乐铂单药治疗乳腺癌的Ⅱ期临床研究

A Phase Ⅱ Clinical Trial of Lobaplatin as a Single Agent in the Treatment of Breast Cancer

为了观察和评价乐铂单药治疗恶性肿瘤的疗效和毒副反应，１９９４年６月至１９９６年１０月，应用单药乐铂治疗复发性或转移性的乳腺癌病人４２例，乐铂５０ｍｇ／ｍ２，静脉滴注，每３周１个疗程，平均治疗２个疗程。结果，ＣＲ１例，ＰＲ１８例，有效率４５．２％。乐铂的毒性反应主要为骨髓毒性，特别是血小板减少，Ⅲ～Ⅳ级占１４．５％，为其剂量限制性毒性；其它常见的不良反应为胃肠道反应（Ⅰ～Ⅱ级）；乐铂的肾毒性和神经毒性不明显。

To evaluate the effect and adverse events of lobaplatin to treat breast cancer,from June 1994 to October 1996,42 patients with histologically proven breast cancer received single agent therapy by lobaplatin 50 mg/m 2 iv drop,repeat 3 weeks.Average 2 cycles were given for each patient.Out of 42 breast cancer,1 CR, 18 PR were observed.The response rate was 45.2%.The main dose limiting toxicity of lobaplatin was myelotoxisity especially thrombocytopenia.The other adverse events were slight and no obvious and nephrotoxisity neurotoxisity were observed.