Manola J, Atkins M, Ibrahim J, Kirkwood J
Dana-Farber Cancer Institute, Boston, MA 02115, USA.
J Clin Oncol. 2000 Nov 15;18(22):3782-93. doi: 10.1200/JCO.2000.18.22.3782.
To identify factors that are prognostic for survival in patients with metastatic melanoma treated in eight Eastern Cooperative Oncology Group (ECOG) trials conducted over the past 25 years.
We identified common, significant patient characteristics collected at baseline on 1,362 eligible patients for inclusion in a pooled analysis. Proportional hazards models were used to examine simultaneously the effects of multiple covariates on survival.
Median survival was 6.4 months (95% confidence interval, 6.1 to 6.9 months.) Factors conferring the greatest increased risk of death included number of metastatic sites (relative risk [RR] = 1.12), ECOG performance status of 1 or more (RR = 1.49), or metastatic disease in the gastrointestinal (GI) tract (RR = 1.49), liver (RR = 1.44), pleura (RR = 1.35), or lung (RR = 1.19). Prior immunotherapy (RR = 0.84) and female sex (RR = 0. 87) were associated with prolonged survival. Although only 12% of patients responded to protocol treatment, landmark analysis showed this to be a significant prognostic factor (RR = 0.57). A model based on three recent studies in which baseline values for alkaline phosphatase, lactate dehydrogenase (LDH), and platelets were available identified an increased number of sites of metastasis (RR = 1.30), abnormal LDH (RR = 1.89), abnormal alkaline phosphatase (RR = 1.76), abnormal platelets (RR = 1.63), and GI metastases (RR = 1. 66) as prognostic for poorer survival. Response to treatment, when examined by landmark analysis of studies with laboratory parameters, was associated with decreased risk of death (RR = 0.47).
This study demonstrates the importance and utility of laboratory parameters as prognostic factors for survival and confirmed the deleterious effects of multiple metastatic sites. Prior immunotherapy and female sex were associated with improved prognosis. Prognostic factors identified in this analysis are consistent with the findings of prior published studies and argue for the adoption of laboratory findings in the staging systems that are used for entry and stratification of clinical trials in the future.
确定在过去25年东部肿瘤协作组（ECOG）开展的8项试验中接受治疗的转移性黑色素瘤患者的生存预后因素。
我们确定了在基线时收集的1362例符合纳入汇总分析条件的患者的常见、显著的患者特征。使用比例风险模型同时检验多个协变量对生存的影响。
中位生存期为6.4个月（95%置信区间，6.1至6.9个月）。导致死亡风险增加最大的因素包括转移部位数量（相对风险[RR]=1.12）、ECOG体能状态为1或更高（RR=1.49）、胃肠道（GI）转移（RR=1.49）、肝脏转移（RR=1.44）、胸膜转移（RR=1.35）或肺转移（RR=1.19）。既往免疫治疗（RR=0.84）和女性（RR=0.87）与生存期延长相关。虽然只有12%的患者对方案治疗有反应，但标志性分析显示这是一个显著的预后因素（RR=0.57）。基于最近三项可获得碱性磷酸酶、乳酸脱氢酶（LDH）和血小板基线值的研究建立的模型确定，转移部位数量增加（RR=1.30）、LDH异常（RR=1.89）、碱性磷酸酶异常（RR=1.76）、血小板异常（RR=1.63）和胃肠道转移（RR=1.66）提示生存预后较差。通过对有实验室参数的研究进行标志性分析来检验治疗反应时，其与死亡风险降低相关（RR=0.47）。
本研究证明了实验室参数作为生存预后因素的重要性和实用性，并证实了多个转移部位的有害影响。既往免疫治疗和女性与预后改善相关。本分析中确定的预后因素与既往发表的研究结果一致，并支持在未来用于临床试验入组和分层的分期系统中采用实验室检查结果。
