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  • 1.
    Colleoni, Marco
    et al.
    International Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, Italy.
    Luo, Weixiu
    International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA.
    Karlsson, Per
    International Breast Cancer Study Group and Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Chirgwin, Jacquie
    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
    International Breast Cancer Study Group and Lucerne Canton Hospital, Lucerne, Switzerland.
    Jerusalem, Guy
    International Breast Cancer Study Group, Centre Hospitalier Universitaire de Liège, Liège University, Liège, Belgium.
    Neven, Patrick
    International Breast Cancer Study Group and Multidisciplinary Breast Center, University Hospitals, Katholieke Universiteit Leuven, Leuven, Belgium.
    Hitre, Erika
    International Breast Cancer Study Group and National Institute of Oncology, Budapest, Hungary.
    Graas, Marie-Pascale
    International Breast Cancer Study Group and Centre Hospitalier Chrétien Clinique St Joseph, Liège, Belgium.
    Simoncini, Edda
    International Breast Cancer Study Group and ASST Spedali Civili di Brescia, Brescia, Italy.
    Kamby, Claus
    Danish Breast Cancer Group and Rigshospitalet, Copenhagen, Denmark.
    Thompson, Alastair
    Scottish Cancer Trials Breast Group and The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
    Loibl, Sibylle
    German Breast Group, Neu-Isenburg, Germany.
    Gavilá, Joaquín
    SOLTI Group and Fundación Instituto Valenciano de Oncologia, Valencia, Spain.
    Kuroi, Katsumasa
    Japan Breast Cancer Research Group and Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
    Marth, Christian
    Austrian Breast & Colorectal Cancer Study Group and Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria.
    Müller, Bettina
    Chilean Cooperative Group for Oncologic Research, Providencia, Santiago, Chile.
    O'Reilly, Seamus
    Cancer Trials Ireland and Cork University Hospital, Cork, Ireland.
    Di Lauro, Vincenzo
    International Breast Cancer Study Group and Centro di Riferimento Oncologico di Aviano, Aviano, Italy.
    Gombos, Andrea
    Medical Oncology Clinic, Institute Jules Bordet, Brussels, Belgium.
    Ruhstaller, Thomas
    Swiss Group for Clinical Cancer Research, International Breast Cancer Study Group, and Breast Center St Gallen, St Gallen, Switzerland.
    Burstein, Harold
    Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
    Ribi, Karin
    International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.
    Bernhard, Jürg
    International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland.
    Viale, Giuseppe
    European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Central Pathology Office and University of Milan, Milan, Italy.
    Maibach, Rudolf
    International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.
    Rabaglio-Poretti, Manuela
    International Breast Cancer Study Group, Inselspital, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland.
    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.
    Coates, Alan S.
    International Breast Cancer Study Group, Milan, Italy; Harvard Medical School, Boston, MA, USA.
    Di Leo, Angelo
    International Breast Cancer Study Group, Milan, Italy; Harvard T H Chan School of Public Health, Boston, MA, USA .
    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.
    Goldhirsch, Aron
    International Breast Cancer Study Group, Milan, Italy; European Institute of Oncology, Milan, Italy.
    The SOLE Investigators,
    Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial2018In: The Lancet Oncology, ISSN 1470-2045, E-ISSN 1474-5488, Vol. 19, no 1, p. 127-138Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: 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.

    METHODS: 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.

    FINDINGS: 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).

    INTERPRETATION: 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.

    FUNDING: Novartis and the International Breast Cancer Study Group.

  • 2.
    Johansson, E.
    et al.
    Department of Surgical Sciences, University Hospital of Uppsala, Uppsala, Sweden.
    Steineck, G.
    Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, Sweden; Division of Clinical Cancer Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
    Holmberg, L.
    Medical School, Division of Cancer Studies, King's College London, London, United Kingdom.
    Johansson, J-E
    Örebro University, School of Health and Medical Sciences. Department of Urology and the Center of Assessment of Medical Technology, Örebro University Hospital, Örebro, Sweden.
    Nyberg, T.
    Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, Sweden.
    Ruutu, M.
    Department of Urology, Helsinki University Hospital, Helsinki, Finland.
    Bill-Axelsson, A.
    Department of Surgical Sciences, University Hospital of Uppsala, Uppsala, Sweden; Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, Sweden.
    Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial2011In: The Lancet Oncology, ISSN 1470-2045, E-ISSN 1474-5488, Vol. 12, no 9, p. 891-899Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years.

    METHODS: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint.

    FINDINGS: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12·2 years (range 7-17) and a median age of 77·0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1·42, 95% CI 1·07-1·88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life.

    INTERPRETATION: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information.

  • 3. Lauby-Secretan, Beatrice
    et al.
    Loomis, Dana
    Grosse, Yann
    El Ghissassi, Fatiha
    Bouvard, Veronique
    Benbrahim-Tallaa, Lamia
    Guha, Neela
    Baan, Robert
    Mattock, Heidi
    Straif, Kurt
    Fiedler, Heidelore
    Örebro University, School of Science and Technology.
    Carcinogenicity of polychlorinated biphenyls and polybrominated biphenyls2013In: The Lancet Oncology, ISSN 1470-2045, E-ISSN 1474-5488, Vol. 14, no 4, p. 287-288Article in journal (Refereed)
1 - 3 of 3
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