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  • 1. Dahlen, Torsten
    et al.
    Edgren, Gustaf
    Lambe, Mats
    Hoglund, Martin
    Bjorkholm, Magnus
    Sandin, Fredrik
    Själander, Anders
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Richter, Johan
    Olsson-Stromberg, Ulla
    Ohm, Lotta
    Back, Magnus
    Stenke, Leif
    Cardiovascular Events Associated With Use of Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia: A Population-Based Cohort Study2016In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 165, no 3, p. 161-166Article in journal (Refereed)
    Abstract [en]

    Background: Tyrosine kinase inhibitors (TKIs) have increased survival dramatically for patients with chronic myeloid leukemia (CML), but continuous administration of these drugs may elicit long-term toxicity. Objective: To investigate the incidence of vascular events in patients with CML treated with first-and second-generation TKIs. Design: Retrospective cohort study using nationwide population-based registries. Setting: Sweden. Patients: All patients diagnosed with chronic-phase CML in Sweden from 2002 to 2012 and treated with a TKI, and 5 age- and sex-matched control individuals per patient. Measurements: Relative risks, expressed as incidence rate ratios comparing patients with control individuals, were calculated. Events per 1000 person-years were assessed in interdrug comparisons. Results: 896 patients, 94.4% with documented TKI treatment, were followed for a median of 4.2 years. There were 54 arterial and 20 venous events in the CML cohort, corresponding to relative risks of 1.5 (95% CI, 1.1 to 2.1) and 2.0 (CI, 1.2 to 3.3), respectively. The event rate for myocardial infarction was higher in patients treated with nilotinib or dasatinib (29 and 19 per 1000 person-years, respectively) than in those receiving imatinib (8 per 1000 person-years), although data are limited and the CIs were wide and overlapped. Among 31 patients treated with a TKI who had myocardial infarction, 26 (84%) had at least 1 major cardiac risk factor diagnosed before the event occurred. Limitations: Patients may have been exposed to multiple TKIs. Data on second-and third-generation TKIs were limited. Conclusion: An increased risk for arterial and venous vascular events was seen in patients with CML treated with a TKI. Further study is needed to determine whether the risk for myocardial infarction increases with second-generation drugs.

  • 2. Gunter, Marc J.
    et al.
    Murphy, Neil
    Cross, Amanda J..
    Dossus, Laure
    Dartois, Laureen
    Fagherazzi, Guy
    Kaaks, Rudolf
    Kühn, Tilman
    Boeing, Heiner
    Aleksandrova, Krasimira
    Tjønneland, Anne
    Olsen, Anja
    Overvad, Kim
    Larsen, Sofus Christian
    Redondo Cornejo, Maria Luisa
    Agudo, Antonio
    Sánchez Pérez, María José
    Altzibar, Jone M.
    Navarro, Carmen
    Ardanaz, Eva
    Khaw, Kay-Tee
    Butterworth, Adam
    Bradbury, Kathryn E.
    Trichopoulou, Antonia
    Lagiou, Pagona
    Trichopoulos, Dimitrios
    Palli, Domenico
    Grioni, Sara
    Vineis, Paolo
    Panico, Salvatore
    Tumino, Rosario
    Bueno-de-Mesquita, Bas
    Siersema, Peter
    Leenders, Max
    Beulens, Joline W. J.
    Uiterwaal, Cuno U.
    Wallström, Peter
    Nilsson, Lena Maria
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Nutritional Research.
    Landberg, Rikard
    Weiderpass, Elisabete
    Skeie, Guri
    Braaten, Tonje
    Brennan, Paul
    Licaj, Idlir
    Muller, David C.
    Sinha, Rashmi
    Wareham, Nick
    Riboli, Elio
    Coffee Drinking and Mortality in 10 European Countries: A Multinational Cohort Study2017In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 167, no 4, p. 236-247Article in journal (Refereed)
    Abstract [en]

    Background: The relationship between coffee consumption and mortality in diverse European populations with variable coffee preparation methods is unclear.

    Objective: To examine whether coffee consumption is associated with all-cause and cause-specific mortality.

    Design: Prospective cohort study.

    Setting: 10 European countries.

    Participants: 521 330 persons enrolled in EPIC (European Prospective Investigation into Cancer and Nutrition).

    Measurements: Hazard ratios (HRs) and 95% CIs estimated using multivariable Cox proportional hazards models. The association of coffee consumption with serum biomarkers of liver function, inflammation, and metabolic health was evaluated in the EPIC Biomarkers subcohort (n = 14 800).

    Results: During a mean follow-up of 16.4 years, 41 693 deaths occurred. Compared with nonconsumers, participants in the highest quartile of coffee consumption had statistically significantly lower all-cause mortality (men: HR, 0.88 [95% CI, 0.82 to 0.95]; P for trend < 0.001; women: HR, 0.93 [CI, 0.87 to 0.98]; P for trend = 0.009). Inverse associations were also observed for digestive disease mortality for men (HR, 0.41 [CI, 0.32 to 0.54]; P for trend < 0.001) and women (HR, 0.60 [CI, 0.46 to 0.78]; P for trend < 0.001). Among women, there was a statistically significant inverse association of coffee drinking with circulatory disease mortality (HR, 0.78 [CI, 0.68 to 0.90]; P for trend < 0.001) and cerebrovascular disease mortality (HR, 0.70 [CI, 0.55 to 0.90]; P for trend = 0.002) and a positive association with ovarian cancer mortality (HR, 1.31 [CI, 1.07 to 1.61]; P for trend = 0.015). In the EPIC Biomarkers subcohort, higher coffee consumption was associated with lower serum alkaline phosphatase; alanine aminotransferase; aspartate aminotransferase; γ-glutamyltransferase; and, in women, C-reactive protein, lipoprotein(a), and glycated hemoglobin levels.

    Limitations: Reverse causality may have biased the findings; however, results did not differ after exclusion of participants who died within 8 years of baseline. Coffee-drinking habits were assessed only once.

    Conclusion: Coffee drinking was associated with reduced risk for death from various causes. This relationship did not vary by country.

    Primary Funding Source: European Commission Directorate-General for Health and Consumers and International Agency for Research on Cancer.

  • 3. Hamer, Davidson H.
    et al.
    Barbre, Kira A.
    Chen, Lin H.
    Grobusch, Martin P.
    Schlagenhauf, Patricia
    Goorhuis, Abraham
    van Genderen, Perry J. J.
    Molina, Israel
    Asgeirsson, Hilmir
    Kozarsky, Phyllis E.
    Caumes, Eric
    Hagmann, Stefan H.
    Mockenhaupt, Frank P.
    Eperon, Gilles
    Barnett, Elizabeth D.
    Bottieau, Emmanuel
    Boggild, Andrea K.
    Gautret, Philippe
    Hynes, Noreen A.
    Kuhn, Susan
    Lash, Ryan
    Leder, Karin
    Libman, Michael
    Malvy, Denis J. M.
    Perret, Cecilia
    Rothe, Camilla
    Schwartz, Eli
    Wilder-Smith, Annelies
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Cetron, Martin S.
    Esposito, Douglas H.
    Travel-Associated Zika Virus Disease Acquired in the Americas Through February 2016 A GeoSentinel Analysis2017In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 166, no 2, p. 99-108Article in journal (Refereed)
    Abstract [en]

    Background: Zika virus has spread rapidly in the Americas and has been imported into many nonendemic countries by travelers. Objective: To describe clinical manifestations and epidemiology of Zika virus disease in travelers exposed in the Americas. Design: Descriptive, using GeoSentinel records. Setting: 63 travel and tropical medicine clinics in 30 countries. Patients: Ill returned travelers with a confirmed, probable, or clinically suspected diagnosis of Zika virus disease seen between January 2013 and 29 February 2016. Measurements: Frequencies of demographic, trip, and clinical characteristics and complications. Results: Starting in May 2015, 93 cases of Zika virus disease were reported. Common symptoms included exanthema (88%), fever (76%), and arthralgia (72%). Fifty-nine percent of patients were exposed in South America; 71% were diagnosed in Europe. Case status was established most commonly by polymerase chain reaction (PCR) testing of blood and less often by PCR testing of other body fluids or serology and plaque-reduction neutralization testing. Two patients developed Guillain-Barre syndrome, and 3 of 4 pregnancies had adverse outcomes (microcephaly, major fetal neurologic abnormalities, and intrauterine fetal death). Limitation: Surveillance data collected by specialized clinics may not be representative of all ill returned travelers, and denominator data are unavailable. Conclusion: These surveillance data help characterize the clinical manifestations and adverse outcomes of Zika virus disease among travelers infected in the Americas and show a need for global standardization of diagnostic testing. The serious fetal complications observed in this study highlight the importance of travel advisories and prevention measures for pregnant women and their partners. Travelers are sentinels for global Zika virus circulation and may facilitate further transmission.

  • 4. Holme, Oyvind
    et al.
    Loberg, Magnus
    Kalager, Mette
    Bretthauer, Michael
    Hernan, Miguel A.
    Aas, Eline
    Eide, Tor J.
    Skovlund, Eva
    Lekven, Jon
    Schneede, Jørn
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Tveit, Kjell Magne
    Vatn, Morten
    Ursin, Giske
    Hoff, Geir
    Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men A Randomized Trial2018In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 168, no 11, p. 775-782Article in journal (Refereed)
    Abstract [en]

    Background: The long-term effects of sigmoidoscopy screening on colorectal cancer (CRC) incidence and mortality in women and men are unclear.

    Objective: To determine the effectiveness of flexible sigmoidoscopy screening after 15 years of follow-up in women and men.

    Design: Randomized controlled trial. (ClinicalTrials.gov: NCT00119912)

    Setting: Oslo and Telemark County, Norway. Participants: Adults aged 50 to 64 years at baseline without prior CRC.

    Intervention: Screening (between 1999 and 2001) with flexible sigmoidoscopy with and without additional fecal blood testing versus no screening. Participants with positive screening results were offered colonoscopy.

    Measurements: Age-adjusted CRC incidence and mortality stratified by sex.

    Results: Of 98 678 persons, 20 552 were randomly assigned to screening and 78 126 to no screening. Adherence rates were 64.7% in women and 61.4% in men. Median follow-up was 14.8 years. The absolute risks for CRC in women were 1.86% in the screening group and 2.05% in the control group (risk difference, -0.19 percentage point [95% CI, -0.49 to 0.11 percentage point]; HR, 0.92 [CI, 0.79 to 1.07]). In men, the corresponding risks were 1.72% and 2.50%, respectively (risk difference, -0.78 percentage point [CI, -1.08 to -0.48 percentage points]; hazard ratio [HR], 0.66 [CI, 0.57 to 0.78]) (P for heterogeneity = 0.004). The absolute risks for death from CRC in women were 0.60% in the screening group and 0.59% in the control group (risk difference, 0.01 percentage point [CI, -0.16 to 0.18 percentage point]; HR, 1.01 [CI, 0.77 to 1.33]). The corresponding risks for death from CRC in men were 0.49% and 0.81%, respectively (risk difference, -0.33 percentage point [CI, -0.49 to -0.16 percentage point]; HR, 0.63 [CI, 0.47 to 0.83]) (P for heterogeneity = 0.014).

    Limitation: Follow-up through national registries.

    Conclusion: Offering sigmoidoscopy screening in Norway reduced CRC incidence and mortality in men but had little or no effect in women.

  • 5. Nichols, Hazel B.
    et al.
    Schoemaker, Minouk J.
    Cai, Jianwen
    Xu, Jiawei
    Wright, Lauren B.
    Brook, Mark N.
    Jones, Michael E.
    Adami, Hans-Olov
    Baglietto, Laura
    Bertrand, Kimberly A.
    Blot, William J.
    Boutron-Ruault, Marie-Christine
    Dorronsoro, Miren
    Dossus, Laure
    Eliassen, A. Heather
    Giles, Graham G.
    Gram, Inger T.
    Hankinson, Susan E.
    Hoffman-Bolton, Judy
    Kaaks, Rudolf
    Key, Timothy J.
    Kitahara, Cari M.
    Larsson, Susanna C.
    Linet, Martha
    Merritt, Melissa A.
    Milne, Roger L.
    Pala, Valeria
    Palmer, Julie R.
    Peeters, Petra H.
    Riboli, Elio
    Sund, Malin
    Umeå University, Faculty of Medicine, Department of Surgical and Perioperative Sciences.
    Tamimi, Rulla M.
    Tjønneland, Anne
    Trichopoulou, Antonia
    Ursin, Giske
    Vatten, Lars
    Visvanathan, Kala
    Weiderpass, Elisabete
    Wolk, Alicja
    Zheng, Wei
    Weinberg, Clarice R.
    Swerdlow, Anthony J.
    Sandler, Dale P.
    Breast Cancer Risk After Recent Childbirth: A Pooled Analysis of 15 Prospective Studies2019In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 170, no 1, p. 22-30Article in journal (Refereed)
    Abstract [en]

    Background: Parity is widely recognized as protective for breast cancer, but breast cancer risk may be increased shortly after childbirth. Whether this risk varies with breastfeeding, family history of breast cancer, or specific tumor subtype has rarely been evaluated.

    Objective: To characterize breast cancer risk in relation to recent childbirth.

    Design: Pooled analysis of individual-level data from 15 prospective cohort studies.

    Setting: The international Premenopausal Breast Cancer Collaborative Group.

    Participants: Women younger than 55 years.

    Measurements: During 9.6 million person-years of follow-up, 18 826 incident cases of breast cancer were diagnosed. Hazard ratios (HRs) and 95% CIs for breast cancer were calculated using Cox proportional hazards regression.

    Results: Compared with nulliparous women, parous women had an HR for breast cancer that peaked about 5 years after birth (HR, 1.80 [95% CI, 1.63 to 1.99]) before decreasing to 0.77 (CI, 0.67 to 0.88) after 34 years. The association crossed over from positive to negative about 24 years after birth. The overall pattern was driven by estrogen receptor (ER)-positive breast cancer; no crossover was seen for ER-negative cancer. Increases in breast cancer risk after childbirth were pronounced when combined with a family history of breast cancer and were greater for women who were older at first birth or who had more births. Breastfeeding did not modify overall risk patterns.

    Limitations: Breast cancer diagnoses during pregnancy were not uniformly distinguishable from early postpartum diagnoses. Data on human epidermal growth factor receptor 2 (HER2) oncogene overexpression were limited.

    Conclusion: Compared with nulliparous women, parous women have an increased risk for breast cancer for more than 20 years after childbirth. Health care providers should consider recent childbirth a risk factor for breast cancer in young women.

    Primary Funding Source: The Avon Foundation, the National Institute of Environmental Health Sciences, Breast Cancer Now and the UK National Health Service, and the Institute of Cancer Research.

  • 6. Schunemann, Holger J.
    et al.
    Lerda, Donata
    Dimitrova, Nadya
    Alonso-Coello, Pablo
    Grawingholt, Axel
    Quinn, Cecily
    Follmann, Markus
    Mansel, Robert
    Sardanelli, Francesco
    Rossi, Paolo Giorgi
    Lebeau, Annette
    Nyström, Lennarth
    Umeå University, Faculty of Medicine, Department of Epidemiology and Global Health.
    Broeders, Mireille
    Ioannidou-Mouzaka, Lydia
    Duffy, Stephen W.
    Borisch, Bettina
    Fitzpatrick, Patricia
    Hofvind, Solveig
    Castells, Xavier
    Giordano, Livia
    Warman, Sue
    Saz-Parkinson, Zuleika
    Autelitan, Mariangela
    Colzani, Edoardo
    Danes, Jan
    Knox, Susan
    Langendam, Miranda
    McGarrigle, Helen
    Perez Gomez, Elsa
    Torresin, Alberto
    van Engen, Ruben
    Young, Kenneth
    van Landsveld-Verhoeven, Cary
    Rigau, David
    Sola, Ivan
    Ballesteros, Monica
    Arevalo-Rodriguez, Ingrid
    Posso, Margarita
    Martinez Garcia, Laura
    Canelo-Aybar, Carlos
    Nino De Guzman, Ena
    Valli, Claudia
    Ricci-Cabello, Ignacio
    Superchi, Cecilia
    Piggott, Thomas
    Baldeh, Tejan
    Parmelli, Elena
    Methods for Development of the European Commission Initiative on Breast Cancer Guidelines Recommendations in the Era of Guideline Transparency2019In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 171, no 4, p. 273-280Article in journal (Refereed)
    Abstract [en]

    Neither breast cancer prevention and early-detection programs, nor their outcomes, are uniform across Europe. This article describes the rationale, methods, and process for development of the European Commission ( EC) Initiative on Breast Cancer Screening and Diagnosis Guidelines. To be consistent with standards set by the Institute of Medicine and others, the EC followed 6 general principles. First, the EC selected, via an open call, a panel with broad representation of areas of expertise. Second, it ensured that all recommendations were supported by systematic reviews. Third, the EC separately considered important subgroups of women, included patient advocates in the guidelines development group, and focused on good communication to inform women's decisions. Fourth, EC rules on conflicts of interest were followed and the GRADE ( Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests. Fifth, it focused its recommendations on outcomes that matter to women, and certainty of the evidence is rated for each. Sixth, the EC elicited stakeholder feedback to ensure that the recommendations remain up to date and relevant to practice. This article describes the approach and highlights ways of disseminating and adapting the recommendations both within and outside Europe, using innovative information technology tools.

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