Eggermont A M, Keilholz U, Testori A, Cook M, Lienard D, Ruiter D J
EORTC-Melanoma Group, Brussels, Belgium.
Ann Surg Oncol. 2001 Oct;8(9 Suppl):38S-40S.
Last year the Melanoma Group of the European Organization for Research and Treatment of Cancer (EORTC-MG) completed accrual (1418 patients) for trial EORTC 18952, a three-arm phase III trial evaluating adjuvant therapy with two different intermediate doses of interferon (IFN) alfa-2b versus observation for stage IIB-III melanoma. About 25% of the patients entered the trial with tumor-positive sentinel nodes (SNs). Prognosis was significantly better in SN-positive patients than in patients with palpable regional node involvement (P < .00001). Subsequently the EORTC-MG embarked on two large phase III trials of adjuvant therapy based on the tumor status of the SN. In trial EORTC 18961 for stage II melanoma, GM2-KLH/QS-21 vaccination is compared with observation (1300 patients); in trial EORTC 18991 for stage III melanoma, 5-year treatment with pegylated interferon alfa-2b (PEG-Intron) is compared with observation (900 patients). Translational research projects will compare SN assessment by hematoxylin and eosin (H&E) staining, immunohistochemistry (IHC), and reverse transcriptase-polymerase chain reaction (RT-PCR) to determine the relative accuracy of each method and its correlation to relapse and survival of patients with stage II melanoma. In stage III patients, a similar workup of the most proximal nonsentinel node in the full lymph-node dissection specimen will indicate the accuracy of each methodology to detect nodal metastasis beyond the SN and the prognostic significance thereof. These findings will be correlated to the results of sequential blood testing by RT-PCR and by tumor marker assays for S100, TA90, and angiostatin. In addition, tumor-positive and tumor-negative SNs will be assessed for activated cytotoxic T lymphocytes and downregulation of dendritic cell functions.
去年，欧洲癌症研究与治疗组织黑色素瘤小组（EORTC-MG）完成了EORTC 18952试验的病例招募（1418例患者），这是一项三臂III期试验，旨在评估两种不同中等剂量的干扰素（IFN）α-2b辅助治疗与IIB-III期黑色素瘤观察治疗的效果。约25%的患者入组时前哨淋巴结（SN）为肿瘤阳性。SN阳性患者的预后明显好于可触及区域淋巴结受累的患者（P <.00001）。随后，EORTC-MG基于SN的肿瘤状态开展了两项大型III期辅助治疗试验。在针对II期黑色素瘤的EORTC 18961试验中，将GM2-KLH/QS-21疫苗接种与观察治疗进行比较（1300例患者）；在针对III期黑色素瘤的EORTC 18991试验中，将聚乙二醇化干扰素α-2b（PEG-Intron）5年治疗与观察治疗进行比较（900例患者）。转化研究项目将比较苏木精和伊红（H&E）染色、免疫组织化学（IHC）和逆转录聚合酶链反应（RT-PCR）对SN的评估，以确定每种方法的相对准确性及其与II期黑色素瘤患者复发和生存的相关性。在III期患者中，对全淋巴结清扫标本中最靠近的非前哨淋巴结进行类似的检查，将表明每种方法检测SN以外淋巴结转移的准确性及其预后意义。这些发现将与RT-PCR和S100、TA90及血管抑素肿瘤标志物检测的系列血液检测结果相关联。此外，将对肿瘤阳性和肿瘤阴性SN评估活化的细胞毒性T淋巴细胞及树突状细胞功能的下调情况。
