Dacarbazine, Cisplatin, and Interferon-alfa-2b with or without Interleukin-2 in metastatic melanoma

• Verfasst von: Keilholz, Ulrich [VerfasserIn]
• Verfasst von: Schadendorf, Dirk [VerfasserIn]
• Titel: Dacarbazine, Cisplatin, and Interferon-alfa-2b with or without Interleukin-2 in metastatic melanoma
• Titelzusatz: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group
• Verf.angabe: Ulrich Keilholz, Cornelis J.A. Punt, Martin Gore, Wim Kruit, Poulam Patel, Danielle Lienard, Jose Thomas, Thomas M. Proebstle, Alexander Schmittel, Dirk Schadendorf, Thierry Velu, Sylvie Negrier, Ulrich Kleeberg, Frederic Lehman, Stefan Suciu, and Alexander M.M. Eggermont
• E-Jahr: 2016
• Jahr: September 21, 2016
• Jahr des Originals: 2005
• Umfang: 8 S.
• Fussnoten: Elektronische Reproduktion der Druckausgabe ; Gesehen am 22.01.2021
• Titel Quelle: Enthalten in: Journal of clinical oncology
• Ort Quelle: Alexandria, Va. : American Society of Clinical Oncology, 1983
• Jahr Quelle: 2005
• Band/Heft Quelle: 23(2005), 27, Seite 6747-6755
• ISSN Quelle: 1527-7755
• DOI: doi:10.1200/JCO.2005.03.202
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1745284656

Abstract

Background: Based on phase II trial results, chemoimmunotherapy combinations have become the preferred treatment for patients with metastatic melanoma in many institutions. This study was performed to determine whether interleukin-2 (IL-2) as a component of chemoimmunotherapy influences survival of patients with metastatic melanoma. Patients and Methods: Patients with advanced metastatic melanoma were randomly assigned to receive dacarbazine 250 mg/m2 and cisplatin 30 mg/m2 on days 1 to 3 combined with interferon-alfa-2b 10 × 106 U/m2 subcutaneously on days 1 through 5 without (arm A) or with (arm B) a high-dose intravenous decrescendo regimen of IL-2 on days 5 through 10 (18 × 106 U/m2/6 hours, 18 × 106 U/m2/12 hours, 18 × 106 U/m2/24 hours, and 4.5 × 106 U/m2 for 3 × 24 hours). Treatment cycles were repeated in the absence of disease progression every 28 days to a maximum of four cycles. Results: Three hundred sixty-three patients with advanced metastatic melanoma were accrued. The median survival was 9 months in both arms, with a 2-year survival rate of 12.9% and 17.6% in arms A and B, respectively (P = .32; hazard ratio, 0.90; 95% CI, 0.72 to 1.11). There was also no statistically significant difference regarding progression-free survival (median, 3.0 v 3.9 months) and response rate (22.8% v 20.8%). Conclusion: Despite its activity in melanoma as a single agent or in combination with interferon-alfa-2b, the chosen schedule of IL-2 added to the chemoimmunotherapy combination had no clinically relevant activity.