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

Stadler, R. (author)
Luger, T. (author)
Bieber, T. (author)
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Kohler, U. (author)
Linse, R. (author)
Technau, K. (author)
Schubert, R. (author)
Schroth, K. (author)
Vakilzadeh, F. (author)
Volkenandt, M. (author)
Gollnick, H. (author)
Von Eick, H. (author)
Bergh Thorén, Fredrik, 1976 (author)
Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine
Strannegard, O. (author)
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 (creator_code:org_t)
2009-07-08
2006
English.
In: Acta Oncol. - : Informa UK Limited. - 0284-186X. ; 45:4, s. 389-99
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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).

Keyword

Adult
Aged
Aged
80 and over
Antineoplastic Combined Chemotherapy Protocols/ therapeutic use
Chemotherapy
Adjuvant
Dacarbazine/administration & dosage
Female
Humans
Interferon-alpha/administration & dosage
Male
Melanoma/drug therapy/ mortality
Middle Aged
Neoplasm Recurrence
Local/drug therapy/mortality/secondary
Neoplasm Staging
Prospective Studies
Skin Neoplasms/drug therapy/ mortality
Survival Rate

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art (subject category)

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