Abstract
In the treatment of renal cell carcinoma both complete (CRs) and partial remissions (PRs) have been obtained using recombinant (r) interferon alpha (IFN-alpha), with response rates ranging from 0 to 31% (mean 16%). rIFN-gamma is a potent immunostimulating agent, but the clinical experience of its use is limited and results are conflicting. In a phase II study with the combination of rIFN-alpha 2c (Boehringer Ingelheim) and rIFN-gamma (Genentech, supplied by Boehringer Ingelheim) in 31 eligible patients, a response rate of 25% was recorded. Based on this observation a randomised phase III study was initiated to investigate the possible advantage of the addition rIFN-gamma to rIFN-alpha 2c treatment. Treatment consisted of rIFN-alpha 2c 30 micrograms m-2 = 10 x 10(6) IU m-2 s.c. twice weekly in arm A and the same dose of rIFN-alpha combined with rIFN-gamma 100 micrograms m-2 = 2 x 10(6) IU m-2 in arm B. Eligibility criteria included documented progression of disease; patients with bone lesions only and overt central nervous system metastases were excluded. Between November 1988 and September 1990, 102 patients were entered into the study. An interim analysis showed a response in 7/53 (13%) patients (two CRs and five PRs) in the rIFN-alpha 2c monotherapy arm and in 2/45 (4%) (one CR and one PR) patients in the combination arm. This difference was not statistically significant (P = 0.17). The probability of missing an eventual 10% advantage for the combination is 0.001. The numbers are insufficient to rule out a negative effect of the addition of rIFN-gamma. The dose intensity of IFN-alpha 2c for the two treatment arms was the same. The addition of rIFN-gamma does not improve the response rate of rIFN-alpha 2c monotherapy. A possible detrimental effect cannot be excluded.
Highlights
Nijnegen, In treatment of renal both ce cmplte (CRs) and partial rmis (PRs) have been obtained using recombinant (r) inteeron alpha (IFN-a), with response rates ranging from 0 to 31%
Eligbility criteria includ documented pro on of disase; patients with bone lesions only and overt central nervous system mastases ded Between November and September 1990, 102 patients we entered into the study
The criteria for measurability of disease were according to the EORTC Data Center procedures manual
Summary
In treatment of renal both ce cmplte (CRs) and partial rmis (PRs) have been obtained using recombinant (r) inteeron alpha (IFN-a), with response rates ranging from 0 to 31%. Based on advantage the of this observation addition with lmised a rIFN-y to (Boehringer combination of lm) in 31. I phase rFN-a, m rIFN-a, eligible patients, a study was initiated treatnenL and response rate of 25%. Twice weeky in arm A and the same dose of rIFN-a combined with rIFN-j pg m-2 = 2 x 10' IU m-2 in arm B. 7/53 (13%) patients (two CRs and five PRs) in the rIFN-ax monotherapy arm and in 2/45 (4%) (one CR and one PR) patients in the combination arm. This differene was not statisl sigifiant (P = 0.17). The addition of rIFN- does not improve the response rate of rIFN42, monotherapy.
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