Haag Georg-Martin, Stocker Gertraud, Quidde Julia, Jaeger Dirk, Lordick Florian
Department of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Im Neuenheimer Feld 460, D-69120, Heidelberg, Germany.
University Cancer Center Leipzig (UCCL), University Hospital Leipzig, Liebigstrasse 20, D-04103, Leipzig, Germany.
BMC Cancer. 2017 Jul 31;17(1):509. doi: 10.1186/s12885-017-3497-9.
The optimal duration of firstline chemotherapy in metastatic esophagogastric cancer is unknown. In most clinical trials therapy was given until tumour progression or limiting toxicity. Maintenance concepts aiming to prolong the duration of response and maintain quality of life have been established in other tumour types but not in esophagogastric cancer. S-1 is an oral fluoropyrimidine with proven efficacy in metastatic esophagogastric cancer.
The Maintenance Teysuno® (S-1) in esophagogastric cancer (MATEO) trial is a multinational, randomized phase II study that explores the role of S-1 maintenance therapy in Her-2 negative, advanced esophagogastric adenocarcinoma. After a 12-week firstline platinum-fluoropyrimidine-based chemotherapy patients without tumour progression are randomized in a 2:1 allocation to receive S-1 alone or continue with the same regimen as during the primary period. The primary endpoint is overall survival. Secondary endpoints include safety and toxicity, progression-free survival and quality of life. Correlative biomarker analyses focus on the identification of a subgroup of patients with a prolonged benefit from S-1 based maintenance therapy.
MATEO will be the first trial to define the role of a S-1 based maintenance therapy in patients having received a platinum-based firstline chemotherapy.
NCT02128243 (date of registration: 29-04-2014).
转移性食管胃癌一线化疗的最佳疗程尚不清楚。在大多数临床试验中，治疗持续至肿瘤进展或出现限制毒性。旨在延长缓解期并维持生活质量的维持治疗理念已在其他肿瘤类型中确立，但在食管胃癌中尚未确立。S-1是一种口服氟嘧啶，在转移性食管胃癌中已证实具有疗效。
食管癌S-1维持治疗（MATEO）试验是一项多国随机II期研究，旨在探索S-1维持治疗在Her-2阴性晚期食管胃腺癌中的作用。在进行为期12周的基于铂类氟嘧啶的一线化疗后，无肿瘤进展的患者按2:1分配随机分组，分别单独接受S-1治疗或继续使用与初始治疗期相同的方案。主要终点是总生存期。次要终点包括安全性和毒性、无进展生存期和生活质量。相关生物标志物分析重点在于确定从基于S-1的维持治疗中获益时间延长的患者亚组。
MATEO将是首个确定基于S-1的维持治疗在接受过铂类一线化疗患者中作用的试验。
NCT02128243（注册日期：2014年4月29日）。
