Dacarbazine and Interferon α with or without Interleukin 2 in Metastatic Melanoma
Author Information
Author(s): Hauschild A, Garbe C, Stolz W, Ellwanger U, Seiter S, Dummer R, Ugurel S, Sebastian G, Nashan D, Linse R, Achtelik W, Mohr P, Kaufmann R, Fey M, Ulrich J, Tilgen W
Primary Institution: Departments of Dermatology, Christian-Albrechts-University, Eberhard-Karls-University, Tübingen
Hypothesis
This study was designed to compare the efficacy of therapy with dacarbazine and interferon α only to that of therapy with dacarbazine and interferon α with the addition of interleukin 2.
Conclusion
There was no difference in survival time or tumor response rates when IL-2 was added to the treatment regimen, but toxicity was increased in patients receiving IL-2.
Supporting Evidence
- 290 patients were randomized to receive either treatment.
- 281 patients were eligible for an intention-to-treat analysis.
- Median survival time was 11.0 months for both treatment arms.
- Objective response rates were 18.0% for DTIC plus IFN-α and 16.1% for DTIC, IFN-α and IL-2.
- Treatment cessation due to adverse reactions was more common in patients receiving IL-2.
Takeaway
The study tested if adding a drug called IL-2 to two other drugs helped people with a type of skin cancer, but it didn't make a difference in how long they lived or how well the treatment worked.
Methodology
290 patients were randomized to receive either dacarbazine and interferon α with or without interleukin 2, with an intention-to-treat analysis performed on 281 eligible patients.
Limitations
Further phase III trials with continuous infusion and higher dosages must be performed before any final conclusions can be drawn on the potential usefulness of IL-2.
Participant Demographics
Patients with advanced metastatic melanoma (stage IV).
Statistical Information
P-Value
0.87
Statistical Significance
p=0.87
Digital Object Identifier (DOI)
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