TY - JOUR
T1 - Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma
T2 - 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
AU - Bottomley, Andrew
AU - Coens, Corneel
AU - Suciu, Stefan
AU - Santinami, Mario
AU - Kruit, Willem
AU - Testori, Alessandro
AU - Marsden, Jeremy
AU - Punt, Cornelis
AU - Salès, François
AU - Gore, Martin
AU - MacKie, Rona
AU - Kusic, Zvonko
AU - Dummer, Reinhard
AU - Patel, Poulam
AU - Schadendorf, Dirk
AU - Spatz, Alain
AU - Keilholz, Ulrich
AU - Eggermont, Alexander
PY - 2009/6/20
Y1 - 2009/6/20
N2 - 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-α-2b (PEG-IFN-α-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-α-2b (n = 627): induction 6 μg/kg/wk for 8 weeks then maintenance 3 μg/kg/wk 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-α-2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN-α-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-α-2b arm being most impaired. Conclusion: PEG-IFN-α-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-α-2b treatment.
AB - 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-α-2b (PEG-IFN-α-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-α-2b (n = 627): induction 6 μg/kg/wk for 8 weeks then maintenance 3 μg/kg/wk 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-α-2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN-α-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-α-2b arm being most impaired. Conclusion: PEG-IFN-α-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-α-2b treatment.
UR - http://www.scopus.com/inward/record.url?scp=67649933805&partnerID=8YFLogxK
U2 - 10.1200/JCO.2008.20.2069
DO - 10.1200/JCO.2008.20.2069
M3 - Article
C2 - 19433686
AN - SCOPUS:67649933805
SN - 0732-183X
VL - 27
SP - 2916
EP - 2923
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 18
ER -