Niederle N, Ostermann J, Achterrath W, Lenaz L, Schmidt C G
Innere Universitätsklinik und Poliklinik, Essen, Federal Republic of Germany.
Cancer Chemother Pharmacol. 1991;28(1):59-62. doi: 10.1007/BF00684958.
In a phase I study, a range of doses of etoposide (200-370 mg/m2 given i.v. daily on 3 consecutive days) were evaluated for tolerance and response as first-line treatment in 26 patients with non-small-cell lung cancer. The dose-limiting toxicity was myelosuppression, especially leukopenia. At dose levels of 350 and 370 mg/m2 etoposide per day, leukopenia of WHO grade 4 occurred in two and one of seven patients, respectively. No thrombocytopenia of this degree was observed. Myelosuppression was quickly reversible and noncumulative. Apart from alopecia, nonhematologic organ toxicities above WHO grade 2 were not seen. Toxicity analysis suggests that the recommended dose of single-agent etoposide for phase II studies in untreated patients is 330-370 mg/m2 given i.v. daily for 3 days. At the dose levels tested, 6 (23%) major responses could be induced. All responses were seen at a starting dose of greater than 300 mg/m2 per day. The median duration of response was 4 months. The median survival for all patients was 8 months and that for responding patients was 15 months.
在一项I期研究中，评估了一系列剂量的依托泊苷（连续3天每日静脉注射200 - 370mg/m²）作为26例非小细胞肺癌患者一线治疗的耐受性和反应。剂量限制性毒性为骨髓抑制，尤其是白细胞减少。在每天依托泊苷剂量为350和370mg/m²时，7例患者中分别有2例和1例出现WHO 4级白细胞减少。未观察到该程度的血小板减少。骨髓抑制可迅速逆转且无累积性。除脱发外，未见到高于WHO 2级的非血液学器官毒性。毒性分析表明，未治疗患者II期研究中单药依托泊苷的推荐剂量为330 - 370mg/m²，静脉注射，每日1次，共3天。在所测试的剂量水平下，可诱导6例（23%）主要反应。所有反应均出现在起始剂量大于每日300mg/m²时。反应的中位持续时间为4个月。所有患者的中位生存期为8个月，有反应患者的中位生存期为15个月。
