吉西他滨局部化疗联合或不联合三维适形外放疗治疗局部晚期胰腺癌的临床观察

Regional intra-arterial chemotherapy with gemcitabine with or without 3-dimensional conformal radiotherapy for locally advanced pancreatic cancer

目的探讨吉西他滨局部化疗联合或不联合三维适形外放疗治疗局部晚期胰腺癌的可行性、疗效及毒副反应。方法 2006年10月至2008年12月入组39例Ⅲ、ⅣA期胰腺癌患者进行前瞻性随机对照研究。试验组18例采用吉西他滨局部化疗联合三维适形外放射治疗,对照组21例仅接受同方案局部化疗。分析两组的肿瘤缓解率、1年和2年生存率、临床受益率及副反应。结果试验组和对照组的总有效率(CR+PR)分别为77.8%和38.1%,差异有统计学性意义(P=0.021);两组中位生存期分别为14.4个月和12.7个月,差异无统计学意义(P=0.102);两组1年生存率分别为61.0%和48.0%,差异无统计学意义(P=0.146);试验组的2年生存率为28.0%,明显高于对照组的10.0%,差异有统计学意义(P=0.022)。试验组的有效率、稳定率和无效率分别为44.4%、22.2%和33.4%,对照组分别为38.1%、33.3%和26.6%,差异无统计学意义(P=0.945)。试验组区域淋巴结转移率低于对照组(P=0.007),两组肝转移发生率差异无统计学意义(P=0.58)。试验组上消化道副反应发生率高于对照组,两组白细胞减少、血小板减少、发热、肝肾功能损伤等并发症发生率相近。结论吉西他滨方案局部化疗联合三维适形外放疗可以提高局部胰腺癌患者的疗效,副作用可控,值得进一步研究。

Objective To compare efficacy and safety of regional intra-arterial chemotherapy using gemcitabine combined with or without conformal radiation treatment regimens for locally advanced pancreatic cancer.Methods Between October 2006 and December 2008,39 patients with Ⅲ or ⅣA stage pancreatic adenocarcinoma were enrolled in a prospective randomized two-institution trial.Eighteen pataients were selected into the combined therapy group（trial group） treated with intra-arterial chemotherapy using gemcitabine combined conformal radiotherapy.The other 21 patients accepted regional chemotherapy using gemcitabine alone composing the control group.The tumor remission rates,survival rates,clinical benefit response（CBP）and side effects were analyzed.Results No patients were excluded.The total effective rate of the trial group and the control group were 77.8% and 38.1%,respectively（P0.05）.The 1-,2-year survival rate of the two groups was 61.0%,48.0% and 28.0%,10.0%.The median survival time of patients treated with chemotherapy alone and chemoradiotherapy was 12.7 and 14.4 months,respectively（P=0.102）.The 2-year survival rate of the trial group was higher than that of the control group（P=0.022） although the 1-year survival rates of the two group were not significant（P=0.146）.The effective rate,stabilized rate and ineffective rate of CBP of the two group were 44.4%,22.2%,33.4% and 38.1%,33.3%,26.6%（P=0.945）.The failure patterns in local-regional relapse were lower in the trial group than that of control group（P=0.007）and with no statistic difference between the two groups of the liver metastasis.The upper gastrointestinal side-effect rate of the trial group was higher than that of the control group.As for the myelosuppression,febrility,liver function and renal function damnification,there was no statistic significance between the two groups（P0.05）.Conclusion While preliminary results indicate promising results with regional intra-arterial chemotherapy using gemcitabine combined 3-dimensional conformal radiotherapy for locally advanced pancreatic cancer,without increasing the complication rate significantly.Reliable data derived from mature phase Ⅲ trials are greatly needed.