Prospective randomised comparison of dacarbazine (DTIC) versus DTIC plus interferon alpha (IFNα) in metastatic melanoma

Annie Young, J Marsden, A Goodman, Andrea Marshall, Janet Dunn

Research output: Contribution to journalArticle

61 Citations (Scopus)


Dacarbazine (DTIC) has been the mainstay of chemotherapy for metastatic melanoma for over two decades, but only 15%-20% of patients respond and benefit is usually transient. Randomized studies combining DTIC with interferon-alpha (IFN-alpha) in advanced disease have so far been inconclusive in terms of response and survival. We report a randomized prospective pilot Phase III trial of DTIC+/-IFN-alpha in patients with metastatic melanoma. The primary endpoint was death. A total of 61 patients were randomized between April 1995 and April 1998. Differences in survival between groups were assessed using log-rank analysis. Quality of life was measured using the European Organization for Research on Treatment of Cancer QLQ C30 (+3) questionnaire. Fifty-seven patients died during the study. The median survival for patients receiving DTIC was 7.2 months (95% confidence interval (CI) 4.4-9.0); it was 4.8 months for DTIC + IFN-alpha (95% CI 2.0=8.0). There was no significant difference in survival between the two treatment arms (chi(unadjusted)(2) = 0.15, P=0.70; chi(adjusted)(2) = 0.01, P=0.91). The 6-month survival of those patients randomized to DTIC alone was 58% compared with 40% for those patients randomized to DTIC + IFN-alpha. There were no differences in quality of life between treatment groups. This study failed to demonstrate a survival benefit for patients receiving IFN-alpha in combination with DTIC. These results are inconclusive primarily owing to the small size of the trial. A meta-analysis is required to determine whether there is a role for the addition of IFN-alpha to DTIC in the treatment of this disease.
Original languageEnglish
Pages (from-to)458-465
Number of pages8
JournalClinical Oncology
Publication statusPublished - 1 Jan 2001


  • metastatic melanoma
  • interferon-alpha
  • randomized clinical trial
  • dacarbazine (DTIC)


Dive into the research topics of 'Prospective randomised comparison of dacarbazine (DTIC) versus DTIC plus interferon alpha (IFNα) in metastatic melanoma'. Together they form a unique fingerprint.

Cite this