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背景肾上腺皮质癌是一种罕见的恶性肿瘤,对细胞毒素治疗应答率低。方法在米托坦治疗基础上,将304例晚期肾上腺皮质癌患者随机分为两组:观察组(n=152)采用依托泊苷(100 mg/m2,第2～4天)、阿霉素(40 mg/m2,第1天)和顺铂(40 mg/m2,第3～4天)联合治疗,4周为1个治疗周期;对照组(n=152)采用链唑霉素(1 g,第1个治疗周期第1～5天;2 g,随后每个治疗周期第1天),3周为1个治疗周期。进展期患者接受替代疗法作为二线治疗。以患者总生存期为主要终点。结果治疗后,观察组治疗应答率明显高于对照组(23.2%vs.9.2%,P<0.001),中位无病情进展时间长于对照组〔5.0个月vs.2.1个月,HR=0.55,95%CI(0.43,0.69),P<0.001〕,但两组总生存期比较,差异无统计学意义〔14.8个月vs.12.0个月,HR=0.79,95%CI(0.61,1.02),P=0.07〕。接受替代疗法的185例患者中,观察组中位无病情进展时间为5.6个月,对照组为2.2个月;未接受替代疗法的117例患者中,观察组总生存期为17.1个月,长于对照组的4.7个月。两组严重毒副作用发生率间无显著差异。结论在米托坦治疗基础上,采用依托泊苷、阿霉素和顺铂联合化疗作为一线治疗,晚期肾上腺皮质癌患者具有较高的治疗反应应答率和较长的无病情进展时间,严重毒副作用发生率及总生存期与采用链唑霉素一线治疗无显著差异。
Background Adrenal cortical cancer is a rare malignancy with a low response rate to cytotoxic therapy. Methods A total of 304 patients with advanced adrenocortical carcinoma were randomly divided into two groups according to the treatment of mitotane. The observation group (n = 152) was treated with etoposide (100 mg / m2, days 2 to 4) (40 mg / m2 on day 1) and cisplatin (40 mg / m2 on days 3 to 4) for 4 weeks for one treatment cycle and control group (n = 152) for streptozotocin g, 1st to 5th days of the treatment cycle; 2 g, then 1st day of each treatment cycle) and 3 weeks to 1 cycle of treatment. Advanced patients receive alternative therapy as second-line treatment. The overall survival of patients as the main endpoint. Results After treatment, the response rate of the observation group was significantly higher than that of the control group (23.2% vs.9.2%, P <0.001). The median progression-free duration was longer than that of the control group [5.0 months vs.2.1 months, HR = 0.55, 95% CI (0.43,0.69), P <0.001). However, there was no significant difference in the overall survival between the two groups (14.8 months vs12.0 months, HR = 0.79,95% CI P = 0.07]. Among the 185 patients who received replacement therapy, the median progression-free progression time was 5.6 months in the observation group and 2.2 months in the control group. Of 117 patients who did not receive replacement therapy, the overall survival of the observation group was 17.1 months, Control group of 4.7 months. There was no significant difference between the two groups in the incidence of serious side effects. Conclusions Based on mitotane therapy, etoposide, doxorubicin and cisplatin combined with chemotherapy as first-line therapy, patients with advanced adrenal cortical cancer have a higher rate of response to treatment response and longer disease-free progression time, severe toxicity There was no significant difference in the incidence of side effects and overall survival with first-line treatment with streptozotocin.