In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 21 ( 2009-07-20), p. 3496-3502
Abstract:
Interferon alfa (IFN-α) has shown clinical efficacy in the adjuvant treatment of patients with high-risk melanoma in several clinical trials, but optimal dosing and duration of treatment are still under discussion. It has been argued that in high-dose IFN-α (HDI), the intravenous (IV) induction phase might be critical for the clinical benefit of the regimen. Patients and Methods In an attempt to investigate the potential role of a modified high-dose induction phase, lymph node–negative patients with resected primary malignant melanoma of more than 1.5-mm tumor thickness were included in this prospective randomized multicenter Dermatologic Cooperative Oncology Group trial. Six hundred seventy-four patients were randomly assigned to receive 4 weeks of a modified HDI scheme. This schedule consisted of 5 times weekly 10 MU/m 2 IFN-α-2b IV for 2 weeks and 5 times weekly 10 MU/m 2 IFN-α-2b administered subcutaneously (SC) for another 2 weeks followed by 23 months of low-dose IFN-α-2b (LDI) 3 MU SC three times a week (arm A). LDI 3 MU three times a week was given for 24 months in arm B. Results Of 650 assessable patients, there were 92 relapses among the 321 patients receiving high-dose induction as compared with 95 relapses among the 329 patients receiving LDI only. Five-year 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-year overall survival rates of 80.2% (arm A) and 82.9% (arm B). Conclusion The addition of a 4-week modified HDI induction phase to a 2-year low-dose adjuvant IFN-α-2b treatment schedule did not improve the clinical outcome.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2008.21.3892
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2009
detail.hit.zdb_id:
2005181-5
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