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Prospective randomized comparison of dacarbazine (DTIC) versus DTIC plus interferon-alpha (IFN-α) in metastatic melanoma
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Young, Annie M., Marsden, J., Goodman, A., Burton, Andrea and Dunn, Janet A. (2001) Prospective randomized comparison of dacarbazine (DTIC) versus DTIC plus interferon-alpha (IFN-α) in metastatic melanoma. Clinical Oncology, 13 (6). pp. 458-465. doi:10.1053/clon.2001.9314 ISSN 0936-6555.
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Official URL: https://doi.org/10.1053/clon.2001.9314
Abstract
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-α) 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-α 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-α (95% CI 2.0-8.0). There was no significant difference in survival between the two treatment arms (X2unadjusted = 0.15, P=0.70; X2adjusted = 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-α. There were no differences in quality of life between treatment groups. This study failed to demonstrate a survival benefit for patients receiving IFN-α 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-α to DTIC in the treatment of this disease.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Clinical Oncology | ||||||
Publisher: | Springer London | ||||||
ISSN: | 0936-6555 | ||||||
Official Date: | December 2001 | ||||||
Dates: |
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Volume: | 13 | ||||||
Number: | 6 | ||||||
Page Range: | pp. 458-465 | ||||||
DOI: | 10.1053/clon.2001.9314 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Restricted or Subscription Access |
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