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EADO: No difference between pegylated, conventional interferon alfa-2b for melanoma
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ASCO 2010 Annual Meeting
CHICAGO — Data from a randomized, phase 3 study indicated that flat low-dose pegylated interferon alfa-2b was not superior to conventional low-dose interferon alfa-2b in patients with melanoma without macrometastatic nodes.
Although low-dose pegylated interferon alfa-2b and conventional low-dose interferon alfa-2b have been proven efficacious in previous studies, the two strategies have never been compared in a head-to-head trial.
Researchers from Europe, led by Jean J. Grob, MD, Service of Dermatologic Hospital Sainte-Marguerite, Marseilles, France, randomly assigned 896 patients with resected melanoma 1.5 mm or larger in thickness to low-dose pegylated interferon alfa-2b three times weekly for 18 months (n=443) or conventional low-dose interferon alfa-2b 100 mcg once-weekly for 3 years (n=453).
The primary endpoint was relapse-free survival. Secondary endpoints were distant metastasis-free survival, OS and grade-3/4 adverse events. Median follow-up was 4.7 years. The results were presented at the 2010 ASCO Annual Meeting.
There were no significant differences in relapse-free survival (HR=0.91; 95% CI, 0.73-1.15), distant-metastasis-free survival (HR=1.02; 95% CI, 0.80-1.32) or OS (HR=1.09; 95% CI, 0.82-1.45).
The median duration of treatment was impacted by grade-3/4 serious adverse events in those assigned low-dose pegylated interferon alfa-2b, with only 28% of patients completing 3 years of treatment.
“When compared with conventional interferon alfa-2b for 3 years duration, low-dose pegylated interferon alfa-2b three times weekly for 18 months did not show superiority,” Grob said during the presentation. – by Jennifer Southall
This is a heterogeneous patient population including stage IIa, IIb, IIc and stage IIIa, IIIb because over 30% of patients had no sentinel node biopsy, had no pathological staging and had only clinical staging. With median follow-up of 4.7 years, all endpoints (recurrence-free survival, distant metastases-free survival, OS) showed no statistical difference; the treatments are essentially equal. The serious adverse events of pegylated-interferon apparently increased significantly after 18 months. Thus, the hypothesis of prolonged pegylated treatment for 36 months at this dose was not feasible. In the United States, there is no standard adjuvant therapy for stage IIa, IIb melanoma. High-dose adjuvant interferon is the standard care for stage IIc and stage III patients. Results of this phase 3 study, unfortunately, will make no changes/impact in adjuvant therapy either in United States or in Europe.
– Wen-Jen Hwu, MD,PhD
HemOnc Today Editorial Board member
For more information:
- Grob JJ. #LBA8506. Presented at: the 2010 ASCO Annual Meeting; June 4-8; Chicago.
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