Ichiki M, Sakurai M, Hayashi I
Gan To Kagaku Ryoho. 1994 Dec;21(16):2787-91.
Phase I/II study of combination regimen composed of cisplatin (CDDP), carboplatin (CBDCA) and etoposide (VP-16) [CPVP] was conducted for small cell lung cancer. The dose level of VP-16 was fixed at 100 mg/m2, while the dosages of CDDP and CBDCA administered at each of the 4 steps were 50/200, 60/200, 60/250 and 70/250 mg/m2, respectively. Nine patients were allocated to each step dose group. Toxicities were evaluated in the first 2 courses to determine the maximum tolerated dose (MTD). As a result, step 3 dosages proved to be MTD, and the dose limiting factor (DLF) was hematotoxicity, but gastro-intestinal toxicity was tolerated. The response (CR+PR) was found in 21 out of 23 patients with evaluable lesions (91%). In the 22 patients who had not received pretreatment, median survival time (M ST) was 16.4 months. These results suggest that the recommended dose is step 2, and that the CPVP regimen is both more tolerable and more effective than the standard regimen. The CPVP regimen warrants further study in phase III trials.
开展了一项针对小细胞肺癌的由顺铂（CDDP）、卡铂（CBDCA）和依托泊苷（VP - 16）组成的联合方案[CPVP]的I/II期研究。VP - 16的剂量水平固定为100 mg/m²，而在4个步骤中每个步骤给予的CDDP和CBDCA剂量分别为50/200、60/200、60/250和70/250 mg/m²。每个步骤剂量组分配9名患者。在前2个疗程中评估毒性以确定最大耐受剂量（MTD）。结果，第3步剂量被证明是MTD，剂量限制因素（DLF）是血液毒性，但胃肠道毒性可耐受。在23例有可评估病变的患者中，有21例出现缓解（CR + PR）（91%）。在22例未接受预处理的患者中，中位生存时间（MST）为16.4个月。这些结果表明推荐剂量为第2步，并且CPVP方案比标准方案更具耐受性且更有效。CPVP方案值得在III期试验中进一步研究。
