Pearl Michael L, Johnston Carolyn M, McMeekin D Scott
Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Reproductive Medicine, State University of New York at Stony Brook, Stony Brook, NY, USA.
Gynecol Obstet Invest. 2007;64(4):193-8. doi: 10.1159/000106489. Epub 2007 Jul 30.
BACKGROUND/AIMS: A phase II study was conducted to assess the activity and toxicity of weekly docetaxel in patients with advanced or recurrent cancer of the cervix.
Eligible patients were required to have measurable disease with adequate performance status, bone marrow, renal and hepatic function. Patients were allowed to receive chemosensitization and not more than one prior chemotherapy regimen excluding taxanes. Docetaxel 35 mg/m2 was administered intravenously weekly for 3 weeks followed by 1 week off until disease progression or adverse effects prohibited further therapy.
Ten patients were entered into this study, all of who were evaluable for toxicity and response. A median of 2 cycles (range 2-6) were administered. The most frequent drug-related toxicities were anemia and fatigue. There were no objective responses. Three patients had stable disease up to 6 cycles. One patient died of exsanguination from a known vaginal metastasis after completing her second cycle. The median progression-free interval was 1.7 months (range 0.9-5.8) and overall survival was 6.9 months (1.6-23.7).
Docetaxel has limited activity in patients with recurrent cancer of the cervix at the dose and schedule tested.
背景/目的：开展一项II期研究，以评估每周使用多西他赛治疗晚期或复发性宫颈癌患者的活性和毒性。
符合条件的患者需有可测量病灶，且体能状态、骨髓、肾和肝功能良好。允许患者接受化疗增敏治疗，且既往接受过不超过一种不含紫杉烷类的化疗方案。多西他赛35mg/m²静脉注射，每周1次，共3周，随后休息1周，直至疾病进展或出现不良反应而停止进一步治疗。
10例患者进入本研究，所有患者均可评估毒性和疗效。中位给药周期数为2个周期（范围2 - 6个周期）。最常见的药物相关毒性为贫血和疲劳。未观察到客观缓解。3例患者疾病稳定达6个周期。1例患者在完成第2个周期治疗后，死于已知阴道转移灶出血。中位无进展生存期为1.7个月（范围0.9 - 5.8个月），总生存期为6.9个月（1.6 - 23.7个月）。
在所测试的剂量和给药方案下，多西他赛治疗复发性宫颈癌患者的活性有限。
