Niijima T, Akaza H, Koyanagi T, Togashi M, Kumamoto Y, Funyu T, Suzuki T, Orikasa S, Yoshikawa K, Koiso K
Hinyokika Kiyo. 1992 Oct;38(10):1201-7.
The combination therapy with natural type human tumor necrosis factor (n-TNF; MHR-24) and human lymphoblastoid interferon-alpha (n-IFN-alpha; MOR-22) was investigated for antitumor effect against renal cell carcinoma in a multiclinic cooperative study throughout Japan. The "Response criteria of Japan Society for Cancer Therapy" were followed for the handling of subjects and the evaluation of antitumor effect. MHR-24 was administered at a daily dosage of 5,000-10,000 JRU by intravenous drip and MOR-22 at a dosage of 5,000,000 IU daily was administered intramuscularly at the same time. Both drugs were administered for 4 weeks or longer. A total of 36 patients were enrolled as subjects in the study. None of them were classified as ineligible. Five patients, were classified as imperfectly evaluable, and 31, as evaluable for the results of treatment. The responses in the evaluable patients were partial response (PR) in 4 patients, minor response (MR) in 3 patients, no change (NC) in 14 patients and progressive disease (PD) in 10 patients, with a response rate of 12.9%. Adverse reactions to the therapy were investigated in all 36 patients. The frequent subjective and objective reactions that occurred were fever, rigors and shivering, anorexia, and generalized malaise, and the frequent abnormal laboratory findings were leukopenia, thrombocytopenia, elevation of GOT, and elevation of GPT.
在一项全日本多中心合作研究中，对天然型人肿瘤坏死因子（n-TNF；MHR-24）与人类淋巴母细胞样α干扰素（n-IFN-α；MOR-22）联合治疗肾细胞癌的抗肿瘤效果进行了研究。在受试者的处理和抗肿瘤效果评估方面遵循了“日本癌症治疗协会的反应标准”。MHR-24通过静脉滴注，每日剂量为5000 - 10000 JRU，同时MOR-22每日剂量为5000000 IU，通过肌肉注射给药。两种药物均给药4周或更长时间。共有36例患者被纳入该研究作为受试者。他们均未被分类为不合格。5例患者被分类为评估不完全，31例患者可对治疗结果进行评估。在可评估的患者中，反应情况为4例部分缓解（PR），3例轻微缓解（MR），14例无变化（NC），10例疾病进展（PD），缓解率为12.9%。对所有36例患者的治疗不良反应进行了调查。常见的主观和客观反应为发热、寒战、发抖、厌食和全身不适，常见的实验室异常结果为白细胞减少、血小板减少、谷草转氨酶升高和谷丙转氨酶升高。
