Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma.

2.50
Hdl Handle:
http://hdl.handle.net/10541/77797
Title:
Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma.
Authors:
Hancock, Barry W; Wheatley, Keith; Harris, S; Ives, Natalie J; Harrison, G; Horsman, J M; Middleton, Mark R; Thatcher, Nick; Lorigan, Paul C ( 0000-0002-8875-2164 ) ; Marsden, J R; Burrows, L; Gore, M
Abstract:
PURPOSE: To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (> or = 4 mm) primary cutaneous melanoma and/or locoregional metastases. PATIENTS AND METHODS: In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma. RESULTS: The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively. There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P =.6; and OR, 0.91; 95% CI, 0.75 to 1.10; P =.3; respectively). Male sex (P =.003) and regional lymph node involvement (P =.0009), but not age (P =.7), were statistically significant adverse features for OS. Subgroup analysis by disease stage, age, and sex did not show any clear differences between interferon-treated and control groups in either OS or RFS. Interferon-related toxicities were modest: grade 3 (and in only one case, grade 4) fatigue or mood disturbance was seen in 7% and 4% respectively, of patients. However, there were 50 withdrawals (15%) from interferon treatment due to toxicity. CONCLUSION: The results from this study, taken in isolation, do not indicate that extended-duration low-dose interferon is significantly better than observation alone in the initial treatment of completely resected high-risk malignant melanoma.
Affiliation:
Academic Unit of Clinical Oncology, The University of Sheffield, Weston Park Hospital, Whitham Rd, Sheffield S10 2SJ, UK. b.w.hancock@sheffield.ac.uk
Citation:
Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma. 2004, 22 (1):53-61 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
1-Jan-2004
URI:
http://hdl.handle.net/10541/77797
DOI:
10.1200/JCO.2004.03.185
PubMed ID:
14665609
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorHancock, Barry W-
dc.contributor.authorWheatley, Keith-
dc.contributor.authorHarris, S-
dc.contributor.authorIves, Natalie J-
dc.contributor.authorHarrison, G-
dc.contributor.authorHorsman, J M-
dc.contributor.authorMiddleton, Mark R-
dc.contributor.authorThatcher, Nick-
dc.contributor.authorLorigan, Paul C-
dc.contributor.authorMarsden, J R-
dc.contributor.authorBurrows, L-
dc.contributor.authorGore, M-
dc.date.accessioned2009-08-19T11:07:09Z-
dc.date.available2009-08-19T11:07:09Z-
dc.date.issued2004-01-01-
dc.identifier.citationAdjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma. 2004, 22 (1):53-61 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid14665609-
dc.identifier.doi10.1200/JCO.2004.03.185-
dc.identifier.urihttp://hdl.handle.net/10541/77797-
dc.description.abstractPURPOSE: To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (> or = 4 mm) primary cutaneous melanoma and/or locoregional metastases. PATIENTS AND METHODS: In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma. RESULTS: The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively. There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P =.6; and OR, 0.91; 95% CI, 0.75 to 1.10; P =.3; respectively). Male sex (P =.003) and regional lymph node involvement (P =.0009), but not age (P =.7), were statistically significant adverse features for OS. Subgroup analysis by disease stage, age, and sex did not show any clear differences between interferon-treated and control groups in either OS or RFS. Interferon-related toxicities were modest: grade 3 (and in only one case, grade 4) fatigue or mood disturbance was seen in 7% and 4% respectively, of patients. However, there were 50 withdrawals (15%) from interferon treatment due to toxicity. CONCLUSION: The results from this study, taken in isolation, do not indicate that extended-duration low-dose interferon is significantly better than observation alone in the initial treatment of completely resected high-risk malignant melanoma.en
dc.language.isoenen
dc.subjectSkin Canceren
dc.subject.meshAdolescent-
dc.subject.meshAdult-
dc.subject.meshAffect-
dc.subject.meshAge Factors-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshDisease-Free Survival-
dc.subject.meshDose-Response Relationship, Drug-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshFatigue-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshInterferon-alpha-
dc.subject.meshMale-
dc.subject.meshMelanoma-
dc.subject.meshMiddle Aged-
dc.subject.meshRisk Factors-
dc.subject.meshSkin Neoplasms-
dc.subject.meshTreatment Outcome-
dc.titleAdjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma.en
dc.typeArticleen
dc.contributor.departmentAcademic Unit of Clinical Oncology, The University of Sheffield, Weston Park Hospital, Whitham Rd, Sheffield S10 2SJ, UK. b.w.hancock@sheffield.ac.uken
dc.identifier.journalJournal of Clinical Oncologyen

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