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口服依托泊苷延长治疗难治性卵巢癌的II期研究。

Phase II study of prolonged oral etoposide in refractory ovarian cancer.

作者信息

Kavanagh J.J., Tresukosol D., De Leon C. Gonzalez, Edwards C.L., Freedman R.S., Hord M., Howell E., Lenzi R., Krakoff I.H., Kudelka A.P.

机构信息

The University of Texas, MD Anderson Cancer Center, Houston, Texas, USA and Chulalongkorn University Hospital, Bangkok, Thailand.

出版信息

Int J Gynecol Cancer. 1995 Sep;5(5):351-354. doi: 10.1046/j.1525-1438.1995.05050351.x.

Abstract

A phase II study of prolonged oral etoposide at 50 mg m-2 was performed in patients with refractory ovarian cancer. A dose schedule algorithm was used to generate a calendar with the number of capsules to be administered each day and the date of blood tests. Fourteen of 15 patients were evaluable for response. Among the evaluable patients, 12 (86%) had poorly differentiated tumors, 13 (93%) had primary or secondary platin-resistant tumors, and 12 (86%) had progressed on a prior taxoid therapy. The median number of prior regimens was four (1-7). Despite the use of a 50-mg capsule of etoposide, the algorithm permitted the delivery of a median of 94% (89-107.5%) of the ideal calculated dose. The dose-limiting toxicity was myelosuppression with a grade 3 or 4 neutropenia in two-thirds of the patients. There were no deaths on the study and no significant neurologic or cardiovascular toxicity noted. There were no objective responses. The median survival of evaluable patients was 8.1 (95% CI 5.6-13.2) months.

摘要

对难治性卵巢癌患者进行了一项口服依托泊苷 50 mg/m² 持续给药的 II 期研究。使用剂量计划算法生成一份日程表,标明每天需服用的胶囊数量以及血液检测日期。15 名患者中有 14 名可评估疗效。在可评估的患者中,12 名(86%)为低分化肿瘤,13 名(93%)为原发性或继发性铂耐药肿瘤,12 名(86%)在先前的紫杉类药物治疗中病情进展。既往治疗方案的中位数为 4 种(1 - 7 种)。尽管使用的是 50 mg 的依托泊苷胶囊,但该算法使实际给药剂量中位数达到理想计算剂量的 94%(89% - 107.5%)。剂量限制性毒性为骨髓抑制,三分之二的患者出现 3 级或 4 级中性粒细胞减少。研究期间无死亡病例,未观察到明显的神经或心血管毒性。未出现客观缓解。可评估患者的中位生存期为 8.1 个月(95%CI 5.6 - 13.2)。

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