高强度聚焦超声治疗不能手术胰腺癌的1年生存分析：中国和保加利亚的多中心临床研究

One-year survival of inoperable pancreatic cancer treated by high intensity focused ultrasound：a retrospective multiple-center clinical trial in China and Bulgaria

摘要:

目的：通过多中心临床研究分析高强度聚焦超声治疗不能手术胰腺癌的1年生存情况。方法：2013年1月到2014年1月，中国和保加利亚的不能手术的胰腺癌患者32例，男/女=20/12，年龄41～81（59.8±9.1）岁。胰腺癌病灶最大径20～60（39.3±9.6） mm，远处转移/无转移的患者18/14例。接受HIFU和/或化疗。记录术后并发症，疼痛变化和生存情况。使用Kaplan-Meier法计算总生存率和中位生存时间，比较化疗与否、是否发生远处转移的患者生存率有无差异（Log-Rank检验）。结果：术后1月，皮肤浅Ⅱ°烧伤者2例，经保守处理后1～2周愈合。伴有胰腺癌相关性疼痛症状的患者30例与术前比较，减轻的24例（80.0%），不变的5例（16.7%），加重的1例（3.3%）。所有患者的1年生存率为38.4%，中位生存时间为12个月。接受辅助化疗的患者1年生存率为57.4%，中位生存时间12月；未接受辅助化疗的患者1年生存率为20.8%，中位生存时间为6月；二者间比较有显著性差异。伴有远处转移的患者1年生存率为0%，中位生存时间为7月；无远处转移的患者1年生存率为49.2%，中位生存时间为12月；二者间比较无统计学差异。结论：中国和保加利亚的不能手术胰腺癌患者均能安全完成HIFU治疗，1年生存率和中位生存时间优于其它非手术治疗手段。辅助化疗能增加生存受益，远处转移是预后不良因素。

Abstract:

Objective：To analyze retrospectively the one-year survives of patients with inoperable pancreatic cancer treated by high intensity focused ultrasound by a multiple-center clinical trial. Methods：From January 2013 to January 2014，32 patients with in-operable pancreatic cancer from China and Bulgaria were involved into the trial. They are male/female=20/12，aged 59.8±9.1（41-81） years. The size of tumor is 39.3±9.6（20-60） mm. the number of patient with/without metastasis are 18/14.The treatment protocol is HIFU or HIFU plus Chemotherapy. The complications，pain levels and survives were recorded after HIFU. The overall survival rate（OS） and median survival time（MST） were calculated by Kaplan-Meier method，and the differences between patients with/without adjuvant chemotherapy or metastasis were compared with log-rank method. Results：Two patients with degree Ⅱ° skin burn were recorded in one month post-HIFU and were cured in 1-2 weeks with conservative treatment. Comparison was made on 30 patients with pancreatic cancer related pain pre-HIFU and post-HIFU. Post-HIFU，the pain levels got released in 24 cases（80.0%），no changed in 5 cases（16.7%），worse in 1 case（3.3%）. The OS of all cases in one year was 38.4% and MST was 12 months. The OS of patients accepted HIFU plus adjuvant chemotherapy/HIFU in one year was 57.4% and 20.8% and MST was 12 months and 6 months，respectively with significant dif－ferences. The OS of patients with/without metastasis was 0% and 49.2% and MST was 7 months and 12 months，respectively without significant differences. Conclusion：All patients from China and Bulgaria with inoperable pancreatic cancer completed the HIFU safely. The one year OS and MST are better than other non-operative methods. HIFU plus adjuvant chemotherapy benefits to the survival，while metastasis is a poor prognosis factor.