10-羟基喜树碱为主的非铂方案治疗复治非小细胞肺癌前瞻性临床研究

Prospective study of hydroxycomptothecine and Ifosfamide regime as second-line treatment in non-small lung cancer

目的评价10-羟基喜树碱(拓僖,HCPT)联合异环磷酰胺(IFO)化疗方案治疗进展期铂类耐药非小细胞肺癌(NSCLC)的有效性及安全性。方法经组织和(或)细胞学证实的Ⅲb~Ⅳ期NSCLC患者,曾有≥2次标准含铂方案联合化疗史。化疗方案为HCPT6mg/m2,d1~4;IFO1.2g/m2,d1~3;每4周重复1次。结果29例患者入组,化疗后部分缓解(PR)3例、无变化(NC)20例、疾病进展(PD)6例,治疗总有效率为13.6%,疾病控制率为72.7%,中位生存期为10.3个月。中位疾病进展时间为4.2个月。化疗的毒副反应主要为白细胞计数中度下降、轻或中度胃肠道反应及皮疹。结论HCPT联合IFO作为铂类耐药的复治方案治疗进展期NSCLC有较好的疗效及安全性。

Objective To evaluate the effectiveness and tolerance of hydroxycomptothecine (HCPT) in combination with ifosfamide (IFO) as the second line treatment for advanced platinum-resistant non-small cell lung cancer. Methods Eligibility on trial of patients with histologically or cytologically confirmed advanced non-small-cell lung cancer(NSCLC, stage Ⅲb or Ⅳ), had received at least 2 cycles of platinum based chemotherapy. The protocol of chemotherapy for patients included HCPT 6 mg/m^2, d1-4 iv and IFO 1.2 g /m^2 d1-3 iv. Results Among the 29 patients, 3 achieved PR, 20 NC, 6 PD. The overall effective rate was 13.6% including disease controlling rate 72.7%, MST 10.3 months, TTP 4.2 months. The main toxicities were moderate leucopenia, slight to moderate gastrointestinal reaction and skin eruption. Conclusion HCPT in combination with IFO as a second-line treatment for advanced platinum-resistant non-small-cell lung cancer is relatively safe and effective.