title: Interleukin-2 and 13-cis retinoic acid as maintenance therapy in advanced ovarian cancer.
abstract: The primary objective was to assess whether low-dose Interleukin-2 (IL-2) and 13-cis-retinoic acid (RA) could decrease serum vascular endothelial growth factor (VEGF) and improve the immune function of patients with advanced ovarian cancer (AOC) responsive to chemotherapy. The secondary end-point was to compare the response of these patients with that of a group of control patients, treated with standard care. Forty-four patients with AOC, responding to chemotherapy and with elevated serum levels of VEGF, were entered into the study from 04/98 to 12/02. After chemotherapy, patients received self-administered subcutaneous IL-2, 1.8x10(6) IU and oral RA, 0.5 mg/kg for 5 days/week for 2 consecutive cycles of 3 weeks, with a 1-week rest, for 1 year and with intermittent schedules for up to 5 years. Eighty-two well-matched controls were selected from a large cohort of patients of similar disease status, treated with standard therapies. A statistically significant decrease of VEGF was observed amongst the 44 evaluable patients. Lymphocyte NK counts and CD4+/CD8+ ratio improved with respect to both baseline values and controls. The progression-free survival (PFS) and overall survival (OS) curves showed a statistically significant improvement in IL-2/RA-treated patients. These preliminary data show that, after chemotherapy for AOC, the administration of low-dose subcutaneous IL-2 and oral RA is feasible, has low toxicity, is cost-effective and improves both PFS and OS.
authors.affiliation: Ospedale Civile di Avezzano, Unità Operativa di Oncologia, Rome, Italy. frecchia1946@libero.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Recchia
authors.forename: Gaetano
authors.initials: G
authors.lastname: Saggio
authors.forename: Alisia
authors.initials: A
authors.lastname: Cesta
authors.forename: Giampiero
authors.initials: G
authors.lastname: Candeloro
authors.forename: Antonio
authors.initials: A
authors.lastname: Nuzzo
authors.forename: Marco
authors.initials: M
authors.lastname: Lombardo
authors.forename: Gaspare
authors.initials: G
authors.lastname: Carta
authors.forename: Silvio
authors.initials: S
authors.lastname: Rea
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology; D018414:CD8-Positive T-Lymphocytes / Q000166:cytology; D045744:Cell Line, Tumor; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D007376:Interleukin-2 / Q000378:metabolism*; D015474:Isotretinoin / Q000378:metabolism*; D007694:Killer Cells, Natural / Q000166:cytology; D008214:Lymphocytes / Q000166:cytology; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000378:metabolism*; D013997:Time Factors; D016896:Treatment Outcome; D014212:Tretinoin / Q000494:pharmacology; D042461:Vascular Endothelial Growth Factor A / Q000378:metabolism
chemical_list: D007376:Interleukin-2; D042461:Vascular Endothelial Growth Factor A; D014212:Tretinoin; D015474:Isotretinoin