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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, 07/20/09
Hauschild A et al. – Study reports that the addition of a 4-week modified high-dose IFN-α (HDI) induction phase to a 2-year low-dose adjuvant IFN-α-2b treatment schedule for patients with high-risk melanoma did not improve the clinical outcome.
Methods- Main objectives of this study were to investigate the:
- Optimal dosing and duration of treatment with IFN-α, and
- If HDI, the intravenous (IV) induction phase might be critical for the clinical benefit of the regimen
- Lymph node–negative pts with resected primary malignant melanoma of >1.5-mm tumor thickness were included
- 674 pts 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 sc for another 2 wks, followed by
- 23 mo 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 mo in arm B
- Of 650 assessable pts, there were 92/321 relapses among pts receiving high-dose induction vs 95/329 relapses among the pts receiving LDI only
- 5-yr relapse-free survival rates were 68.0% (arm A) and 67.1% (arm B), respectively
- Likewise, 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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