A phase II study of oral VP-16-213 in non-seminomatous testicular cancer

F. Cavalli , O. Klepp , J. Renard , M. Röhrt , P. Alberto , for the E.O.R.T.C. Early Clinical Trials Group
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引用次数: 39

Abstract

In a disease-oriented phase II study, thirty-three patients with advanced non-seminomatous testicular cancer were treated with oral VP-16-213 175 mg/m2/day for three consecutive days repeated every week. All patients had previously received extensive chemotherapy and twenty patients also had prior radiotherapy, Of 30 evaluable patients, 6 experienced partial remission for a median duration of 3.5 months, whereas minor regression or stabilization of the disease was achieved in 7 patients for a median duration of 2.5 months. Leukopenia was dose-limiting and resulted in dose reduction or treatment delay in 55% of the scheduled courses. The definite antitumor activity of VP-16-213 in non-seminomatous testicular cancer warrants its incorporation into combination chemotherapy for this disease.

口服VP-16-213治疗非半瘤性睾丸癌的II期研究
在一项以疾病为导向的II期研究中,33例晚期非半瘤性睾丸癌患者接受口服VP-16-213 175 mg/m2/天,连续3天,每周重复。所有患者之前都接受过广泛的化疗,20名患者之前也接受过放疗。在30名可评估的患者中,6名患者经历了3.5个月的中位缓解,而7名患者的疾病轻微消退或稳定,中位持续时间为2.5个月。白细胞减少是剂量限制性的,在55%的计划疗程中导致剂量减少或治疗延迟。VP-16-213在非半瘤性睾丸癌中具有明确的抗肿瘤活性,值得将其纳入该疾病的联合化疗中。
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