ProMACE-CytaBOM方案治疗难治性及复发中高度恶性非霍奇金淋巴瘤的对照研究

Randomized controlled study of proMACE-CytaBOM regimen in treatment of patients with relapsed or refractory intermediate and high grade non-Hodgkin’s lymphoma

目的:观察ProMACE CytaBOM方案治疗复发及难治性中高度恶性非霍奇金淋巴瘤(non Hodgkin’slymphoma,NHL)的临床疗效及毒副反应,并与DICE方案比较。方法:41例复发及难治性中高度恶性NHL患者随机分为两组:治疗组20例,采用Pro MACE CytaBOM方案治疗;对照组21例,采用DICE方案治疗。结果:治疗组与对照组两组CR率分别为35.0%和28.6%,χ2=0.196,P=0.658;两组总有效率分别为70.0%和71.4%,χ2=0.010,P=0.920;经过中位15个月(5～27个月)的随访,两组1、2年总生存率及中位生存期分别为65.0%、34.7%、19个月和64.8%、34.6%、16个月,χ2=0.210,P=0.645;两组1、2年无疾病进展生存率及中位疾病进展时间分别为40.0%、11.4%、11个月和41.9%、17.4%、11个月,χ2=0.000,P=0.964,差异均无统计学意义。两组毒副反应亦相似。结论:ProM ACE CytaBOM方案是复发及难治性非霍奇金淋巴瘤患者的一个有效的解救治疗方案。

OBJECTIVE： To observe the clinical effect and toxicity of ProMACE-CytaBOM regimen in the treatment of patients with relapsed or refractory intermediate and high grade Non-Hodgkin＇ s Lymphoma, compared with DICE regimen. METHODS： Forty-one patients with relapsed or refractory intermediate and high grade Non-Hodgkin＇s lymphoma were randomly divided into two groups： 20 cases in treatment group treated with ProMACE-CytaBOM regimen, 21eases in compared group treated with DICE regimen. RESULT： The difference of complete response rate and response rate between the treatment group and the compared group were not significant （35.0% vs 28.6%,X^2=0. 196,P=0.658; 70.0% vs 71.4%,X^2 =0.010, P= 0. 920 respectively）. With a median follow up of 15 months （ranged from 5-27 ranged）, the 1-, 2-year survival and median survival time for the two groups was 65.0%, 34. 7%, 19 months and 64. 8%, 34. 6%, 16 months respectively （X^2 =0. 210, P=0. 645）; the 1-, 2- year progress free survival and median time to progress was 40.0 %, 11.4%, 11 months and 41.9%, 17. 4%, 11 months respectively （X^2 =0. 000,P=0. 964）. The toxicity of the two groups was similar. CONCLUSIONS： ProMACE-CytaBOM regimen is an effective saving regimen for patients with relapsed or refractory intermediate and high grade non- Hodgkin＇ s lymphoma.