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Interferon did not improve disease-free, overall survival in melanoma

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Efficacy of adjuvant high-dose interferon alfa-2b and completion lymph node dissection was not demonstrated in patients with melanoma with a single positive sentinel lymph node.

“There were no statistically significant differences in disease-free survival or overall survival for patients with a single tumor-positive sentinel node randomized to high dose interferon alfa-2b compared to observation,” said Kelly McMasters, MD, PhD, chairman for the department of surgery at the University of Louisville, during his presentation of the Sunbelt Melanoma Trial results at the 2008 ASCO Annual Meeting.

The trial included 3,619 patients with cutaneous melanoma ≥1.0 mm Breslow thickness. It was conducted at 79 institutions in the United States and Canada. Patients underwent sentinel lymph node biopsy and were divided into two protocols. The primary endpoints were disease-free and overall survival.

Patients with a single tumor-positive sentinel lymph node were randomly assigned to observation (n=106) vs. high-dose interferon (n=112) in Protocol A. Patients with tumor-negative sentinel lymph nodes underwent reverse transcriptase polymerase chain reaction (RT-PCR) to detect melanoma-specific mRNA. Those with RT-PCR-positive sentinel lymph node were randomly assigned to observation (n=180) vs. completion lymph node dissection (n=192) vs. completion lymph node dissection plus interferon (n=184) in Protocol B.

No significant differences were reported in disease free survival for protocol A (HR=0.82; 95% CI, 0.47-1.40). “In terms of overall survival, there was no statistically significant difference for patients treated with interferon. The five-year overall survival rate was 75.4% for those in the observation arm vs. 72.9% for patients in the interferon-treated arm,” McMasters said. "It must be noted that the study was underpowered to detect small differences in survival, however.”

Similarly, no significant differences were reported in disease-free survival or overall survival in patients assigned to completion lymph node dissection or completion lymph node dissection plus interferon, compared with observation in protocol B. – by Stacey L. Adams

McMasters K. #9003. Presented at: 2008 ASCO Annual Meeting; May 30-June 3, 2008; Chicago.