Phase II trial of ifosfamide with mesna in previously treated metastatic sarcoma.
Phase II trial of ifosfamide with mesna in previously treated metastatic sarcoma.
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异环磷酰胺联合美司钠治疗既往治疗过的转移性肉瘤的 II 期试验。
DOI：
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发表时间：
1985
期刊：
影响因子：
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通讯作者：
M. Schwen
中科院分区：
文献类型：
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作者：
K. Antman;D. Montella;C. Rosenbaum;M. Schwen
42例患者静脉滴注异环磷酰胺2-2.5g/m2/d，X4，在28例可评价的成人软组织肉瘤患者中有10例(36%)有部分反应，包括2例软骨肉瘤，9例儿童肉瘤(尤文氏肉瘤、骨源性肉瘤或横纹肌肉瘤)无一例部分缓解。所有的儿科患者对长达18个月的复杂的三到六种药物方案都没有反应。使用和不使用环磷酰胺的患者的应答率(32%；22名患者中的7名患者；15名患者中的20%，3名患者)没有显著差异，支持体外证据表明这两种相关化合物之间没有交叉耐药性。骨髓抑制是剂量限制的。在异环磷酰胺治疗期间，每4小时静脉注射400-500 mg的美斯纳，患者未出现出血性膀胱炎。恶心和呕吐一般为轻度或中度。脱发是普遍的，但可以逆转。在最初的11名患者中，有5名患者出现嗜睡或出现视觉幻觉(在对这5名患者进行的12个疗程中的6个疗程中)。只有一名患者有两次神经毒性发作。在减少静脉注射止吐剂和主要麻醉药的使用后，在接下来的27名患者中，有5名患者出现了单次神经毒性发作。大多数患者出现无症状酸中毒，其中一例需要碳酸氢盐替代。异环磷酰胺在以前治疗过的肉瘤患者中似乎很活跃，应该在先前治疗范围较小的患者中进行评估。
Ifosfamide given to 42 patients iv at 2-2.5 g/m2/day X 4 resulted in partial responses in ten of 28 (36%) evaluable patients with adult soft tissue sarcomas, including two of two with chondrosarcoma; none of nine with pediatric sarcomas (Ewing's sarcoma, osteogenic sarcoma, or rhabdomyosarcoma) achieved partial response. All of the pediatric patients had failed to respond to complicated three- to six-drug regimens of up to 18 months in duration. The response rates in patients with and without prior cyclophosphamide (32%; seven responses among 22 patients; and 20%, three responses among 15 patients) were not significantly different, supporting in vitro evidence of a lack of cross-resistance between the two related compounds. Myelosuppression was dose-limiting. Hemorrhagic cystitis was not observed in patients treated with 400-500 mg of mesna iv every 4 hours during ifosfamide treatment. Nausea and vomiting were generally mild or moderate. Alopecia was universal but reversible. Of the first 11 patients, five became somnolent or developed visual hallucinations (during six of the 12 total courses administered to the five patients). Only one patient had two episodes of neurotoxicity. After reduction of the use of iv antiemetics and major narcotics, single episodes of neurotoxicity were seen in five of the next 27 patients. An asymptomatic acidosis developed in most patients, requiring bicarbonate replacement in one. Ifosfamide appears to be active in previously treated patients with sarcomas and should be evaluated in patients with less extensive prior treatment.