Fan Yun, Huang Zhi-yu, Zhang Yi-ping, Sun Lin
Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou 310022, P. R. China.
Ai Zheng. 2002 Dec;21(12):1368-71.
BACKGROUND & OBJECTIVE: EP regimen[etoposide (VP-16) + cisplatin (DDP)] is a standard regimen for treatment of small cell lung cancer (SCLC), but the cure rate is still low. Teniposide (VM-26) is highly active single agent for SCLC as VP-16, and penetratable through blood-brain barrier. This clinical trial was designed to compare the efficacy and toxicity of teniposide plus cisplatin (VM-26 + DDP) regimen and EP regimen in treatment of SCLC, and the possible role of VM-26 on prevention of brain metastasis of SCLC.
A total of 70 previously untreated SCLC patients without brain metastasis were included; 34 patients received VM-26 + DDP and 36 patients received EP. The characteristics of patients were comparable according to chi 2 test.
The overall response rate-was 76.5% for VM-26 + DDP group with 12 complete response (CR) and 14 partial response (PR), and 69.4% in the EP group with 12 CR and 13 PR (P = 0.595). The median duration of survival was 10.4 months for VM-26 + DDP group versus 9.8 months for EP group (P > 0.05). The 1, 2, and 5-year survival rates were 35.3%, 14.7%, 8.8% in the VM-26 + DDP group; and 38.9%, 13.9%, 8.3% in the EP group (P > 0.05, without statistical difference). The rate of brain metastasis was 5.9% for VM-26 + DDP group and 19.4% for EP group (P = 0.027, with statistical difference). The main toxicity was mylosuppression (I-II); there was no significant difference between the two groups (P > 0.05).
VM-26 + DDP is a highly active regimen for treatment of SCLC; there is no difference in the effectiveness and toxicity versus EP regimen; VM-26 is possibly effective in prevention of brain metastasis in SCLC patients.
EP方案（依托泊苷（VP - 16）+顺铂（DDP））是治疗小细胞肺癌（SCLC）的标准方案，但治愈率仍较低。替尼泊苷（VM - 26）作为一种对SCLC有高度活性的单药，其活性与VP - 16相当，且能穿透血脑屏障。本临床试验旨在比较替尼泊苷联合顺铂（VM - 26 + DDP）方案与EP方案治疗SCLC的疗效和毒性，以及VM - 26在预防SCLC脑转移方面的可能作用。
共纳入70例既往未接受过治疗且无脑转移的SCLC患者；34例患者接受VM - 26 + DDP方案治疗，36例患者接受EP方案治疗。根据卡方检验，两组患者的特征具有可比性。
VM - 26 + DDP组的总缓解率为76.5%，其中完全缓解（CR）12例，部分缓解（PR）14例；EP组的总缓解率为69.4%，其中CR 12例，PR 13例（P = 0.595）。VM - 26 + DDP组的中位生存期为10.4个月，EP组为9.8个月（P > 0.05）。VM - 26 + DDP组的1年、2年和5年生存率分别为35.3%、14.7%、8.8%；EP组分别为38.9%、13.9%、8.3%（P > 0.05，无统计学差异）。VM - 26 + DDP组的脑转移率为5.9%，EP组为19.4%（P = 0.027，有统计学差异）。主要毒性为骨髓抑制（I - II级）；两组之间无显著差异（P > 0.05）。
VM - 26 + DDP是治疗SCLC的高效方案；与EP方案相比，在有效性和毒性方面无差异；VM - 26可能对预防SCLC患者的脑转移有效。
