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Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma : a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group . PURPOSE Interferon ( IFN ) -based adjuvant therapy in melanoma is associated with significant side effects , which necessitates evaluation of health-related quality of life ( HRQOL ) . Our trial examined the HRQOL effects of adjuvant pegylated IFN-alpha-2b ( PEG-IFN-alpha-2b ) versus observation in patients with stage III melanoma . METHODS A total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation ( n = 629 ) or PEG-IFN-alpha-2b ( n = 627 ) : induction 6 micrograms/kg/wk [ DOSAGE ERROR CORRECTED ] for 8 weeks then maintenance 3 micrograms/kg/wk [ DOSAGE ERROR CORRECTED ] for an intended total duration of 5 years . The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL . RESULTS At 3.8 years of median follow-up , for the primary end point , recurrence-free survival ( RFS ) , risk was reduced by 18 % ( hazard rate = 0.82 ; P = .01 ) in the PEG-IFN-alpha-2b arm compared with observation . Significant and clinically meaningful differences occurred with the PEG-IFN-alpha-2b treatment arm compared with the observation group , showing decreased global HRQOL at month 3 ( -11.6 points ; 99 % CI , -8.2 to -15.0 ) and year 2 ( -10.5 points ; 99 % CI , -6.6 to -14.4 ) . Many of the other scales showed statistically significant differences between scores when comparing the two arms . From a clinical point of view , important differences were found for five scales : two functioning scales ( social and role functioning ) and three symptom scales ( appetite loss , fatigue , and dyspnea ) , with the PEG-IFN-alpha-2b arm being most impaired . CONCLUSION PEG-IFN-alpha-2b leads to a significant and sustained improvement in RFS . There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-alpha-2b treatment .
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Intervention_Educational
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30
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Outcome_Other
health-related quality of life
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Outcome_Other
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30
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Outcome_Mortality
recurrence-free survival ( RFS )
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Outcome_Other
HRQOL
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Outcome_Other
social
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Outcome_Mental
and
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Outcome_Other
role functioning
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Outcome_Physical
appetite loss
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Outcome_Physical
fatigue
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Outcome_Physical
dyspnea
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Outcome_Other
global HRQOL
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Participant_Condition
stage III melanoma
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Participant_Sample-size
1,256
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Participant_Condition
stage III melanoma
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Participant_Condition
after full lymphadenectomy