Effectiveness and toxicity of Interleukin 2, Interferon α,and 5-Fluorouracil in patients with Metastatic Renal Cell Cancer

Purpose:
The purpose of this study was
to evaluate the potential efficacy and
toxicity for the treatment of metastatic
renal cell cancer.

Material and methods:
During the first
4 weeks of treatment, patients received
s.c. IL-2 (Proleukin) in weeks 1 and 4
(10 MIU/m² once daily on days 3-5), in
weeks 2 and 3 (5 MIU/m² once daily on
days 3-5). During weeks 2 and 3, the
dosage for IFN-2B (Roferon) was 5 MIU/m²
on days 1, 3 and 5, in weeks 5-8
(10 MIU/m² once daily on days 1, 3 and 5.
During weeks 5-8, 5-Fu (5 Fluorouracyl)
1000 mg/m² was administered once
weekly by a bolus i.v. injection. Eighteen
patients entered the study. All had
undergone a nephrectomy and had
progressive metastatic disease.

Results:
There were one patient with
complete responses (CRs) and three with
partial responses (PRs) for an objective
response rate of 22.2% (95% confidence
interval). The CR durations were
20 months for one patient. The patient
who remains disease-free had the
disease in the lung and kidney. The PR
durations ranged from 2 to 9 months. The
median survival of the study group is 8.7
months (range 1 to 23 months). The most
common toxicities during IL-2/IFN and
5-Fu were fatigue, nausea/vomiting,
anorexia, skin rash, injection site
inflammation, diarrhea, fever. 12 of 18
patients experienced grade 2/3
granulocytopenia, and four other patients
experienced thrombocytopenia. An
out-patient treatment system was feasible
and positively viewed by the patients.

Conclusions:
In view of a lack of effective
therapy methods, the immunochemotherapy
applied by the authors on all
metastatic renal cell carcinoma patients,
may be an optional treatment, with an
acceptable level of complications.