Seidman A D, Scher H I, Heinemann M H, Bajorin D F, Sternberg C N, Dershaw D D, Silverberg M, Bosl G J
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021.
Cancer. 1991 Dec 15;68(12):2561-5. doi: 10.1002/1097-0142(19911215)68:12<2561::aid-cncr2820681205>3.0.co;2-g.
A Phase I-II trial of gallium nitrate was conducted in 40 patients with bidimensionally measurable urothelial tract tumors who had failed to respond to combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin. Partial responses were observed in 4 of 23 patients (17.4%) who received 350 mg/m2/d or more for 5 days by continuous intravenous infusion. In two additional patients who received 350 mg/m2/d or more, a minor response and a mixed response were observed. The median duration of response was 4 months (range, 2 to 8 months). A dose-response relationship was suggested because no responses were observed in 17 patients who received less than 350 mg/m2/d. Myelosuppression was minimal. The dose-limiting toxic reaction was a reversible optic neuropathy that occurred in 3 of 11 patients who received 400 mg/m2/d. Further evaluation of infusional gallium nitrate is warranted in patients with urothelial tract malignant tumors.
对40例二维可测量的尿路上皮肿瘤患者进行了硝酸镓的I-II期试验，这些患者对甲氨蝶呤、长春碱、阿霉素和顺铂联合化疗无反应。23例接受持续静脉输注350mg/m²/天或更高剂量达5天的患者中，有4例（17.4%）出现部分缓解。另外2例接受350mg/m²/天或更高剂量的患者，分别出现轻微缓解和混合缓解。缓解的中位持续时间为4个月（范围2至8个月）。由于17例接受剂量低于350mg/m²/天的患者未观察到缓解，提示存在剂量反应关系。骨髓抑制轻微。剂量限制性毒性反应是可逆性视神经病变，在11例接受400mg/m²/天的患者中有3例发生。对于尿路上皮恶性肿瘤患者，有必要对硝酸镓输注进行进一步评估。
