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NORDIC: No OS benefit with intermediate-dose interferon alfa-2b in melanoma
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HEMONC TODAY Melanoma and Cutaneous Malignancies.
NEW YORK — Phase-3 results from the NORDIC trial showed that there was no survival advantage for patients with melanoma assigned to adjuvant therapy with intermediate-dose interferon alfa-2. However, researchers did observe a significant relapse-free survival benefit.
The findings were consistent with the results of the EORTC 18952, said Johan Hansson, MD, PhD, with the department of oncology-pathology at Karolinska Institutet in Stockholm.
"Intermediate dose interferon seems to have significant effect on RFS. In our trial, combined in the two arms, we had a hazard ratio of 0.8 and the two year arm in the EORTC trial had a similar hazard ratio," he said. "But we don't see sig on OS effect in either trial."
Hansson added that interferon clearly has some limited effect. A personalized adjuvant interferon therapy might be advantageous if researchers can develop markers identifying the patients most likely to benefit, he said.
Other studies showed that high-dose interferon improved relapse-free survival in patients with stage IIB-IIC or III melanoma, but the drug's effect on OS had not been researched. To avoid the toxic effects associated with high-dose regimens, researchers in the NORDIC trial used an intermediate dose.
From 1996 to 2004, researchers at 35 centers in Denmark, Finland, Norway and Sweden enrolled 855 patients into the randomized, open-label, phase 3, parallel-group trial. As a control, 284 patients were assigned to observation (Group A). Another 285 were assigned to 4 weeks of 10 million units interferon alfa-2b followed by 12 months of maintenance therapy with 10 million units interferon alfa-2b (Group B) and 286 were assigned to 1 month of induction with 24 months of maintenance on the same dosage (Group C). Neither researchers nor patients were masked to treatment assignment.
At a median follow-up of 72.4 months, OS was 56.1 months for Group A, 72.1 months for Group B and 64.3 months for Group C (P=.60). The combined HR for OS in the interferon groups was 0.91 (95% CI, 0.74-1.10).
Median RFS was 23.2 months for Group A vs. 37.8 months in Group B and 28.6 months for Group C. HR=0.80 (95% CI, 0.67-0.96) for the combined interferon groups; in EORTC 18952, HR was 0.82 (95% CI 0.71-0.96) for patients assigned to interferon.
"When we look at the hazard ratio for relapse, we see a 20% decrease in relapses, which is statistically significant," Hansson said.
Fatigue was the most common grade-3/grade-4 adverse event, observed in five patients in Group A, 28 in Group B and 32 in Group C.- by Jason Harris
Dr. Hansson reported receiving research support and consultancy fees from Merck, and consultancy fees from Bristol-Myers Squibb and Roche.
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