Trial Information

Adjuvant Low-Dose Interleukin-2 (IL2) Plus Interferone-Alpha (IFN) in Operable Renal Cell Cancer (RCC). Phase III, Randomized, Multicenter Trial of the Italian Oncology Group for Clinical Research (GOIRC).

For pts with non-metastatic RCC, no standard adjuvant treatment exists. Immunotherapy (IT)
using IFN and/or IL2 is effective in metastatic disease setting. Low and chronically
repeated doses of IL2 plus IFN induce a persistent stimulation of the immune system with no
relevant toxicity.

Surgically treated RCC pts were randomized to the following arms: A) low-dose IT; B) control
arm. IT consisted of a 4-week cycle of s.c. IL2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1
million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 of each week). Cycles were
repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years.
Each patient received 12 cycles in 5 years. Inclusion criteria were as follows: histological
diagnosis of RCC, age <75 yrs, radical or partial nephrectomy within the past 3 months, pT1
(diameter of T > 2,5 cm), T2, T3 a-b-c; pN0-pN3, M0; good cardiac and renal function and no
autoimmune disease.