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ISRN Immunology
Volume 2012 (2012), Article ID 324235, 10 pages
http://dx.doi.org/10.5402/2012/324235
Clinical Study

The Florida Melanoma Trial I: A Prospective Multicenter Phase I/II Trial of Postoperative Hypofractionated Adjuvant Radiotherapy with Concurrent Interferon-Alfa-2b in the Treatment of Advanced Stage III Melanoma with Long-Term Toxicity Follow-Up

1Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA
221st Century Oncology Translational Research Consortium, Scottsdale, AZ 85251, USA
3Department of Surgery, University of South Florida, Tampa, FL 33612, USA
4Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA
5Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL 33146, USA
6Department of Biostatistics, Moffitt Cancer Center, Tampa, FL 33612, USA
7Health Outcomes & Behavior Program, Moffitt Cancer Center, Tampa, FL 33612, USA

Received 8 September 2011; Accepted 16 October 2011

Academic Editors: A. Bensussan and D. Saverino

Copyright © 2012 Steven E. Finkelstein et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Radiotherapy (RT) and interferon-alfa-2b (IFN α-2b) have individually been used for adjuvant therapy stage III melanoma with high-risk pathologic features. We hypothesized that concurrent adjuvant RT and IFN α-2b may decrease the risk of regional recurrence following surgery with acceptable toxicity. A prospective multicenter phase I/II study was conducted to evaluate hypofractionated RT with concurrent IFN. Induction IFN α-2b, 20 MU/m2/d, was administered IV ×5 consecutive days every week for 4 weeks. Next, RT 30 Gy in 5 fractions was given with concurrent IFN α-2b, 10 MU/m2 SQ 3 times per week on days alternating with RT. Subsequent maintenance therapy consisted of adjuvant IFN α-2b, 10 MU/m2 SQ 3 times per week to a total of 1 year. To fully evaluate patterns of failure, long-term follow-up was conducted for up to 10 years. A total of 29 consenting patients were enrolled between August 1997 and March 2000. The maximum (worst) grade of acute nonhematologic toxicity during concurrent RT/IFN α-2b (and up to 2 weeks post RT) was grade 3 skin toxicity noted in 2 patients (9%). Late effects were limited. Probability of regional control was 78% (95% CI: 55%–90%) at 12 months. The median follow-up (range) was 80 (51–106) months among ten survivors (43%). The median overall survival was 34.5 months while the median failure-free survival was 19.9 months. Postoperative concurrent hypofractionated RT with IFN α-2b for advanced stage III melanoma appears to be associated with acceptable toxicity and may provide reasonable in-field control in patients at high risk of regional failure.