Phase II study of N-methylformamide (N-MF) (NSC 3051) in patients with advanced epithelial ovarian cancer. A Gynecologic Oncology Group study.
Phase II study of N-methylformamide (N-MF) (NSC 3051) in patients with advanced epithelial ovarian cancer. A Gynecologic Oncology Group study.
复制标题
N-甲基甲酰胺 (N-MF) (NSC 3051) 在晚期上皮性卵巢癌患者中的 II 期研究。
DOI：
10.1007/bf00177257
复制
发表时间：
1990
影响因子：
3.4
通讯作者：
Munoz,A
中科院分区：
文献类型：
--
作者：
McGuire3rd,WP;Blessing,JA;Berek,JS;Munoz,A
44例晚期可测量的卵巢上皮癌患者接受了97个疗程的n -甲基甲酰胺（N-MF）治疗，剂量范围为600-800 mg/m2，静脉注射，每天5天，每28天。41名患者之前接受过手术，并接受过一次化疗方案。只有7名患者之前接受过放射治疗。所有患者均为妇科肿瘤组（GOG）表现状态0、1或2。观察到三个部分反应。正如早期临床试验预测的那样，血液学不良反应极为罕见。一个主要的毒性是由肌痛、关节痛、胸膜痛、腹痛、周围神经病变、厌食、嗜睡和工作状态下降（疼痛嗜睡综合征）组成的综合征，这些综合征在停药后是可逆的。这种不良反应与停止N-MF的肝毒性一样常见。根据先前对该药的研究报告，肝毒性也很常见，通常是可逆的，也是停药的原因。在这群既往治疗过的卵巢癌患者中，低水平的临床活性和令人不快的不良反应使得该药物不太可能在上皮性卵巢癌的治疗中发挥任何重要作用。
Forty-four patients with advanced, measurable, epithelial carcinoma of the ovary were treated with 97 courses of N-methylformamide (N-MF) at doses ranging from 600–800 mg/m2, intravenously, daily for 5 days every 28 days. Forty-one patients had prior surgery and had received one prior chemotherapy regimen. Only seven patients had received any prior radiation therapy. All patients were Gynecologic Oncology Group (GOG) performance status 0, 1, or 2. Three partial responses were seen. Hematologic adverse effects were extremely rare as predicted by early clinical trials. One major toxicity was a syndrome consisting of some combination of myalgias, arthralgias, pleuritic pain, abdominal pain, peripheral neuropathy, anorexia, lethargy, and declining performance status (painlethargy syndrome) that was reversible with discontinuation of the drug. This adverse effect was as common a reason as hepatic toxicity for discontinuation of N-MF. As reported in previous studies with this drug, hepatic toxicity was also common, usually reversible, and also a cause for discontinuation of the drug. The low level of clinical activity and the unpleasant adverse effects in this population of patients with previously treated ovarian cancer makes it unlikely that this drug will play any significant role in treatment of epithelial ovarian cancer.