Acordes por la Paz y la compañía discográfica Dopamihna Pop han apoyado a MSF( MEDICOS SIN FRONTERAS) a contribuir a través de la música a expandir la solidaridad con los enfermos olvidados. Para ello han lanzado un triple CD con versiones de temas de The Beatles interpretados por artistas nacionales y extranjeros como Andrés Calamaro, Miguel Ríos, Coque Malla, Coti, Las Coronas, Medina Azahara, Ilegales, Manolo Tena, Julia Baird, TheA Quarrymen, etc.
Los beneficios obtenidos de su venta se destinarán a proyectos de MSF de lucha contra enfermedades olvidadas.
Diario digital con noticias de actualidad relacionadas con el mundo de la salud. Novedades, encuestas, estudios, informes, entrevistas. Con un sencillo lenguaje dirigido a todo el mundo. Y algunos consejos turísticos para pasarlo bien
Traductor
24 September 2011
Unequal access to cancer care can no longer be tolerated: radical change needed to deliver affordable care in developed countries
Cancer is one of the leading causes of death and morbidity worldwide, and its economic burden grows year by year. In 2008, the worldwide cost of cancer due to premature death and disability, excluding direct medical costs, was estimated to be US$895 billion.
An expert report from The Lancet Oncology Commission, a group of some of the world’s leading cancer specialists, from patient advocates to economists and healthcare professionals, published today, tries to tackle the difficult problem of how to deliver affordable high quality and equitable cancer care in developed countries. Presenting the report to the 2011 European Multidisciplinary Cancer Congress today, Professor Richard Sullivan from the King’s Health Partners Integrated Cancer Centre, a collaboration between King’s College London and its partner NHS Foundation Trusts – Guy’s and St Thomas’ and King’s College Hospital, UK, said that ageing populations and the increasing complexity and cost of new cancer treatments meant that this issue needed urgent solutions.
"The Economist Intelligence Unit estimates the costs associated with new cancer cases alone in 2009 to be at least $286 billion. Medical costs make up more than half the economic burden, and productivity losses account for nearly a quarter. By 2030, there will be an estimated 22 million new patients with cancer per year worldwide," he said. "The global challenge to countries is how to deliver reasonably priced cancer care to all citizens – i.e. make cancer care affordable to individuals and society."
At a time when the global cancer burden is shifting to low and middle-income countries, it may seem strange to concentrate on wealthier nations, the authors say, but the unique health and disease trajectory involved in those countries through the added burden of significant acute, infectious and chronic disease necessitates a separate approach. The massive increase in expenditure on cancer care in high income countries over the last two decades is due to many factors: over-utilisation (for example, tests which are useful in one setting and not in another), high-cost innovation, disincentivisation driven by reimbursement rules and defensive medical practice – more tests and treatment to counter litigation-driven culture – consumer-driven over-demand, and futile over-treatment at the end of life.
The authors identify a whole range of immediate and medium term measures that need to be introduced to reduce the current cost base of delivering cancer care and manage the future cost curves of particularly expensive interventions such as cancer medicines. Radical action is needed to simplify and integrate patient treatment pathways, new models of care with lower cost bases need to be implemented and a whole new approach to expensive interventions – from mandatory cost-effectiveness analysis, to the prohibition of off-label use and new economic models for reimbursement and incentivisation – must be driven through healthcare systems.
Educating the public, patients and policymakers about the key issues in delivering affordable cancer care is also essential, say the authors. "Making individual patients more sensitive to the costs of care is necessary for an informed public debate around this critical issue," said Professor Sullivan.
A radical shift in cancer policy is required, the report’s authors say. Political tolerance of unfairness in access to affordable cancer treatment is unacceptable. The cancer community needs to take responsibility and not accept a sub-standard evidence base and an ethos of very small benefit at whatever cost; rather there should be fair prices and real value from new technologies.
"We are at a crossroads for affordable cancer care, where our choices – or refusal to make choices – will affect the lives of millions of people. Do we bury our heads in the sand, keep our fingers crossed, and hope that it turns out fine, or do we have difficult debates and make hard choices within a socially responsible, cost-effective, and sustainable framework? The consensus from all those involved is that policy makers, politicians, patients, and health care professionals need to address this issue now," Professor Sullivan said.
An expert report from The Lancet Oncology Commission, a group of some of the world’s leading cancer specialists, from patient advocates to economists and healthcare professionals, published today, tries to tackle the difficult problem of how to deliver affordable high quality and equitable cancer care in developed countries. Presenting the report to the 2011 European Multidisciplinary Cancer Congress today, Professor Richard Sullivan from the King’s Health Partners Integrated Cancer Centre, a collaboration between King’s College London and its partner NHS Foundation Trusts – Guy’s and St Thomas’ and King’s College Hospital, UK, said that ageing populations and the increasing complexity and cost of new cancer treatments meant that this issue needed urgent solutions.
"The Economist Intelligence Unit estimates the costs associated with new cancer cases alone in 2009 to be at least $286 billion. Medical costs make up more than half the economic burden, and productivity losses account for nearly a quarter. By 2030, there will be an estimated 22 million new patients with cancer per year worldwide," he said. "The global challenge to countries is how to deliver reasonably priced cancer care to all citizens – i.e. make cancer care affordable to individuals and society."
At a time when the global cancer burden is shifting to low and middle-income countries, it may seem strange to concentrate on wealthier nations, the authors say, but the unique health and disease trajectory involved in those countries through the added burden of significant acute, infectious and chronic disease necessitates a separate approach. The massive increase in expenditure on cancer care in high income countries over the last two decades is due to many factors: over-utilisation (for example, tests which are useful in one setting and not in another), high-cost innovation, disincentivisation driven by reimbursement rules and defensive medical practice – more tests and treatment to counter litigation-driven culture – consumer-driven over-demand, and futile over-treatment at the end of life.
The authors identify a whole range of immediate and medium term measures that need to be introduced to reduce the current cost base of delivering cancer care and manage the future cost curves of particularly expensive interventions such as cancer medicines. Radical action is needed to simplify and integrate patient treatment pathways, new models of care with lower cost bases need to be implemented and a whole new approach to expensive interventions – from mandatory cost-effectiveness analysis, to the prohibition of off-label use and new economic models for reimbursement and incentivisation – must be driven through healthcare systems.
Educating the public, patients and policymakers about the key issues in delivering affordable cancer care is also essential, say the authors. "Making individual patients more sensitive to the costs of care is necessary for an informed public debate around this critical issue," said Professor Sullivan.
A radical shift in cancer policy is required, the report’s authors say. Political tolerance of unfairness in access to affordable cancer treatment is unacceptable. The cancer community needs to take responsibility and not accept a sub-standard evidence base and an ethos of very small benefit at whatever cost; rather there should be fair prices and real value from new technologies.
"We are at a crossroads for affordable cancer care, where our choices – or refusal to make choices – will affect the lives of millions of people. Do we bury our heads in the sand, keep our fingers crossed, and hope that it turns out fine, or do we have difficult debates and make hard choices within a socially responsible, cost-effective, and sustainable framework? The consensus from all those involved is that policy makers, politicians, patients, and health care professionals need to address this issue now," Professor Sullivan said.
Smaller, faster trials can improve cancer patient survival; new drugs could become available more quickly
With the advent of personalised medicine, gains in cancer survival over the long term could be improved by running smaller, faster trials with less stringent evidence criteria, a researcher told the 2011 European Multidisciplinary Cancer Congress today.
The introduction of targeted treatments means the traditional large-scale clinical trial is not always the most effective way of getting new treatments to cancer patients who need them, said Dr. Marie-Cécile Le Deley, Associate Professor of Clinical Epidemiology and Biostatistics at the Institut Gustave-Roussy, Villejuif, France. The increased knowledge of tumour biology has meant that common cancers are more and more frequently recognised as consisting of small subsets with particular abnormalities. These abnormalities might be targeted by specific therapies, but the ability to test many of the promising agents available is hindered by the need to invest many resources into running a single large trial over many years, she said.
Working with colleagues at The Mayo Clinic in Rochester, Minnesota, USA, Dr. Le Deley simulated a series of two-treatment superiority trials (where a new treatment is compared with the existing standard therapy), taking place over 15 years and using different design parameters. These included the number of trials performed during the period, and the criteria used to adopt an experimental treatment as the new standard. The researchers used these studies to estimate, for different strategies, the survival improvements that could be expected over a 15-year research period.
"We found that there were important gains in survival attributable to a strategy of conducting more trials with smaller sample sizes and relaxed evidential criteria compared with those required under traditional trial designs," said Dr. Le Deley. "The downside of this approach is that we also reduce the certainty of the findings: we might select as a new temporary standard a treatment that does not work better than the existing best therapy, but the fact that we will conduct many more trials will allow such errors to be quickly remedied.
"Considering that many new targeted agents have fewer safety issues than the older cytotoxic (cell killing) treatments, we feel that the risk of accepting a few therapies that offer no benefit, but with a very low chance of a truly poorer outcome, for a greater long-term benefit at the end seems reasonable. The possibility of a small number of backward steps in the series of trials should not lead us to discard the whole process. The classical, large sample-size clinical trials are designed to avoid wrong decisions, but take a very long time to reach a definitive result when the disease is rare."
In rare diseases, the ability to pursue many of the promising agents available for clinical testing is hindered by the need to invest much effort in a single direction by running a large trial over many years, the researchers say. However, they believe that statisticians and regulators may be more difficult to convince of the need for change. "The culture within these groups is very risk-averse," said Dr. Le Deley. "Their conservative approach is reasonable; the higher the strength of evidence, the lower the risk of wrong decision. But in rare diseases, which could include many small subsets of cancers, this approach is counterproductive as soon as many new agents become available for clinical testing. We need a more flexible process to cater for this situation."
Dr Le Deley makes it clear that her recommendation to decrease the sample size and relax the decision criteria makes sense only if there is no way to increase the trial accrual rate, and thus that the proposal should not be taken as an encouragement to abandon collaborative projects with potential for broad participation. The traditional, large-scale clinical trial will still be needed, but smaller, targeted trials should be allowed where appropriate, and these could lead to quicker results, and in the long term, greater gains, say the researchers.
The introduction of targeted treatments means the traditional large-scale clinical trial is not always the most effective way of getting new treatments to cancer patients who need them, said Dr. Marie-Cécile Le Deley, Associate Professor of Clinical Epidemiology and Biostatistics at the Institut Gustave-Roussy, Villejuif, France. The increased knowledge of tumour biology has meant that common cancers are more and more frequently recognised as consisting of small subsets with particular abnormalities. These abnormalities might be targeted by specific therapies, but the ability to test many of the promising agents available is hindered by the need to invest many resources into running a single large trial over many years, she said.
Working with colleagues at The Mayo Clinic in Rochester, Minnesota, USA, Dr. Le Deley simulated a series of two-treatment superiority trials (where a new treatment is compared with the existing standard therapy), taking place over 15 years and using different design parameters. These included the number of trials performed during the period, and the criteria used to adopt an experimental treatment as the new standard. The researchers used these studies to estimate, for different strategies, the survival improvements that could be expected over a 15-year research period.
"We found that there were important gains in survival attributable to a strategy of conducting more trials with smaller sample sizes and relaxed evidential criteria compared with those required under traditional trial designs," said Dr. Le Deley. "The downside of this approach is that we also reduce the certainty of the findings: we might select as a new temporary standard a treatment that does not work better than the existing best therapy, but the fact that we will conduct many more trials will allow such errors to be quickly remedied.
"Considering that many new targeted agents have fewer safety issues than the older cytotoxic (cell killing) treatments, we feel that the risk of accepting a few therapies that offer no benefit, but with a very low chance of a truly poorer outcome, for a greater long-term benefit at the end seems reasonable. The possibility of a small number of backward steps in the series of trials should not lead us to discard the whole process. The classical, large sample-size clinical trials are designed to avoid wrong decisions, but take a very long time to reach a definitive result when the disease is rare."
In rare diseases, the ability to pursue many of the promising agents available for clinical testing is hindered by the need to invest much effort in a single direction by running a large trial over many years, the researchers say. However, they believe that statisticians and regulators may be more difficult to convince of the need for change. "The culture within these groups is very risk-averse," said Dr. Le Deley. "Their conservative approach is reasonable; the higher the strength of evidence, the lower the risk of wrong decision. But in rare diseases, which could include many small subsets of cancers, this approach is counterproductive as soon as many new agents become available for clinical testing. We need a more flexible process to cater for this situation."
Dr Le Deley makes it clear that her recommendation to decrease the sample size and relax the decision criteria makes sense only if there is no way to increase the trial accrual rate, and thus that the proposal should not be taken as an encouragement to abandon collaborative projects with potential for broad participation. The traditional, large-scale clinical trial will still be needed, but smaller, targeted trials should be allowed where appropriate, and these could lead to quicker results, and in the long term, greater gains, say the researchers.
Bone-strengthening drug gives pain relief in prostate cancer bone metastases
Many prostate cancer patients develop bone metastases, and controlling the pain these cause can be difficult. Now the first large randomised Phase III trial of a bisphosphonate drug in these patients has shown that a single dose of the drug is as good for pain relief as single dose radiotherapy, the standard treatment for bone metastases. Results of the trial were presented today at the 2011 European Multidisciplinary Cancer Congress.
Professor Peter Hoskin, consultant clinical oncologist at the Mount Vernon Cancer Centre, Northwood, UK, and Professor of Clinical Oncology at University College, London, and colleagues, randomised 470 patients with primary prostate cancer and painful bone metastases to receive either a single dose of radiation or a single intravenous infusion of the bisphosphonate Ibandranate (IB). Patients reported their primary site of pain at entry into the trial, and then at four, eight, twelve, 26 and 52 weeks after treatment.
Those who had not responded to the first treatment at four weeks crossed over to the alternative therapy and received their second treatment no later than week eight. Pain levels were measured at four and twelve weeks by examining analgesic use, using a combination of scoring via the WHO pain ladder [2] and the Mercadante method, which defines analgesic use in morphine equivalents.
"We found that using IB was as good as single dose radiotherapy in controlling pain," said Prof Hoskin. "Although there were more patients in the IB group with worse Mercadante scores at four weeks who needed re-treatment, at six and twelve months there was no long-term difference in pain relief between the two groups."
Side effects were few; short-lived nausea and stomach upsets if radiotherapy passes through the abdomen and flu-like symptoms with IB. The patients in the trial were well balanced as to age, site of pain, prior treatment and performance status. The median survival of the four groups was 11.8 months (radiotherapy only), 11.4 months (IB only), 12.7 months (radiotherapy then IB), and 16.8 months (IB then radiotherapy).
"We hope to analyse these survival differences further in the hope that it can give us further pointers as to how and whether we should use a combination of treatments," Prof Hoskin said. "Currently we are unsure about the optimal timing and scheduling of treatment for these patients."
The constant turnover of bone is kept in balance by the interaction of osteoblasts, which form bone, and osteoclasts, which beak it down. Bisphosphonates work by sticking to calcium and binding to it, thus preventing bone loss through inhibiting the activity of osteoclasts.
Bone metastases are common in many primary cancers. "They are a serious problem for many men with prostate cancer, and can cause intense pain as well as fractures and spinal cord compression," Prof Hoskin said. "But there are also patients who have bone metastases and only mild or moderate pain, which can be readily controlled by analgesics. Others have multiple metastatic sites, but only one causes significant pain. There are many questions still to be answered in this field."
The researchers intend to follow up their work with a study looking at biomarkers for bone resorption. "If we can correlate these markers with response to both radiotherapy and IB we will be able to see whether they can predict which patients would respond best to which treatment," said Prof Hoskin. "Currently we don’t know exactly how radiotherapy works in bone metastases – we just know that it does. We hope to be able to shed more light on this in our follow-up study.
"It is important to stress that radiotherapy still has a crucial role to play and is a highly effective treatment for many cancer patients. For patients with solitary metastases, pathological fracture, where the bone breaks due to weakness, and neurological complications of bone metastases, it remains the treatment of choice. Our research adds to the arsenal of the many effective treatments now available, and we believe that the findings will also be applicable to other primary cancers that can lead to bone metastases, for example breast cancer, where they are very common," he concluded.
Professor Peter Hoskin, consultant clinical oncologist at the Mount Vernon Cancer Centre, Northwood, UK, and Professor of Clinical Oncology at University College, London, and colleagues, randomised 470 patients with primary prostate cancer and painful bone metastases to receive either a single dose of radiation or a single intravenous infusion of the bisphosphonate Ibandranate (IB). Patients reported their primary site of pain at entry into the trial, and then at four, eight, twelve, 26 and 52 weeks after treatment.
Those who had not responded to the first treatment at four weeks crossed over to the alternative therapy and received their second treatment no later than week eight. Pain levels were measured at four and twelve weeks by examining analgesic use, using a combination of scoring via the WHO pain ladder [2] and the Mercadante method, which defines analgesic use in morphine equivalents.
"We found that using IB was as good as single dose radiotherapy in controlling pain," said Prof Hoskin. "Although there were more patients in the IB group with worse Mercadante scores at four weeks who needed re-treatment, at six and twelve months there was no long-term difference in pain relief between the two groups."
Side effects were few; short-lived nausea and stomach upsets if radiotherapy passes through the abdomen and flu-like symptoms with IB. The patients in the trial were well balanced as to age, site of pain, prior treatment and performance status. The median survival of the four groups was 11.8 months (radiotherapy only), 11.4 months (IB only), 12.7 months (radiotherapy then IB), and 16.8 months (IB then radiotherapy).
"We hope to analyse these survival differences further in the hope that it can give us further pointers as to how and whether we should use a combination of treatments," Prof Hoskin said. "Currently we are unsure about the optimal timing and scheduling of treatment for these patients."
The constant turnover of bone is kept in balance by the interaction of osteoblasts, which form bone, and osteoclasts, which beak it down. Bisphosphonates work by sticking to calcium and binding to it, thus preventing bone loss through inhibiting the activity of osteoclasts.
Bone metastases are common in many primary cancers. "They are a serious problem for many men with prostate cancer, and can cause intense pain as well as fractures and spinal cord compression," Prof Hoskin said. "But there are also patients who have bone metastases and only mild or moderate pain, which can be readily controlled by analgesics. Others have multiple metastatic sites, but only one causes significant pain. There are many questions still to be answered in this field."
The researchers intend to follow up their work with a study looking at biomarkers for bone resorption. "If we can correlate these markers with response to both radiotherapy and IB we will be able to see whether they can predict which patients would respond best to which treatment," said Prof Hoskin. "Currently we don’t know exactly how radiotherapy works in bone metastases – we just know that it does. We hope to be able to shed more light on this in our follow-up study.
"It is important to stress that radiotherapy still has a crucial role to play and is a highly effective treatment for many cancer patients. For patients with solitary metastases, pathological fracture, where the bone breaks due to weakness, and neurological complications of bone metastases, it remains the treatment of choice. Our research adds to the arsenal of the many effective treatments now available, and we believe that the findings will also be applicable to other primary cancers that can lead to bone metastases, for example breast cancer, where they are very common," he concluded.
New bone-targeting drug delays onset of metastases in hormone-resistant prostate cancer patients
Inhibiting a protein involved in bone metabolism can delay the onset of the bone metastases which are common in men with a particular form of prostate cancer, a researcher will tell the 2011 European Multidisciplinary Cancer Congress today.
Professor StÈphane Oudard, Head of the Oncology Department at the Georges Pompidou Hospital, Paris, France, says that his team’s research on the effects of the monoclonal antibody denosumab (XGEVA TM) is the first large-scale clinical trial to show such an effect.
Up to 90% of men with prostate cancer that is resistant to hormone treatment will have their primary tumour metastasise to bone. The onset of such metastases means that the cancer is entering a chronic and, thereafter, a terminal phase, and this has major physical and psychological consequences for the patient.
"Being able to delay this turning point is therefore very significant. We have shown that the use of denosumab in this group of patients can impede the onset of bone metastases by just over four months," says Prof Oudard.
The drug works by inhibiting a protein called RANKL, which is key to the formation of osteoclasts. Unlike osteoblasts, which form bone, osteoclasts are involved in its destruction. If the formation of osteoclasts can be impeded, the bone will remain strong and can continue to hold out against the development of metastases.
The researchers enrolled 1432 men into the trial and randomised them into two groups – one to receive the active drug and the other placebo. They were also encouraged to take calcium and vitamin D supplements for bone health. In July 2010 more than 660 of the patients had either developed bone metastases or had died. The trial was then unblinded and the results analysed.
"We found that denosumab prolonged bone metastasis-free survival significantly as compared with placebo, and that these results were consistent among different sub-groups of the disease and demographic variables such as age, ethnicity, and geographical location. From this we can conclude that, whatever the patient characteristics (initially based on a high prostate specific antigen (PSA) value [3] and/or a short PSA doubling time), denosumab can delay the appearance of bone metastasis. In a condition where there is currently no effective treatment, this is a highly significant finding," Prof Oudard will say.
According to the researchers, patients with bone metastases have an almost five times higher risk of death compared with patients without bone metastases. "Effective therapies are already in place for both early (hormone-sensitive) and advanced (hormone-resistant) prostate cancer, but until now there was a gap in the treatment plan for this group of patients, who are hormone-resistant but have not yet developed metastatic disease," says Prof Oudard.
The trial showed that the adverse effects of the drug were limited, being relatively similar between both the denosumab and the placebo groups. Low blood calcium levels and osteonecrosis of the jaw, a deterioration of the jawbone, were slightly more frequent in the denosumab group, and back pain was the most commonly reported adverse effect in this group.
"Bone is one of the most common places for cancer to spread, and we believe that it is a very fertile environment for tumour cells," says Prof Oudard. "When cancer spreads to bone, the tumour cells settle in their new micro-environment and continue to grow. Once established, they increase the breakdown of bone, which releases an excess of growth factors back into the blood stream, which then further stimulate tumour growth."
Patients with bone metastases face critical complications. Often the first symptom is pain, which can be severe and debilitating in the majority of patients. Growth of the tumour in the bone weakens the bone itself and puts the patients at risk for serious skeletal-related events (SREs), such as fractures and spinal cord compression. SREs can be profoundly disrupting to a patient’s life and strategies to prevent or delay the spread of cancer to the bone can give them a respite from this.
If the osteoclast-mediated bone destruction can be hindered through inhibiting the RANKL protein, the cycle of bone destruction and tumour proliferation can be held back. Given that 90% of men with advanced prostate cancer will have their tumour spread to the bone, the potential advantages of RANKL inhibition are great, the researchers say.
"In this group of patients with castrate resistant prostate cancer, once they have developed bone metastases they are only likely to survive for around two years," says Prof Oudard. "Our trial has shown that denosumab prolongs the period before metastasis where the patients’ quality of life has not yet suffered to a great extent. For the first time, we have shown that targeting the bone micro-environment can work in this way. We believe that in future we may be able to do even better by combining denosumab with other targeted treatments," he will conclude.
ECCO President Professor Michael Baumann said: "This is the first large clinical trial to demonstrate that targeting of the bone micro-environment significantly delays onset of bone metastases in hormone resistant prostate cancer patients with high risk for development of bone metastases. What is really striking here is that the effect holds true for all sub-groups of patients evaluated. This offers new options for a considerable group of patients and also will stimulate important further research in this field."
ESMO spokesman Dr. Joaquim Belmunt, from the Medical Oncology Service, Hospital del Mar, Barcelona, said: "Denosumab, being the first agent able to delay the onset of bone metastasis in castrate-resistant prostate cancer, represents a paradigm shift in our beliefs about the†limited efficacy of the presently available anti-metastatic strategies. The way this activity will translate into survival benefit will require future investigation."
Professor StÈphane Oudard, Head of the Oncology Department at the Georges Pompidou Hospital, Paris, France, says that his team’s research on the effects of the monoclonal antibody denosumab (XGEVA TM) is the first large-scale clinical trial to show such an effect.
Up to 90% of men with prostate cancer that is resistant to hormone treatment will have their primary tumour metastasise to bone. The onset of such metastases means that the cancer is entering a chronic and, thereafter, a terminal phase, and this has major physical and psychological consequences for the patient.
"Being able to delay this turning point is therefore very significant. We have shown that the use of denosumab in this group of patients can impede the onset of bone metastases by just over four months," says Prof Oudard.
The drug works by inhibiting a protein called RANKL, which is key to the formation of osteoclasts. Unlike osteoblasts, which form bone, osteoclasts are involved in its destruction. If the formation of osteoclasts can be impeded, the bone will remain strong and can continue to hold out against the development of metastases.
The researchers enrolled 1432 men into the trial and randomised them into two groups – one to receive the active drug and the other placebo. They were also encouraged to take calcium and vitamin D supplements for bone health. In July 2010 more than 660 of the patients had either developed bone metastases or had died. The trial was then unblinded and the results analysed.
"We found that denosumab prolonged bone metastasis-free survival significantly as compared with placebo, and that these results were consistent among different sub-groups of the disease and demographic variables such as age, ethnicity, and geographical location. From this we can conclude that, whatever the patient characteristics (initially based on a high prostate specific antigen (PSA) value [3] and/or a short PSA doubling time), denosumab can delay the appearance of bone metastasis. In a condition where there is currently no effective treatment, this is a highly significant finding," Prof Oudard will say.
According to the researchers, patients with bone metastases have an almost five times higher risk of death compared with patients without bone metastases. "Effective therapies are already in place for both early (hormone-sensitive) and advanced (hormone-resistant) prostate cancer, but until now there was a gap in the treatment plan for this group of patients, who are hormone-resistant but have not yet developed metastatic disease," says Prof Oudard.
The trial showed that the adverse effects of the drug were limited, being relatively similar between both the denosumab and the placebo groups. Low blood calcium levels and osteonecrosis of the jaw, a deterioration of the jawbone, were slightly more frequent in the denosumab group, and back pain was the most commonly reported adverse effect in this group.
"Bone is one of the most common places for cancer to spread, and we believe that it is a very fertile environment for tumour cells," says Prof Oudard. "When cancer spreads to bone, the tumour cells settle in their new micro-environment and continue to grow. Once established, they increase the breakdown of bone, which releases an excess of growth factors back into the blood stream, which then further stimulate tumour growth."
Patients with bone metastases face critical complications. Often the first symptom is pain, which can be severe and debilitating in the majority of patients. Growth of the tumour in the bone weakens the bone itself and puts the patients at risk for serious skeletal-related events (SREs), such as fractures and spinal cord compression. SREs can be profoundly disrupting to a patient’s life and strategies to prevent or delay the spread of cancer to the bone can give them a respite from this.
If the osteoclast-mediated bone destruction can be hindered through inhibiting the RANKL protein, the cycle of bone destruction and tumour proliferation can be held back. Given that 90% of men with advanced prostate cancer will have their tumour spread to the bone, the potential advantages of RANKL inhibition are great, the researchers say.
"In this group of patients with castrate resistant prostate cancer, once they have developed bone metastases they are only likely to survive for around two years," says Prof Oudard. "Our trial has shown that denosumab prolongs the period before metastasis where the patients’ quality of life has not yet suffered to a great extent. For the first time, we have shown that targeting the bone micro-environment can work in this way. We believe that in future we may be able to do even better by combining denosumab with other targeted treatments," he will conclude.
ECCO President Professor Michael Baumann said: "This is the first large clinical trial to demonstrate that targeting of the bone micro-environment significantly delays onset of bone metastases in hormone resistant prostate cancer patients with high risk for development of bone metastases. What is really striking here is that the effect holds true for all sub-groups of patients evaluated. This offers new options for a considerable group of patients and also will stimulate important further research in this field."
ESMO spokesman Dr. Joaquim Belmunt, from the Medical Oncology Service, Hospital del Mar, Barcelona, said: "Denosumab, being the first agent able to delay the onset of bone metastasis in castrate-resistant prostate cancer, represents a paradigm shift in our beliefs about the†limited efficacy of the presently available anti-metastatic strategies. The way this activity will translate into survival benefit will require future investigation."
El 26 se celebra el Día Mundial de la Anticoncepción en favor de los derechos
Este lunes 26 de septiembre se celebra el Día Mundial de la Anticoncepción( DMA), una iniciativa puesta en marcha en el año 2007 por el laboratorio Bayer y apoyada en la actualidad por diez importantes organizaciones internacionales con el objetivo de sensibilizar a la población mundial de los beneficios que la anticoncepción tiene para la salud y el bienestar, especialmente de las mujeres.
Desde entonces, año tras año, se ha ido tomando conciencia de que la anticoncepción no sólo debe abordarse desde la perspectiva de la salud, ya de por sí muy importante, sino que forma parte de los derechos sexuales y reproductivos.
En esta edición, enfocada a la gente joven, el lema es: "Vive tu vida. Conoce tus derechos. Aprende sobre anticoncepción", donde se pretende llamar la atención sobre el derecho que todas las personas tienen para decidir sobre su sexualidad y su anticoncepción, para lo que es imprescindible recibir una correcta información y formación.
Desde entonces, año tras año, se ha ido tomando conciencia de que la anticoncepción no sólo debe abordarse desde la perspectiva de la salud, ya de por sí muy importante, sino que forma parte de los derechos sexuales y reproductivos.
En esta edición, enfocada a la gente joven, el lema es: "Vive tu vida. Conoce tus derechos. Aprende sobre anticoncepción", donde se pretende llamar la atención sobre el derecho que todas las personas tienen para decidir sobre su sexualidad y su anticoncepción, para lo que es imprescindible recibir una correcta información y formación.
Derechos sexuales y reproductivos
Los derechos sexuales se fundamentan en el derecho a disfrutar de una vida sexual satisfactoria y placenetera en todo el ciclo vital, libre de coerción y discriminación y respetuosa con la autonomía sexual de las personas. Implica garantizar la salud sexual, entendida como un estado de bienestar físico, emocional, mental y social en relación con la sexualidad.
Los derechos reproductivos se basan en el reconocimiento y respeto a la capacidad de decidir libre y responsablemente, sin discriminación, coerción o violencia, si se desea o no tener hijos o hijas. Supone garantizar la salud reproductiva, entendida como un estado de bienestar físico, emocional y social, y no de simple ausencia de enfermedad o dolencia, en todos los aspectos relacionados con el sistema reproductivo, así como sus funciones y procesos.
**Vídeo de la campaña "DERECHOS SEXUALES Y REPRODUCTIVOS"( de la Federación de Planificación Familiar Estatal, FPFE, 2010) en:
www.fpfe.org
Los derechos reproductivos se basan en el reconocimiento y respeto a la capacidad de decidir libre y responsablemente, sin discriminación, coerción o violencia, si se desea o no tener hijos o hijas. Supone garantizar la salud reproductiva, entendida como un estado de bienestar físico, emocional y social, y no de simple ausencia de enfermedad o dolencia, en todos los aspectos relacionados con el sistema reproductivo, así como sus funciones y procesos.
**Vídeo de la campaña "DERECHOS SEXUALES Y REPRODUCTIVOS"( de la Federación de Planificación Familiar Estatal, FPFE, 2010) en:
www.fpfe.org
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