| 1. |
- Bergh, Jonas, et al.
(författare)
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Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer : A randomised trial
- 2000
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 356:9239, s. 1384-1391
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Tidskriftsartikel (refereegranskat)abstract
- Background: Chemotherapy drug distribution varies greatly among individual patients. Therefore, we developed an individualised fluorouracil, epirubicin, cyclophosphamide (FEC) regimen to improve outcomes in patients with high-risk early breast cancer. We then did a randomised trial to compare this individually tailored FEC regimen with conventional adjuvant chemotherapy followed by consolidation with high-dose chemotherapy with stem-cell support. Methods: 525 women younger than 60 years of age with high-risk primary breast cancer were randomised after surgery to receive nine cycles of tailored FEC to haematological equitoxicity with granulocyte colony-stimulating factor (G-CSF) support (n=251), or three cycles of FEC at standard doses followed by high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin (CTCb), and peripheral-blood stem-cell or bone-marrow support (n=274). Both groups received locoregional radiation therapy and tamoxifen for 5 years. The primary outcome measure was relapse-free survival, and analysis was by intention to treat. Findings: At a median follow-up of 34.3 months, there were 81 breast-cancer relapses in the tailored FEC group versus 113 in the CTCb group (double triangular method p=0.04). 60 deaths occurred in the tailored FEC group and 82 in the CTCb group (log-rank p=0.12). Patients in the CTCb group experienced more grade 3 or 4 acute toxicity compared with the tailored FEC group (p<0.0001). Two treatment-related deaths (0.7%) occurred in the CTCb group. Six patients in the tailored FEC group developed acute myeloid leukaemia and three developed myelodysplastic syndrome. Interpretation: Tailored FEC with G-CSF support resulted in a significantly improved relapse-free survival and fewer grade 3 and 4 toxicities compared with marrow-supported high-dose chemotherapy with CTCb as adjuvant therapy of women with high-risk primary breast cancer.
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| 2. |
- Wilking, Nils, et al.
(författare)
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Drug utilization research in the area of cancer drugs
- 2016
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Ingår i: Drug Utilization Research: Methods and Applications. - 9781118949788 ; , s. 315-327
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Bokkapitel (refereegranskat)abstract
- Increased biological understanding of cancer diseases has resulted in a paradigm shift in the medical treatment of cancer. Despite encouraging advances, most cancer types are still incurable and cancer is the second most common cause of death in developed countries.The high price of cancer drugs is a major challenge to equal access and puts heavy strains on public health care payers. After sharp increases in the 2000s, total expenditures on cancer drugs have levelled off due to patent expiration of many expensive and widely used drugs.Cancer drug utilization studies cover a great variety of topics. Four main research areas are patient adherence, physician adherence to guidelines, effectiveness and safety (outcomes research) and access (market uptake).Most cancer drugs are classified under Anatomical Therapeutic Chemical (ATC) group L. The use of defined daily dose (DDD) as a measurement unit is feasible for oral cancer drugs. As most cancer drugs are administered as infusions or injections at hospitals, usage is commonly measured in milligrams.Drug utilization research in the area of cancer is faced with a lack of data. Comparisons are challenging, as prices and population bases vary across regions. The linkage of registries and health care databases that include cancer drug usage will create improved opportunities in the future.
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| 3. |
- Bergenmar, Mia, et al.
(författare)
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Audio-recorded information to patients considering participation in cancer clinical trials - a randomized study
- 2014
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Ingår i: Acta Oncologica. - 1651-226X. ; 53:9, s. 1197-1204
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Tidskriftsartikel (refereegranskat)abstract
- Background. Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial. Material and methods. Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent. Results. A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge. Conclusion. The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.
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| 4. |
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| 5. |
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| 6. |
- Jönsson, Bengt, et al.
(författare)
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Comparator report on patient access to cancer medicines in Europe revisited
- 2016
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- In a new report, the Swedish Institute for Health Economics (IHE) compares the cancer situation in EU28 plus Norway and Switzerland. The report builds on a previous comparative study conducted in 2005 and provides a comprehensive view of the development of cancer in Europe over the past two decades. The report shows that the number of people diagnosed with cancer continue to increase in Europe, up by 30 percent between 1995 and 2012 due to a growing and aging population. Despite this growth and an increased spending on cancer medicines the overall spending on cancer care has remained stable at around six percent of total health expenditure largely due to a shift towards outpatient care. The report also concludes that there is great difference in access to medicines, in particular between richer and poorer countries but also between countries with similar purchasing power. The access problem requires collaboration between policy makers, payers, regulators, HTA bodies and manufacturers. Local solutions seem most feasible to balance the risk and reward of new treatment options between payers and manufacturers and reflect the affordability levels of different countries.
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| 7. |
- Jönsson, Bengt, et al.
(författare)
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Comparator Report on Patient Access to Cancer Medicines in Europe Revisited - A UK Perspective
- 2017
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- IHE has published a new comparator report on the cost of cancer and access to cancer medicines. The report is a condensed version of the previously published report, Comparator report on patient access to cancer medicines in Europe revisited (IHE Report 2016:4) and focusing on the UK.The report reveals similar trends in the UK as in the rest of Europe: incidence of cancer is increasing, as is mortality in absolute terms but once demographic factors is accounted for mortality has decreased due to increased survival. However, compared to countries with similar economic status the UK lags behind.
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| 8. |
- Jönsson, Bengt, et al.
(författare)
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Får norska cancerpatienter den behandling de förtjänar?
- 2006
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Ingår i: Tidsskrift for den Norske Lægeforening. - : Norwegian Medical Assocation. - 0807-7096 .- 0029-2001. ; 126:21, s. 2828-2829
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- För de patienter som idag insjuknar med cancer, är skillnaden mellan tidigt och sent användande av nya förbättrade läkemedel skillnaden mellan att få eller inte få chansen till optimal behandling. Norska cancerpatienter må ha tillgång till modern cancerbehandling på samma sätt som andra patienter har inom stora delar av Europa.
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| 9. |
- Jönsson, Bengt, et al.
(författare)
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The cost and burden of cancer in the European Union 1995–2014
- 2016
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 1879-0852 .- 0959-8049. ; 66, s. 162-170
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Tidskriftsartikel (refereegranskat)abstract
- Background: There is an intense debate about the cost of cancer and the value of new treatments. However, there is limited data on the cost of cancer in the European Union (EU) and how costs relate to the burden of disease. This paper presents new estimates on the development of the cost of cancer in the EU 1995–2014, with a focus on the major cost components: total health expenditure, cancer drugs, and production loss due to premature mortality.Methods: Data on overall health expenditure were combined with national disease estimates to derive cancer-specific health expenditure. Data on drug sales were obtained from IMS Health, and epidemiological data were used to calculate life years lost due to cancer.Findings: Health expenditure on cancer increased continuously from €35.7 billion in 1995 to €83.2 billion in 2014 in the EU and spending on cancer drugs from €7.6 billion in 2005 to €19.1 billion in 2014 (current prices). Yet the share of total health expenditure devoted to cancer was mostly constant (around 6 per cent). While expenditures on cancer drugs increased in both absolute and relative terms, other expenditures were stable or decreased, despite increases in cancer incidence driven by a growing and ageing population. Reductions in cancer mortality during working age resulted in decreasing production loss due to premature mortality.Interpretation: Health spending on cancer as a share of total health expenditure is rather low and stable despite the growing incidence and relative burden of cancer. Problems to reallocate funding in health care systems under economic pressure may be one explanation and shifting costs from inpatient to ambulatory care another.
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| 10. |
- Laakso, Mervi, et al.
(författare)
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Basoluminal carcinoma: A new biologically and prognostically distinct entity between basal and luminal breast cancer
- 2006
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Ingår i: Clinical Cancer Research. - 1078-0432. ; 12:14, s. 4185-4191
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Breast carcinomas expressing basal epithelium cytokeratins constitute a tumor subgroup that is typically hormone receptor negative and shows a distinct gene expression profile. Based on variable basal cytokeratin immunostaining patterns, we hypothesized that the "basal phenotype" tumor group may comprise more than one biological entity. Experimental Design: Basal cytokeratins 5 and 14 (CK5/14) were stained by immunohistochemistry and the percentage of positive cells was defined by image analysis. The results thus obtained were compared with clinicopathologic characteristics and relapse-free survival. Results: Of the 506 breast tumors, 53 (10.5%) showed immunoreactivity for CK5/14. Basal cytokeratin expression showed up as two microscopically distinguishable subtypes, i.e., a uniformly positive type ("basal") and a partially positive type ("basoluminal") often displaying a checkerboard-type intratumoral heterogeneity. These subgroups could also be separated with a third basal cytokeratin (CK17, P < 0,0001). Both basal and basoluminal subtypes were hormone receptor negative and of high grade, but differed with respect to the Ki-67 labeling index (P = 0.0014), vimentin (P = 0.005), and c-kit (P = 0.02), which were more frequently expressed in basal than in basoluminal tumors. In contrast, the amplification of HER-2 was found almost exclusively in the basoluminal subgroup (P = 0.009). Compared with the basal tumors, basoluminal tumors associated with significantly shorter relapse-free survival (P = 0.01), which was not explained by their more frequent HER-2 amplification. Conclusions: We conclude that the intratumoral heterogeneity in basal cytokeratin expression can be used to define two distinct breast cancer subtypes, basal and basoluminal, with distinctive features related to proliferation activity, oncogene and biomarker status, and patient survival.
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