重组β-干扰素最大耐受剂量用于晚期非小细胞肺癌患者的II期研究：一项癌症与白血病B组研究

A phase II study of recombinant beta-interferon at maximum tolerated dose in patients with advanced non-small cell lung cancer: a cancer and leukemia group B study.

作者信息

Wheeler R H, Herndon J E, Clamon G H, Green M R

机构信息

Comprehensive Cancer Center, University of Alabama at Birmingham 35294-3300.

出版信息

J Immunother Emphasis Tumor Immunol. 1994 Apr;15(3):212-6. doi: 10.1097/00002371-199404000-00007.

DOI:10.1097/00002371-199404000-00007

PMID:8032544

Abstract

Forty-one patients with advanced non-small cell lung cancer (NSCLC) were entered into a phase II study of high dose recombinant interferon (rIFN)-beta. Patients received intravenous (i.v.) rIFN-beta on a Monday, Wednesday, Friday schedule with a weekly dose escalation until > or = grade 3 toxicity or 720 x 10(6) IU/dose was achieved. Thirty-eight patients were eligible. Seventeen patients received the highest planned dose of rIFN-beta and 11 experienced dose-limiting toxicity at lower doses. Ten patients developed progressive disease before grade 3 toxicity was reached. There were no objective responses observed. Significant and dose-limiting toxicities included nausea and vomiting, fever, rigors, severe dyspnea, hypotension, and hypertension. IFN-beta has no measurable antitumor activity against NSCLC even at maximum tolerated doses (MTDs).

摘要

41例晚期非小细胞肺癌（NSCLC）患者进入高剂量重组干扰素（rIFN）-β的II期研究。患者于周一、周三、周五接受静脉注射rIFN-β，每周剂量递增，直至出现≥3级毒性或达到720×10⁶IU/剂量。38例患者符合条件。17例患者接受了计划的最高剂量rIFN-β，11例在较低剂量时出现剂量限制性毒性。10例患者在达到3级毒性之前病情进展。未观察到客观缓解。显著的剂量限制性毒性包括恶心、呕吐、发热、寒战、严重呼吸困难、低血压和高血压。即使在最大耐受剂量（MTD）下，IFN-β对NSCLC也没有可测量的抗肿瘤活性。