THE TREATMENT OF METASTATIC RENAL-CELL CARCINOMA PATIENTS WITH RECOMBINANT HUMAN GAMMA-INTERFERON

PURPOSE Activity has been reported in phase II single-center, open-lab el studies after administration of low-dose recombinant interferon gam ma-1b (rIFN-gamma) to patients with metastatic renal cell carcinoma, w ith an overall objective response proportion of around 15%. To confirm these data and define the complete response rate, we conducted a mult icenter open-label trial in which 204 patients with metastatic renal c ell carcinoma were treated with rIFN-gamma. PATIENTS AND METHODS Two h undred and seven patients (134 males, 73 females, mean age 59) were en rolled, and 202 were evaluable, rIFN-gamma, 60: mu g/m(2), was adminis tered subcutaneously once every 7 days until disease progression. RESU LTS There were three (1.5%) complete responses and three (1.5%) partia l responses, for an overall response proportion of 3% (95% CI: 1.2%, 6 .7%). The median response duration was 13.3 months (range: 2 to 23 mon ths). The median survival was 13.4 months (5.5 months to 29.2 months). Three (1%) deaths were observed during the course of study; they were considered to be related to progressive metastatic renal cell carcino ma. Toxicity was minimal, with 14% of patients experiencing grade 3/4 toxicity. The most frequent adverse events were chills (59%), fever (5 8%), asthenia (53%), nausea (29%), and headache (18%). Multivariate an alysis revealed that younger age, higher performance status, higher he moglobin, and lower LDH were predictive of survival. DISCUSSION Recomb inant interferon gamma 1b has only minimal efficacy in the treatment o f metastatic renal cell carcinoma. Pretreatment variables associated w ith increased survival were male sex, higher Karnofsky performance sta tus, higher hemoglobin, and low LDH.