Article (Scientific journals)
Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial
Ribi, Karin; Luo, Weixiu; Colleoni, Marco et al.
2019In British Journal of Cancer, 120, p. 959-967
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Abstract :
[en] Background: In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients’ quality of life (QoL). Methods: In the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months. Results: There was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25–30% of patients reported a clinically relevant worsening in key symptoms and global QoL. Conclusion: Less symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative. Clinical trial information: Clinical trial information: NCT00651456. © 2019, Cancer Research UK.
Disciplines :
Oncology
Author, co-author :
Ribi, Karin;  Quality of Life Office, International Breast Cancer Study Group Coordinating Center, Bern, Switzerland
Luo, Weixiu;  International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, United States
Colleoni, Marco;  Division of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy
Karlsson, Per;  Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy/Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden
Chirgwin, Jacquie H.;  Box Hill and Maroondah Hospitals, Monash UniversityVIC, Australia
Aebi, Stefan;  Luzerner Kantonsspital, Lucerne, Switzerland
JERUSALEM, Guy  ;  Centre Hospitalier Universitaire de Liège - CHU > Département de médecine interne > Service d'oncologie médicale
Neven, Patrick;  Multidisciplinary Breast Center, University Hospitals, KU Leuven, Leuven, Belgium
Di Lauro, Vincenzo;  Division of Medical Oncology B, CRO-Aviano, Aviano, Italy
Gomez, H. L.;  Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru
Ruhstaller, T.;  Breast Center St. Gallen, Swiss Group for Clinical Cancer Research and International Breast Cancer Study Group, Bern, Switzerland
Abdi, E.;  The Tweed Hospital, Tweed Heads, NSW & Griffith University Gold Coast, Southport, Australia
Biganzoli, L.;  Hospital of Prato-AUSL Toscana Centro, Istituto Toscano Tumori, Prato, Italy
Müller, B.;  Chilean Cooperative Group for Oncologic Research (GOCCHI), Providencia, Santiago, Chile
Barbeaux, A.;  CHR Verviers, Verviers, Belgium
Graas, M.-P.;  CHC Clinique St. Joseph, Liège, Belgium
Rabaglio, M.;  Bern University Hospital, Inselspital, Bern, Switzerland
Francis, P. A.;  Peter MacCallum Cancer Center, University of Melbourne, Melbourne and Breast Cancer Trials Australia & New Zealand, University of Newcastle, Newcastle, Australia
Foukakis, T.;  Department of Oncology, Karolinska Institute and University Hospital, Stockholm, Sweden
Pagani, O.;  Institute of Oncology of Southern Switzerland, Bellinzona, Geneva University Hospitals, Geneva, Swiss Group for Clinical Cancer Research (SAKK) and International Breast Cancer Study Group, Bern, Switzerland
Graiff, C.;  Division of Medical Oncology, Ospedale Centrale di Bolzano, Bolzano, Italy
Vorobiof, D.;  Sandton Oncology Centre, Johannesburg, South Africa
Maibach, R.;  International Breast Cancer Study Group Coordinating Center, Bern, Switzerland
Di Leo, A.;  Hospital of Prato-AUSL Toscana Centro, Istituto Toscano Tumori, Prato, Italy
Gelber, R. D.;  International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA, United States
Goldhirsch, A.;  International Breast Cancer Study Group and IEO, European Institute of Oncology IRCCS, Milan, Italy
Coates, A. S.;  International Breast Cancer Study Group and University of Sydney, Sydney, Australia
Regan, M. M.;  International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, United States
Bernhard, J.;  Quality of Life Office, International Breast Cancer Study Group Coordinating Center and Bern University Hospital, Inselspital, Bern, Switzerland
on behalf of the SOLE Investigators
More authors (20 more) Less
Language :
English
Title :
Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial
Publication date :
2019
Journal title :
British Journal of Cancer
ISSN :
0007-0920
eISSN :
1532-1827
Publisher :
Nature Publishing Group
Volume :
120
Pages :
959-967
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 29 May 2019

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