Recombinant interleukin-2 in metastatic renal cell carcinoma—A European multicentre phase II study

H. von der Maase , P. Geertsen , N. Thatcher , C. Jasmin , A. Mercatello , S.D. Fosså , M. Symann , G. Stoter , G. Nagel , L. Israel , R. Oskam , P. Palmer , C.R. Franks
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引用次数: 47

Abstract

This multinational, multicentre study represents the introduction of recombinant interleukin-2 (rIL-2) in Europe. From December 1987 to June 1989, 57 eligible patients with metastatic renal cell cancer were treated with rIL-2 administered as continuous intravenous infusion. 8 out of 51 evaluable patients responded (16%), 2 complete remission (CR) and 6 partial remission (PR). 10 patients had no change (20%). The response duration for CR was 209 and 394+ days. The median response duration for PR was 371 (range 140–506+) days. Dose-limiting grade 3–4 toxicities were hypotension in 52% of the patients, arrhythmia (4%), dyspnoea (8%), creatinine rise (4%), peripheral neurotoxicity (10%) and central neurotoxicity (10%). Toxicities most often recovered solely on interrupted therapy. 2 patients died due to catheter-related septicaemia and one patient died of rIL-2 induced renal failure. The study confirmed the antitumour efficacy of rIL-2 in renal cell cancer. Toxicities were numerous, but manageable by close observation in a normal oncology ward without routine use of an intensive care unit.

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重组白介素-2在转移性肾细胞癌中的作用——一项欧洲多中心II期研究
这项跨国、多中心的研究代表了重组白介素-2 (il -2)在欧洲的引入。从1987年12月到1989年6月,57例符合条件的转移性肾细胞癌患者接受了持续静脉输注rIL-2的治疗。51例可评估患者中有8例(16%)缓解,2例完全缓解(CR)和6例部分缓解(PR)。10例患者无变化(20%)。CR的反应持续时间分别为209天和394+天。PR的中位反应持续时间为371天(140-506天以上)。剂量限制的3-4级毒性为:52%的患者低血压、4%的患者心律失常、8%的患者呼吸困难、4%的患者肌酐升高、10%的患者周围神经毒性和10%的患者中枢神经毒性。毒性通常仅在中断治疗后才恢复。2例患者死于导管相关性败血症,1例患者死于il -2引起的肾功能衰竭。研究证实了rIL-2在肾细胞癌中的抗肿瘤作用。毒性是很多的,但在正常的肿瘤病房密切观察,没有常规使用重症监护病房控制。
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