Objective To establish whether the use of interferon-alpha might resul
t in improved survival, using two large series of patients with advanc
ed renal cell cancer treated during studies of chemotherapy and biolog
ical therapy, respectively. Patients and methods Patients treated eith
er in the Eastern Cooperative Oncology Group (ECOG) chemotherapy proto
cols (327 patients) or in protocols employing interferon as part of a
European randomized study or phase II studies at the Norwegian Radium
Hospital (231 patients) were retrospectively analysed. Groups for comp
arison were matched by exclusion of those with an ECOG performance sta
tus >2, no prior nephrectomy, brain metastases or prior chemotherapy.
Univariate analysis of prognostic factors for survival was performed b
y the log rank method and multivariate analysis by Cox regression. Res
ults Univariate analysis of the whole population showed that performan
ce status, time from diagnosisto treatment, sites of metastases and th
e use of interferon carried the greatest prognostic significance. In m
ultivariate analysis, the use of interferon remained a significant pre
dictor of survival (P<0.001). Subgroup analysis suggested that the imp
act of interferon treatment was greatest in those patients with two of
the following characteristics; good performance status, an interval o
f >2 years from diagnosis to treatment and no more than one site of me
tastasis. Conclusion Although a prospective randomized trial is needed
to establish definite benefit from the use of interferon in advanced
renal cell cancer, this analysis supports the rationale for performing
such a trial, particularly in patients with relatively good prognosti
c features. Patients should be entered into the Medical Research Counc
il study comparing interferon with medroxyprogesterone acetate.