Sequential administration of interferon gamma and interleukin-2 in metastatic renal cell carcinoma: results of a phase II trial. Austrian Renal Cell Carcinoma Study Group.
BACKGROUND
Because of the known efficacy of several cytokines in the treatment of advanced renal cell cancer (RCC), we have conducted a phase II trial of the efficacy and toxicity of subcutaneous interferon gamma (IFNgamma) and interleukin-2 (IL-2).


METHODS
63 patients with progressive metastatic RCC were treated with 100 microg recombinant IFNgamma1b administered three times weekly during weeks 1 and 2 and with 4.5 MU recombinant IL-2 administered on 4 consecutive days during weeks 3 and 4, every 6 weeks.


RESULTS
11% of patients had an objective response (CR: 3%, PR: 8%), 33% had SD. Toxicity was generally mild. The median duration of remissions (CR + PR) was 9.6 months; the median duration of SD 8 months. A significant survival benefit was evident at a median observation time of 51 months for patients (44%) responding to therapy (P < 0.0001).


CONCLUSIONS
we conclude that sequential treatment with IFNgamma and IL-2 may prolong survival in patients with metastatic RCC responding to therapy.
Schmidinger
M
M
Department of Medicine I, University Hospital, Vienna, Austria.
Steger
G G
GG
Wenzel
C
C
Locker
G J
GJ
Brodowicz
T
T
Budinsky
A C
AC
Wiltschke
C
C
Kramer
G
G
Marberger
M
M
Zielinski
C C
CC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007371:Interferon-gamma / Q000008:administration & dosage / Q000009:adverse effects; D007376:Interleukin-2 / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage; D016019:Survival Analysis
D007376:Interleukin-2; D011994:Recombinant Proteins; D007371:Interferon-gamma; C082598:aldesleukin