title: Immunotherapy in patients with less than complete response to chemotherapy.
abstract: BACKGROUND
  Patients with metastatic solid tumors (MST) with less than a complete response to chemotherapy (L-CR), a depressed immune system and elevated serum vascular endothelial growth factor (VEGF) lack defined treatment options. The primary endpoint evaluated in this study was whether interleukin-2 (IL-2) and 13-cisretinoic acid (RA) treatment reduced VEGF and improved immune function in such patients. Secondary endpoints were objective response, relapse-free survival (RFS), and overall survival (OS).
  
  
  METHODS
  One hundred consecutive MST patients with L-CR and a mean serum VEGF of 421.0 pg/mm3 were enrolled. Patients self-administered subcutaneous IL-2 1.8 x 10(6) IU/day, and oral RA 0.5 mg/kg/day x 5 days/week for 2 cycles of 3 weeks/month for 1 year and continued until progression.
  
  
  RESULTS
  After a median follow-up of 78 months, a statistically significant VEGF decrease and improvements in lymphocyte, NK, and CD4+/CD8+ ratio were observed. Twenty-four patients were converted to a CR; their 5-year RFS and OS rates were each 96%. No WHO grade 3 or 4 toxicities were observed.
  
  
  CONCLUSIONS
  Administration of IL-2/RA to this patient population produced a significant decrease in VEGF, improvement of prognostically relevant immunological parameters, and durable response in 25% of patients.
authors.affiliation: Unità Operativa di Oncologia, Ospedale Civile di Avezzano, Italy. frecchia1946@libero.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Recchia
authors.forename: Giampiero
authors.initials: G
authors.lastname: Candeloro
authors.forename: Stefano
authors.initials: S
authors.lastname: Necozione
authors.forename: Roberta
authors.initials: R
authors.lastname: Bisegna
authors.forename: Massimo
authors.initials: M
authors.lastname: Bratta
authors.forename: Silvio
authors.initials: S
authors.lastname: Rea