晚期口腔颌面部恶性肿瘤超声热化疗的Ⅰ/Ⅱ期临床研究

A phase Ⅰ/Ⅱ study of ultrasound hyperthermia combined with chemotherapy in advanced oral and maxillofacial-head & neck carcinoma

目的观察超声热化疗对晚期口腔颌面部恶性肿瘤的疗效和毒副反应。方法 2005年2月至2008年2月57例局部晚期口腔颌面恶性肿瘤患者入组,其中热化疗组(n=27)在全身化疗同期给予局部超声热疗,治疗温度40～42℃,每次40min,隔日1次,共5次,28天为1周期,共2～3周期。化疗组(n=30)仅接受了2～3个周期相同方案的化疗。评价两组患者的有效率、远期生存率和毒副反应。结果超声热化疗组有效率为51.85%(14/27),且6例晚期患者再次获手术指征;化疗组有效率为23.33%(7/30)。中位随访时间为25.6个月,两组患者的中位生存时间分别为32.5个月和29.0个月,2年生存率分别为59.26%和56.67%,差异无统计学意义(P=0.531)。超声热疗的主要毒副反应是加热区皮肤的轻度烫伤(9/27)和Ⅰ度疼痛(10/27),但均按计划完成治疗疗程。结论超声热疗能显著提高化疗的有效率,二者具有协同抗肿瘤作用。超声热疗安全、可行,未见相关的严重毒副反应,联合化疗后急性毒性反应可以耐受。

Objective To investigate the therapeutic effect and main side-effect of ultrasound hyperthermia combined with chemotherapy in oral and maxillofacial-headneck carcinoma. MethodsFifty-seven patients were enrolled in this clinical trail from February 2005 to February 2008.The treatment group（n=27） received 2-3 cycles of thermo-chemotherapy;the therapeutic temperature were 40-42 ℃;the ultrasound hyperthermia were performed for 40 minutes every other day for 5 times;28 days was a cycle.The chemotherapy group（n=30） simply received 2-3 cycles chemotherapy.The response rate,survival rate and side-effect of the two groups were evaluated. ResultsThe total response rate of thermo-chemotherapy group was 51.85%（14/27）,which was higher than that of the chemotherapy group（23.33%）.There were significant differences between 2 groups.Six patients in treatmon group regamed operation indication.The mean follow-up time was 25.6 months,and the median survival time were 32.5 and 29.0 months;the 2 year survival rate were 59.26% and 56.67% respectively（P0.05）.The main local side-effects of hyperthermia were light skin burns（9/27） and Ⅰ degree ache（10/27）,but all the patients finished the treatment plan. ConclusionUltrasound hyperthermia improves the chemotherapeutic effect significantly which posses synergistic anti-tumor effect.Ultrasound hyperthermia is safety and feasible.There are no hyperthermia related serious side-effects.The acute toxic reaction of hyperthermia combined with chemotherapy is acceptable.