Phase II study of interferon-gamma versus interleukin-2 and interferon-alpha 2b in metastatic renal cell carcinoma.
OBJECTIVE
In a randomized phase II study we evaluated response, survival and side effects of low dose recombinant interferon-gamma in 30 patients (group 1) versus recombinant interleukin-2 and interferon-alpha 2b in 30 (group 2) with metastatic renal cell carcinoma.


METHODS
Group 1 received 200 micrograms interferon-gamma subcutaneously once a week. Group 2 received 4 x 4.8 x 10(6) IU/m.2 interleukin-2 subcutaneously on days 1 and 22, 2 x 4.8 x 10(6) IU/m.2 on days 2 and 23, and 2 x 2.4 x 10(6) IU/m.2 combined with interferon-alpha 2b subcutaneously at 3 x 10(6) IU/m.2 on days 3, 5, 24 and 26, and 6 x 10(6) IU/m.2 3 times weekly for 6 weeks.


RESULTS
Toxicity grades 2 and 3 (World Health Organization) were observed in group 2 only. After followup of 13 months there was no remission in group 1 compared to 7 remissions in group 2, with 23 cases of progressive disease detected.


CONCLUSIONS
Combination therapy showed an objective response rate of 23% (p = 0.01). Although survival was not a primary aim of the study, there was a tendency toward no significant difference in survival when evaluating these relatively small groups (p = 0.49).
Lümmen
G
G
Department of Urology, University of Essen Medical School, Germany.
Goepel
M
M
Möllhoff
S
S
Hinke
A
A
Otto
T
T
Rübben
H
H
D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000401:mortality / Q000556:secondary* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D007371:Interferon-gamma / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D015996:Survival Rate
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins; D007371:Interferon-gamma