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Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial.

Colleoni, Marco (författare)
International Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, Italy
Luo, Weixiu (författare)
International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA
Karlsson, Per, 1963 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,International Breast Cancer Study Group and Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Chirgwin, Jacquie (författare)
International Breast Cancer Study Group, Australia and New Zealand Breast Cancer Trials Group, and Box Hill and Maroondah Hospitals, Monash University, Melbourne, VIC, Australia
Aebi, Stefan (författare)
International Breast Cancer Study Group and Lucerne Canton Hospital, Lucerne, Switzerland
Jerusalem, Guy (författare)
International Breast Cancer Study Group, Centre Hospitalier Universitaire de Liège, Liège University, Liège, Belgium
Neven, Patrick (författare)
International Breast Cancer Study Group and Multidisciplinary Breast Center, University Hospitals, Katholieke Universiteit Leuven, Leuven, Belgium
Hitre, Erika (författare)
International Breast Cancer Study Group and National Institute of Oncology, Budapest, Hungary
Graas, Marie-Pascale (författare)
International Breast Cancer Study Group and Centre Hospitalier Chrétien Clinique St Joseph, Liège, Belgium
Simoncini, Edda (författare)
International Breast Cancer Study Group and ASST Spedali Civili di Brescia, Brescia, Italy
Kamby, Claus (författare)
Danish Breast Cancer Group and Rigshospitalet, Copenhagen, Denmark
Thompson, Alastair (författare)
Scottish Cancer Trials Breast Group and The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Loibl, Sibylle (författare)
German Breast Group, Neu-Isenburg, Germany
Gavilá, Joaquín (författare)
SOLTI Group and Fundación Instituto Valenciano de Oncologia, Valencia, Spain
Kuroi, Katsumasa (författare)
Japan Breast Cancer Research Group and Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan
Marth, Christian (författare)
Austrian Breast & Colorectal Cancer Study Group and Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria
Müller, Bettina (författare)
Chilean Cooperative Group for Oncologic Research, Providencia, Santiago, Chile
O'Reilly, Seamus (författare)
Cancer Trials Ireland and Cork University Hospital, Cork, Ireland
Di Lauro, Vincenzo (författare)
International Breast Cancer Study Group and Centro di Riferimento Oncologico di Aviano, Aviano, Italy
Gombos, Andrea (författare)
Medical Oncology Clinic, Institute Jules Bordet, Brussels, Belgium
Ruhstaller, Thomas (författare)
Swiss Group for Clinical Cancer Research, International Breast Cancer Study Group, and Breast Center St Gallen, St Gallen, Switzerland
Burstein, Harold (författare)
Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
Ribi, Karin (författare)
International Breast Cancer Study Group Coordinating Center, Bern, Switzerland
Bernhard, Jürg (författare)
International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland
Viale, Giuseppe (författare)
European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Central Pathology Office and University of Milan, Milan, Italy
Maibach, Rudolf (författare)
International Breast Cancer Study Group Coordinating Center, Bern, Switzerland
Rabaglio-Poretti, Manuela (författare)
International Breast Cancer Study Group, Inselspital, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland
Gelber, Richard D (författare)
Coates, Alan S (författare)
Di Leo, Angelo (författare)
International Breast Cancer Study Group, Milan, Italy; Harvard T H Chan School of Public Health, Boston, MA, USA
Regan, Meredith M (författare)
Goldhirsch, Aron (författare)
International Breast Cancer Study Group, Milan, Italy; European Institute of Oncology, Milan, Italy
Coates, Alan S. (författare)
International Breast Cancer Study Group, Milan, Italy; Harvard Medical School, Boston, MA, USA
Gelber, Richard D. (författare)
International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Frontier Science & Technology Research Foundation, Boston, MA, USA
Valachis, Antonis, 1984- (bidragsgivare)
Malar Hospital, Eskilstuna,The SOLE Investigators
Regan, Meredith M. (författare)
International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
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Elsevier, 2018
2018
Engelska.
Ingår i: The Lancet. Oncology. - : Elsevier. - 1474-5488 .- 1470-2045. ; 19:1, s. 127-138
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • In animal models of breast cancer, resistance to continuous use of letrozole can be reversed by withdrawal and reintroduction of letrozole. We therefore hypothesised that extended intermittent use of adjuvant letrozole would improve breast cancer outcome compared with continuous use of letrozole in postmenopausal women.We did the multicentre, open-label, randomised, parallel, phase 3 SOLE trial in 240 centres (academic, primary, secondary, and tertiary care centres) in 22 countries. We enrolled postmenopausal women of any age with hormone receptor-positive, lymph node-positive, and operable breast cancer for which they had undergone local treatment (surgery with or without radiotherapy) and had completed 4-6 years of adjuvant endocrine therapy. They had to be clinically free of breast cancer at enrolment and without evidence of recurrent disease at any time before randomisation. We randomly assigned women (1:1) to treatment groups of either continuous use of letrozole (2·5 mg/day orally for 5 years) or intermittent use of letrozole (2·5 mg/day orally for 9 months followed by a 3-month break in years 1-4 and then 2·5 mg/day during all 12 months of year 5). Randomisation was done by principal investigators or designee at respective centres through the internet-based system of the International Breast Cancer Study Group, was stratified by type of previous endocrine therapy (aromatase inhibitors only vs selective oestrogen receptor modulators only vs both therapies), and used permuted block sizes of four and institutional balancing. No one was masked to treatment assignment. The primary endpoint was disease-free survival, analysed by the intention-to-treat principle using a stratified log-rank test. All patients in the intention-to-treat population who initiated protocol treatment during their period of trial participation were included in the safety analyses. This study is registered with ClinicalTrials.gov, number NCT00553410, and EudraCT, number 2007-001370-88; and long-term follow-up of patients is ongoing.Between Dec 5, 2007, and Oct 8, 2012, 4884 women were enrolled and randomised after exclusion of patients at a non-adherent centre, found to have inadequate documentation of informed consent, immediately withdrew consent, or randomly assigned to intervention groups in error. 4851 women comprised the intention-to-treat population that compared extended intermittent letrozole use (n=2425) with continuous letrozole use (n=2426). After a median follow-up of 60 months (IQR 53-72), disease-free survival was 85·8% (95% CI 84·2-87·2) in the intermittent letrozole group compared with 87·5% (86·0-88·8) in the continuous letrozole group (hazard ratio 1·08, 95% CI 0·93-1·26; p=0·31). Adverse events were reported as expected and were similar between the two groups. The most common grade 3-5 adverse events were hypertension (584 [24%] of 2417 in the intermittent letrozole group vs 517 [21%] of 2411 in the continuous letrozole group) and arthralgia (136 [6%] vs 151 [6%]). 54 patients (24 [1%] in the intermittent letrozole group and 30 [1%] in the continuous letrozole group) had grade 3-5 CNS cerebrovascular ischaemia, 16 (nine [<1%] vs seven [<1%]) had grade 3-5 CNS haemorrhage, and 40 (19 [1%] vs 21 [1%]) had grade 3-5 cardiac ischaemia. In total, 23 (<1%) of 4851 patients died while on trial treatment (13 [<1%] of 2417 patients in the intermittent letrozole group vs ten [<1%] of 2411 in the continuous letrozole group).In postmenopausal women with hormone receptor-positive breast cancer, extended use of intermittent letrozole did not improve disease-free survival compared with continuous use of letrozole. An alternative schedule of extended adjuvant endocrine therapy with letrozole, including intermittent administration, might be feasible and the results of the SOLE trial support the safety of temporary treatment breaks in selected patients who might require them.Novartis and the International Breast Cancer Study Group.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Nyckelord

Aged
Antineoplastic Agents
administration & dosage
adverse effects
Aromatase Inhibitors
administration & dosage
adverse effects
Biomarkers
Tumor
analysis
Breast Neoplasms
chemistry
drug therapy
mortality
pathology
Chemotherapy
Adjuvant
Disease-Free Survival
Drug Administration Schedule
Female
Humans
Letrozole
Middle Aged
Nitriles
administration & dosage
adverse effects
Postmenopause
Receptor
ErbB-2
analysis
Receptors
Estrogen
analysis
Receptors
Progesterone
analysis
Time Factors
Treatment Outcome
Triazoles
administration & dosage
adverse effects

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