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Prospective randomized multicenter adjuvant Dermatologic Cooperative Oncology Group trial of low-dose interferon alfa-2b with or without a modified high-dose interferon alfa-2b induction phase in patients with lymph node-negative melanoma
Journal of Clinical Oncology, 05/15/09
Hauschild A et al. - In a study to assess the use of low-dose interferon alfa-2b with or without a modified high-dose interferon alfa-2b induction phase in pts with lymph node-negative melanoma, it was found that the addition of a 4-wk modified high-dose IFN-α (HDI) induction phase to a 2-yr low-dose adjuvant IFN-α-2b treatment schedule did not improve clinical outcome.
Methods- In an attempt to investigate the potential role of a modified high-dose induction phase, lymph node–negative pts with resected primary malignant melanoma of more than 1.5-mm tumor thickness were included in this trial.
- 674 pts were randomly assigned to receive 4 wks of a modified HDI scheme.
- This schedule consisted of 5 times weekly 10 MU/m2 IFN-α-2b IV for 2 wks and 5 times weekly 10 MU/m2 IFN-α-2b administered subcutaneously (SC) for another 2 wks followed by 23 mos of low-dose IFN-α-2b (LDI) 3 MU SC 3 times a wk (arm A).
- LDI 3 MU 3 times a week was given for 24 mos in arm B.
- Of 650 assessable pts, there were 92 relapses among the 321 pts receiving high-dose induction vs 95 relapses among the 329 pts receiving LDI only.
- 5-yr relapse-free survival rates were 68.0% (arm A) and 67.1% (arm B), respectively.
- Melanoma-related fatalities were similar between both groups, resulting in 5-yr overall survival rates of 80.2% (arm A) and 82.9% (arm B).
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