Hauschild, A. and Garbe, C. and Stolz, W. and Ellwanger, U. and Seiter, S. and Dummer, R. and Ugurel, S. and Sebastian, G. and Nashan, D. and Linse, R. and Achtelik, W. and Mohr, P. and Kaufmann, R. and Fey, M. and Ulrich, J. and Tilgen, W. (2001) Dacarbazine and interferon alpha with or without interleukin 2 in metastatic melanoma: a randomized phase III multicentre trial of the Dermatologic Cooperative Oncology Group (DeCOG). BRITISH JOURNAL OF CANCER, 84 (8). pp. 1036-1042. ISSN 0007-0920
Full text not available from this repository.Abstract
In several phase II-trials encouraging tumour responses rates in advanced metastatic melanoma (stage IV; AJCC-classification) have been reported for the application of biochemotherapy containing interleukin 2. This study was designed to compare the efficacy of therapy with dacarbazine (DTIC) and interferon alpha (IFN-alpha) only to that of therapy with DTIC and IFN-alpha with the addition of interleukin 2 (IL-2) in terms of the overall survival time and rate of objective remissions and to provide an elaborated toxicity profile for both types of therapy. 290 patients were randomized to receive either DTIC (850 mg/m(2) every 28 days) plus IFN-alpha 2a/b (3 MIU/m(2), twice on day 1, once daily from days 2 to 5; 5 MIU/m(2) 3 times a week from week 2 to 4) with or without IL-2 (4.5 MIU/m(2) for 3 hours i.v. on day 3; 9.0 MIU/m(2) i.v. day 3/4; 4.5 MIU/m(2) s.c. days 4 to 7). The treatment plan required at least 2 treatment cycles (8 weeks of therapy) for every patient. Of 290 randomized patients 281 were eligible for an intention-to-treat analysis. There was no difference in terms of survival time from treatment onset between the two arms (median 11.0 months each). In 273 patients treated according to protocol tumour response was assessable. The response rates did not differ between both arms (P = 0.87) with 18.0% objective responses (9.7% PR; 8.3% CR) for DTIC plus IFN-alpha as compared to 16.1% (8.8% PR; 7.3% CR) for DTIC, IFN-alpha and IL-2. Treatment cessation due to adverse reactions was significantly more common in patients receiving IL-2 (13.9%) than in patients receiving DTIC/IFN-alpha only (5.6%). In conclusion, there was neither a difference in survival time nor in tumour response rates when IL-2, applied according to the combined intravenous and subcutaneous schedule used for this study, was added to DTIC and IFN-alpha. However, toxicity was increased in melanoma patients treated with IL-2. Further phase III trials with continuous infusion and higher dosages must be performed before any final conclusions can be drawn on the potential usefulness of IL-2 in biochemotherapy of advanced melanoma. (C) 2001 Cancer Research Campaign.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CUTANEOUS MELANOMA; MALIGNANT-MELANOMA; RECOMBINANT INTERLEUKIN-2; ADJUVANT THERAPY; CISPLATIN; COMBINATION; TAMOXIFEN; CHEMOTHERAPY; RISK; CHEMOIMMUNOTHERAPY; melanoma; metastasis; interferons; interleukin 2; biochemotherapy |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Feb 2022 16:50 |
| Last Modified: | 01 Feb 2022 16:50 |
| URI: | https://pred.uni-regensburg.de/id/eprint/41493 |
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