Sakurai M, Ichiki M, Hayashi I
Department of Internal Medicine, Cancer Institute Hospital, Tokyo, Japan.
Lung Cancer. 1996 Sep;15(2):225-32. doi: 10.1016/0169-5002(96)00586-7.
A Phase I/II study of combination chemotherapy with cisplatin (CDDP), carboplatin (CBDCA) and etoposide (VP-16) (CPVP) was conducted in patients with small cell lung cancer. The dose level of etoposide was fixed at 100 mg/m2, while the doses of CDDP and CBDCA administered at each of the four steps were 50/200, 60/200, 60/250 and 70/250 mg/m2, respectively. Nine patients were allocated to each step dose group. Adverse effects were evaluated during the first two courses to establish the maximum tolerated dose (MTD). As a result, the step 3 doses turned out to be the MTD. The dose-limiting factor was hematotoxicity. Gastrointestinal toxicity was also present, but was tolerated. The overall response rate in patients with measurable or evaluable lesions was 91%. In 22 chemotherapy-naive patients, the median survival time was 16.6 months. These results suggest that the recommended dose is step 2, and that the CPVP regimen might be both more tolerable and more effective than the standard PVP regimen. Based on the above findings, CPVP therapy warrants further study in Phase II and III trials.
对小细胞肺癌患者进行了顺铂（CDDP）、卡铂（CBDCA）和依托泊苷（VP - 16）联合化疗（CPVP）的I/II期研究。依托泊苷的剂量水平固定为100mg/m²，而在四个步骤中每个步骤给予的顺铂和卡铂剂量分别为50/200、60/200、60/250和70/250mg/m²。每个步骤剂量组分配9名患者。在前两个疗程中评估不良反应以确定最大耐受剂量（MTD）。结果，第3步剂量被证明是MTD。剂量限制因素是血液毒性。胃肠道毒性也存在，但可耐受。可测量或可评估病变患者的总缓解率为91%。在22例初治化疗患者中，中位生存时间为16.6个月。这些结果表明推荐剂量为第2步，并且CPVP方案可能比标准PVP方案更耐受且更有效。基于上述发现，CPVP疗法值得在II期和III期试验中进一步研究。
