摘要
目的 评价替莫唑胺（TMZ）联合同步三维适形放疗（3D-CRT）治疗恶性脑胶质瘤的效果及患者不良反应。方法 92例经病理证实的恶性脑胶质瘤患者（Ⅲ级50例、Ⅳ级42例）按随机抽签法分为观察组与对照组。对照组46例（Ⅲ级26例、Ⅳ级20例）给予术后常规放疗，采取单纯放疗，总剂量60～66 Gy。观察组46例（Ⅲ级24例、Ⅳ级22例），在放疗期间每日口服TMZ 75 mg／m2，放疗结束后4周，继续给予TMZ标准5 d方案辅助化疗6个周期，每1个周期28 d。第1个周期用量150 mg／m2，连用5 d，无明显血液学毒性后，从第2个周期起剂量增至200 mg／m2。结果 观察组与对照组相比有效（完全缓解＋部分缓解）率分别为71.7 %（33／46）和32.6 %（15／46）（P＜0.001）。观察组1、2、3年生存率分别为71.7 %、47.8 %、36.9 %，对照组分别为56.5 %、26.1 %、15.2 %，2、3年生存率差异有统计学意义（P＝0.031、0.018）；中位生存时间分别为22个月和12个月，差异有统计学意义（P＝0.015）。观察组不良反应轻微，仅限于Ⅰ、Ⅱ级。结论 TMZ联合同步放疗治疗恶性脑胶质瘤的效果优于局部单纯放疗，可明显提高患者的2、3年生存率，而且患者的不良反应轻微，临床耐受性良好。
Objective To evaluate the survival and adverse effects of adjuvant concurrent temozolomid （TMZ） combined with radiochemotherapy in postoperative patients with high grade intracranial glioma. Methods 84 postoperative patients with high grade intracranial glioma were randomly divided into the observation group （42 cases including 25 gradeⅢcases and 17 grade Ⅳ cases） and the control group （42 cases including 23 gradeⅢcases and 19 grade Ⅳ cases）. All patients were treated with concurrent radiochemotherapy after surgical operations, the total radiation dose was 60-66 Gy. The patients in observation group were given daily oral TMZ 75 mg/m2 during radiotherapy. 4 weeks after radiotherapy, all of the patients received 6 cycles of TMZ, each cycle lasted 5 days with 28 days interval between each cycles. 150 mg/m2 of TMZ was given for the first cycle for 5 days, followed by 200 mg/m2 of drug for the rest of the cycles if no significant drug related toxicities were observed. Results The overall response rates （CR＋PR） were 71.7 % （33/46） in the observation group, and 32.6 % （15/46） in the control group, and with significant difference between the two groups （P 〈 0.001）. The 1, 2 and 3 year survival rates of patients in the observation group were 71.7 %, 47.8 %, 36.9 %, and 56.5 %, 26.1 %, 15.2 % in the control group. The significant differences were found in 2-year and 3-year survival rates between the two groups （P = 0.031, 0.018）. The median recurrent period in the observation group were 22 and 12 months in the control group, and with singnificant difference （P = 0.015）. The main side effects were limited to grade Ⅰ or Ⅱ. Conclusions Concurrent TMZ combined with radiotherapy in the treatment of high grade gliomas has better clinical efficacy, and can improve the 2-year and 3-year survival rates. Patients tolerate the strategy well and no severe toxicities are observed.
出处
《肿瘤研究与临床》
CAS
2014年第2期102-105,共4页
Cancer Research and Clinic
基金
南京军区南京总医院面上项目（2012057）
