Publications (118) View all
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Article: A Review of Breast Cancer Care and Outcomes in Latin America.
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ABSTRACT: This review presents an overview of breast cancer care, burden, and outcomes in Latin America, as well as the challenges and opportunities for improvement. Information was gleaned through a review of the literature, public databases, and conference presentations, in addition to a survey of clinical experts and patient organizations from the region. Breast cancer annual incidence (114,900 cases) and mortality (37,000 deaths) are the highest of all women's cancers in Latin America, and they are increasing. Twice as many breast cancer deaths are expected by 2030. In Peru, Mexico, Colombia, and Brazil, diagnosis and death at younger ages deprives society of numerous productive years, as does high disease occurrence in Argentina and Uruguay. Approximately 30%-40% of diagnoses are metastatic disease. High mortality-to-incidence ratios (MIRs) in Latin America indicate poor survival, partly because of the late stage at diagnosis and poorer access to treatment. Between 2002 and 2008, MIRs decreased in all countries, albeit unevenly. Costa Rica's change in MIR outpaced incidence growth, indicating impressive progress in breast cancer survival. The situation is similar, although to a lesser extent, in Colombia and Ecuador. The marginal drops of MIRs in Brazil and Mexico mainly reflect incidence growth rather than progress in outcomes. Panama's MIR is still high. Epidemiological data are scattered and of varying quality in Latin America. However, one could ascertain that the burden of breast cancer in the region is considerable and growing due to demographic changes, particularly the aging population, and socioeconomic development. Early diagnosis and population-wide access to evidence-based treatment remain unresolved problems, despite progress achieved by some countries.The Oncologist 02/2013; · 3.91 Impact Factor -
Article: Cancer vaccines and immunotherapeutics: Challenges for pricing, reimbursement and market access.
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ABSTRACT: Public payment is key to market access for new therapeutics including cancer vaccines and cancer immunotherapeutics. However, the methodology for economic evaluation aimed at informing decisions about pricing and reimbursement is different for cancer vaccines, such as HPV for preventing the occurrence or incidence of cancer, and immunotherapeutics for treatment of patients with manifest cancer. Vaccination against HPV is a traditional public health intervention, where the role of economic evaluation is to inform decisions about optimal vaccination strategies. The decision is about funding for a vaccination program, aimed at vaccinating a defined population at risk, either at a national or regional level. The methodology of economic evaluation is based on statistical modeling of number of cases prevented over a long time period, and the costs and health outcome related to this, for different vaccination strategies For immunotherapeutics, the role of economic evaluation is to assist decisions about reimbursement and guidelines for treatment of patients with establish disease, very often at advanced stages with short life expectancy. The focus is on alternative treatment options, and the costs and outcomes associated with these. Alternatives may be best supportive care, immunotherapeutics or other treatments like surgery, radiotherapy and other anti-cancer drugs. From an economic perspective the type of therapy does not matter, only costs and outcome associated with the relevant alternatives. The main controversy about reimbursement of immunotherapeutics, as with other new cancer drugs, has been the cost of treatment, mainly determined by the price of the therapy, in relation to the expected benefits in terms of survival and quality of life. This paper reviews the evidence on cost-effectiveness, the reimbursement decisions made, and the impact on market access for new immunotherapeutics. Sipuleucel-T (Provenge (®) ) and abiraterone (Zytiga (®) ) for treatment of prostate cancer and ipilimumab (Yervoy (®) ) as well as vemurafenib (Zelboraf (®) ) for treatment of metastatic melanoma are used as examples of the economic issues involved in analysis and decision-making.Human vaccines & immunotherapeutics. 08/2012; 8(9). -
Article: Hormone replacement therapy after breast cancer: 10 year follow up of the Stockholm randomised trial.
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ABSTRACT: BACKGROUND: The management of hormonal deficiency symptoms in breast cancer survivors is an unsolved problem. While hormone replacement therapy (HRT) may increase the risk of breast cancer in healthy women, its effects on recurrence is unclear. Observational studies have suggested decreased recurrence rates from HRT. The few clinical trials in this field have all been closed preterm. METHODS: The Stockholm trial was started in 1997 and designed to minimise the dose of progestogen in the HRT arm. Disease-free women with a history of breast cancer were randomised to HRT (n=188) or no HRT (n=190). The trial was stopped in 2003 when another Swedish study (HABITS, the Hormonal Replacement After Breast Cancer - Is it Safe?) reported increased recurrence. However the Stockholm material showed no excess risk after 4years of follow-up. A long term follow-up has now been performed. FINDINGS: After 10.8years of follow-up, there was no difference in new breast cancer events: 60 in the HRT group versus 48 among controls (hazard ratio (HR)=1.3; 95% confidence interval (CI)=0.9-1.9). Among women on HRT, 11 had local recurrence and 12 distant metastases versus 15 and 12 for the controls. There were 14 contra-lateral breast cancers in the HRT group and four in the control group (HR=3.6; 95% CI=1.2-10.9; p=0.013). No differences in mortality or new primary malignancies were found. INTERPRETATION: The number of new events did not differ significantly between groups, in contrast to previous reports. The increased recurrence in HABITS has been attributed to higher progestogen exposure. As both trials were prematurely closed, data do not allow firm conclusions. Both studies found no increased mortality from breast cancer or other causes from HRT. Current guidelines typically consider HRT contraindicated in breast cancer survivors. Findings suggest that, in some women symptom relief may outweigh the potential risks of HRT.European journal of cancer (Oxford, England: 1990) 08/2012; · 4.12 Impact Factor -
Article: Tailored chemotherapy doses based on toxicity in breast cancer result in similar quality of life values, irrespective of given dose levels.
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ABSTRACT: From March 1994 to March 1998, breast cancer patients (an estimated relapse risk with 70% or more within five years with standard therapy) were randomised to treatment with tailored fluorouracil, epirubicin, and cyclophosphamide (FEC) therapy or FEC followed by marrow-supported high dose therapy in the Scandinavian Breast Group 9401 study. The aim of the present paper was to investigate differences in toxicity and eight health-related quality of life (HRQoL) variables (physical functioning, role functioning, emotional functioning, social functioning, cognitive functioning, fatigue, nausea-vomiting, and global quality of life) between women in the six dose steps used in the tailored and granulocyte colony stimulating factor supported FEC-arm at the assessment point 16 weeks after random assignment to treatment. The European Organization and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30 were mailed to the patients. A total of 157 (87%) in the tailored FEC-group responded to the questionnaire within the time frame 16 weeks after inclusion in the study. Overall, toxicity was low, reaching grade 1-2 also in the higher dose steps. There were no overall differences between the dose steps on any of the tested HRQoL variables. Patients at dose step 4 scored statistically significantly higher on physical functioning than patients at dose step 1 (p = 0.022) and compared to those at dose step 2 (p = 0.014). Patients at dose steps -2 and -1 (combined to one group) reported statistically significantly higher mean scores on cognitive functioning than patients at dose step 1 (p = 0.022). Patients who received higher doses, based on the tailored dosing strategy, did not seem to have worse HRQoL than those who had lower doses.Acta oncologica (Stockholm, Sweden) 02/2011; 50(3):338-43. · 2.27 Impact Factor -
Article: Levels of knowledge and perceived understanding among participants in cancer clinical trials - factors related to the informed consent procedure.
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ABSTRACT: An informed consent from patients participating in cancer clinical trials is mandatory according to international and national guidelines and laws. Insufficient knowledge and understanding by trial participants have been reported in several studies. The aims of this study were to investigate factors of importance for knowledge and understanding about cancer clinical trials among trial participants. All patients consenting to a phase II or III clinical trial during 1 year were invited (n = 325). Data on knowledge and perceived understanding were collected by a questionnaire, Quality of Informed Consent. are based on data from 268 patients (82%). Associations between knowledge and perceived understanding as well as clinical, socio-economic factors, and factors related to the informed consent procedure were tested. Results In the multivariate analysis no statistically significant associations were found between knowledge and any of the factors. Patients who reported longer time for trial information before their decision to participate, those who found the decision easy to take, and patients who reported use of other information sources had statistically significant higher perceived understanding. No differences in mean scores for knowledge or perceived understanding were found for any of the clinical factors (age, gender, diagnostic group, trial phase), socio-economic factors (education, marital status), and the following factors related to the informed consent procedure; presence of relative or nurse at information about the trial or previous participation in clinical trials. No study specific questions were included due to the number of trials (n = 35). Strategies to increase patients' knowledge needs to be elaborated in order to improve the fulfilment of the requirements of informed consent in participants in cancer clinical trials.Clinical Trials 01/2011; 8(1):77-84. · 1.92 Impact Factor
