Yoshida T, Takagi T, Shimoyama M, Mikuni C, Suzuki K, Egami K, Furusawa S, Nomura T, Mori M, Sugimoto T
Dept. of Internal Medicine, Toyama Prefectural Central Hospital.
Gan To Kagaku Ryoho. 1994 Dec;21(16):2793-801.
We conducted a multi-institutional (33 institutes), late phase II study with a 21-consecutive-day oral administration of etoposide for malignant lymphoma. Patient entry criteria were either those refractory to standard therapies or those for whom no appropriate therapy was available. A once-daily dose of 50 mg/body was administered for 21 consecutive days. Of the evaluable 83 among 88 entry patients, the overall response rate was 53.0% (44/83), including 10 CR; 52.5% (42/80, 9 CR) with non-Hodgkin's lymphoma and 100% (2/2, 1 CR) with Hodgkin's disease. Regarding abnormal laboratory findings, myelosuppression was observed; the incidence rates of leukopenia (23.3% with Grade 3), neutropenia (32.6%), hemoglobin decrease (17.4%) and thrombocytopenia (4.7%) were 70.9%, 65.1%, 54.7% and 19.8%, respectively. Major adverse reactions and their incidence were: anorexia 43.0%, alopecia 37.2%, nausea/vomiting 32.6%, fatigue 18.6%, stomatitis 15.1%, fever 7.0% and diarrhea 5.8%. Therefore, a 21-consecutive-day oral administration of 50 mg/body/day or 75 mg/body/day appears to be effective for the treatment of malignant lymphoma.
我们进行了一项多机构（33个机构）的II期晚期研究，对恶性淋巴瘤患者连续21天口服依托泊苷。患者入选标准为对标准疗法耐药或无合适治疗方案的患者。每日一次，剂量为50mg/体，连续给药21天。88例入选患者中，83例可评估，总缓解率为53.0%（44/83），包括10例完全缓解（CR）；非霍奇金淋巴瘤患者的缓解率为52.5%（42/80，9例CR），霍奇金病患者的缓解率为100%（2/2，1例CR）。关于实验室检查异常，观察到骨髓抑制；白细胞减少（3级发生率为23.3%）、中性粒细胞减少（32.6%）、血红蛋白降低（17.4%）和血小板减少（4.7%）的发生率分别为70.9%、65.1%、54.7%和19.8%。主要不良反应及其发生率为：厌食43.0%、脱发37.2%、恶心/呕吐32.6%、疲劳18.6%、口腔炎15.1%、发热7.0%和腹泻5.8%。因此，连续21天口服50mg/体/天或75mg/体/天似乎对恶性淋巴瘤的治疗有效。
