| 12. |
- Winther, Stine Braendegaard, et al.
(författare)
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Randomized study comparing full dose monotherapy (S-1 followed by irinotecan) and reduced dose combination therapy (S-1/oxaliplatin followed by S-1/irinotecan) as initial therapy for older patients with metastatic colorectal cancer : NORDIC 9
- 2017
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Ingår i: BMC Cancer. - : BIOMED CENTRAL LTD. - 1471-2407. ; 17
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Tidskriftsartikel (refereegranskat)abstract
- Background: Metastatic colorectal cancer (mCRC) is a disease of older age, but there is a relative lack of knowledge about effects of chemotherapy in older patients as they are under-represented in clinical trials. Little data can guide whether the strategy in older mCRC patients should be a sequential full-dose monotherapy chemotherapy approach or a dose-reduced combination chemotherapy approach. The oral 5FU prodrug S-1 seems to have less side effects than capecitabine and should be an optimal drug for older patients, but few data are available. Improved geriatric assessments are needed to select which older patients should receive therapy.Methods: The NORDIC 9 trial is a Nordic multicenter randomized phase II study comparing full dose monotherapy (S-1 30 mg/m(2) twice daily days 1-14 every 3 weeks, followed by second line irinotecan 250-350 mg/m(2) iv day 1 every 3 weeks or 180-250 mg/m(2) iv day 1 every 2 weeks) with reduced dose combination therapy (S-1 20 mg/m(2) days 1-14 + oxaliplatin 100 mg/m(2) iv day 1 every 3 weeks, followed by second line S-1 20 mg/m(2) days 1-14 + irinotecan 180 mg/m(2) day 1 every 3 week) for older patients (>= 70 years) with mCRC who are not candidates for full-dose standard combination therapy. Additional bevacizumab (7.5 mg/kg) is optional in first-line. Blood samples and tumor tissue will be collected to investigate predictive markers. Geriatric screening tools (G-8, VES-13, Timed-Up-and- Go and Handgrip strength), Charlson Comorbidty Index and quality of life (EORTC QLQ-C30) will be evaluated as predictors of efficacy and toxicity. The target sample size is 150 patients. The primary endpoint is progression-free survival and secondary endpoints are time-to-failure of strategy, overall survival, response rate, toxicity, and correlations between biomarkers, pre-treatment characteristics and geriatric assessments.Discussion: The study will add knowledge on how to treat older mCRC patients who are not candidates for standard combination therapy. Furthermore it may provide understanding of efficacy and tolerability of chemotherapy in older cancer patients and thus offer a better chance for tailored treatment strategies in these patients.
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| 13. |
- Zelaya Blandon, Elmer, et al.
(författare)
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Breaking the cycles of poverty : Strategies, achievements, and lessons learned in Los Cuatro Santos, Nicaragua, 1990-2014
- 2017
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Ingår i: Global Health Action. - : Taylor & Francis. - 1654-9716 .- 1654-9880. ; 10:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: In a post-war frontier area in north-western Nicaragua that was severely hit by Hurricane Mitch in 1998, local stakeholders embarked on and facilitated multi-dimensional development initiatives to break the cycles of poverty. Objective: The aim of this paper is to describe the process of priority-setting, and the strategies, guiding principles, activities, achievements, and lessons learned in these local development efforts from 1990 to 2014 in the Cuatro Santos area, Nicaragua. Methods: Data were derived from project records and a Health and Demographic Surveillance System that was initiated in 2004. The area had 25,893 inhabitants living in 5,966 households in 2014. Results: A participatory process with local stakeholders and community representatives resulted in a long-term strategic plan. Guiding principles were local ownership, political reconciliation, consensus decision-making, social and gender equity, an environmental and public health perspective, and sustainability. Local data were used in workshops with communities to re-prioritise and formulate new goals. The interventions included water and sanitation, house construction, microcredits, environmental protection, school breakfasts, technical training, university scholarships, home gardening, breastfeeding promotion, and maternity waiting homes. During the last decade, the proportion of individuals living in poverty was reduced from 79 to 47%. Primary school enrolment increased from 70 to 98% after the start of the school breakfast program. Under-five mortality was around 50 per 1,000 live births in 1990 and again peaked after Hurricane Mitch and was approaching 20 per 1,000 in 2014. Several of the interventions have been scaled up as national programs. Conclusions: The lessons learned from the Cuatro Santos initiative underline the importance of a bottom- up approach and local ownership of the development process, the value of local data for monitoring and evaluation, and the need for multi-dimensional local interventions to break the cycles of poverty and gain better health and welfare.
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