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Sökning: onr:"swepub:oai:gup.ub.gu.se/274130" > Extended adjuvant i...

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FältnamnIndikatorerMetadata
00012447naa a2201189 4500
001oai:gup.ub.gu.se/274130
003SwePub
008240410s2018 | |||||||||||000 ||eng|
009oai:DiVA.org:oru-79797
0247 a https://gup.ub.gu.se/publication/2741302 URI
0247 a https://doi.org/10.1016/S1470-2045(17)30715-52 DOI
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-797972 URI
040 a (SwePub)gud (SwePub)oru
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Colleoni, Marcou International Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, Italy4 aut
2451 0a Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial.
264 1b Elsevier,c 2018
500 a This trial was funded by Novartis and the International Breast Cancer Study Group (IBCSG). Novartis provided the letrozole used in this study. Support for the coordinating group, IBCSG, was provided by the Frontier Science & Technology Research Foundation; the Swiss Group for Clinical Cancer Research; Cancer Research Switzerland, Oncosuisse, and Cancer League Switzerland; and the Foundation for Clinical Cancer Research of Eastern Switzerland. SOLE is a Breast International Group trial (BIG 01-07).
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
653 a Aged
653 a Antineoplastic Agents
653 a administration & dosage
653 a adverse effects
653 a Aromatase Inhibitors
653 a administration & dosage
653 a adverse effects
653 a Biomarkers
653 a Tumor
653 a analysis
653 a Breast Neoplasms
653 a chemistry
653 a drug therapy
653 a mortality
653 a pathology
653 a Chemotherapy
653 a Adjuvant
653 a Disease-Free Survival
653 a Drug Administration Schedule
653 a Female
653 a Humans
653 a Letrozole
653 a Middle Aged
653 a Nitriles
653 a administration & dosage
653 a adverse effects
653 a Postmenopause
653 a Receptor
653 a ErbB-2
653 a analysis
653 a Receptors
653 a Estrogen
653 a analysis
653 a Receptors
653 a Progesterone
653 a analysis
653 a Time Factors
653 a Treatment Outcome
653 a Triazoles
653 a administration & dosage
653 a adverse effects
7001 a Luo, Weixiuu International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA4 aut
7001 a Karlsson, Per,d 1963u 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, Sweden4 aut0 (Swepub:gu)xkperd
7001 a Chirgwin, Jacquieu International Breast Cancer Study Group, Australia and New Zealand Breast Cancer Trials Group, and Box Hill and Maroondah Hospitals, Monash University, Melbourne, VIC, Australia4 aut
7001 a Aebi, Stefanu International Breast Cancer Study Group and Lucerne Canton Hospital, Lucerne, Switzerland4 aut
7001 a Jerusalem, Guyu International Breast Cancer Study Group, Centre Hospitalier Universitaire de Liège, Liège University, Liège, Belgium4 aut
7001 a Neven, Patricku International Breast Cancer Study Group and Multidisciplinary Breast Center, University Hospitals, Katholieke Universiteit Leuven, Leuven, Belgium4 aut
7001 a Hitre, Erikau International Breast Cancer Study Group and National Institute of Oncology, Budapest, Hungary4 aut
7001 a Graas, Marie-Pascaleu International Breast Cancer Study Group and Centre Hospitalier Chrétien Clinique St Joseph, Liège, Belgium4 aut
7001 a Simoncini, Eddau International Breast Cancer Study Group and ASST Spedali Civili di Brescia, Brescia, Italy4 aut
7001 a Kamby, Clausu Danish Breast Cancer Group and Rigshospitalet, Copenhagen, Denmark4 aut
7001 a Thompson, Alastairu Scottish Cancer Trials Breast Group and The University of Texas MD Anderson Cancer Center, Houston, TX, USA4 aut
7001 a Loibl, Sibylleu German Breast Group, Neu-Isenburg, Germany4 aut
7001 a Gavilá, Joaquínu SOLTI Group and Fundación Instituto Valenciano de Oncologia, Valencia, Spain4 aut
7001 a Kuroi, Katsumasau Japan Breast Cancer Research Group and Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan4 aut
7001 a Marth, Christianu Austrian Breast & Colorectal Cancer Study Group and Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria4 aut
7001 a Müller, Bettinau Chilean Cooperative Group for Oncologic Research, Providencia, Santiago, Chile4 aut
7001 a O'Reilly, Seamusu Cancer Trials Ireland and Cork University Hospital, Cork, Ireland4 aut
7001 a Di Lauro, Vincenzou International Breast Cancer Study Group and Centro di Riferimento Oncologico di Aviano, Aviano, Italy4 aut
7001 a Gombos, Andreau Medical Oncology Clinic, Institute Jules Bordet, Brussels, Belgium4 aut
7001 a Ruhstaller, Thomasu Swiss Group for Clinical Cancer Research, International Breast Cancer Study Group, and Breast Center St Gallen, St Gallen, Switzerland4 aut
7001 a Burstein, Haroldu Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA4 aut
7001 a Ribi, Karinu International Breast Cancer Study Group Coordinating Center, Bern, Switzerland4 aut
7001 a Bernhard, Jürgu International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland4 aut
7001 a Viale, Giuseppeu European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Central Pathology Office and University of Milan, Milan, Italy4 aut
7001 a Maibach, Rudolfu International Breast Cancer Study Group Coordinating Center, Bern, Switzerland4 aut
7001 a Rabaglio-Poretti, Manuelau International Breast Cancer Study Group, Inselspital, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland4 aut
7001 a Gelber, Richard Du 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, USA4 aut
7001 a Coates, Alan Su International Breast Cancer Study Group, Milan, Italy; Harvard Medical School, Boston, MA, USA4 aut
7001 a Di Leo, Angelou International Breast Cancer Study Group, Milan, Italy; Harvard T H Chan School of Public Health, Boston, MA, USA4 aut
7001 a Regan, Meredith Mu International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA4 aut
7001 a Goldhirsch, Aronu International Breast Cancer Study Group, Milan, Italy; European Institute of Oncology, Milan, Italy4 aut
7001 a Valachis, Antonis,d 1984-u Malar Hospital, Eskilstuna,The SOLE Investigators4 ctb0 (Swepub:oru)asvs
7102 a International Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, Italyb International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA4 org
7730 t The Lancet. Oncologyd : Elsevierg 19:1, s. 127-138q 19:1<127-138x 1474-5488x 1470-2045
8564 8u https://gup.ub.gu.se/publication/274130
8564 8u https://doi.org/10.1016/S1470-2045(17)30715-5
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-79797

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