Tampere, Finland
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Cuzick J.,Queen Mary, University of London | Sestak I.,Queen Mary, University of London | Forbes J.F.,University of Newcastle | Knox J.,Queen Mary, University of London | And 10 more authors.
The Lancet | Year: 2014

Background Aromatase inhibitors eff ectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the effi cacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease. Methods Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specifi c criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratifi ed by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confi rmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319. Findings 1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 5.0 years (IQR 3.0-7.1), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 0.47, 95% CI 0.32-0.68, p<0.0001). The predicted cumulative incidence of all breast cancers after 7 years was 5.6% in the placebo group and 2.8% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specifi c causes were more common in one group than the other (p=0.836). Interpretation Anastrozole eff ectively reduces incidence of breast cancer in high-risk postmenopausal women. This fi nding, along with the fact that most of the side-eff ects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer. Funding Cancer Research UK, the National Health and Medical Research Council Australia, Sanofi -Aventis, and AstraZeneca.


Saarto T.,University of Helsinki | Sievanen H.,UKK Institute for Health Promotion Research | Kellokumpu-Lehtinen P.,University of Tampere | Nikander R.,UKK Institute for Health Promotion Research | And 17 more authors.
Osteoporosis International | Year: 2012

Summary The ability of combined step aerobic-and circuittraining to prevent bone loss after breast cancer treatments was related to skeletal site and patients' menopausal status. Among premenopausal breast cancer survivors, a 12-month exercise intervention completely prevented bone loss at the femoral neck, whereas no exercise effect was seen at lumbar spine or at neither site in postmenopausal women. Introduction The primary objective of this randomised clinical trial was to determine the preventive effect of supervised weight-bearing jumping exercises and circuit training on bone loss among breast cancer patients. Methods Of 573 breast cancer survivors aged 35-68 years randomly allocated into exercise or control group after adjuvant treatments, 498 (87%) were included in the final analysis. The 12-month exercise intervention comprised weekly supervised step aerobic-and circuit-exercises and similar home training. Bone mineral density (BMD) at lumbar spine and femoral neck were measured by dualenergy X-ray absorptiometry. Physical performance was assessed by 2-km walking and figure-8 running tests, and the amount of physical activity was estimated in metabolic equivalent-hours/week. Results In premenopausal women, bone loss at the femoral neck was prevented by exercise, the mean BMD changes being -0.2% among the trainees vs. -1.4% among the controls (p=0.01). Lumbar bone loss could not be prevented (-1.9% vs. -2.2%). In postmenopausal women, no significant exercise-effect on BMD was found either at the lumbar spine (-1.6% vs. -2.1%) or femoral neck (-1.1% vs. -1.1%). Conclusions This 12-month aerobic jumping and circuit training intervention completely prevented femoral neck bone loss in premenopausal breast cancer patients, whereas no effect on BMD was seen in postmenopausal women. © International Osteoporosis Foundation and National Osteoporosis Foundation 2011.


PubMed | Breast Unit, University of Newcastle, Italian National Cancer Institute, The Royal Marsden NHS Trust and 7 more.
Type: Journal Article | Journal: Lancet (London, England) | Year: 2014

Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease.Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confirmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319.1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 50 years (IQR 30-71), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 047, 95% CI 032-068, p<00001). The predicted cumulative incidence of all breast cancers after 7 years was 56% in the placebo group and 28% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specific causes were more common in one group than the other (p=0836).Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women. This finding, along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer.Cancer Research UK, the National Health and Medical Research Council Australia, Sanofi-Aventis, and AstraZeneca.


Palva T.,Pirkanmaa Cancer Society | Ranta H.,Pirkanmaa Cancer Society | Ranta H.,Pihlajalinna Ltd. | Koivisto A.-M.,University of Tampere | And 4 more authors.
European Journal of Cancer | Year: 2013

Aims of the study: This prospective study was performed to investigate the effects of 5-year's use of tamoxifen in preventive setting on endometrium and gynaecological symptoms. Material and methods: Altogether 96 women were treated either with tamoxifen (TAM, n = 45) or placebo (PLA, n = 51) for up to 5 years in a randomised, double-blind IBIS I breast cancer prevention trial, clinically followed-up for an additional year and for the occurrence of malignancies at least 9 years between 2/1995 and 7/2009 in Finland. The gynaecological follow-up with trans-vaginal ultrasound and endometrial biopsies were performed at baseline, at 2.5 and 5 years and at the 6 years follow-up visit. Results: Women in the TAM group discontinued the treatment significantly more often (44% versus 22%; p = 0.017) and earlier (at 15 versus 30 months; p = 0.044), than those in the PLA group. In postmenopausal women the median endometrial thickness was significantly increased at five years in the TAM group (median 4.3 versus 2.0 mm, p = 0.011), but there was no difference between the groups at one year after the treatment. There were also statistically significantly more referrals to hospitals due to gynaecological findings in the TAM group (risk rates (RR) 3.15; 95% confidence intervals (CI) 1.12-10.10), but no differences in hysterectomy rates or other serious adverse event rates were observed. Conclusions: The discontinuation rate in the TAM group was high, and the discontinuations also occurred early. Even though there were significantly more non-serious gynaecological events during the TAM treatment, routine gynaecological follow-up cannot be recommended. © 2012 Elsevier Ltd. All rights reserved.


Wu J.C.-Y.,University of Tampere | Anttila A.,Mass Screening Registry | Yen A.M.-F.,National Taiwan University | Hakama M.,University of Tampere | And 6 more authors.
Breast Cancer Research and Treatment | Year: 2010

Evaluation of long-term effectiveness of population-based breast cancer service screening program in a small geographic area may suffer from self-selection bias and small samples. Under a prospective cohort design with exposed and non-exposed groups classified by whether women attended the screen upon invitation, we proposed a Bayesian acyclic graphic model for correcting self-selection bias with or without incorporation of prior information derived from previous studies with an identical screening program in Sweden by chronological order and applied it to an organized breast cancer service screening program in Pirkanmaa center of Finland. The relative mortality rate of breast cancer was 0.27 (95% CI 0.12-0.61) for the exposed group versus the non-exposed group without adjusting for self-selection bias. With adjustment for selection-bias, the adjusted relative mortality rate without using previous data was 0.76 (95% CI 0.49-1.15), whereas a statistically significam result was achieved [0.73 (95% CI 0.57-0.93)] with incorporation of previous information. With the incorporation of external data sources from Sweden in chronological order, adjusted relative mortality rate was 0.67 (0.55-0.80). We demonstrated how to apply a Bayesian acyclic graphic model with self-selection bias adjustment to evaluating an organized but non-randomized breast cancer screening program in a small geographic area with a significant 27% mortality reduction that is consistent with the previous result but more precise. Around 33% mortality was estimated by taking previous randomized controlled data from Sweden. © Springer Science+Business Media, LLC. 2009.


Paimela H.,University of North Norway | Malila N.,Finnish Cancer Registry | Malila N.,University of Tampere | Palva T.,Pirkanmaa Cancer Society | And 3 more authors.
British Journal of Surgery | Year: 2010

Background: Faecal occult blood test (FOBT) screening has been shown to decrease the incidence and mortality from colorectal cancer. This study compared the stage profile of patients with colorectal cancer diagnosed at the first FOBT screening round with that of an unscreened control group. Methods: Subjects aged 60-64 years were allocated randomly to biennial FOBT screening (52 998 subjects) or a control group (53 002) in a Finnish prospective public health policy in 2004-2006. FOBT was performed with a guaiac test. At the end of 2007 the screened and control populations were linked to the Finnish Cancer Registry database, and the colonoscopic findings in the screen positives were analysed. Results: Early-stage colorectal cancer was observed in 52 per cent of the FOBT-positive subjects, in 42·2 per cent of the total screened population and in 38 per cent of the control population (P = 0·191 for FOBT positives, P = 0·592 for total screened population). The prevalence of adenomas and colorectal cancer was 31·5 and 8·2 per cent respectively among the 806 subjects with a positive FOBT. Some 27·3 per cent of all colorectal tumours in the screened population were interval cancers. The tumour was located in the right colon in 28·9 per cent of the screened subjects and 22 per cent of controls (P = 0·255). Conclusion: Biennial FOBT screening improves detection of colorectal cancer at the first screening round, but the high percentage of interval cancers is a cause for concern. © 2010 British Journal of Surgery Society Ltd.


Malila N.,University of Tampere | Palva T.,Pirkanmaa Cancer Society | Malminiemi O.,Laboratoriokeskus Oy | Paimela H.,University Hospital of North Norway | And 6 more authors.
Journal of Medical Screening | Year: 2011

Introduction Mortality from colorectal cancer has been shown to decrease by repeated screening using faecal occult blood (FOB) testing in randomized screening trials. This report presents coverage and performance of organized screening among the general population in Finland. Methods In 2004-2007, people aged 60-69 years were randomized into biennial screening and control arms. The screening test was a guaiac-based FOB test (Hemoccultw) with dietary restriction and three test cards for six consecutive samples. Test positives were referred for full colonoscopy. The programme was launched in 2004 and subsequently it expanded over regions and age-cohorts. Results In 2007, the programme covered one-third of the target population and 74,592 people had been invited for screening, of them 26,866 for the second round. Uptakes for the first and second rounds, respectively, were 62% and 68% in men and 77% and 80% in women. The proportion of test positives increased from 2.4% to 2.9% from the first to the second round and the positive predictive value for cancers decreased from 7.5% to 4.3%. Conclusions By 2007, organized colorectal cancer screening covered one-third of the target population in Finland. Implementation of screening measured with response rate was successful and met the criteria for a public health programme, but performance in terms of positive predictive value needs monitoring.


Nikander R.,University of Helsinki | Nikander R.,Pirkanmaa Hospital District | Nikander R.,UKK Institute for Health Promotion Research | Sievanen H.,UKK Institute for Health Promotion Research | And 6 more authors.
Journal of Musculoskeletal Neuronal Interactions | Year: 2012

In this 12-month RCT, we examined whether aerobic impact exercise training (3x/week) could facilitate breast cancer survivors' recovery by enhancing their bone structural strength, physical performance and body composition. After the adjuvant chemoand/or radiotherapy, 86 patients were randomly assigned into the training or control group. Structural bone traits were assessed with pQCT at the tibia and with DXA at the femoral neck. Agility (figure-8 running), jump force and power (force platform), grip strength and cardiovascular fitness (2-km walk test) were also assessed. Training effects on outcome variables were estimated by two-way factorial ANCOVA using the study group and menopausal status as fixed factors. Bone structural strength was better maintained among the trainees. At the femoral neck, there was a small but significant 2% training effect in the bone mass distribution (p=0.05). At the tibial diaphysis, slight 1% to 2% training effects (p=0.03) in total cross-sectional area and bone structural strength were observed (p=0.03) among the postmenopausal trainees. Also, 3% to 4% training effects were observed in the figure-8 running time (p=0.03) and grip strength (p=0.01). In conclusion, vigorous aerobic impact exercise training has potential to maintain bone structural strength and improve physical performance among breast cancer survivors.


PubMed | University of Tampere, Institute for Statistical and Epidemiological Cancer Research, Finnish Medical Society Duodecim, Pirkanmaa Cancer Society and 4 more.
Type: Journal Article | Journal: BMJ open gastroenterology | Year: 2015

Screening for colorectal cancer (CRC) with guaiac-based faecal occult-blood test (FOBT) has been reported to reduce CRC mortality in randomised trials in the 1990s, but not in routine screening, so far. In Finland, a large randomised study on biennial FOB screening for CRC was gradually nested as part of the routine health services from 2004. We evaluate the effectiveness of screening as a public health policy in the largest population so far reported.We randomly allocated (1:1) men and women aged 60-69years to those invited for screening and those not invited (controls), between 2004 and 2012. This resulted in 180210 subjects in the screening arm and 180282 in the control arm. In 2012, the programme covered 43% of the target age population in Finland.The median follow-up time was 4.5years (maximum 8.3years), with a total of 1.6 million person-years. The CRC incidence rate ratio between the screening and control arm was 1.11 (95% CI 1.01 to 1.23). The mortality rate ratio from CRC between the screening and control arm was 1.04 (0.84 to 1.28), respectively. The CRC mortality risk ratio was 0.88 (0.66 to 1.16) and 1.33 (0.94 to 1.87) in males and females, respectively.We did not find any effect in a randomised health services study of FOBT screening on CRC mortality. The substantial effect difference between males and females is inconsistent with the evidence from randomised clinical trials and with the recommendations of several international organisations. Even if our findings are still inconclusive, they highlight the importance of randomised evaluation when new health policies are implemented.002_2010_august.

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