The Florida Melanoma Trial I : A Prospective Multicenter Phase III 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
Joint Authors
DeConti, Ronald
Rao, Nikhil
Finkelstein, Steven Eric
Yu, Daohai
Feun, Lynn
Sondak, Vernon K.
Trotti, Andy
Zhu, Weiwei
Reintgen, Douglas
Cruse, Wayne
Gwede, Clement
Source
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-02-19
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Finkelstein, Steven Eric& Trotti, Andy& Rao, Nikhil& Reintgen, Douglas& Cruse, Wayne& Feun, Lynn…[et al.]. 2012. The Florida Melanoma Trial I : A Prospective Multicenter Phase III 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. ISRN Immunology،Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-463512
Modern Language Association (MLA)
Finkelstein, Steven Eric…[et al.]. The Florida Melanoma Trial I : A Prospective Multicenter Phase III 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. ISRN Immunology No. 2012 (2012), pp.1-10.
https://search.emarefa.net/detail/BIM-463512
American Medical Association (AMA)
Finkelstein, Steven Eric& Trotti, Andy& Rao, Nikhil& Reintgen, Douglas& Cruse, Wayne& Feun, Lynn…[et al.]. The Florida Melanoma Trial I : A Prospective Multicenter Phase III 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. ISRN Immunology. 2012. Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-463512
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-463512