Format

Send to

Choose Destination
J Clin Oncol. 2015 Dec 1;33(34):4077-84. doi: 10.1200/JCO.2014.59.6932. Epub 2015 Oct 26.

Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial.

Author information

1
Peter Mohr, Elbe-Klinikum Buxtehude, Buxtehude; Axel Hauschild and Michael Weichenthal, University Hospital Schleswig-Holstein, Kiel; Uwe Trefzer, Charité-Universitätsmedizin Berlin, Berlin; Alexander Enk, University Hospital Heidelberg, Heidelberg; Wolfgang Tilgen, University Hospital, Homburg/Saarland; Carmen Loquai, University of Mainz, Mainz; Thomas Haalck, Universitätsklinikum Hamburg-Eppendorf, Hamburg; Ralf Gutzmer, Hannover Medical School, Hannover; Norbert Brockmeyer, Ruhr-Universität Bochum, Bochum; Erhard Hölzle, Oldenburg Hospital, Oldenburg; Cord Sunderkötter, University of Münster, Münster; Cornelia Mauch, University of Cologne, Cologne; Annette Stein, Universitätsklinikum Carl Gustav Carus, Dresden; Lars A. Schneider, University of Ulm, Ulm; Maurizio Podda, Darmstadt Hospital, Darmstadt; Daniela G[uml]oppner, University Hospital Magdeburg, Magdeburg; Dirk Schadendorf, University Hospital Essen, Essen, Germany; Helen Gogas, Hellenic Cooperative Oncology Group, Athens, Greece; Josef Koller, Paracelsus Medical University, Salzburg, Austria; and Reinhard Dummer, University Hospital of Zurich, Zurich, Switzerland. peter.mohr@elbekliniken.de.
2
Peter Mohr, Elbe-Klinikum Buxtehude, Buxtehude; Axel Hauschild and Michael Weichenthal, University Hospital Schleswig-Holstein, Kiel; Uwe Trefzer, Charité-Universitätsmedizin Berlin, Berlin; Alexander Enk, University Hospital Heidelberg, Heidelberg; Wolfgang Tilgen, University Hospital, Homburg/Saarland; Carmen Loquai, University of Mainz, Mainz; Thomas Haalck, Universitätsklinikum Hamburg-Eppendorf, Hamburg; Ralf Gutzmer, Hannover Medical School, Hannover; Norbert Brockmeyer, Ruhr-Universität Bochum, Bochum; Erhard Hölzle, Oldenburg Hospital, Oldenburg; Cord Sunderkötter, University of Münster, Münster; Cornelia Mauch, University of Cologne, Cologne; Annette Stein, Universitätsklinikum Carl Gustav Carus, Dresden; Lars A. Schneider, University of Ulm, Ulm; Maurizio Podda, Darmstadt Hospital, Darmstadt; Daniela G[uml]oppner, University Hospital Magdeburg, Magdeburg; Dirk Schadendorf, University Hospital Essen, Essen, Germany; Helen Gogas, Hellenic Cooperative Oncology Group, Athens, Greece; Josef Koller, Paracelsus Medical University, Salzburg, Austria; and Reinhard Dummer, University Hospital of Zurich, Zurich, Switzerland.

Abstract

PURPOSE:

To evaluate the efficacy, safety, tolerability, and quality of life (QoL) in patients receiving intravenous, intermittent high-dose interferon alfa-2b (IFN-α-2b [iHDI]) compared with standard high-dose IFN-α-2b (HDI).

PATIENT AND METHODS:

Patients with stage III resected lymph node or in-transit metastasis from cutaneous malignant melanoma were randomly assigned to receive either a standard HDI regimen or three courses of IFN-α-2b 20 MIU/m(2) administered intravenously 5 days a week for 4 weeks then repeated every 4 months. Distant metastasis-free survival was the primary end point for efficacy analysis. In addition, relapse-free survival, overall survival, safety as determined by Common Terminology Criteria for Adverse Events criteria, and QoL were secondary end points.

RESULTS:

Of 649 patients enrolled, 22 patients were excluded from the intent-to-treat analysis. The remaining 627 patients were well balanced between the arms according to sex, age, and stage. After a median follow-up of 55 months, a multivariable Cox model revealed no significant differences for distant metastasis-free survival (hazard ratio [HR], 1.21; P = .12) or overall survival (HR, 1.01; P = .85). In contrast, the difference for relapse-free survival was significant (HR, 1.27; P = .03), favoring standard HDI. Early termination of treatment because of adverse events or QoL occurred significantly more often with HDI than with iHDI (26.0% v 14.8%; P < .001).

CONCLUSION:

Although the safety and QoL profiles for the intermittent regimen were favorable, no significant difference was observed for survival while the HR for relapse with iHDI was increased. Therefore, an iHDI regimen, as tested here, cannot be recommended as adjuvant treatment for high-risk melanoma.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00226408.

PMID:
26503196
DOI:
10.1200/JCO.2014.59.6932
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center