Verweij J
Department of Medical Oncology, Rotterdam Cancer Institute, Netherlands.
Anticancer Drugs. 1995 Jul;6 Suppl 4:19-24. doi: 10.1097/00001813-199507004-00004.
Results are summarized for two phase II studies of docetaxel as first-line therapy for advanced squamous cell carcinoma of the head and neck (SCCHN) and one study of docetaxel as second-line therapy for advanced soft tissue sarcomas. In all three studies, docetaxel was administered at a dose of 100 mg/m2 by intravenous infusion over 1 h every 3 weeks. A total of 62 patients were enrolled in the SCCHN trials, of whom 57 were evaluable for response. The combined overall response rate in the SCCHN patients was 35%. Median duration of overall response was 6.5 months in the EORTC-ECTG study. In the DFCI study, median durations of complete and partial remission were 6.75 months and 4.45 months, respectively. These results are at least comparable to those achieved with other single-agent therapies in this setting. In the soft tissue sarcoma study, 29 of the 31 patients enrolled were evaluable for response. Five patients (17%) achieved a partial response to docetaxel as second-line therapy and a further nine (31%) had stable disease. Median duration of response in these patients with soft tissue sarcomas was 5 months. Again, these results are similar to those seen with the three most active single agents in soft tissue sarcomas when used as second-line therapy. Docetaxel may therefore represent a useful drug in both advanced SCCHN and soft tissue sarcomas.
总结了多西他赛作为晚期头颈部鳞状细胞癌(SCCHN)一线治疗的两项II期研究以及多西他赛作为晚期软组织肉瘤二线治疗的一项研究的结果。在所有三项研究中,多西他赛均以100mg/m²的剂量,每3周静脉输注1小时给药。共有62例患者纳入SCCHN试验,其中57例可评估疗效。SCCHN患者的联合总缓解率为35%。在欧洲癌症研究与治疗组织-欧洲癌症治疗协作组(EORTC-ECTG)研究中,总缓解的中位持续时间为6.5个月。在丹娜法伯癌症研究院(DFCI)研究中,完全缓解和部分缓解的中位持续时间分别为6.75个月和4.45个月。这些结果至少与在这种情况下使用其他单药疗法所取得的结果相当。在软组织肉瘤研究中,纳入的31例患者中有29例可评估疗效。5例患者(17%)作为二线治疗对多西他赛取得部分缓解,另有9例(31%)病情稳定。这些软组织肉瘤患者的中位缓解持续时间为5个月。同样,这些结果与软组织肉瘤中三种最有效的单药作为二线治疗时所见的结果相似。因此,多西他赛可能是晚期SCCHN和软组织肉瘤的一种有用药物。