Phase I study of cis-diamminedichloroplatinum(II) administered as a constant 5-day infusion.

Phase I study of cis-diamminedichloroplatinum(II) administered as a constant 5-day infusion.
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顺式二氯二氨铂 (II) 连续 5 天输注的 I 期研究。

DOI:
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发表时间:
1980
期刊:
Cancer treatment reports
影响因子:
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通讯作者:
J. Lokich
J. Lokich
中科院分区:
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文献类型:
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作者:
J. Lokich

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本文报告30例不同类型的转移性恶性肿瘤患者,用顺铂(DDP)持续静脉滴注120小时。起始剂量为20 mg/m2/天(100 mg/m2/疗程),并逐步递增至40 mg/m2/天(200 mg/m2/疗程)。在30 mg/m2/天(150 mg/m2/疗程)剂量下观察到剂量限制性毒性,表现为骨髓抑制,特别是在剂量大于或等于30 mg/m2/天的14例患者中的13例中出现血小板减少症。大剂量给药方案的胃肠道毒性特征强度较低,但具有累积性和剂量相关性。尽管有充分的水化和每日利尿治疗,30例患者中仍有5例发生肾毒性反应。只有两名接受四个疗程持续输注DDP的患者发生了周围神经病变。在6例患者中观察到抗肿瘤作用(口腔癌,2例;淋巴瘤,1例;前列腺癌,1例;肝癌,1例;支气管癌,1例)。DDP持续静脉输注治疗的推荐起始剂量为30 mg/m2/天,持续5天。
Thirty patients with metastatic malignancy of various types were treated with cis-diamminedichloroplatinum(II) (DDP) administered by continuous infusion for 120 hours. The starting dose was 20 mg/m2/day (100 mg/m2/course) and was escalated by stages to 40 mg/m2/day (200 mg/m2/course). Dose-limiting toxicity was observed at 30 mg/m2/day (150 mg/m2/course), manifested as marrow suppression and particularly thrombocytopenia in 13 of 14 patients evaluated at doses greater than or equal to 30 mg/m2/day. The gastrointestinal toxicity characteristic of bolus treatment schedules was less intense but was cumulative and dose-related. Renal toxic effects developed in five of 30 patients in spite of adequate hydration and daily diuretic therapy. Peripheral neuropathy developed in the only two patients who received four courses of continuous-infusion DDP. Antitumor effects were observed in six patients (oral cancer, two; lymphoma, one; prostatic cancer, one; hepatoma, one; and bronchogenic carcinoma, one). The recommended starting dose for continuous venous infusion therapy with DDP is 30 mg/m2/day for 5 days.