高强度聚焦超声联合替吉奥治疗晚期胰腺癌的临床观察

Clinical observation of high intensity focused ultrasound plus S-1 for advanced pancreatic carcinoma

目的探讨高强度聚焦超声（HIFU）联合替吉奥（S-1）治疗晚期胰腺癌的疗效。方法选取120例不能切除的晚期胰腺癌患者随机分为A组（n=61）和B组（n=59）,两组均接受口服S-1治疗。根据体表面积（BSA）制定方案：BSA〈1.25m2,80mg/d;1.25~1.5m2,100mg/d;〉1.5m2,120mg/d;d1~d14,3周为1周期。仅A组在S-1基础上联合HIFU。根据实体瘤疗效评价标准（RECIST）1.0版评价近期疗效并计算有效率（RR）和疾病控制率（DCR）,采用NCI CTCAE 3.0标准评价毒副反应,记录疼痛缓解率并随访患者生存情况。结果全组均可评价近期疗效。A组获CR 3例、PR 15例、SD 28例和PD15例,RR和DCR分别为29.5%和75.4%;B组获CR 1例、PR 5例、SD 15例和PD 38例,RR和DCR分别为10.2%和35.6%;A组的RR和DCR均高于B组（P〈0.05）。A组的中位生存期（OS）为11.2个月,6、12个月的生存率分别为80.0%和40.0%,均优于A组的7.9个月、70.0%和10.0%,差异有统计学意义（P〈0.05）。A组的疼痛缓解率为57.4%（35/61）,高于B组的20.3%（12/59）,差异有统计学意义（P〈0.05）。两组均无3~4级毒副反应,1~2级毒副反应为贫血、中性粒细胞减少、血小板减少、恶心、腹泻、手足综合征及神经毒性,组间差异均无统计学意义（P〉0.05）。结论 HIFU联合S-1方案治疗晚期胰腺癌的疗效较好,毒副反应较轻且患者可耐受,是治疗晚期胰腺癌的一种有效手段。

Objective To evaluate the efficacy of high intensity focused ultrasound （HIFU） in combination with S-1 in treat- ment of advanced pancreatic carcinoma. Methods A total of 120 patients with unresectable advanced pancreatic carcinoma were ran- domly assigned into group A （n = 61 ） and group B （n = 59）. All patients received oral S-1, Oral S-1 was administered at 80mg/day for body surface area（BSA） less than 1.25m2, 100mg/day for BSA 1.25-1.5m2, and 120mg/day for BSA more than 1.5m2 on days 1-14 every 3 weeks. Only group A received HIFU in combination with S-1. The response evaluation criteria for solid tumor（RECIST） 1.0 were adopted to evaluate recent curative effect and calculate the response rate（RR） and disease control rate（DCR）. The toxicity was assessed using NCI CTC 3.0. The pain relief rate was analyzed and patients were followed up. Results All patients were included in the objective response evaluation. The treatment achieved CR in 3 cases, PR in 15 cases, SD in 28 cases and PD in 15 cases of group A and CR in 1 case, PR in 5 cases, SD in 15 cases and PD in 38 cases of group B. The RR and DCR in group A were 29. 5% and 75.4%, higher than 10. 2% and 35.6% in group B with significant difference（P〈0. 05）. The median overall survival time was 11.2 months and 6-, 12-months survival rates were 80. 0% and 40. 0% in group A, were superior to 7. 9 months, 70.0% and 10. 0% in group B with significant difference（P〈0. 05）. The pain relief rate in group A was 57.4% （35/61）, higher than 20. 3% （12/59） in group B with significant difference（P〈0. 05）. No significant difference was observed on grade 3-4 toxicities between both groups. No significant difference was observed on grade 1-2 toxicities, including anemia, neutropenia, thrombocytopenia, nausea, diarrhea, hand- foot syndrome and neurotoxicity（P〉0. 05）. Conclusion The HIFU in combination with S-1 shows a favorable benefit and can be well tolerated in patients with advanced pancreatic earcionoma.