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Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial.

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Title: Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial.
Authors: Eggermont AM (AUTHOR), Suciu S (AUTHOR), Santinami M (AUTHOR), Testori A (AUTHOR), Kruit WH (AUTHOR), Marsden J (AUTHOR), Punt CJ (AUTHOR), Salès F (AUTHOR), Gore M (AUTHOR), Mackie R (AUTHOR), Kusic Z (AUTHOR), Dummer R (AUTHOR), Hauschild A (AUTHOR), Musat E (AUTHOR), Spatz A (AUTHOR), Keilholz U (AUTHOR), EORTC Melanoma Group (CORPORATE AUTHOR), Eggermont, Alexander M M (AUTHOR), Suciu, Stefan (AUTHOR), Santinami, Mario (AUTHOR)
Source: Lancet. 7/12/2008, Vol. 372 Issue 9633, p117-126. 10p.
Abstract: Background: Any benefit of adjuvant interferon alfa-2b for melanoma could depend on dose and duration of treatment. Our aim was to determine whether pegylated interferon alfa-2b can facilitate prolonged exposure while maintaining tolerability.Methods: 1256 patients with resected stage III melanoma were randomly assigned to observation (n=629) or pegylated interferon alfa-2b (n=627) 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years. Randomisation was stratified for microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumour thickness, sex, and centre. Randomisation was done with a minimisation technique. The primary endpoint was recurrence-free survival. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00006249.Findings: All randomised patients were included in the primary efficacy analysis. 608 patients in the interferon group and 613 patients in the observation group were included in safety analyses. The median length of treatment with pegylated interferon alfa-2b was 12 (IQR 3.8-33.4) months. At 3.8 (3.2-4.2) years median follow-up, 328 recurrence events had occurred in the interferon group compared with 368 in the observation group (hazard ratio 0.82, 95% CI 0.71-0.96; p=0.01); the 4-year rate of recurrence-free survival was 45.6% (SE 2.2) in the interferon group and 38.9% (2.2) in the observation group. There was no difference in overall survival between the groups. Grade 3 adverse events occurred in 246 (40%) patients in the interferon group and 60 (10%) in the observation group; grade 4 adverse events occurred in 32 (5%) patients in the interferon group and 14 (2%) in the observation group. In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%). Treatment with pegylated interferon alfa-2b was discontinued because of toxicity in 191 (31%) patients.Interpretation: Adjuvant pegylated interferon alfa-2b for stage III melanoma has a significant, sustained effect on recurrence-free survival. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial.
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  Data: <searchLink fieldCode="AR" term="%22Eggermont+AM%22">Eggermont AM</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Suciu+S%22">Suciu S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Santinami+M%22">Santinami M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Testori+A%22">Testori A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kruit+WH%22">Kruit WH</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Marsden+J%22">Marsden J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Punt+CJ%22">Punt CJ</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Salès+F%22">Salès F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gore+M%22">Gore M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mackie+R%22">Mackie R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kusic+Z%22">Kusic Z</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dummer+R%22">Dummer R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hauschild+A%22">Hauschild A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Musat+E%22">Musat E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Spatz+A%22">Spatz A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Keilholz+U%22">Keilholz U</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22EORTC+Melanoma+Group%22">EORTC Melanoma Group</searchLink> (CORPORATE AUTHOR)<br /><searchLink fieldCode="AR" term="%22Eggermont%2C+Alexander+M+M%22">Eggermont, Alexander M M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Suciu%2C+Stefan%22">Suciu, Stefan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Santinami%2C+Mario%22">Santinami, Mario</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 7/12/2008, Vol. 372 Issue 9633, p117-126. 10p.
– Name: Abstract
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  Data: <bold>Background: </bold>Any benefit of adjuvant interferon alfa-2b for melanoma could depend on dose and duration of treatment. Our aim was to determine whether pegylated interferon alfa-2b can facilitate prolonged exposure while maintaining tolerability.<bold>Methods: </bold>1256 patients with resected stage III melanoma were randomly assigned to observation (n=629) or pegylated interferon alfa-2b (n=627) 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years. Randomisation was stratified for microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumour thickness, sex, and centre. Randomisation was done with a minimisation technique. The primary endpoint was recurrence-free survival. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00006249.<bold>Findings: </bold>All randomised patients were included in the primary efficacy analysis. 608 patients in the interferon group and 613 patients in the observation group were included in safety analyses. The median length of treatment with pegylated interferon alfa-2b was 12 (IQR 3.8-33.4) months. At 3.8 (3.2-4.2) years median follow-up, 328 recurrence events had occurred in the interferon group compared with 368 in the observation group (hazard ratio 0.82, 95% CI 0.71-0.96; p=0.01); the 4-year rate of recurrence-free survival was 45.6% (SE 2.2) in the interferon group and 38.9% (2.2) in the observation group. There was no difference in overall survival between the groups. Grade 3 adverse events occurred in 246 (40%) patients in the interferon group and 60 (10%) in the observation group; grade 4 adverse events occurred in 32 (5%) patients in the interferon group and 14 (2%) in the observation group. In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%). Treatment with pegylated interferon alfa-2b was discontinued because of toxicity in 191 (31%) patients.<bold>Interpretation: </bold>Adjuvant pegylated interferon alfa-2b for stage III melanoma has a significant, sustained effect on recurrence-free survival. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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