局部晚期胰腺癌放疗并同期5-FU对比吉西他滨的疗效分析

Gemcitabine vs. 5-FU with radiotherapy for locally advanced pancreatic carcinomas

目的 比较放疗联合5-氟尿嘧啶（5-FU）与放疗联合吉西他滨治疗局部晚期胰腺癌的疗效及放、化疗不良反应.方法 回顾性分析第四军医大学西京医院放疗科2007年1月到2011年1月收治的56例局部晚期不可手术切除的胰腺癌患者的资料.入组患者均采用三维适形或三维适形调强放疗并同期给予单药5-FU或吉西他滨化疗.放疗剂量每次1.8 ～2 Gy,每周5次,总剂量45 ～ 50.4 Gy,共25～ 28次.同期吉西他滨化疗组共30例,在放疗期间的第1、8、15、22天以500 mg/m2体表面积的剂量、10 mg· （m2）-1·min-1微量泵泵入给药；放疗结束后休息3周,再以800 mg· （m2）-1·d-1的剂量静脉滴注,每周1次,连用3～4周.同期5-FU化疗组共26例,放疗期间以500 mg· （m2）-1·d-l剂量静脉滴注,每周第1～5天给药,14 d一个周期；放疗结束后休息3周,按照800 mg·（m2）-1·d-1的剂量静脉滴注,每周第1～5天给药,14 d一个周期,连用3～4个周期.观察疗效和不良反应,并对患者进行随访,随访截止日为2013年6月,计算患者中位生存时间和l、2年生存率.结果 全组客观有效率（CR＋ PR）为73.2％,放疗联合5-FU组总有效率为65.3％,放疗联合吉西他滨组总有效率80.0％（P＜0.05）.全组1、2年生存率分别为48.2％和14.3％,中位生存期为15.2个月,其中放疗联合5-FU组分别为42.3％、11.5％、13.3个月,放疗联合吉西他滨组分别为53.3％、16.7％、16.6个月,两组患者生存率差异无统计学意义（P=0.071）.治疗结束后全组疼痛客观缓解率（VAS评分＜4分）为83.3％,放疗联合5-FU组为75％,放疗联合吉西他滨组为90％.放疗联合吉西他滨治疗组发生3～4级骨髓抑制率显著高于放疗联合5-FU组,差异具有统计学意义（20.0％比7.6％,P＜0.05）.结论 手术不能切除的局部晚期胰腺癌患者采用放疗联合吉西他滨化疗在长期生存、疼痛缓解方面较放疗联合5-FU具有优势,但骨髓抑制的不良反应较强.

Objective To evaluate the efficacy,adverse events of gemcitabine vs.5-FU with radiotherapy for locally advanced pancreatic carcinomas.Methods Between January 2007 and January 2011,a total of 56 patients with locally advanced pancreatic carcinomas was included and clinical data were retrospectively analyzed.All patients received 3-DCRT radiotherapy with individual dose of 1.8 ～ 2 Gy,5 times per week,and total dose of 45 ～ 50.4 Gy for 25 ～ 28 fractions,and received concurrent chemotherapy （5-FU or gemcitabine）.The patients （n =30） in gemcitabine group were treated with gemcitabine （500 rng/m2 at the 1st,8th,15th,22nd day,at 10 mg · （m2）-1 · min-1,through micro-pump） during radiotherapy; 3 weeks after radiotherapy the patients received gemcitabine infusion at a dose of 800 mg · （m2）-1 · d-1,one time per week,for 3 or 4 cycles.The patients （n =26） in 5-FU group were treated with 5-FU （500 mg/m2 at the 1 ～ 5th day per week,IV）,the cycle was repeated every 2 weeks during radiotherapy; 3 weeks later the patients received 5-FU infusion at a dose of 800 mg · （m2）-1 · d-1,the 1st ～5th day per week,the cycle was repeated every 2 weeks ; with a total of 3 or 4 cycles.The efficacy and adverse events were observed,and the patients were followed until June 2013,and the median survival,1 year and 2 year survival was calculated.Results Of the 56 patients,the overall response （CR ＋ PR） rate was 73.2%,and it was 65.3% in radiotherapy with 5-FU group,80.0% in radiotherapy with gemcitabine group （P 〈 0.05）.The overall one and two year survival rate was 48.2% and 14.3%,while median survival was 15.2 months,and the corresponding values were 42.3%,11.5%,13.3 months in radiotherapy with 5-FU group,and 53.3%,16.7%,16.6 months in radiotherapy with gemcitabine group,and the survival difference between the two groups was not statistically significant （P =0.071）.At the end of treatment,the pain-relief rate （VAS score 〈4） of the 56 patients was 83.3%,it was 75.0% in 5-FU group and 90.0% in gemcitabine group.In radiotherapy with gemcitabine group,the incidence of 3～ 4 grade myelosuppression was significantly higher than that in radiotherapy with 5-FU group,and the difference between the two groups was statistically significant （20.0% vs 7.6%,P 〈 0.05）.Conclusions For the locally advanced pancreatic carcinomas,radiotherapy with gemcitabine can improve pain-relief and prolong survival compared with radiotherapy with 5-FU,but the incidence of adverse event of myelosuppression is higher.