Danish Hasan H, Patel Kirtesh R, Switchenko Jeffrey M, Gillespie Theresa W, Jhaveri Jaymin, Chowdhary Mudit, Abugideiri Mustafa, Delman Keith A, Lawson David H, Khan Mohammad K
aDepartment of Radiation Oncology bBiostatistics and Bioinformatics Shared Resource cDepartment of Surgery, Division of Surgical Oncology dDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Melanoma Res. 2016 Dec;26(6):595-603. doi: 10.1097/CMR.0000000000000292.
Recently, TROG 02.01 results showed that in stage III melanoma patients with nodal metastasis, adjuvant radiation to lymph node basin after nodal dissection improves lymph node field relapse without an overall survival (OS) benefit. However, this trial was neither designed nor powered to detect an OS difference. In the present study, we analyzed patients in the National Cancer Database (NCDB) with stage III melanoma with pathologically involved nodes and compared survival outcomes of adjuvant radiation and no-radiation cohorts. Inclusion criteria were as follows: age at least 18 years; diagnosed 2003-2011; surgery to regional lymph nodes; pathologically involved lymph nodes; and American Joint Committee on Cancer stage (IIIA-C). We used propensity score matching analysis to compare the OS of patients with similar baseline demographic, clinical, and pathologic characteristics who received adjuvant radiation and no adjuvant radiation. Overall, 912 patients were analyzed with an average age at diagnosis of 54.4 years and a median follow-up time of 5.5 years. In this cohort, the 5-year OS was 69.0, 51.1, and 30.6% for stage IIIA, IIIB, and IIIC, respectively. On propensity score-adjusted multivariate analysis, we found that adjuvant radiation had no statistically significant impact on OS (hazard ratio: 1.09, 95% confidence interval: 0.75-1.58, P=0.640). Furthermore, age older than 60 years, number of nodes, increasing pathologic stage, and absence of immunotherapy correlated with worse OS. In this NCDB analysis, we found that the adjuvant radiotherapy for node-positive, stage III melanoma patients did not improve OS. This is consistent with TROG 02.01; however, there may be patient selection bias not accounted for by the NCDB.
最近,TROG 02.01研究结果显示,在伴有淋巴结转移的III期黑色素瘤患者中,淋巴结清扫术后对淋巴结区域进行辅助放疗可改善淋巴结区域复发情况,但对总生存期(OS)并无益处。然而,该试验在设计和效能上均无法检测出OS差异。在本研究中,我们分析了美国国立癌症数据库(NCDB)中伴有病理证实淋巴结受累的III期黑色素瘤患者,并比较了辅助放疗组和未放疗组的生存结局。纳入标准如下:年龄至少18岁;2003年至2011年确诊;接受区域淋巴结手术;病理证实淋巴结受累;以及美国癌症联合委员会(AJCC)分期(IIIA - C)。我们采用倾向评分匹配分析来比较接受辅助放疗和未接受辅助放疗且具有相似基线人口统计学、临床和病理特征患者的OS。总体而言,共分析了912例患者,诊断时的平均年龄为54.4岁,中位随访时间为5.5年。在该队列中,IIIA期、IIIB期和IIIC期患者的5年OS分别为69.0%、51.1%和30.6%。在倾向评分调整的多变量分析中,我们发现辅助放疗对OS无统计学显著影响(风险比:1.09,95%置信区间:0.75 - 1.58,P = 0.640)。此外,年龄大于60岁、淋巴结数量、病理分期增加以及未接受免疫治疗与较差的OS相关。在这项NCDB分析中,我们发现对于淋巴结阳性的III期黑色素瘤患者,辅助放疗并不能改善OS。这与TROG 02.01研究结果一致;然而,可能存在NCDB未考虑到的患者选择偏倚。