口服依托泊苷连续给药21天治疗宫颈癌或卵巢癌的II期早期试验。ETP 21研究组——宫颈癌-卵巢癌组

[Early phase II trial of oral etoposide administered for 21 consecutive days in patients with cervical or ovarian cancer. ETP 21 Study Group--Cervical-Ovarian Cancer Group].

作者信息

Noda K, Tanaka K, Ozaki M, Hirabayasi K, Hasegawa K, Nishiya I, Yakushiji M, Izumi R, Tomoda Y, Ogita Y, Sugimori H, Yamabe T, Kudo R, Yajima A, Terashima Y, Fujii S, Suzuoki Y, Okada H, Kono I, Ochiai K, Yamamoto T, Ikeda M, Umesaki N, Saito T, Niitani H

机构信息

Dept. of Obstetrics and Gynecology, Kinki University School of Medicine.

出版信息

Gan To Kagaku Ryoho. 1998 Nov;25(13):2061-8.

PMID:9838908

Abstract

We conducted multi-site early phase II trial or oral etoposide administered for 21 consecutive days in patients with cervical or ovarian cancer in cooperation with 19 institutes. Fifty mg/body of oral etoposide was administered daily for 21 consecutive days. Cycles were repeated every 28 days. In cervical cancer, 24 patients were enrolled and 17 of them were evaluated. The overall response rate including CR and PR was 23.5% (4/17). In ovarian cancer, 18 patients out of 21 enrolled were evaluated. The overall response rate was 16.7% (3/18). The primary toxicity observed was myelosuppression such as leukopenia, neutropenia, hemoglobin decrease and thrombocytopenia. Other adverse effects were anorexia, nausea, vomitting, fatigue, alopecia and stomatitis. From these results we concluded that oral etoposide administered for 21 consecutive days was effective against cervical cancer.

摘要

我们与19家机构合作，对宫颈癌或卵巢癌患者进行了多中心早期II期试验，连续21天口服依托泊苷。口服依托泊苷剂量为50mg/体，连续21天每日给药。每28天重复一个周期。在宫颈癌患者中，入组24例，其中17例接受评估。包括完全缓解（CR）和部分缓解（PR）在内的总缓解率为23.5%（4/17）。在卵巢癌患者中，21例入组患者中有18例接受评估。总缓解率为16.7%（3/18）。观察到的主要毒性是骨髓抑制，如白细胞减少、中性粒细胞减少、血红蛋白降低和血小板减少。其他不良反应有厌食、恶心、呕吐、疲劳、脱发和口腔炎。从这些结果我们得出结论，连续21天口服依托泊苷对宫颈癌有效。