Department of Stomatology, Xuzhou Central Hospital, Affiliated Xuzhou Hospital, College of Medicine, Southeast University, Xuzhou, 221000, China,
Cell Biochem Biophys. 2014 Jan;68(1):181-4. doi: 10.1007/s12013-013-9686-5.
The present study aimed to evaluate efficacy and adverse effects of Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen in the treatment of advanced oral carcinoma. Nine patients with advanced oral carcinoma were treated with Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen (test group). The treatment was given as follows: Nimotuzumab 200 mg, given as intravenous infusion once a week for 6 weeks; docetaxel and cisplatin, 75 mg/m(2) each, on day 1 only; 5-fluorouracil, 750 mg/m(2) infused continually for 8 h, used from day 1 to 5; the total cycle was for 21 days. Another eight patients comprised control group (docetaxel-cisplatin-fluorouracil regimen alone). Study patients from both groups were evaluated for objective response. The response rate was significantly (p = 0.044) higher in test group (88.9 vs. 37.5 % in control group). The disease control rate also tended to be higher in test group (100 vs. 62.5 % in control group; p = 0.083). The major adverse effects were bone marrow suppression, nausea, vomiting, and alopecia. The incidence of adverse effects was similar between both study groups. In conclusion, Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen is effective and safe in the treatment of advanced oral carcinoma.
本研究旨在评估尼莫单抗联合多西他赛-顺铂-氟尿嘧啶方案治疗晚期口腔癌的疗效和不良反应。9 例晚期口腔癌患者采用尼莫单抗联合多西他赛-顺铂-氟尿嘧啶方案（试验组）治疗。治疗方法如下：尼莫单抗 200mg，每周静脉滴注 1 次，共 6 周；多西他赛和顺铂各 75mg/m2，仅第 1 天使用；氟尿嘧啶 750mg/m2，连续输注 8 小时，第 1 天至第 5 天使用；总周期为 21 天。另 8 例患者为对照组（单独使用多西他赛-顺铂-氟尿嘧啶方案）。两组研究患者均评估客观缓解。试验组的缓解率显著更高（p=0.044，88.9%比对照组的 37.5%）。试验组的疾病控制率也有更高的趋势（100%比对照组的 62.5%；p=0.083）。主要不良反应为骨髓抑制、恶心、呕吐和脱发。两组研究的不良反应发生率相似。结论：尼莫单抗联合多西他赛-顺铂-氟尿嘧啶方案治疗晚期口腔癌有效且安全。
