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  • Colleoni, MarcoInternational Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, Italy (författare)

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

  • Artikel/kapitelEngelska2018

Förlag, utgivningsår, omfång ...

  • Elsevier,2018

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/274130
  • https://gup.ub.gu.se/publication/274130URI
  • https://doi.org/10.1016/S1470-2045(17)30715-5DOI
  • urn:nbn:se:oru:diva-79797urn

Kompletterande språkuppgifter

  • Språk:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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).
  • 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 och genrebeteckningar

  • MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin hsv//swe
  • MEDICAL AND HEALTH SCIENCES Clinical Medicine hsv//eng
  • 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

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Luo, WeixiuInternational Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA(Swepub:gu)785264 (författare)
  • Karlsson, Per,1963Gothenburg 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(Swepub:gu)xkperd (författare)
  • Chirgwin, JacquieInternational Breast Cancer Study Group, Australia and New Zealand Breast Cancer Trials Group, and Box Hill and Maroondah Hospitals, Monash University, Melbourne, VIC, Australia(Swepub:gu)785263 (författare)
  • Aebi, StefanInternational Breast Cancer Study Group and Lucerne Canton Hospital, Lucerne, Switzerland(Swepub:gu)785266 (författare)
  • Jerusalem, GuyInternational Breast Cancer Study Group, Centre Hospitalier Universitaire de Liège, Liège University, Liège, Belgium(Swepub:gu)785267 (författare)
  • Neven, PatrickInternational Breast Cancer Study Group and Multidisciplinary Breast Center, University Hospitals, Katholieke Universiteit Leuven, Leuven, Belgium(Swepub:gu)785265 (författare)
  • Hitre, ErikaInternational Breast Cancer Study Group and National Institute of Oncology, Budapest, Hungary(Swepub:gu)785268 (författare)
  • Graas, Marie-PascaleInternational Breast Cancer Study Group and Centre Hospitalier Chrétien Clinique St Joseph, Liège, Belgium(Swepub:gu)785270 (författare)
  • Simoncini, EddaInternational Breast Cancer Study Group and ASST Spedali Civili di Brescia, Brescia, Italy(Swepub:gu)785269 (författare)
  • Kamby, ClausDanish Breast Cancer Group and Rigshospitalet, Copenhagen, Denmark(Swepub:gu)785271 (författare)
  • Thompson, AlastairScottish Cancer Trials Breast Group and The University of Texas MD Anderson Cancer Center, Houston, TX, USA(Swepub:gu)785272 (författare)
  • Loibl, SibylleGerman Breast Group, Neu-Isenburg, Germany(Swepub:gu)785273 (författare)
  • Gavilá, JoaquínSOLTI Group and Fundación Instituto Valenciano de Oncologia, Valencia, Spain(Swepub:gu)785274 (författare)
  • Kuroi, KatsumasaJapan Breast Cancer Research Group and Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan(Swepub:gu)785275 (författare)
  • Marth, ChristianAustrian Breast & Colorectal Cancer Study Group and Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria(Swepub:gu)785276 (författare)
  • Müller, BettinaChilean Cooperative Group for Oncologic Research, Providencia, Santiago, Chile(Swepub:gu)785278 (författare)
  • O'Reilly, SeamusCancer Trials Ireland and Cork University Hospital, Cork, Ireland(Swepub:gu)785277 (författare)
  • Di Lauro, VincenzoInternational Breast Cancer Study Group and Centro di Riferimento Oncologico di Aviano, Aviano, Italy(Swepub:gu)785280 (författare)
  • Gombos, AndreaMedical Oncology Clinic, Institute Jules Bordet, Brussels, Belgium(Swepub:gu)785279 (författare)
  • Ruhstaller, ThomasSwiss Group for Clinical Cancer Research, International Breast Cancer Study Group, and Breast Center St Gallen, St Gallen, Switzerland(Swepub:gu)785282 (författare)
  • Burstein, HaroldDana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA(Swepub:gu)785281 (författare)
  • Ribi, KarinInternational Breast Cancer Study Group Coordinating Center, Bern, Switzerland(Swepub:gu)785284 (författare)
  • Bernhard, JürgInternational Breast Cancer Study Group Coordinating Center, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland(Swepub:gu)785283 (författare)
  • Viale, GiuseppeEuropean Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Central Pathology Office and University of Milan, Milan, Italy(Swepub:gu)785285 (författare)
  • Maibach, RudolfInternational Breast Cancer Study Group Coordinating Center, Bern, Switzerland(Swepub:gu)785286 (författare)
  • Rabaglio-Poretti, ManuelaInternational Breast Cancer Study Group, Inselspital, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland(Swepub:gu)785288 (författare)
  • Gelber, Richard D (författare)
  • Coates, Alan S (författare)
  • Di Leo, AngeloInternational Breast Cancer Study Group, Milan, Italy; Harvard T H Chan School of Public Health, Boston, MA, USA(Swepub:gu)785290 (författare)
  • Regan, Meredith M (författare)
  • Goldhirsch, AronInternational Breast Cancer Study Group, Milan, Italy; European Institute of Oncology, Milan, Italy(Swepub:gu)785292 (författare)
  • Gelber, Richard D.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 (författare)
  • Valachis, Antonis,1984-Malar Hospital, Eskilstuna,The SOLE Investigators(Swepub:oru)asvs (bidragsgivare)
  • Regan, Meredith M.International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA (författare)
  • Coates, Alan S.International Breast Cancer Study Group, Milan, Italy; Harvard Medical School, Boston, MA, USA (författare)
  • International Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, ItalyInternational Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA (creator_code:org_t)
  • Göteborgs universitet
  • Gothenburg University

Sammanhörande titlar

  • Ingår i:The Lancet. Oncology: Elsevier19:1, s. 127-1381474-54881470-2045

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