1. Phase III randomized study of two fluorouracil combinations with either interferon alfa-2a or leucovorin for advanced colorectal cancer. Corfu-A Study Group
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A. Jorgensen, C. Cripps, R. Mayer Steinacker, Y. Merrouche, A. Man, G. Batist, J. Schuller, M. Wirth, S. Pyrhonen, G. Vantrappen, H. Bergermann, B. Weinerman, A. Jakobsen, A. Scaletzky, J. Seitz, Jean A. Maroun, H. Ravn, J. Bury, E. Francois, D. Lutz, R. Johansson, H. Smith, C. Blaes, F. Porzsolt, B. May, E. Pannuti, M. Budde, John A. Levi, Peter Sherman, J. Skillings, R. Goel, J. Heise, M. Froimtchuk, P. Guillou, M. De Lourdes Lopes De Oliveira, W. Kocha, P. Lankisch, P. Selby, K. Bertelsen, M Namer, John Stewart, Euan Walpole, R. Mertelsmann, J. Primrose, S. Holmstrom, P. Carey, J. Mejlholm, David R. Bell, Damien Thomson, U. Ward, G. Boos, Allan Solomon Zimet, V. Fosser, R. Luykx, T. Shore, G. Massimini, Stephen P. Ackland, Michael D. Green, E. Lindegaard Madsen, J. Salomon, M. Colleoni, A. K. L. Yap, John Zalcberg, G. Cartei, M. Schupp, E. E. Holdener, M. Giovannini, R. Egeli, C. Berg, P. Rebattu, Y. Becouarn, N. Brunsgaard, L. Cockey, C. Sodomann, L. Lepoutre, M. Reginster, M. Kjaer, E. Sandberg, J. Greving, L. De Facq, S. Somers, R. Brunet, O. P. Isokangas, E. Van Cutsem, C. Gadeberg, U. Fogl, E. Bajetta, P. Rougier, V. Kataja, and D. Dalley
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Adult ,Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Adolescent ,Leucovorin ,Interferon alfa-2a ,Interferon alpha-2 ,Drug Administration Schedule ,law.invention ,Advanced colorectal cancer ,Randomized controlled trial ,Interferon ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Aged ,Aged, 80 and over ,business.industry ,Remission Induction ,Interferon-alpha ,Middle Aged ,Combined Modality Therapy ,Recombinant Proteins ,Survival Rate ,Fluorouracil ,Toxicity ,Female ,Colorectal Neoplasms ,business ,medicine.drug - Abstract
PURPOSE To compare the efficacy and toxicity profiles of a combination of fluorouracil (5-FU) with recombinant human interferon alfa-2a (Roferon-A; Hoffman La-Roche AG, Basel, Switzerland) versus the combination of 5-FU with leucovorin (LV) in the treatment of advanced colorectal cancer. PATIENTS AND METHODS A total of 496 previously untreated colorectal cancer patients were randomized to receive either Roferon-A (9 MIU) subcutaneously three times per week, with 5-FU (750 mg/m2/d) by continuous intravenous (i.v.) infusion (CIV) on days 1 to 5, then, after a 9-day hiatus, as a weekly i.v. bolus at the same dose (IFN/5-FU); or LV (200 mg/m2/d) by i.v. infusion plus 5-FU (370 mg/m2/d) by i.v. bolus on days 1 to 5, repeated every 4 weeks (LV/5-FU). RESULTS There were no significant differences between IFN/5-FU and LV/5-FU in the overall response rate (21% v 18%), duration of response (7.3 v 6.2 months), or survival time (median, 11.0 v 11.3 months). Toxicity profiles differed; constitutional symptoms and myelosuppression were more frequent and more severe with IFN/5-FU, and gastrointestinal symptoms with LV/5-FU. More patients interrupted treatment for adverse events (AEs) with IFN/5-FU than with LV/5-FU. Five treatment-related deaths occurred with each regimen. CONCLUSION The combination IFN/5-FU produced response rates, response durations, and survival times similar to those with LV/5-FU. Biochemical modulation of 5-FU by either IFN or LV appears to result in equivalent efficacy; however, fewer patients were able to tolerate the specified IFN/5-FU combination used in this study.
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- 1995
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