title: Daily low-dose subcutaneous recombinant interleukin-2 by alternate weekly administration: antitumor activity and immunomodulatory effects.
abstract: A phase II clinical trial of subcutaneous recombinant Interleukin 2 (rIL-2) given by 5 days pulses followed by a 9 days rest has been performed in patients affected by renal cell carcinoma, malignant melanoma and colorectal cancer. A total of 25 patients entered the study, completed at least six courses of treatment, and were evaluable for toxicity and response to treatment. This schedule of subcutaneous rIL-2 was well tolerated and no World Health Organization grade 3 side effects were observed. A 33.3% response rate was recorded in patients affected by renal cell carcinoma, although no major responses were achieved in patients with malignant melanoma and colorectal cancer. A durable increase of natural killer activity retained by poeripheral blood mononuclear cells was demonstrated in these patients and was paralleled by increased serum levels of interferon gamma and tumor necrosis factor a without changes of circulating interleukin-1d. It is concluded that this schedule of pulse administration of subcutaneous rIL-2 has antitumor activity in renal cell carcinoma and produces durable biomodulatory effects.
authors.affiliation: Cattedra di Oncologia Medica, Facoltà di Medicina, Università, Federico II di Napoli, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Tagliaferri
authors.forename: C
authors.initials: C
authors.lastname: Barile
authors.forename: M
authors.initials: M
authors.lastname: Caraglia
authors.forename: R
authors.initials: R
authors.lastname: Guarrasi
authors.forename: D
authors.initials: D
authors.lastname: Morelli
authors.forename: B
authors.initials: B
authors.lastname: Ricciardi
authors.forename: A
authors.initials: A
authors.lastname: Martignetti
authors.forename: M T
authors.initials: MT
authors.lastname: Librera
authors.forename: E
authors.initials: E
authors.lastname: Matano
authors.forename: A
authors.initials: A
authors.lastname: Della Vecchia
authors.forename: G
authors.initials: G
authors.lastname: Catalano
authors.forename: M
authors.initials: M
authors.lastname: Famiani
authors.forename: G
authors.initials: G
authors.lastname: Palmieri
authors.forename: P
authors.initials: P
authors.lastname: Correale
authors.forename: A R
authors.initials: AR
authors.lastname: Bianco
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000097:blood / Q000188:drug therapy*; D015179:Colorectal Neoplasms / Q000097:blood / Q000188:drug therapy*; D016207:Cytokines / Q000097:blood; D004334:Drug Administration Schedule; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000097:blood / Q000188:drug therapy*; D008545:Melanoma / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D016207:Cytokines; D007155:Immunologic Factors; D007376:Interleukin-2; D011994:Recombinant Proteins