Background

Completion lymph node dissection (CLND) has long been the standard treatment for stage III melanomas identified as metastasis on the sentinel node (SN-positive). Two major changes occurred in 2017 and 2018, the change in the CLND criteria for SN-positive patients and the approval of several adjuvant therapies could revolutionize such management approach. However, their effects have not been fully investigated on the real-world outcomes of stage III melanoma patients. Therefore, we investigated the impact of these changes on the prognosis of Japanese stage III melanoma patients.

Methods

Totally, 119 stage III, SN-positive melanoma patients were included. They were categorized into those diagnosed as SN-positive between January 2015 and June 2017 (pre-June 2017 group) and between July 2017 and December 2019 (post-July 2017 group). Recurrence-free survival (RFS), overall survival, and prognostic factors were analyzed.

Results

The frequency of patients who received CLND was significantly higher in the pre-June 2017 group (p = 0.001), and those who received adjuvant therapy were significantly higher in the post-July 2017 group (p < 0.001). The 2-year RFS was 50.1% and 68.5% in the pre-June and post-July 2017 groups, respectively (p = 0.049). Cox proportional hazards model analysis for RFS showed that adjuvant therapies reduce the risk of recurrence (hazard ratio 0.37; 95% confidence interval 0.14–0.99; p = 0.047).

Conclusion

Changes in the CLND criteria in SN-positive patients and the approval of adjuvant therapies for stage III melanomas have significantly impacted Japanese melanoma medicine. Adjuvant therapy tended to prolong patient’s RFS while omitting immediate CLND had no significant negative influence on it.

中文翻译：

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完成淋巴结清扫标准的变化和辅助治疗的批准对日本 III 期黑色素瘤患者真实世界结果的影响

背景

完成性淋巴结清扫术 (CLND) 长期以来一直是被确定为前哨淋巴结转移（SN 阳性）的 III 期黑色素瘤的标准治疗方法。2017 年和 2018 年发生了两个重大变化，SN 阳性患者 CLND 标准的变化和几种辅助疗法的批准可能会彻底改变这种管理方法。然而，尚未对它们对 III 期黑色素瘤患者的真实世界结果的影响进行充分研究。因此，我们调查了这些变化对日本 III 期黑色素瘤患者预后的影响。

方法

总共包括 119 名 III 期、SN 阳性黑色素瘤患者。他们被分为2015年1月至2017年6月（2017年6月前组）和2017年7月至2019年12月（2017年7月后组）诊断为SN阳性的患者。分析了无复发生存期（RFS）、总生存期和预后因素。

结果

2017 年 6 月前组接受 CLND 的患者频率显着更高（p  = 0.001），2017 年 7 月后组接受辅助治疗的患者频率显着更高（p  < 0.001）。2017 年 6 月前和 7 月后组的 2 年 RFS 分别为 50.1% 和 68.5%（p  = 0.049）。RFS 的 Cox 比例风险模型分析表明，辅助治疗可降低复发风险（风险比 0.37；95% 置信区间 0.14–0.99；p  = 0.047）。

结论

SN 阳性患者 CLND 标准的变化以及 III 期黑色素瘤辅助治疗的批准对日本黑色素瘤医学产生了重大影响。辅助治疗倾向于延长患者的 RFS，而省略立即 CLND 对其没有显着的负面影响。