title: Subcutaneous low-dose recombinant interleukin 2 and alpha-interferon in patients with metastatic renal cell carcinoma.
abstract: A double-institution phase II study was performed in patients with metastatic renal cell carcinoma treated subcutaneously (s.c.) with interleukin 2 (IL-2) and alpha-interferon (INF-alpha). Thirty-eight patients were treated over a course of 7 weeks. Initially (day 1 + 2) patients received s.c. IL-2 at 18 x 10(6) IU m-2. During the following 6 weeks, patients received s.c. IL-2 at 3.6 x 10(6) IU m-2 for 5 days per week and s.c. INF-alpha at 5 x 10(6) for 3 days per week. Thirty-eight patients were evaluated for response. An objective response was seen in seven patients (18.4 +/- 12.3%), with one complete response and six partial responses. Median duration of response was 6.7 months. Toxicity could be evaluated in 38 patients and was limited. Mild to moderate toxicity included fever (97%), fatigue or malaise (76%), nausea or vomiting (50%), anorexia (32%), hypotension (26%), neurological disturbances (26%) and hypercreatininaemia (39%). In addition, four grade IV haematological toxicities were noted. No cardiac side-effects were seen. IL-2 and INF-alpha given by this schedule can be safely administered in an outpatient setting. The objective response rate was similar to our previous treatments with high-dose IL-2 given as a continuous infusion.
authors.affiliation: Department of Medical Oncology, Foundation Bergonié, Comprehensive Cancer Centre, Bordeaux, France.
authors.forename: A
authors.initials: A
authors.lastname: Ravaud
authors.forename: S
authors.initials: S
authors.lastname: Négrier
authors.forename: L
authors.initials: L
authors.lastname: Cany
authors.forename: Y
authors.initials: Y
authors.lastname: Merrouche
authors.forename: M
authors.initials: M
authors.lastname: Le Guillou
authors.forename: J Y
authors.initials: JY
authors.lastname: Blay
authors.forename: M
authors.initials: M
authors.lastname: Clavel
authors.forename: R
authors.initials: R
authors.lastname: Gaston
authors.forename: R
authors.initials: R
authors.lastname: Oskam
authors.forename: T
authors.initials: T
authors.lastname: Philip
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000473:pathology / Q000628:therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007370:Interferon Type I / Q000627:therapeutic use / Q000633:toxicity*; D007376:Interleukin-2 / Q000627:therapeutic use / Q000633:toxicity*; D007680:Kidney Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011994:Recombinant Proteins / Q000627:therapeutic use / Q000633:toxicity
chemical_list: D007370:Interferon Type I; D007376:Interleukin-2; D011994:Recombinant Proteins