Curtin J P, Blessing J A, Webster K D, Rose P G, Mayer A R, Fowler W C, Malfetano J H, Alvarez R D
Department of Obstetrics and Gynecology, Cornell University Medical College, NY, USA.
J Clin Oncol. 2001 Mar 1;19(5):1275-8. doi: 10.1200/JCO.2001.19.5.1275.
A phase II trial of paclitaxel was initiated in advanced nonsquamous carcinoma of the cervix to determine its activity in patients who had failed standard chemotherapy.
Eligible patients had at least one measurable lesion. The starting dose of paclitaxel was 170 mg/m(2) (135 mg/m(2) for patients with prior pelvic radiation) given as a 24-hour continuous intravenous infusion with courses repeated every 3 weeks. Dose escalation to 200 mg/m(2) and de-escalation to 110 mg/m(2) were allowed based on adverse effects.
In this trial, 42 assessable patients were initially entered onto the study, and 13 responses were seen; four patients had a complete response, and nine patients had a partial response. The overall response rate was 31%. The primary and dose-limiting toxicity was neutropenia.
The response rate to paclitaxel exceeds the rates reported using other single agents in nonsquamous carcinoma of the cervix.
开展一项紫杉醇治疗晚期非鳞状宫颈癌的II期试验，以确定其在标准化疗失败患者中的活性。
符合条件的患者至少有一处可测量病灶。紫杉醇起始剂量为170mg/m²（既往接受盆腔放疗的患者为135mg/m²），通过24小时持续静脉输注给药，每3周重复一个疗程。根据不良反应情况，允许剂量增至200mg/m²或降至110mg/m²。
在本试验中，最初有42例可评估患者入组研究，观察到13例有反应；4例患者完全缓解，9例患者部分缓解。总缓解率为31%。主要的剂量限制性毒性为中性粒细胞减少。
在非鳞状宫颈癌中，紫杉醇的缓解率超过了使用其他单一药物所报告的缓解率。
