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Title
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EORTC (30885) randomised phase III study with recombinant interferon alpha and recombinant interferon alpha and gamma in patients with advanced renal cell carcinoma
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Author
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Abstract
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| 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 pg 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 mu g 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. |
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Language
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English
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Source (journal)
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The British journal of cancer. - London
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Publication
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London
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1995
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ISSN
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0007-0920
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DOI
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10.1038/BJC.1995.75
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Volume/pages
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71
:2
(1995)
, p. 371-375
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ISI
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A1995QF12000030
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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