Real-world clinical outcome and safety of adjuvant human Interferon-alpha1b in resected stage IIIB or IIIC melanoma: results of a retrospective study

Abstract

BackgroundHuman interferon-α1b (hIFN-α1b) is the first genetically engineered drug approved by the National Medical Product Administration for cancer therapy in China. hIFN-α1b is a relatively safe therapy and can improve survival in advanced melanoma and its long-term efficacy against resection of stage III melanoma is unknown.ObjectiveThe objective of this study is to assess the safety and efficacy of hIFN-α1b in patients with resected stage III melanoma.MethodsThe clinical data were collected from patients who underwent resection of stage IIIB or IIIC melanoma and received subcutaneous injection of hIFN-α1b every other day. The efficacy of hIFN-α1b was determined by rate of recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and overall survival (OS). Safety data were acquired by review of adverse events at follow-ups.ResultsThe study included a total of 61 patients. The median follow-up duration was 45 months. The RFS at 12, 24, and 36 months were observed to be 75.4%, 47.4%, and 37.2% respectively, while the DMFS rates were found to be 83.6%, 65.5%, and 62.2%. Furthermore, the OS rates at these time points were recorded as being 100%, 81.9%, and 71.5%. The overall tolerability of hIFN-α1b was satisfactory, with only 8.2% of the patients experiencing grade 3/4 toxicity and no treatment-related deaths observed.ConclusionOur findings suggest that adjuvant hIFN-α1b treatment is relatively safe and may potentially enhance the rate of RFS, DMFS and OS in patients who have undergone resection for stage IIIB or IIIC melanoma.