Phase I/II study of a short course of weekly cisplatin in patients with advanced solid tumours.
Phase I/II study of a short course of weekly cisplatin in patients with advanced solid tumours.
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DOI：
10.1038/bjc.1993.429
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发表时间：
1993-10
影响因子：
8.8
通讯作者：
Verweij, J
中科院分区：
文献类型：
--
作者：
Planting, A S;van der Burg, M E;de Boer-Dennert, M;Stoter, G;Verweij, J
25 名晚期实体瘤患者参与了为期 6 个周期的顺铂 I/II 期研究。十九名患者接受过化疗，六名患者之前接受过治疗。起始剂量为 50 mg m-2 week-1。该剂量可以在没有重大毒性的情况下逐步增加至 70 mg m-2 week-1。剂量为 80 mg m-2 时，发生 3 级骨髓抑制以及 1 级肾毒性和神经毒性。最大耐受剂量为 85 mg m-2，伴有剂量限制性血小板减少症。高渗盐水可有效预防肾毒性。昂丹司琼在治疗的最初几周是一种非常有效的止吐药，但其疗效随后逐渐减弱。在头颈癌、黑色素瘤和间皮瘤中观察到了反应。在 80 mg m-2 的剂量水平下，达到了最佳剂量强度。该时间表将在第二阶段研究中进一步测试。
Twenty-five patients with advanced solid tumours were entered in a phase I/II study of six, weekly cycles of cisplatin. Nineteen patients were chemonaive and six were previously treated. The starting dose was 50 mg m-2 week-1. This dose could be escalated without major toxicity to 70 mg m-2 week-1. At a dose of 80 mg m-2 myelosuppression grade 3 occurred as well as grade 1 nephro- and neurotoxicity. The maximum tolerated dose was 85 mg m-2 with dose limiting thrombocytopenia. Hypertonic saline was effective in preventing nephrotoxicity. Ondansetron was a very effective antiemetic in the first weeks of treatment but its efficacy waned later on. Responses were observed in head and neck cancer, melanoma and mesothelioma. At the dose level of 80 mg m-2 the optimal dose intensity was reached. This schedule will be tested further in phase II studies.