title: Recombinant interleukin-2 in metastatic renal cell carcinoma--a European multicentre phase II study.
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.
authors.affiliation: Department of Oncology, Herlev University Hospital, Copenhagen, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: von der Maase
authors.forename: P
authors.initials: P
authors.lastname: Geertsen
authors.forename: N
authors.initials: N
authors.lastname: Thatcher
authors.forename: C
authors.initials: C
authors.lastname: Jasmin
authors.forename: A
authors.initials: A
authors.lastname: Mercatello
authors.forename: S D
authors.initials: SD
authors.lastname: Fosså
authors.forename: M
authors.initials: M
authors.lastname: Symann
authors.forename: G
authors.initials: G
authors.lastname: Stoter
authors.forename: G
authors.initials: G
authors.lastname: Nagel
authors.forename: L
authors.initials: L
authors.lastname: Israel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000556:secondary*; D004341:Drug Evaluation; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins