Department of Surgical Oncology, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, the Netherlands.
Department of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.
Eur J Cancer. 2020 Jul;134:9-18. doi: 10.1016/j.ejca.2020.04.022. Epub 2020 May 23.
Based on recent advances in the management of patients with sentinel node (SN)-positive melanoma, we aimed to develop prediction models for recurrence, distant metastasis (DM) and overall mortality (OM).
The derivation cohort consisted of 1080 patients with SN-positive melanoma from nine European Organization for Research and Treatment of Cancer (EORTC) centres. Prognostic factors for recurrence, DM and OM were studied with Cox regression analysis. Significant factors were incorporated in the models. Performance was assessed by discrimination (c-index) and calibration in cross-validation across centres. The models were externally validated using a prospective cohort consisting of 705 German patients with SN-positive: 473 trial participants of the German Dermatologic Cooperative Oncology Group study (DeCOG-SLT) and 232 screened patients. A nomogram was developed for graphical presentation.
The final model for recurrence and the calibrated models for DM and OM included ulceration, age, SN tumour burden and Breslow thickness. The models showed reasonable calibration. The c-index for the recurrence, DM and OM model was 0.68, 0.70 and 0.70, respectively, and 0.70, 0.72 and 0.74, respectively, in external validation. The EORTC-DeCOG model identified a robust low-risk group, with all identified low-risk patients (approximately 4% of the entire population) having a 5-year recurrence probability of <25% and an overall 5-year recurrence rate of 13%. A model including information on completion lymph node dissection (CLND) showed only marginal improvement in model performance.
The EORTC-DeCOG nomogram provides an adequate prognostic tool for patients with SN-positive melanoma, without the need for CLND. It showed consistent results across validation. The nomogram could be used for patient counselling and might aid in adjuvant therapy decision-making.
基于最近在处理前哨淋巴结(SN)阳性黑色素瘤患者方面的管理进展,我们旨在建立复发、远处转移(DM)和总死亡率(OM)的预测模型。
推导队列由来自欧洲癌症研究与治疗组织(EORTC)的 9 个中心的 1080 名 SN 阳性黑色素瘤患者组成。使用 Cox 回归分析研究了复发、DM 和 OM 的预后因素。将显著因素纳入模型中。通过跨中心交叉验证评估了性能的区分度(c 指数)和校准度。使用由 705 名 SN 阳性德国患者组成的前瞻性队列对模型进行了外部验证:473 名德国皮肤病合作肿瘤学组研究(DeCOG-SLT)的试验参与者和 232 名筛查患者。开发了一个列线图用于图形展示。
复发的最终模型和校准的 DM 和 OM 模型包括溃疡、年龄、SN 肿瘤负担和 Breslow 厚度。这些模型显示出合理的校准。复发、DM 和 OM 模型的 c 指数分别为 0.68、0.70 和 0.70,外部验证分别为 0.70、0.72 和 0.74。EORTC-DeCOG 模型确定了一个稳健的低风险组,所有确定的低风险患者(约占总人口的 4%)在 5 年内复发概率<25%,整体 5 年内复发率为 13%。包含完成淋巴结清扫(CLND)信息的模型仅显示出对模型性能的边际改善。
EORTC-DeCOG 列线图为 SN 阳性黑色素瘤患者提供了一种适当的预后工具,而无需进行 CLND。它在验证中表现出一致的结果。该列线图可用于患者咨询,并可能有助于辅助治疗决策。