Phase I study of continuous-infusion cisplatin.
Phase I study of continuous-infusion cisplatin.
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连续输注顺铂的 I 期研究。
DOI：
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发表时间：
1986
期刊：
影响因子：
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通讯作者：
T. Ervin
中科院分区：
文献类型：
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作者：
M. Posner;A. Skarin;J. Clark;T. Ervin
21 名患者连续输注顺铂 5 天。研究的剂量为 20、25 和 30 mg/m2/天。当以 3 L 生理盐水/天给药时，以 30 mg/m2/天的剂量连续输注顺铂与 9 名患者中的 2 名患者出现神经病变，并导致 4 名患者出现肌酐升高（大于 2 mg/dl）。在较低剂量下未观察到神经毒性或肾毒性。严重血小板减少症（低于50,000/微升）与剂量无关，发生在19%的疗程中。白细胞减少症很少。恶心和呕吐很容易控制。 38% 的课程中未发现毒性。可评估 19 名患者的反应。该组中有 6 名患者获得部分缓解（32%），5 名患者出现最低缓解（25%），8 名患者出现疾病进展（42%）。 7 名患者之前接受过顺铂推注治疗（20 mg/m2/天，持续 5 天），但化疗失败。在这些患者中，一名患者有部分反应，三名患者反应最小，三名患者病情进展。结论是，本方案中给出的连续输注顺铂在 25 mg/m2/天的剂量下具有良好的耐受性，并且可以对高剂量推注顺铂失败的患者产生反应。
Cisplatin was administered to 21 patients as a continuous infusion over 5 days. Doses of 20, 25, and 30 mg/m2/day were studied. When administered in 3 L of normal saline/day, continuous-infusion cisplatin at a dose of 30 mg/m2/day was associated with neuropathy in two of nine patients and creatinine elevations (greater than 2 mg/dl) in four. No neurotoxicity or nephrotoxicity was observed at lower doses. Severe thrombocytopenia (less than 50,000/microliter) was unrelated to dose and occurred in 19% of the courses. Leukopenia was minimal. Nausea and vomiting were easily controlled. No toxicity was seen in 38% of the courses. Nineteen patients were evaluable for response. Six patients achieved partial response (32%), five had minimal response (25%), and eight had progressive disease (42%) in this group. Seven patients had received cisplatin previously as a bolus treatment (20 mg/m2/day for 5 days) and failed on chemotherapy. Among these patients there was one with partial response, three with minimal response, and three with progressive disease. It is concluded that continuous-infusion cisplatin, as given in this protocol, is well-tolerated at a dose of 25 mg/m2/day and can result in responses in patients failing bolus cisplatin at high doses.