Planting A S, van der Burg M E, de Boer-Dennert M, Stoter G, Verweij J
Department of Medical Oncology, Rotterdam Cancer Institute/Daniel den Hoed Kliniek, The Netherlands.
Br J Cancer. 1993 Oct;68(4):789-92. doi: 10.1038/bjc.1993.429.
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.
25例晚期实体瘤患者进入了一项关于顺铂的I/II期研究，该研究为期六周，每周进行一次治疗。19例患者为初治患者，6例为既往接受过治疗的患者。起始剂量为50mg/m²每周。该剂量可逐步增加至70mg/m²每周，且无严重毒性。在剂量为80mg/m²时，出现了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85mg/m²，剂量限制性毒性为血小板减少。高渗盐水在预防肾毒性方面有效。昂丹司琼在治疗的最初几周是一种非常有效的止吐药，但后期其疗效减弱。在头颈部癌、黑色素瘤和间皮瘤中观察到了反应。在80mg/m²的剂量水平达到了最佳剂量强度。该治疗方案将在II期研究中进一步测试。
