Abstract
8544 Background: Acral melanoma (AM) is the predominant subtype of cutaneous melanoma in the Chinese population. Clinical trials on adjuvant therapy have not previously been reported in this subgroup. Therefore, we conducted this exploratory study in order to observe potential optimal dose intensity and duration of high-dose interferon (HD-IFN) in Chinese postoperative high-risk AM patients. Methods: Patients with resected high-risk (stages IIb-IIIc) AM were randomly assigned to a regimen of 4-week (arm A: 15×106 U/m2 d1-5/w×4w) or 1-year adjuvant HD-IFN (arm B: 15×106 U/m2 d1-5/w×4w, 9×106 U tiw×48w), respectively. The endpoints were relapse-free survival (RFS), overall survival (OS) and toxicities. Results: 158 postoperative patients with AM of stage IIb-IIIc were enrolled in this study, of whom 147 patients were eligible for survival analysis. With a median follow-up of 36.1 months, median RFS for arm A (4 weeks) and arm B (1 year) were 17.9 months and 22.5 months, respectively (P=0.72). There was a trend towards longer RFS with arm B (1 year) although not statistically significant. Stratified analysis demonstrated that RFS of very-high-risk patients (IIIb-IIIc) was statistically shorter in arm A compared with arm B (7.6 months and 12.0 months, respectively; P=0.02). The median RFS of patients with more nodal metastases (n ≥3) was shorter in arm A compared with arm B (3.3 months and 11.9 months, respectively; P=0.004). In addition, there were no statistical differences between groups stratified by age, gender and primary ulceration. Safety analysis showed the most common adverse effects to be Grade 1/2 flu-like symptoms, fatigue, hepatotoxicity, hematologic toxicity and anorexia in both arms; patients in arm B had higher incidence of Grade 3/4 hepatotoxicity (P=0.03), but these were reversible. Conclusions: The preliminary results of this study demonstrated no statistically significance were detected in RFS between the 4 weeks and 1 year regimen for all the high-risk population, while a 1-year regimen showed a significant clinical benefit in patients with stage IIIb-IIIc AM or nodal metastases ≥3. Further survival data are needed for long-term follow-up.
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