Saito H, Shimokata K, Yamamoto M, Saka H, Sakai S, Saito H
Department of Medicine, Chubu National Hospital, Aichi, Japan.
Cancer Chemother Pharmacol. 1993;32(2):134-6. doi: 10.1007/BF00685616.
We conducted a phase II study to evaluate the antitumor activity and safety of concurrent continuous infusion of cisplatin and etoposide in advanced non-small-cell lung cancer (NSCLC). Cisplatin (30 mg/m2 daily) and etoposide (80 mg/m2 daily) were given as a 24-h continuous infusion for 72 h to 48 patients with previously untreated advanced NSCLC. Of the 46 evaluable patients, 9 achieved a partial response, for an overall response rate of 20% (95% confidence interval, 9.4%-33.9%). The median duration of response was 23 weeks. The median duration of survival for all patients was 34.4 weeks. The major toxicity was hematologic. Leukopenia (WHO grade > or = 3) was observed in 22 patients (48%) and thrombocytopenia (WHO grade > or = 3), in 13 patients (28%). In all, 20 patients (43%) experienced severe anemia (WHO grade > or = 3). Nonhematologic toxicity mainly consisted of moderate to severe alopecia in 33 patients (72%) and moderate to severe nausea and vomiting in 25 patients (54%). No significant nephrotoxicity was seen. We conclude that a 72-h concurrent continuous infusion of cisplatin and etoposide does not appear to be active against advanced NSCLC.
我们开展了一项II期研究，以评估顺铂和依托泊苷同步持续输注治疗晚期非小细胞肺癌（NSCLC）的抗肿瘤活性和安全性。将顺铂（每日30mg/m²）和依托泊苷（每日80mg/m²）以24小时持续输注的方式给予48例先前未接受过治疗的晚期NSCLC患者，持续72小时。在46例可评估的患者中，9例获得部分缓解，总缓解率为20%（95%置信区间，9.4%-33.9%）。缓解持续时间的中位数为23周。所有患者的生存持续时间中位数为34.4周。主要毒性为血液学毒性。22例患者（48%）出现白细胞减少（世界卫生组织（WHO）分级≥3级），13例患者（28%）出现血小板减少（WHO分级≥3级）。共有20例患者（43%）出现严重贫血（WHO分级≥3级）。非血液学毒性主要包括33例患者（72%）出现中度至重度脱发，25例患者（54%）出现中度至重度恶心和呕吐。未观察到明显的肾毒性。我们得出结论，顺铂和依托泊苷同步持续输注72小时似乎对晚期NSCLC无活性。
