Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial.

Autor: Stadler, Rudolf, Luger, Thomas, Bieber, Thomas, Köhler, Ulrike, Linse, Ruthild, Technau, Kristin, Schubert, Roland, Schroth, Katja, Vakilzadeh, Feredoun, Volkenandt, Matthias, Gollnick, Harald, Von Eick, Harald, Thoren, Fredrik, Strannegård, Örjan
Předmět:
Zdroj: Acta Oncologica; Jun2006, Vol. 45 Issue 4, p389-399, 11p, 1 Diagram, 2 Charts, 3 Graphs
Abstrakt: In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II–III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6-month treatment with 3 MU thrice weekly of highly purified natural interferon-alpha (n = 128; arm A) or received no adjuvant treatment (n = 124; arm B). Treatment was well tolerated. After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR = 0.65, CI = 0.46–0.97, p = 0.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49–1.00, p = 0.052). The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modelling, after adjusting for identified predictive variables, was almost 50% (p = 0.002). The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40–0.90, p = 0.013). [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index