Social value of a quality-adjusted life year (QALY) in Spain: the point of view of oncologists

PURPOSE: The economic situation showed that the resources devoted to health spending are limited, making rationalisation of their consumption necessary. The relevance of pharmacoeconomic analyses is becoming crucial. The ECO Foundation, promoting the quality of oncology care, set out to analyse the consensus on the new therapeutic targets inclusion and the integration of pharmacoeconomics when evaluating their effectiveness. METHODS: Study about pharmacoeconomic estimations was performed during the first ECO-Seminar (2010). It was developed using a modified Delphi method, in four stages: (1) committee coordinator establishment, (2) expert-panel selection, (3) preparation and submission of survey (1 question) by email, and (4) analysis of the degree of consensus reached. RESULTS: Results were obtained from surveys completed by 35 experts. Regarding the tolerable annual cost for the approval of new drugs, 68.8 % of the respondents considered a cost per quality-adjusted life year (QALY) gained between 30,000 and 100,000 acceptable (34.4 % 30,000-60,000; 34.4 % 60,000-100,000), 21.9 % of the respondents found costs between 100,000-150,000/QALY and 9.3 % of the respondents found costs above 150,000/QALY acceptable. CONCLUSIONS: The costs of new drugs are higher than traditional treatments, making it a priority to identify subgroups of patients with specific molecular profiles as candidates for higher-efficiency-targeted therapies. The allocation of the available resources to the most effective interventions, to achieve the best clinical outcomes with lower costs and best subjective profile possible, allows expenditure to be rationalised. Pharmacoeconomic studies are a basic tool for obtaining better health outcomes according to the available resources, while also considering the other needs of the population (AU)

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Second primary malignancies in patients with neuroendocrine tumors

PURPOSE: An association between neuroendocrine tumors (NETs) and second primary malignancies (SPMs) has been reported. We have examined the incidence and etiology of SPMs in patients with NETs included in the Neuroendocrine Tumor Association of Andalusia (ATNEA) Registry. METHODS: Data on 111 patients were collected. Sex, age, NET site, chromogranin A levels, neuropeptide secretion and disease stage were compared between NETs with and without SPMs. RESULTS: SPMs were present in 21 patients (18.9 %): five colorectal tumors, four non-small-cell lung cancers, three gastric cancers, two tumors in the small intestine, one hepatocarcinoma, two ovarian tumors, one breast adenocarcinoma, one hypernephroma, one bladder cancer, and one neuroblastoma. SPMs were present in 18 % of patients with a gastrointestinal NET and 22 % of those with a non-gastrointestinal NET. SPMs were found in 23 % of patients with elevated levels of serum chromogranin A, compared to 17 % of patients with normal levels, and in 22 % of patients with functional tumors, compared to 11 % of those with non-functional tumors. Finally, SPMs were observed in 24 % of patients with a local or locoregional tumor but in only 13 % of those with a metastatic tumor. No other differences between patients with and without SPMs were observed. CONCLUSIONS: The percentage of patients with SPMs in the ATNEA Registry is similar to those reported in other series. In our registry, patients with functional NETs and local/locoregional tumors have higher probability of SPMs. The low number of patients, selection bias and other etiologic factors of SPMs may have influenced our results (AU)

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Oncological translational research in the Spanish national health system: the INTRO study

OBJECTIVES: Under the auspices of the Foundation for Excellence and Quality in Oncology (ECO), the Translational Research in Oncology Medical Services Study (INTRO) was conducted with the aim of describing the current state of, and future expectations for translational cancer research in Spanish medical centres. The first step in the investigation was intended to analyse the current condition of the national Medical Oncology Services network by examining different aspects of the oncology research field. METHODS: A descriptive and observational multicentre study was performed at a statewide level; information was collected by surveying a cross-section of all those responsible for Medical Oncology Services in Spain. RESULTS: The survey was completed by key informants, who were selected independently by each service, between September 2010 and April 2011. We were able to gather comprehensive data from a total of 27 Spanish hospitals. These data enabled us to describe the allocation of human and material resources devoted to clinical and translational research across the Medical Oncology Services and to describe the organisational and functional components of these services and units. These data included information pertaining to the activities developed, their funding sources, and their functional dependence on other internal or external bodies. Finally, we explored the degree of dissemination and use of some specific techniques used for the genetic diagnosis of cancer, which have recently been introduced in Medical Oncology within the Spanish healthcare system. CONCLUSIONS:A wide range of variability exists between different oncology services in Spanish hospitals. Time should be spent reflecting on the need and opportunities for improvement in the development of translational research within the field of oncology (AU)

No disponible

Social value of a quality-adjusted life year (QALY) in Spain: the point of view of oncologists.

PURPOSE: The economic situation showed that the resources devoted to health spending are limited, making rationalisation of their consumption necessary. The relevance of pharmacoeconomic analyses is becoming crucial. The ECO Foundation, promoting the quality of oncology care, set out to analyse the consensus on the new therapeutic targets inclusion and the integration of pharmacoeconomics when evaluating their effectiveness. METHODS: Study about pharmacoeconomic estimations was performed during the first ECO-Seminar (2010). It was developed using a modified Delphi method, in four stages: (1) committee coordinator establishment, (2) expert-panel selection, (3) preparation and submission of survey (1 question) by email, and (4) analysis of the degree of consensus reached. RESULTS: Results were obtained from surveys completed by 35 experts. Regarding the tolerable annual cost for the approval of new drugs, 68.8 % of the respondents considered a cost per quality-adjusted life year (QALY) gained between €30,000 and 100,000 acceptable (34.4 % €30,000-60,000; 34.4 % €60,000-100,000), 21.9 % of the respondents found costs between €100,000-150,000/QALY and 9.3 % of the respondents found costs above €150,000/QALY acceptable. CONCLUSIONS: The costs of new drugs are higher than traditional treatments, making it a priority to identify subgroups of patients with specific molecular profiles as candidates for higher-efficiency-targeted therapies. The allocation of the available resources to the most effective interventions, to achieve the best clinical outcomes with lower costs and best subjective profile possible, allows expenditure to be rationalised. Pharmacoeconomic studies are a basic tool for obtaining better health outcomes according to the available resources, while also considering the other needs of the population.

Second primary malignancies in patients with neuroendocrine tumors.

PURPOSE: An association between neuroendocrine tumors (NETs) and second primary malignancies (SPMs) has been reported. We have examined the incidence and etiology of SPMs in patients with NETs included in the Neuroendocrine Tumor Association of Andalusia (ATNEA) Registry. METHODS: Data on 111 patients were collected. Sex, age, NET site, chromogranin A levels, neuropeptide secretion and disease stage were compared between NETs with and without SPMs. RESULTS: SPMs were present in 21 patients (18.9 %): five colorectal tumors, four non-small-cell lung cancers, three gastric cancers, two tumors in the small intestine, one hepatocarcinoma, two ovarian tumors, one breast adenocarcinoma, one hypernephroma, one bladder cancer, and one neuroblastoma. SPMs were present in 18 % of patients with a gastrointestinal NET and 22 % of those with a non-gastrointestinal NET. SPMs were found in 23 % of patients with elevated levels of serum chromogranin A, compared to 17 % of patients with normal levels, and in 22 % of patients with functional tumors, compared to 11 % of those with non-functional tumors. Finally, SPMs were observed in 24 % of patients with a local or locoregional tumor but in only 13 % of those with a metastatic tumor. No other differences between patients with and without SPMs were observed. CONCLUSIONS: The percentage of patients with SPMs in the ATNEA Registry is similar to those reported in other series. In our registry, patients with functional NETs and local/locoregional tumors have higher probability of SPMs. The low number of patients, selection bias and other etiologic factors of SPMs may have influenced our results.

Oncological translational research in the Spanish national health system: the INTRO study.

OBJECTIVES: Under the auspices of the Foundation for Excellence and Quality in Oncology (ECO), the Translational Research in Oncology Medical Services Study (INTRO) was conducted with the aim of describing the current state of, and future expectations for translational cancer research in Spanish medical centres. The first step in the investigation was intended to analyse the current condition of the national Medical Oncology Services network by examining different aspects of the oncology research field. METHODS: A descriptive and observational multicentre study was performed at a statewide level; information was collected by surveying a cross-section of all those responsible for Medical Oncology Services in Spain. RESULTS: The survey was completed by key informants, who were selected independently by each service, between September 2010 and April 2011. We were able to gather comprehensive data from a total of 27 Spanish hospitals. These data enabled us to describe the allocation of human and material resources devoted to clinical and translational research across the Medical Oncology Services and to describe the organisational and functional components of these services and units. These data included information pertaining to the activities developed, their funding sources, and their functional dependence on other internal or external bodies. Finally, we explored the degree of dissemination and use of some specific techniques used for the genetic diagnosis of cancer, which have recently been introduced in Medical Oncology within the Spanish healthcare system. CONCLUSIONS: A wide range of variability exists between different oncology services in Spanish hospitals. Time should be spent reflecting on the need and opportunities for improvement in the development of translational research within the field of oncology.

Effectiveness of daily versus non-daily granulocyte colony-stimulating factors in patients with solid tumours undergoing chemotherapy: a multivariate analysis of data from current practice.

We conducted a multicentre, retrospective, observational study including patients with solid tumours (excluding breast cancer) that received granulocyte colony-stimulating factors (G-CSF) and chemotherapy. We investigated the effectiveness of daily vs. non-daily G-CSFs (pegfilgrastim) adjusting by potential confounders. The study included 391 patients (211 daily G-CSF; 180 pegfilgrastim), from whom 47.3% received primary prophylaxis (PP) (57.8% pegfilgrastim), 26.3% secondary prophylaxis (SP: initiation after cycle 1 and no reactive treatment in any cycle) (51.5% pegfilgrastim) and 26.3% reactive treatment (19.4% pegfilgrastim). Only 42.2% of patients with daily G-CSF and 46.2% with pegfilgrastim initiated prophylaxis within 72 h after chemotherapy, and only 10.5% of patients with daily G-CSF received it for ≥ 7 days. In the multivariate models, daily G-CSF was associated with higher risk of grade 3-4 neutropenia (G3-4N) vs. pegfilgrastim [odds ratio (OR): 1.73, 95% confidence interval (CI): 1.004-2.97]. Relative to SP, PP protected against G3-4N (OR for SP vs. PP: 6.0, 95%CI: 3.2-11.4) and febrile neutropenia (OR: 3.1, 95%CI: 1.1-8.8), and was associated to less chemotherapy dose delays and reductions (OR for relative dose intensity <85% for SP vs. PP: 3.1, 95%CI: 1.7-5.4) and higher response rate (OR: 2.1, 95%CI: 1.2-3.7). Data suggest that pegfilgrastim, compared with a daily G-CSF, and PP, compared with SP, could be more effective in preventing neutropenia and its related events in the clinical practice.

La Ortopedia infantil para pediatras de Atención Primaria / No disponible

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UFT in combination as adjuvant therapy for breast cancer. Grupo Oncologico de Sevilla Seville, Spain.

Between 1989 and 1993, 409 evaluable patients with breast cancer have been treated with tegafur and uracil (UFT) in an adjuvant setting in two different trials. Data from both trials were reviewed in December 1995 after a mean follow-up of 5.09 +/- 1.1 years (range, 2.9 to 7.1 years). The aim of the first trial was to demonstrate the activity of UFT 400 mg/day for 6 months plus prednimustine 60 mg/m2 for 7 consecutive days, every 28 days in 6 cycles given orally (arm B). This scheme was compared with 6 cycles of cyclophosphamide 600 mg/m2, plus methotrexate 40 mg/m2, plus fluorouracil 600 mg/m2, every 4 weeks (arm A). In this study, 187 premenopausal women were evaluable, 96 in arm A and 91 in arm B, all of whom had positive axillary nodes. Although there were more younger patients in arm A than in arm B, prognostic factors were similar in both groups. Disease-free survival and overall survival were similar in both arms. However, some concern is raised by the low disease-free survival rate. The toxicity was mild (mainly nausea and vomiting and alopecia) and slightly worse in arm A. We believe that oral administration could be a useful alternative to the parenteral route. In the second trial, 222 evaluable patients received 20 mg/day of tamoxifen (Nolvadex) for 1 year (arm A), or the same dose of tamoxifen plus UFT 400 mg/day for 6 months. All patients were postmenopausal, and the characteristics of the tumors were the same as those in patients in the first trial. In arm A there were 109 patients and in arm B, 113. The groups were well balanced. The overall survival and the disease-free survival rates were equal in both arms, but were longer in arm B in the subset of patients with five or more axillary-involved nodes. The toxicity was negligible in both arms. We conclude that UFT/tamoxifen might be useful in postmenopausal patients with five or more involved nodes who are unable to follow a more aggressive schedule because of their age or low performance status.

Epirubicin in rectal cancer.

Taking into account previous results with epirubicin in colorectal cancer, in January, 1985, an oriented Phase II trial was started in patients with measurable rectal cancer, previously untreated with chemotherapy. Ten patients were treated with 80 mg/m2 every 3 weeks, and another 10 patients with 100 mg/m2 every 3 weeks. One patient from the 80 mg/m2 group and 3 from the 100 mg/m2 group reached partial remission for 4, 9+, 15 and 72+ weeks. Median survival for all patients was 16 months. Hematological toxicity was not a limiting factor. Anemia was significantly more frequent in the higher dose group; clinical cardiotoxicity was not observed. The incidences of nausea/vomiting and mucositis were low. Considering the low toxicity and the responses observed, additional studies seem to be indicated with an increase in the epirubicin dose.