重组DNAα2人干扰素在非网状内皮系统恶性肿瘤患者中的I期临床耐受性研究。

A phase I clinical tolerance study of rDNA alpha 2 human interferon in patients with non-reticuloendothelial system malignancies.

作者信息

Edelstein M B, Schellekens H, Laurent T, Gauci L

出版信息

Eur J Cancer Clin Oncol. 1983 Jul;19(7):891-4. doi: 10.1016/0277-5379(83)90053-6.

Abstract

Twenty-seven patients with non-reticuloendothelial malignancies were treated with a single intramuscular injection of recombinant leukocyte alpha 2 interferon (rIFN) to assess clinical tolerance and define a maximum tolerated dose. A single patient in each of six increasing dosage groups (0.3 X 10(6) IU, 1 X 10(6) IU, 3 X 10(6) IU, 10 X 10(6) IU, 30 X 10(6) IU, 100 X 10(6) IU) received a low dose (0.01 X 10(6) IU) and served as a control for subjective and objective toxicity measurements. Severe fatigue proved dose-limiting at 100 X 10(6) IU, and all dosages above 3.0 X 10(6) IU produced one or more signs or symptoms, which typically resembled a 'flu-like' syndrome. Objective toxicity was mild to moderate (leukopenia, thrombopenia) and no toxicities were found not already known from work with interferon obtained directly from leukocytes. Evidence of an antitumor effect was apparent in 3/19 evaluable patients.

摘要

27例非网状内皮系统恶性肿瘤患者接受了单次肌肉注射重组白细胞α2干扰素（rIFN），以评估临床耐受性并确定最大耐受剂量。六个递增剂量组（0.3×10⁶IU、1×10⁶IU、3×10⁶IU、10×10⁶IU、30×10⁶IU、100×10⁶IU）每组各有1例患者接受低剂量（0.01×10⁶IU）注射，并作为主观和客观毒性测量的对照。100×10⁶IU时严重疲劳成为剂量限制因素，3.0×10⁶IU以上的所有剂量均产生一种或多种体征或症状，这些症状通常类似于“流感样”综合征。客观毒性为轻度至中度（白细胞减少、血小板减少），未发现直接从白细胞获得的干扰素研究中未知的毒性。19例可评估患者中有3例出现抗肿瘤效应的证据。