HCE方案一线治疗小细胞肺癌的临床观察

背景与目的 化疗是小细胞肺癌的主要治疗方法。本研究拟探讨羟基喜树碱联合依托泊苷、卡铂组成的HCE方案治疗小细胞肺癌的临床疗效和耐受性。方法 将初治小细胞肺癌患者随机分入HCE方案和依托泊苷联合顺铂（EP）方案组，比较两组的临床疗效和毒副反应。结果 HCE组中评价疗效者31例，完全缓解率为54．8％（17／31），总有效率为90．3％（28／31）；EP组40例，完全缓解率为22．5％（9／40），总有效率为70．0％（28／40），两组完全缓解率比较有显著性差异（P〈0．01）。两组中位疾病进展时间分别为6个月及10个月（P〈0．05）；1年生存率分别为72．4％、69．4％（P〉0．05），2年生存率分别为51．7％、44．4％（P〈0．05），3年生存率分别为40．0％、29．2％（P〈0．05）；中位生存期分别为11．5个月及25个月（P〈0．05）；两组的主要不良反应为骨髓抑制及胃肠道反应，HCE组骨髓抑制及肝功异常发生率高于EP组，但无显著性差异（P〉0．05），胃肠道反应显著低于EP组（P〈0．01）。结论 HCE方案治疗小细胞肺癌疗效肯定，完全缓解率高，毒副作用轻，值得进一步推广。

Clinical study of HCE regimen in the treatment of small cell lung cancer

Backgroud and objective Chemotherapy is main treatment of small cell lung cancer (SCLC). This aim of this study is to evaluate the effects and the adverse effects of HCE regimen (hydroxycamptothecin + etoposide + carboplatin) in treatment of SCLC. Methods Patients with previously untreated SCLC were randomized into two groups: HCE group (treated by HCE regimen) and EP group (treated by etoposide and cisplatin). The chemotherapeutic effects and the adverse effects were compared between two groups. Results A total of 71 patients could be evaluated. The overall response rate was 90.3% (28/31) for HCE group with 17 complete response (CR) and 11 partial response (PR), and 70.0% (28/40) in the EP group with 9 CR and 19 PR. The CR was significantly different between two groups. The median survival time of the HCE group and EP group were 11.5 and 25 months respectively. The 1-year survival rate was 72.4% vs 69.4% (P> 0.05), 2-year survival rate was 51.7% vs 44.4% (P<0.05), and 3-year survival rate was 40.0% vs 29.2% (P<0.05). Myelosuppression, diarrhea and vomiting were the main toxicities in two groups. The incidence of myelosuppression was higher in the HCE group than that in the EP group but without statistical difference (P>0.05), whereas the incidence of nausea and vomiting were significantly lower than that in the EP group (P<0.01). Conclusion HCE regimen is an effective regimen for previously untreated SCLC with high CR and slight toxicity. It may be worthy of further clinical investigation.