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目的探讨活化单倍相合异基因造血干细胞(allogeneic haploidentical hematopoietic stem cells,haplo-HSC)治疗各类晚期难治性肿瘤的安全性和临床疗效。方法42例晚期转移性或化疗抵抗性肿瘤患者入组,均接受一个疗程haplo-HSC治疗,分别通过影像学检查、生活质量评分以及外周血淋巴细胞亚群、细胞因子变化情况来评估临床疗效和免疫学反应。结果①42例患者中,7例部分缓解(PR),25例疾病稳定(SD),10例疾病进展(PD),有效率(CR+PR)为16.67%,临床获益率(CR+PR+SD)为76.19%。中位随访时间21个月,中位达进展时间(mTTP)为3.7个月,中位生存时间为7.8个月,1年生存率为14%;②治疗后患者的CD3+、CD4+、CD4+/CD8+、CD3–CD16+CD56+NK均明显升高(P<0.05),而CD8+、CD4+CD25+Treg明显降低(P<0.05);TNF-α、IFN-γ等Th1类细胞因子明显升高(P<0.01),而TGF-β明显下降(P<0.05);③除一过性的发热、乏力外,未出现其他不良反应。结论晚期难治性肿瘤患者,采用活化haplo-HSC治疗可以增强自身免疫功能,提高生存率和生活质量,并且有良好的耐受性。
Objective To investigate the safety and clinical efficacy of haploidentical hematopoietic stem cells (haplo-HSC) in the treatment of advanced refractory tumors. Methods Forty-two patients with advanced metastatic or chemoresistant tumors were enrolled in the study. All patients were treated with haplo-HSC for one course of treatment. The clinical efficacy and the changes of peripheral blood lymphocyte subsets and cytokines were evaluated by imaging examination, quality of life score, Immunological reaction. Results Among the 42 patients, partial response (PR), partial degeneration (25 cases), progressive disease (PD) and effective rate (CR + PR) were 16.67% SD) was 76.19%. The median follow-up time was 21 months, the median time to progression (mTTP) was 3.7 months, the median survival time was 7.8 months and the 1-year survival rate was 14%. After treatment, the levels of CD3 +, CD4 +, CD4 + / CD8 + , CD3-CD16 + CD56 + NK were significantly increased (P <0.05), but CD8 +, CD4 + CD25 + Treg were significantly lower (P <0.05); Th1 cytokines such as TNF- P <0.01), while TGF-βdecreased significantly (P <0.05). ③In addition to a transient fever, fatigue, no other adverse reactions. Conclusions In patients with advanced refractory tumors, the treatment with activated haplo-HSC can enhance the autoimmune function, improve the survival rate and quality of life, and have good tolerance.