Planting A S, van der Burg M E, van den Bent M J, de Boer-Dennert M, Stoter G, Verweij J
Department of Medical Oncology (Division of Experimental Chemotherapy), Rotterdam Cancer Institute, The Netherlands.
Br J Cancer. 1996 May;73(10):1265-7. doi: 10.1038/bjc.1996.242.
In a phase I study of weekly administered cisplatin combined with oral etoposide, we observed a partial response in 4 out of 11 patients with metastatic colorectal cancer. Subsequently, we performed a phase II study to investigate the activity of this combination as first-line treatment in this disease. Fourteen patients with metastatic colorectal cancer were enrolled in this study. Treatment consisted of cisplatin, administered in 3% sodium chloride, at a dose of 70 mg m-2 on days 1, 8 and 15 and days 29, 36 and 43 combined with oral etoposide 50 mg absolute dose daily on days 1-15 of both courses. Patients with stable disease or better continued treatment with etoposide 50 mg m-2 orally on days 1-21 every 28 days. A partial response was observed in two patients with liver metastases (14%; 95% confidence limits 2-42%) for 30 and 32 weeks. Five patients had stable disease. Toxicity consisted mainly of anaemia, leucocytopenia, nausea and vomiting. Tinnitus was reported by six patients. The activity of the combination cisplatin-oral etoposide in the schedule is only minimal in metastatic colorectal cancer.
在一项每周给予顺铂联合口服依托泊苷的I期研究中，我们观察到11例转移性结直肠癌患者中有4例出现部分缓解。随后，我们进行了一项II期研究，以调查这种联合方案作为该疾病一线治疗的活性。14例转移性结直肠癌患者入组该研究。治疗方案为：顺铂用3%氯化钠溶解，在第1、8和15天以及第29、36和43天以70mg/m²的剂量给药，同时在两个疗程的第1 - 15天每天口服绝对剂量50mg的依托泊苷。病情稳定或更好的患者每28天在第1 - 21天口服50mg/m²的依托泊苷继续治疗。两名肝转移患者出现部分缓解（14%；95%置信区间2 - 42%），缓解持续30周和32周。5例患者病情稳定。毒性主要包括贫血、白细胞减少、恶心和呕吐。6例患者报告有耳鸣。顺铂 - 口服依托泊苷联合方案在该给药方案下对转移性结直肠癌的活性仅为最低限度。
