title: Immunotherapy of renal cell carcinoma with granulocyte macrophage colony stimulating factor and very low dose interleukin-2.
abstract: We have performed a translational phase II trial testing an original immunotherapy schedule based on the monthly subcutaneous (s.c.) administration of hrGM-CSF (days 1 through 5) and very low dose hrIL-2 (days 6 through 15) in 19 patients with metastatic renal cell carcinoma. Bone pain, first dose reaction to GM-CSF, asthenia and fever were the most common side effects. A partial response, and a disease stabilization were respectively observed in 4 and 11 cases, with a rate of objective response and a disease control rate respectively of 21% and 79%. We recorded a time to progression of 9 months and a 2- and 3-year survival respectively of 42% (8/19 patients) and 26% (5/19 patients). Our results suggest that this GM-CSF/hrIL-2 combination is active and well tolerated in patients with renal cell carcinoma and deserves to be investigated in larger comparative trials.
authors.affiliation: Interdipartimental Oncopharmacology Center, Faculty of Medicine, University of Siena, Viale Bracci 11, 53100 Siena, Italy.
authors.forename: Pierpaolo
authors.initials: P
authors.lastname: Correale
authors.forename: Stefania
authors.initials: S
authors.lastname: Marsili
authors.forename: Marianna
authors.initials: M
authors.lastname: Sabatino
authors.forename: Francesco
authors.initials: F
authors.lastname: Montagnani
authors.forename: Giorgio
authors.initials: G
authors.lastname: Giorgi
authors.forename: Guido
authors.initials: G
authors.lastname: Francini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000378:metabolism / Q000627:therapeutic use*; D006801:Humans; D007167:Immunotherapy / Q000191:economics / Q000379:methods*; D007376:Interleukin-2 / Q000378:metabolism / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins / Q000737:chemistry; D016896:Treatment Outcome
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor