Monotherapy and Combination Therapy with Interferon-α, Interferon-γ, and Tumor Necrosis Factor-α in Metastatic Renal Cell Carcinoma

Mulder, P.H.M. de; Franssen, M.P.H.; Punt, C. J. A.; Debruyne, F.M.J.

doi:10.1007/978-3-642-75853-9_13

Cited by 1 publication

(3 citation statements)

References 21 publications

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“…The IFN-y dose used in the present study was within the same range. One of the explanations of the generally low response rate in combination studies could be the relatively low dose of IFN-given in these studies (De Mulder et al, 1991). In the present study this explanation is unlikely in view of the almost identical dose intensity of IFN-2c in the two treatment arms.…”

Section: Toxicitymentioning

confidence: 54%

“…Observed grade II and III toxicity is given in Table IV obtained from pooled data is about 17% (Krown, 1987;Muss, 1988;Horoszewicz et al, 1989;De Mulder et al, 1991). (Geboers et al, 1988).…”

Section: Toxicitymentioning

confidence: 99%

“…The maximal tolerated dose of was 30 gm 2 (6-36 pg m-). The feasibility and efficacy of this approach was proven in the tratment of a second cohort of patients (De Mulder et al, 1991 (Figure 1). The time to progression is given in Figure 2.…”

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confidence: 99%

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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

Mulder

Oosterhof²,

Bouffioux³

et al. 1995

Br J Cancer

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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 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.

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Section: Toxicitymentioning

confidence: 54%