Hauschild, Axel and Weichenthal, Michael and Rass, Knuth and Linse, Ruthild and Ulrich, Jens and Stadler, Rudolf and Volkenandt, Matthias and Grabbe, Stephan and Proske, Ulrike and Schadendorf, Dirk and Brockmeyer, Norbert and Vogt, Thomas and Rompel, Rainer and Kaufmann, Roland and Kaatz, Martin and Naeher, Helmut and Mohr, Peter and Eigentler, Thomas and Livingstone, Elisabeth and Garbe, Claus (2009) Prospective Randomized Multicenter Adjuvant Dermatologic Cooperative Oncology Group Trial of Low-Dose Interferon Alfa-2b With or Without a Modified High-Dose Interferon Alfa-2b Induction Phase in Patients With Lymph Node-Negative Melanoma. JOURNAL OF CLINICAL ONCOLOGY, 27 (21). pp. 3496-3502. ISSN 0732-183X,
Full text not available from this repository. (Request a copy)Abstract
Purpose Interferon alfa (IFN-alpha) has shown clinical efficacy in the adjuvant treatment of patients with high-risk melanoma in several clinical trials, but optimal dosing and duration of treatment are still under discussion. It has been argued that in high-dose IFN-alpha (HDI), the intravenous (IV) induction phase might be critical for the clinical benefit of the regimen. Patients and Methods In an attempt to investigate the potential role of a modified high-dose induction phase, lymph node-negative patients with resected primary malignant melanoma of more than 1.5-mm tumor thickness were included in this prospective randomized multicenter Dermatologic Cooperative Oncology Group trial. Six hundred seventy-four patients were randomly assigned to receive 4 weeks of a modified HDI scheme. This schedule consisted of 5 times weekly 10 MU/m(2) IFN-alpha-2b IV for 2 weeks and 5 times weekly 10 MU/m(2) IFN-alpha-2b administered subcutaneously (SC) for another 2 weeks followed by 23 months of low-dose IFN-alpha-2b (LDI) 3 MU SC three times a week (arm A). LDI 3 MU three times a week was given for 24 months in arm B. Results Of 650 assessable patients, there were 92 relapses among the 321 patients receiving high-dose induction as compared with 95 relapses among the 329 patients receiving LDI only. Five-year relapse-free survival rates were 68.0% (arm A) and 67.1% (arm B), respectively. Likewise, melanoma-related fatalities were similar between both groups, resulting in 5-year overall survival rates of 80.2% (arm A) and 82.9% (arm B). Conclusion The addition of a 4-week modified HDI induction phase to a 2-year low-dose adjuvant IFN-alpha-2b treatment schedule did not improve the clinical outcome.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HIGH-RISK MELANOMA; STAGE IIB/III MELANOMA; CUTANEOUS MELANOMA; MALIGNANT-MELANOMA; THERAPY; ALPHA-2A; METASTASES; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 10 Sep 2020 09:29 |
| Last Modified: | 10 Sep 2020 09:29 |
| URI: | https://pred.uni-regensburg.de/id/eprint/28698 |
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