Temozolomide in combination with interferon-alfa versus temozolomide alone in patients with advanced metastatic melanoma: a randomized, phase III, multicenter study from the Dermatologic Cooperative Oncology Group
Purpose: Temozolomide (TMZ) has shown efficacy in metastatic melanoma equal to that of dacarbazine (DTIC), the standard chemotherapeutic agent for melanoma. As the combination with interferon-alfa (IFN-α) appears superior to single-agent DTIC regarding response rates, the purpose of this study was t...
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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
September 21, 2016
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| In: |
Journal of clinical oncology
Year: 2005, Jahrgang: 23, Heft: 35, Pages: 9001-9007 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.2005.01.1551 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2005.01.1551 Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2005.01.1551 
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| Verfasserangaben: | Roland Kaufmann, Konstanze Spieth, Ulrike Leiter, Cornelia Mauch, Peter von den Driesch, Thomas Vogt, Ruthild Linse, Wolfgang Tilgen, Dirk Schadendorf, Jürgen C. Becker, Günther Sebastian, Sven Krengel, Lutz Kretschmer, Claus Garbe, and Reinhard Dummer |
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| 245 | 1 | 0 | |a Temozolomide in combination with interferon-alfa versus temozolomide alone in patients with advanced metastatic melanoma |b a randomized, phase III, multicenter study from the Dermatologic Cooperative Oncology Group |c Roland Kaufmann, Konstanze Spieth, Ulrike Leiter, Cornelia Mauch, Peter von den Driesch, Thomas Vogt, Ruthild Linse, Wolfgang Tilgen, Dirk Schadendorf, Jürgen C. Becker, Günther Sebastian, Sven Krengel, Lutz Kretschmer, Claus Garbe, and Reinhard Dummer |
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| 520 | |a Purpose: Temozolomide (TMZ) has shown efficacy in metastatic melanoma equal to that of dacarbazine (DTIC), the standard chemotherapeutic agent for melanoma. As the combination with interferon-alfa (IFN-α) appears superior to single-agent DTIC regarding response rates, the purpose of this study was to compare TMZ alone and TMZ plus IFN-α in terms of objective response (OR), overall survival, and safety in a prospective, randomized, multicenter trial. Patients and Methods: Two hundred ninety-four patients with untreated stage IV metastatic melanoma (American Joint Committee on Cancer staging system) were randomly assigned to receive either oral TMZ alone (200 mg/m2/day; days 1 through 5 every 28 days) or in combination with subcutaneous IFN-α (5 MU/m2; days 1, 3, and 5 every week). Results: Two hundred eighty-two patients were eligible for an intent-to-treat analysis, 271 patients were treated per protocol. In the TMZ + IFN-α arm, 33 (24.1%) of 137 patients responded to therapy (partial or complete remission) whereas in the monotherapy arm, in 18 (13.4%) of 134 patients, a response was evident. Thus, the response rate was significantly higher in the combination arm (P = .036). Median survival time was 8.4 months for patients treated with TMZ (95% CI, 7.07 to 9.27) and 9.7 months for those treated with the combination (95% CI, 8.26 to 11.18; P = .16). Dose modifications and interval prolongations due to hematologic toxicity were significantly more frequent in the TMZ + IFN-α arm (P < .001). Conclusion: In metastatic melanoma treatment with TMZ + IFN-α leads to a significantly superior OR rate compared to treatment with TMZ alone, which did not translate into prolonged survival in our study population. | ||
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