例风险模型比较有无复发或远处转移的全因生存率；以及根据 1-5 年内复发状态分层的全因生存的里程碑分析。在手术切除后的 39 个月中位随访期间，567 例患者中有 223 例（39%）出现复发，其中 171 例（30%）发生远处转移。手术切除后的中位 OS 为 117.6 个月[95%置信区间（CI），104.7-未达到]，中位 rwRFS 为 49.8 个月（95%CI，39.6-61.0），中位 rwDMFS 为 70.9 个月（95%CI，58.4-89.1）。我们观察到 rwRFS 与 OS 之间以及 rwDMFS 与 OS 之间存在很强的相关性（Kendall τ 分别为 0.73 和 0.82）。复发后（全因生存调整后的危险比[HR]，7.48；95%CI，4.55-12.29）或远处转移（调整后的 HR，11.00；95%CI，6.92-17.49）死亡风险显著增加。手术后 1、3 和 5 年的里程碑，复发或远处转移后死亡风险仍然显著升高。这些发现支持在完全切除 IIB 期或 IIC 期黑色素瘤后，将复发/rwRFS 和远处转移/rwDMFS 作为 OS 的替代终点。
