RT Journal Article
SR Electronic
T1 Phase II Randomized Study of Interleukin-2 with or without 13-cis Retinoic Acid as Maintenance Therapy in Patients with Advanced Cancer Responsive to Chemotherapy
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 3149
OP 3157
VO 25
IS 4
A1 RECCHIA, FRANCESCO
A1 SAGGIO, GAETANO
A1 CESTA, ALISIA
A1 ALESSE, EDOARDO
A1 GALLO, RITA
A1 NECOZIONE, STEFANO
A1 REA, SILVIO
YR 2005
UL http://ar.iiarjournals.org/content/25/4/3149.abstract
AB Aim: In a previous phase 1B study, we determined the optimal biological dose of interleukin-2 (IL-2) and 13-cis retinoic acid (RA), given as maintenance therapy to patients with a variety of solid tumors, responding to chemotherapy, with a high risk of relapse. This therapy produced a statistically significant increase of the CD4+/CD8+ ratio, natural killer (NK) and lymphocyte cell counts and a decrease of vascular endothelial growth factor (VEGF). The aim of this phase II randomized study was to verify the role of RA in this drug combination. Patients and Methods: One hundred and twelve patients, with locally advanced or metastatic tumors responding to chemotherapy, were randomized to receive IL-2, 1.8×106 I.U. for 5 days/week for 2 consecutive cycles of 3 weeks, with a 1-week interval (arm A), or the same regimen plus oral RA, 0.5 mg/Kg (arm B). VEGF, the CD4+/CD8+ ratio, NK and tumor markers were assessed every 2 months and response every 4 months. Results: The baseline characteristics were well balanced between the two treatment arms for age, performance status, type of disease, amount of previous chemotherapy and baseline values of NK, CD4+/CD8+ and VEGF. Toxicity was minor in both arms. After a median follow-up of 42 months, all immunological parameters improved in both arms with respect to the baseline values; this improvement was statistically more significant in arm B. There was no statistically significant difference in progression-free and in overall survival between the two arms. Conclusion: These data show that low-dose IL-2 and oral RA is more effective than IL-2 alone in improving all known prognostically significant parameters in a variety of solid tumors, including an increase of lymphocytes and a decrease of VEGF. Copyright© 2005 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved