Post-marketing studies are commonly performed to follow-up on the safety and effectiveness of a drug or vaccine after approval has been obtained. These post-marketing studies may involve the ...collection of real-world data from registries and clinical biobanks in order to obtain real-world evidence. As this approach can monitor the effects of pharmaceutical products over decades, it is particularly necessary for the development of safe and effective vaccines. A long-term follow-up (LTFU) study was initiated as an extension of a phase 3 clinical study (V501–015; NCT00092534) to assess the effectiveness, immunogenicity and safety of the quadrivalent human papillomavirus (qHPV) vaccine for up to 14 years after the start of vaccination. The LTFU study included participants from Denmark, Iceland, Norway, and Sweden, and assessed qHPV vaccine effectiveness against cervical pre-cancers and cancers caused by the oncogenic HPV types 16 and 18. In particular, our study utilized Nordic national health registries, in which individual patient records were linked by a unique Personal Identity Number. Here, we describe the overall implementation and methodology of the qHPV vaccine LTFU study conducted in the Nordic region. The LTFU study format we describe here supported a comprehensive follow-up process, with near-complete retrieval of registry data and specimens from local laboratories achieved in a timely manner; therefore, we have demonstrated that such a collection is feasible and can be used to address stringent post-marketing requirements.
•Post-marketing studies may involve the collection of real-world evidence.•Real-world evidence for qHPV vaccination was obtained from Nordic health registries.•Our methodology resulted in almost complete registry data and specimen retrieval.•Timely collection of data for post-marketing requirements was achieved.
Abstract On a population-based sample of 13,500 European breast cancer patients mostly diagnosed in 1996–1998 and archived by 26 cancer registries, we used logistic regression to estimate odds of ...conservative surgery plus radiotherapy (BCS + RT) versus other surgery, in T1N0M0 cases by country, adjusted for age and tumour size. We also examined: BCS + RT in relation to total national expenditure on health (TNEH); chemotherapy use in N + patients; tamoxifen use in oestrogen-positive patients; and whether ⩾10 nodes were examined in lymphadenectomies. Stage, diagnostic examinations and treatments were obtained from clinical records. T1N0M0 cases were 33.0% of the total. 55.0% of T1N0M0 received BCS + RT, range 9.0% (Estonia) to 78.0% (France). Compared to France, odds of BCS + RT were lower in all other countries, even after adjusting for covariates. Women of 70–99 years had 67% lower odds of BCS + RT than women of 15–39 years. BCS + RT was 20% in low TNEH, 58% in medium TNEH, and 64% in high TNEH countries. Chemotherapy was given to 63.0% of N + and 90.7% of premenopausal N + (15–49 years), with marked variation by country, mainly in post-menopause (50–99 years). Hormonal therapy was given to 55.5% of oestrogen-positive cases, 44.6% at 15–49 years and 58.8% at 50–99 years; with marked variation across countries especially in premenopause. The variation in breast cancer care across Europe prior to the development of European guidelines was striking; older women received BCS + RT much less than younger women; and adherence to ‘standard care’ varied even among countries with medium/high TNEH, suggesting sub-optimal resource allocation.
INTRODUCTION: In the coming years, an increase in the number of cancer cases can be expected in Iceland. It is important to gain more insight into the experiences of the diagnostic- and treatment ...phase among those diagnosed with cancer to improve quality of life and life expectancy. METHODS: The study included 4575 individuals diagnosed with cancer between 2015 and 2019 in Iceland, 18 years or older at the time. Participants answered an on-line questionnaire once between 2020 and 2021. RESULTS: A total of 1672 (37%) individuals responded to the questionnaire. The mean age at diagnosis was 59 years (±12). The majority of participants were informed on their cancer diagnosis during a doctor’s appointment (67%), but a quarter (25%) received the information by telephone. A total of 77% of participants were satisfied with the diagnostic process, thereof relatively fewer women than men (73% vs. 83%) (p<0,001). Fewer of those who received the cancer diagnosis by telephone were pleased with the diagnostic process (62%) compared with those receiving information during a doctor’s appointment (85%) (p<0,001). More women (58%) than men (33%) expressed the need for support regarding mental well-being from healthcare professionals during the diagnostic process (p <0.001). In 2015, 36% of participants started treatment more than month after diagnosis, compared with 51% in 2019. The need for various specific resources during treatment, e.g. physiotherapy, psychological services or nutritional counseling were regularly assessed among 20-30% of participants. CONCLUSION: A quarter of respondents diagnosed with cancer received information about the diagnosis over the phone instead of an interview. There is a suggestion that the time from diagnosis to the start of cancer treatment is increasing. It is necessary to assess whether it is possible to support individuals with cancer better during the diagnostic- and treatment phase based on their individual needs.
Objective The aim of the current study was to assess the relation between occupational exposure to solvents and the risk of acute myeloid leukemia (AML). Methods Altogether, this study comprises 15 ...332 incident cases of AML diagnosed in Finland, Norway, Sweden, and Iceland from 1961-2005 and 76 660 controls matched by year of birth, sex, and country. Occupational records were linked with Nordic Occupational Cancer Study job exposure matrix (JEM) to estimate quantitative values for 26 occupational exposure factors. Hazard ratios (HR) with 95% confidence intervals (95% CI) were estimated by using conditional logistic regression models. Results We did not observe statistically significantly increased risk for exposure to any of the solvents. HR estimates for high levels of toluene (HR 1.35, 95% CI 0.74-2.46), aromatic hydrocarbon solvents (ARHC) (HR 1.18, 95% CI 0.76-1.86), and moderate-to-high levels of trichloroethylene were slightly but non-significantly elevated. We did not observe an association between benzene exposure and AML in this study. Conclusions This study did not provide clear evidence for an association between occupational solvent exposure and AML. There was some indication for an excess risk in the groups of workers exposed to toluene, trichloroethylene, and ARHC.
Physical activity in adult life may reduce prostate cancer risk. Data are scarce on the role of activity during early adulthood, as well as combined recreational and occupational physical activity on ...prostate cancer risk and mortality. We undertook a prospective study of 8,221 Icelandic men (born 1907 to 1935) in the population-based Reykjavik Study. At enrollment, between 1967 and 1987, the men provided information on regular recreational physical activity since the age of 20 years as well as current occupational activity. Through linkage to nationwide cancer and mortality registers, the men were followed for prostate cancer diagnosis and mortality through 2009. We used Cox models to calculate the relative risk of prostate cancer by level of physical activity. During a mean follow-up of 24.8 years, 1,052 men were diagnosed with prostate cancer, of whom 349 had advanced disease (stage 3+ or prostate cancer death). Neither recreational nor occupational physical activity was, independently or combined, associated with overall or localized prostate cancer. Compared with physically inactive men, we observed a nonsignificant lower risk of advanced prostate cancer HR, 0.67; 95% confidence interval (CI), 0.42-1.07 among men reporting both recreational and occupational physical activities (P value for interaction = 0.03). Awaiting confirmation in larger studies with detailed assessment of physical activity, our data suggest that extensive physical activity beginning in early adulthood may reduce the risk of advanced prostate cancer.
PurposeTo describe a newly created all-Nordic cohort of patients with gastro-oesophageal reflux disease (GORD), entitled the Nordic Antireflux Surgery Cohort (NordASCo), which will be used to compare ...participants having undergone antireflux surgery with those who have not regarding risk of cancers, other diseases and mortality.ParticipantsIncluded were individuals with a GORD diagnosis recorded in any of the nationwide patient registries in the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) in 1964–2014 (with various start and end years in different countries). Data regarding cancer, other diseases and mortality were retrieved from the nationwide registries for cancer, patients and causes of death, respectively.Findings to dateThe NordASCo includes 945 153 individuals with a diagnosis of GORD. Of these, 48 433 (5.1%) have undergone primary antireflux surgery. Median age at primary antireflux surgery ranged from 47 to 52 years in the different countries. The coding practices of GORD seem to have differed between the Nordic countries.Future plansThe NordASCo will initially be used to analyse the risk of developing known or potential GORD-related cancers, that is, tumours of the oesophagus, stomach, larynx, pharynx and lung, and to evaluate the mortality in the short-term and long-term perspectives. Additionally, the cohort will be used to evaluate the risk of non-malignant respiratory conditions that might be caused by aspiration of gastric contents.
The strong correlation between smoking and exposure to oncogenic human papillomaviruses (HPVs) has made it difficult to verify the independent role of smoking in cervical carcinogenesis. Thus, the ...authors evaluated this role. Five large Nordic serum banks containing samples from more than 1,000,000 subjects were linked with nationwide cancer registries (1973–2003). Serum samples were retrieved from 588 women who developed invasive cervical cancer and 2,861 matched controls. The samples were analyzed for cotinine (a biomarker of tobacco exposure) and antibodies to HPV types 16 and 18, herpes simplex virus type 2, and Chlamydia trachomatis. Smoking was associated with the risk of squamous cell carcinoma (SCC) among HPV16- and/or HPV18-seropositive heavy smokers (odds ratio = 2.7, 95% confidence interval: 1.7, 4.3). A similar risk of SCC (odds ratio = 3.2, 95% confidence interval: 2.6, 4.0) was found in heavy smokers after adjustment for HPV16/18 antibodies. The point estimates increased with increasing age at diagnosis and increasing cotinine level. This study confirms that smoking is an independent risk factor for cervical cancer/SCC in women infected with oncogenic HPVs. These findings emphasize the importance of cervical cancer prevention among women exposed to tobacco smoke.
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