体外高频热疗联合吉西他滨治疗晚期复治型胆系肿瘤的疗效

Efficacy of high-frequency hyperthermia combined with gemcitabine for treatment of advanced recurrent biliary tract cancer

目的:观察体外高频热疗联合吉西他滨治疗晚期胆系肿瘤的近期疗效和安全性。方法:62例晚期胆系肿瘤患者随机分为两组。治疗组31例,给予吉西他滨静脉化疗:吉西他滨1 000 mg·m-2·d-1,静脉滴注30 min,d1,d8和d15给药,用药2 h后以及d2,d9和d16行上腹部体外高频热疗,每次45 min。对照组31例,仅给予吉西他滨单药静脉化疗:吉西他滨1000 mg·m-2·d-1,静脉滴注30 min,d1,d8和d15给药。28 d为1个周期,至少治疗2个周期以上,按RECIST 1.1评价疗效,同时综合评估临床受益反应指标,包括疼痛、体力状况及体重变化。按照NCI CTC 3.0版标准评价毒性反应。结果:治疗组有效率(RR)为32.3%,疾病控制率(DCR)为80.6%,临床受益反应率(CBR)为83.9%;对照组有效率为16.1%,疾病控制率为41.9%,CBR为58.1%。治疗组和对照组各项指标有明显差异(P<0.05)。不良反应主要为骨髓抑制和消化道反应,两组无明显差异。结论:体外高频热疗联合吉西他滨治疗晚期胆系肿瘤具有较好的近期疗效,不良反应可耐受,值得进一步推广。

Objective： To observe the effect and safety of high-frequency hyperthermia combined with gemcitabine for treatment of recurrent biliary tract cancer. Methods： 62 patients with recurrent biliary tract cancer were randomly divided into two groups. 31 patients in the treatment group were given chemotherapy gemcitabine （1 000 mg·m^-2·d^-1 , 30 min, iv, d 1, 8,15） combined with high-frequency hyperthermia （after 2 h and d 2, 9, 16）. 31 patients in the control group were given chemotherapy gemcitabine （ 1 000 mg·m^-2·d^-1, 30 min, iv, d 1, 8, 15 ）. 28 days were one cycle. The curative effects were estimated according to the criteria of RECIST 1.1 and the clinical benefit response rate（CBR） referring to pain, physical status and body weight were evaluated. The safety was evaluated according to NCICTC 3.0 version criteria. Results：The response rate, the disease control rate and the clinical benefit response rate in the treatment group were 32.3% , 80.6% and 83.9% , respectively, which was significantly higher than that of control group（ 16.1% , 41.95% and 58.1% , respectively）. The toxicities were marrow depression and alimentary tract reactions and there was no significant difference in the two group. Conclusion： High-frequency hyperthermia combined with gemcitabine for patients with recurrent biliary tract cancer was effective and safe, the adverse reactions was tolerable.