Center for Dermatooncology, Department of Dermatology, and Central Malignant Melanoma Registry of the German Dermatological Society, Eberhard-Karls-University of Tuebingen, Tuebingen, Germany.
PLoS One. 2012;7(1):e29791. doi: 10.1371/journal.pone.0029791. Epub 2012 Jan 19.
This study investigated survival probabilities and prognostic factors in sentinel lymph node biopsy (SLNB) staged patients with cutaneous melanoma (CM) with the aim of defining subgroups of patients who are at higher risk for recurrences and who should be considered for adjuvant clinical trials.
Patients with primary CM who underwent SLNB in the Department of Dermatology, University of Tuebingen, Germany, between 1996 and 2009 were included into this study. Survival probabilities and prognostic factors were evaluated by Kaplan-Meier and multivariate Cox proportional hazard models.
1909 SLNB staged patients were evaluated. Median follow-up time was 44 months. Median tumor thickness was 1.8 mm, ulceration was present in 31.8% of cases. The 5-year Overall Survival (OS) was 90.3% in SLNB negative patients (IB 96.2%, IIA 87.0%, IIB 78.1%, IIC 72.6%). Patients with micrometastases (stage IIIA/B) had a 5-year OS rate of 70.9% which was clearly less favorable than for stages I-II. Multivariate analysis revealed tumor thickness, ulceration, body site, histopathologic subtype and SLNB status as independent significant prognostic factors.
Survival rates of patients with primary CM in stages I-II were shown to be much more favorable than previously reported from non sentinel node staged collectives. For future clinical trials, sample size calculations should be adapted using survival probabilities based on sentinel node staging.
本研究旨在确定复发风险较高的患者亚组,并考虑将其纳入辅助临床试验,对接受前哨淋巴结活检(SLNB)分期的皮肤黑素瘤(CM)患者的生存概率和预后因素进行了研究。
纳入德国图宾根大学皮肤科 1996 年至 2009 年间进行 SLNB 的原发性 CM 患者。通过 Kaplan-Meier 和多变量 Cox 比例风险模型评估生存概率和预后因素。
共评估了 1909 例 SLNB 分期患者。中位随访时间为 44 个月。中位肿瘤厚度为 1.8mm,溃疡占 31.8%。SLNB 阴性患者的 5 年总生存率(OS)为 90.3%(IB 为 96.2%,IIA 为 87.0%,IIB 为 78.1%,IIC 为 72.6%)。微转移(III A/B 期)患者的 5 年 OS 率为 70.9%,明显低于 I-II 期。多变量分析显示肿瘤厚度、溃疡、身体部位、组织病理学亚型和 SLNB 状态是独立的显著预后因素。
与非前哨淋巴结分期的集合体相比,I-II 期原发性 CM 患者的生存率明显更为有利。对于未来的临床试验,应根据前哨淋巴结分期的生存概率进行样本量计算。