Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
Long-term treatment with pegylated interferon alfa-2b in stage III melanoma had a significant and sustained impact on relapse-free survival (RFS), according to the results of the largest adjuvant trial ever conducted in patients with stage III melanoma. Results of the Phase III study, led by the European Organisation for the Research and Treatment of Cancer (EORTC) and supported by Schering-Plough, were presented today by Alexander Eggermont, M.D., Ph.D. at the 43rd Annual Meeting of the American Society of Clinical Oncology.
"Advanced stage melanoma remains difficult to treat and a need still exists to find treatment options," said Alexander Eggermont, M.D., Ph.D., lead investigator and head of the department of surgical oncology, Erasmus University Medical Center, Rotterdam, The Netherlands. "These findings demonstrate the benefit of an increased relapse-free survival (RFS) despite no difference in overall survival."
Median RFS was 34.8 months in the pegylated interferon alfa-2b arm vs. 25.5 months in the observational arm (p-value 0.01). Median distant metastasis-free survival (DMFS) was 45.6 months in subjects receiving pegylated interferon alfa-2b therapy versus 36.1 months in observational arm (p-value 0.11).
The response to therapy appeared to be most pronounced in a subgroup of subjects with only microscopic nodal involvement (patients with positive sentinel node(s) who experienced both increased relapse-free survival (RFS) (p-value 0.02) and distant metastasis-free survival (DMFS) (p-value 0.03). This group of patients constituted
43 percent of the trial population. At present, because of the increased use of sentinel node staging(1), this patient population largely constitutes the majority of patients diagnosed with stage III disease.
In the study, participants reached a median 88 percent and 83 percent relative dose intensity, or percent of planned dose intensity, during the induction and maintenance phases, respectively. Forty percent (251 subjects) ceased pegylated interferon alfa-2b therapy due to toxicity or patient's withdrawal of consent, while approximately 23 percent of subjects continued into year 4 and 5 of treatment. Grade 3 or 4 toxicities, mostly grade 3 in severity, were reported in 45 percent of subjects in the pegylated interferon alfa-2b arm versus
12 percent in the observational arm. These events included primarily Grade 3 fatigue, hepatotoxicity and depression. An ECOG 0-1 Performance Status was maintained in 83 percent of patients during the maintenance phase. These data represent the planned final analysis with a median follow-up of 3.8 years; study participants will be followed for survival for a total of 10 years. -http://www.schering-plough.com
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