Day C L, Mihm M C, Lew R A, Harris M N, Kopf A W, Fitzpatrick T B, Harrist T J, Golomb F M, Postel A, Hennessey P, Gumport S L, Raker J W, Malt R A, Cosimi A B, Wood W C, Roses D F, Gorstein F, Rigel D, Friedman R J, Mintzis M M, Sober A J
Ann Surg. 1982 Jan;195(1):35-43. doi: 10.1097/00000658-198201001-00006.
Fourteen variables were tested for their ability to predict visceral or bony metastases in 177 patients with clinical Stage I melanoma of intermediate thickness (1.51 - 3.39 mm). A Cox multivariate analysis yielded a combination of four variables that best predicted bony or visceral metastases for these patients: 1) mitoses greater than 6/min 2 (p = 0.0007), 2) location other than the forearm of leg) p = 0.009, 3) ulceration width greater than 3 mm (p = 0.04), 4) microscopic satellites (p = 0.05). The overall prognostic model chi square was 32.40 with 4 degrees of freedom (p less than 10 (-5). Combinations of the above variables were used to separate these patients into at least two risk groups. The high risk patients had at least a 35% or greater chance of developing visceral metastases within five years, while the low risk group had greater than an 85% chance of being disease free at five years. Criteria for the high risk group were as follows: 1) mitoses greater than 6/mm 2 in at least one area of the tumor, irrespective of primary tumor location, or 2) a melanoma located at some site other than the forearm or leg and histologic evidence in the primary tumor of either ulceration greater than 3 mm wide or microscopic satellites. The low risk group was defined as follows: 1) mitoses less than or equal to 6/mm 2 and a location on the leg or forearm, or 2) mitoses less than or equal to 6/mm 2 and the absence in histologic sections of the primary tumor of both microscopic satellites and ulceration greater then 3 mm wide. The number of patients in this series who did not undergo elective regional node dissection (N = 47) was probably too small to detect any benefit from this procedure. Based on survival rates from this and other studies, it is estimated that approximately 1500 patients with clinical Stage I melanoma of intermediate thickness in each arm of a randomized clinical trial would be needed to detect an increase in survival rates from elective regional node dissection.
对177例临床I期中等厚度（1.51 - 3.39毫米）黑色素瘤患者的14个变量进行了检测，以评估其预测内脏或骨转移的能力。Cox多变量分析得出了四个变量的组合，该组合能最好地预测这些患者的骨或内脏转移情况：1）有丝分裂数大于6/分钟²（p = 0.0007），2）位于腿部或前臂以外的部位（p = 0.009），3）溃疡宽度大于3毫米（p = 0.04），4）微小卫星灶（p = 0.05）。总体预后模型卡方值为32.40，自由度为4（p小于10^(-5)）。利用上述变量的组合将这些患者分为至少两个风险组。高风险患者在五年内发生内脏转移的几率至少为35%或更高，而低风险组在五年内无病生存的几率大于85%。高风险组的标准如下：1）肿瘤至少一个区域的有丝分裂数大于6/毫米²，无论原发肿瘤位置如何；或2）黑色素瘤位于腿部或前臂以外的某个部位，且原发肿瘤组织学证据显示溃疡宽度大于3毫米或有微小卫星灶。低风险组的定义如下：1）有丝分裂数小于或等于6/毫米²且位于腿部或前臂；或2）有丝分裂数小于或等于6/毫米²，且原发肿瘤组织切片中既无微小卫星灶也无溃疡宽度大于3毫米的情况。本系列中未接受选择性区域淋巴结清扫术的患者数量（N = 47）可能太少，无法检测到该手术的任何益处。根据本研究及其他研究的生存率估计，在一项随机临床试验的每个臂中，大约需要1500例临床I期中等厚度黑色素瘤患者，才能检测到选择性区域淋巴结清扫术使生存率提高。
