恶性黑色素瘤生物化疗的临床研究初探

Clinical trial of biochemotherapy versus chemotherapy or biotherapy for malignant melanoma

目的观察并比较Ⅲ、Ⅳ期恶性黑色素瘤患者应用生物化学治疗、生物治疗或化学治疗的近期和远期疗效。方法分析82例Ⅲ、Ⅳ期恶性黑色素瘤患者化学治疗(顺铂、氮烯咪胺、吉西他滨),生物治疗(白介素2、干扰素α、树突状细胞疫苗)或生物化疗(上述两者结合)的临床疗效。其中生物化疗组32例、生物治疗组26例、化学治疗组24例。中位随访时间2年(1～4年)。结果近期疗效:生物化疗组有效率(RR)为71.9%,与生物治疗组(RR46.2%)和化学治疗组(RR54.2%)相比,有显著差异(P<0.05)。远期疗效:生物化疗组的中位生存时间(MST)为34个月,与生物治疗组(MST26个月)和化学治疗组(MST14个月)相比,有显著性差异(P<0.05)。各组的2年生存率分别为40.6%、38.5%和12.5%。生物化疗组毒副作用明显高于其他两组,但经一般处理,患者均可耐受。结论细胞因子联合树突状细胞疫苗能明显提高接受化疗的恶性黑色素瘤患者治疗的有效率。

Objective To compare the short-term and long term efficacy of chemotherapy with biotherapy and same chemotherapy followed by biotherapy on malignant melanoma in stage Ⅲ and Ⅳ. Methods 82 cases with malignant melanoma were treated with chemotherapy （dacarbazing, cis-platin and carmustine） or biotherapy （interleukin-2, interferon α and dendritic cell vaccine） or biochemotherapy （chemotherapy plus biotherapy）. Among them, 32 cases were received biochemotherapy, 26 for biotherapy and 24 for chemotherapy. Therapentic response was assessed every 3 cycles. The median time of follow up was 2 years （1-4 years）. Results Response rate was 71.9% for biochemotherapy, 46. 2% for biotherapy and 54.2% for chemotherapy （P〈0.05）. The median survival time （MST） for patients treated with biochemotherapy was 34 months with a 2-year survival rate of 40. 6%, that with biotherapy was 26 months with a 2- year survival rate of 38. 5%, and that with chemotherapy was 14 months with a 2-year survival rate of 12. 5% （P〈0.05）. Biochemotherapy produced substantially more constitutional, hemodynamic, and myelosuppressive toxic effects, but tolerable with treatment. Conclusion Cytokines plus dendritic cell vaccine substantially augment the antitumor activity of chemotherapy at the expense of considerable more tox icity in patients with metastatic melanoma