Phase II trial of the oral platinum complex JM216 in non-small-cell lung cancer: An EORTC early clinical studies group investigation
Phase II trial of the oral platinum complex JM216 in non-small-cell lung cancer: An EORTC early clinical studies group investigation
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DOI：
10.1023/a:1008245709924
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发表时间：
1997-06-01
影响因子：
50.5
通讯作者：
Hanauske, A
中科院分区：
文献类型：
--
作者：
Judson, I;Cerny, T;Hanauske, A
背景：JM216是一种具有剂量限制性骨髓抑制毒性的新型口服铂复合物，目前正在进行II期评估。患者和方法：JM216被评估为非小细胞肺癌的一线治疗，17名患者接受120 mg/m(2)/天，每三周重复五天。结果：毒性是可控的，最常见的副作用是恶心、呕吐、腹泻、便秘和乏力，骨髓抑制通常为< 2级，并且没有中性粒细胞减少性败血症或出血的病例。十三名患者的反应可完全评估，没有持续客观反应的报告。据报告，一名疾病稳定的患者在三个疗程后有部分缓解，但在四个疗程后再次出现进展。另外五名患者疾病稳定 (46.2%)。结论。尽管一些患者图谱具有有效的缓解作用，但 JM216 似乎对非小细胞肺癌没有显着的抗肿瘤活性。
Background: JM216 is a new oral platinum complex with dose-limiting toxicity myelosuppression, now undergoing phase II evaluation,Patients and methods: JM216 was evaluated as first line therapy in non-small-cell lung cancer, Seventeen patients received 120 mg/m(2)/day for five days repeated every three weeks.Results: Toxicity was manageable, the commonest side-effects being nausea, vomiting, diarrhoea, constipation and asthenia, Myelososuppression was generally grade < 2 and there were no cases of neutropenic sepsis or bleeding. Thirteen patients were fully evaluable for response, No sustained objectivity responses were reported. One patient was reported as stable disease had a partial response after three courses but was progressing again after four, An additional five patients had stable disease (46.2%).Conclusions. Although some patients map have had useful palliation, JM216 did not appear to have significant antitumour activity in non-small-cell lung cancer.