Taguchi T
Cancer. 1986 Apr 15;57(8 Suppl):1705-8. doi: 10.1002/1097-0142(19860415)57:8+<1705::aid-cncr2820571314>3.0.co;2-u.
A Phase I study of interferon alfa-2a was conducted in 20 patients with disseminated cancer to establish the relationship between dose and interferon-related side effects. Fever was the most common side effect, and was not dose-related. Other side effects not related to dose included flu-like symptoms, gastrointestinal symptoms, and numbness of fingers and toes. A dose-response relationship was seen for leukopenia, thrombocytopenia, and the elevation of serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT). A Phase II study was then conducted in 641 patients to evaluate the efficacy of interferon alfa-2a in a number of disseminated malignant neoplasms. The 415 male and 226 female patients, almost all of whom had malignancies refractory to standard therapy, were treated with interferon alfa-2a at an initial daily dose of 3 X 10(6) U for 3 days. Doses were increased gradually at 3- to 7-day intervals until the therapeutic dosage was established. The daily dose could not exceed 50 X 10(6) U, and treatment was continued for at least one month. Efficacy rates, for 65 patients who achieved partial or complete responses, based on the total number of evaluable patients by cancer type were: 11/49 (22.4%), multiple myeloma; 4/21 (19%), lymphomas; 15/108 (13.8%), renal cell carcinoma; 2/30 (6.6%), bladder cancer; 4/39 (10.2%), brain tumors; 5/26 (19.2%), melanoma; 12/12 (100%), cutaneous lymphoma; 10/19 (52.6%), other skin cancers; 2/30 (6.6%), bone and soft tissue sarcomas. Overall, 65/371 (17.5%) of evaluable subjects responded.
对20例播散性癌症患者进行了α-2a干扰素的I期研究，以确定剂量与干扰素相关副作用之间的关系。发热是最常见的副作用，且与剂量无关。其他与剂量无关的副作用包括流感样症状、胃肠道症状以及手指和脚趾麻木。白细胞减少、血小板减少以及血清谷草转氨酶（SGOT）和血清谷丙转氨酶（SGPT）升高呈现剂量反应关系。随后对641例患者进行了II期研究，以评估α-2a干扰素对多种播散性恶性肿瘤的疗效。415例男性和226例女性患者，几乎所有人的恶性肿瘤对标准治疗均耐药，初始每日剂量为3×10⁶U的α-2a干扰素治疗3天。剂量每隔3至7天逐渐增加，直至确定治疗剂量。每日剂量不得超过50×10⁶U，治疗持续至少1个月。根据可评估患者总数按癌症类型计算，65例达到部分或完全缓解患者的有效率分别为：多发性骨髓瘤，11/49（22.4%）；淋巴瘤，4/21（19%）；肾细胞癌，15/108（13.8%）；膀胱癌，2/30（6.6%）；脑肿瘤，4/39（10.2%）；黑色素瘤，5/26（19.2%）；皮肤淋巴瘤，12/12（100%）；其他皮肤癌，10/19（52.6%）；骨和软组织肉瘤，2/30（6.6%）。总体而言，371例可评估受试者中有65例（17.5%）有反应。
