Broun E R, Iseminger K A, Rose P G, Lentz S L, Malfetano J H, Lincoln S, Mannel R
Division of Bone Marrow Transplant/Hematology/Oncology, St. Louis University School of Medicine, Missouri 63110, USA.
Am J Clin Oncol. 1997 Feb;20(1):78-80. doi: 10.1097/00000421-199702000-00017.
A Phase II trial of edatrexate in patients with recurrent cervical carcinoma was conducted by the Gynecologic Oncology Group (GOG). Twenty patients were treated with edatrexate at a dose of 80 mg/m2 i.v. weekly for 5 consecutive weeks per cycle. Four patients received an inadequate trial and were inevaluable for response. Among the 16 patients evaluable for response, there were no objective responses: 50% had stable disease, 50% had progressive disease. All 20 patients were evaluable for toxicity, predominantly stomatitis and bone marrow suppression were substantial. Grades 3-4 bone marrow toxicity were observed in eight of 20 (40%) patients, and there were two deaths due to neutropenic sepsis. Fanconi's syndrome, possibly treatment related, was seen in two patients. Edatrexate administered in this dose and schedule has no demonstrated activity and has severe toxicity in patients with previously-treated advanced cervical cancer.
妇科肿瘤学组（GOG）开展了一项关于依达曲沙治疗复发性宫颈癌患者的II期试验。20例患者接受依达曲沙治疗，剂量为80mg/m²，静脉注射，每周1次，每个周期连续5周。4例患者接受的试验不充分，无法评估疗效。在可评估疗效的16例患者中，无客观缓解：50%疾病稳定，50%疾病进展。所有20例患者均可评估毒性，主要为口腔炎，骨髓抑制严重。20例患者中有8例（40%）出现3-4级骨髓毒性，2例因中性粒细胞减少性败血症死亡。2例患者出现可能与治疗相关的范科尼综合征。以该剂量和方案给药的依达曲沙在先前治疗的晚期宫颈癌患者中未显示出活性，且毒性严重。
