Онкология

[Наталья П.]

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Health Technol Assess. 2007 Jan;11(1):1-90.

Pemetrexed disodium for the treatment of malignant pleural mesothelioma: a systematic review and economic evaluation.

Dundar Y, Bagust A, Dickson R, Dodd S, Green J, Haycox A, Hill R, McLeod C, Walley T.

Liverpool Reviews and Implementation Group, University of Liverpool, UK.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of pemetrexed disodium in combination with cisplatin for the treatment of unresectable pleural mesothelioma in chemotherapy-naive patients.
DATA SOURCES: Electronic databases were searched up to May 2005.
REVIEW METHODS: The systematic review was conducted following accepted guidelines. An assessment of the economic submission received from the manufacturer of pemetrexed was also carried out. This comprised two sections, each employing an economic model. One of these models was then reformulated in order to carry out a separate exploration of economic performance.
RESULTS: One randomised controlled trial comparing pemetrexed and cisplatin with cisplatin alone, and involving a total study population of 448 patients, met the inclusion criteria. Pemetrexed in combination with cisplatin in this trial showed a 2.8-month gain in median survival compared with cisplatin alone in an intention-to-treat (ITT) population (12.1 and 9.3 months, respectively, p = 0.020, hazard ratio of 0.77). During the trial, increased reporting of severe toxicity in the pemetrexed arm led to a change in the protocol to add folic acid and vitamin B12 supplementation to therapy. For fully supplemented patients (n = 331) the hazard ratio for median survival in favour of pemetrexed plus cisplatin was also comparable (0.75), but of borderline significance between treatment arms (p = 0.051). The trial inclusion criteria restricted recruitment to those with a Karnofsky performance status of 70 or greater (equivalent to ECOG/WHO 0 or 1 scales more widely used in the UK). Quality of life scores using the Lung Cancer Symptom Scale demonstrated significantly greater improvement for pain and dyspnoea for patients in the combination group compared with those in the cisplatin group. In the ITT population, the incidence of serious toxicities with pemetrexed plus cisplatin was higher compared with cisplatin alone. However, the grade 3/4 toxicities of the combination arm, particularly leucopenia, neutropenia and diarrhoea, were found to be greatly improved by the addition of vitamin B12 and folic acid. The existing published economic literature was very limited. The economic evaluation conducted by the study (and that submitted by the manufacturer) suggested that pemetrexed is unlikely to be considered cost-effective at conventionally accepted thresholds in the UK for all patients, mainly because of the high cost of pemetrexed itself compared with cisplatin. These findings were better for some patient subgroups, e.g. especially for fully supplemented (FS) patients with good performance status (0/1) and advanced disease (AD). These findings seem robust. The estimated cost-effectiveness results were for the FS population, incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained = pound59,600; for the FS with AD population, ICER per QALY = pound47,600; for the FS with performance status 0/1 population, ICER per QALY = pound49,800; and for the FS with performance status 0/1 and AD population, ICER per QALY = pound36,700.
CONCLUSIONS: The new therapy examined in this document demonstrates an extension of life expectancy and palliation, as measured by time to progression of disease and other end-points. However, the absolute benefit obtained is small, and it needs to be weighed against the benefits of effective palliative care services. The limited benefit was also at the expense of considerable toxicity to patients. The economic evaluation conducted in this study and that of the manufacturers suggest that pemetrexed is not cost-effective at conventional thresholds for all patients. Cost-effectiveness seems better for some patient subgroups, e.g. especially for patients with good performance status and with advanced diseases, where it is estimated the ICER per QALY would be pound36,700. Given the relatively small number of patients with mesothelioma, albeit increasing, the overall budget impact of pemetrexed would be unlikely to be more than pound5 million per year at present costs. Much more research is needed into the optimum chemotherapy for patients with mesothelioma and a clear definition of what constitutes best supportive care.

[Наталья П.]

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Health Technol Assess. 2006 Nov;10(45):1-160.

Clinical effectiveness and cost-effectiveness of laparoscopic surgery for colorectal cancer: systematic reviews and economic evaluation.

Murray A, Lourenco T, de Verteuil R, Hernandez R, Fraser C, McKinley A, Krukowski Z, Vale L, Grant A.

Health Services Research Unit, University of Aberdeen, UK.

OBJECTIVE: The aim of this study was to determine the clinical effectiveness and cost-effectiveness of laparoscopic, laparoscopically assisted (hereafter together described as laparoscopic surgery) and hand-assisted laparoscopic surgery (HALS) in comparison with open surgery for the treatment of colorectal cancer.
DATA SOURCES: Electronic databases were searched from 2000 to May 2005. A review of economic evaluations was undertaken by the National Institute for Health and Clinical Excellence in 2001. This review was updated from 2000 until July 2005.
REVIEW METHODS: Data from selected studies were extracted and assessed. Dichotomous outcome data from individual trials were combined using the relative risk method and continuous outcomes were combined using the Mantel-Haenszel weighted mean difference method. Summaries of the results from individual patient data (IPD) meta-analyses were also presented. An economic evaluation was also carried out using a Markov model incorporating the data from the systematic review. The results were first presented as a balance sheet for comparison of the surgical techniques. It was then used to estimate cost-effectiveness measured in terms of incremental cost per life-year gained and incremental cost per quality-adjusted life-year (QALY) for a time horizon up to 25 years.
RESULTS: Forty-six reports on 20 studies [19 randomised controlled trials (RCTs) and one IPD meta-analysis] were included in the review of clinical effectiveness. The RCTs were of generally moderate quality with the number of participants varying between 16 and 1082, with 10 having less than 100 participants. The total numbers of trial participants who underwent laparoscopic or open surgery were 2429 and 2139, respectively. A systematic review of four papers suggested that laparoscopic surgery is more costly than open surgery. However, the data they provided on effectiveness was poorer than the evidence from the review of effectiveness. The estimates from the systematic review of clinical effectiveness were incorporated into a Markov model used to estimate cost-effectiveness for a time horizon of up to 25 years. In terms of incremental cost per life-year, laparoscopic surgery was found to be more costly and no more effective than open surgery. With respect to incremental cost per QALY, few data were available to differentiate between laparoscopic and open surgery. The results of the base-case analysis indicate that there is an approximately 40% chance that laparoscopic surgery is the more cost-effective intervention at a threshold willingness to pay for a QALY of pound30,000. A second analysis assuming equal mortality and disease-free survival found that there was an approximately 50% likelihood at a similar threshold value. Broadly similar results were found in the sensitivity analyses. A threshold analysis was performed to investigate the magnitude of QALY gain associated with quicker recovery following laparoscopic surgery required to provide an incremental cost per QALY of pound30,000. The implied number of additional QALYs required would be 0.009-0.010 compared with open surgery.
CONCLUSIONS: Laparoscopic resection is associated with a quicker recovery (shorter time to return to usual activities and length of hospitalisation) and no evidence of a difference in mortality or disease-free survival up to 3 years following surgery. However, operation times are longer and a significant number of procedures initiated laparoscopically may need to be converted to open surgery. The rate of conversion may be dependent on experience in terms of both patient selection and performing the technique. Laparoscopic resection appears more costly to the health service than open resection, with an estimated extra total cost of between pound250 and pound300 per patient. In terms of relative cost-effectiveness, laparoscopic resection is associated with a modest additional cost, short-term benefits associated with more rapid recovery and similar long-term outcomes in terms of survival and cure rates up to 3 years. Assuming equivalence of long-term outcomes, a judgement is required as to whether the benefits associated with earlier recovery are worth this extra cost. The long-term follow-up of the RCT cohorts would be very useful further research and ideally these data should be incorporated into a wider IPD meta-analysis. Data on the long-term complications of surgery such as incisional hernias and differences in outcomes such as persisting pain would also be valuable. Once available, further data on both costs and utilities should be included in an updated model. At this point, further consideration should then be given as to whether additional data should be collected within ongoing trials. Few data were available to assess the relative merits of HALS. Ideally, there should be more data from methodologically sound RCTs. Further research is needed on whether the balance of advantages and disadvantages of laparoscopic surgery varies within subgroups based on the different stages and locations of disease. Research relating to the effect of experience on performance is also required.

[Наталья П.]

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Health Technol Assess. 2006 Nov;10(41):1-204.

The clinical and cost-effectiveness of oxaliplatin and capecitabine for the adjuvant treatment of colon cancer: systematic review and economic evaluation.

Pandor A, Eggington S, Paisley S, Tappenden P, Sutcliffe P.

School of Health and Related Research (ScHARR), University of Sheffield, UK.

OBJECTIVES: To assess the clinical and cost-effectiveness of oxaliplatin in combination with 5-fluorouracil/leucovorin (5-FU/LV), and capecitabine monotherapy (within their licensed indications), as adjuvant therapies in the treatment of patients with Stage III (Dukes' C) colon cancer after complete surgical resection of the primary tumour, as compared with adjuvant chemotherapy with an established fluorouracil-containing regimen.
DATA SOURCES: Ten electronic bibliographic databases were searched from inception to January 2005. Searches were supplemented by hand searching relevant articles, sponsor and other submissions of evidence to the National Institute of Health and Clinical Excellence and conference proceedings.
REVIEW METHODS: A systematic review and meta-analysis (where appropriate) of clinical efficacy evidence and a cost-effectiveness review and economic modelling were carried out. Marginal costs, life years gained and cost-effectiveness acceptability curves were estimated. Probabilistic sensitivity analysis was used to generate information on the likelihood that each of the interventions was optimal.
RESULTS: Three randomised active-controlled trials, of varying methodological quality, were included in the review. The MOSAIC trial and NSABP C-07 study considered the addition of oxaliplatin to adjuvant treatment (albeit administered in different 5-FU/LV regimens) and the X-ACT study compared oral capecitabine with bolus 5-FU/LV alone. A review of the available evidence indicated that in patients with Stage III colon cancer, oxaliplatin in combination with an infusional de Gramont schedule of 5-FU/LV (FOLFOX4) was more effective in preventing and delaying disease recurrence than infusional 5-FU/LV alone (de Gramont regimen). Serious adverse events and treatment discontinuations due to toxicity were more evident with oxaliplatin-based regimens (FOLFOX4 and FLOX regimen) than infusional or bolus 5-FU/LV alone (de Gramont and Roswell Park regimen). Oral capecitabine was at least equivalent in disease-free survival to the bolus Mayo Clinic 5-FU/LV regimen for patients with resected Stage III colon cancer. Although, the safety and tolerability profile of capecitabine was superior to that of the Mayo Clinic 5-FU/LV regimen, it has not been evaluated in comparison with other less toxic 5-FU/LV regimens currently in common use in the UK. Based on the assumptions and survival analysis methods used, the cost-effectiveness analysis using economic modelling estimated that capecitabine was a dominating strategy and resulted in a cost-saving of approximately pound3320 per patient in comparison with the Mayo Clinic 5-FU/LV regimen, while also providing an additional 0.98 quality-adjusted life-years (QALYs) over a 50-year model time horizon. Oxaliplatin in combination with 5-FU/LV (FOLFOX4 regimen) is estimated to cost an additional pound2970 per QALY gained when compared with the de Gramont 5-FU/LV regimen and demonstrated superior survival outcomes with marginal costs. The uncertainty analysis suggests that both interventions have a high probability of being cost-effective at a threshold of both pound20,000 and pound30,000. An indirect comparison of the FOLFOX4 and Mayo Clinic 5-FU/LV regimens suggests that the use of FOLFOX4 in place of the Mayo Clinic 5-FU/LV regimen would cost an additional pound5777 per QALY gained. An incremental cost-effectiveness ratio (ICER) is estimated to be approximately pound13,000 per QALY gained from treatment with FOLFOX4 compared with capecitabine. However, if the Mayo Clinic and the de Gramont 5-FU/LV regimens are assumed to be equivalent in terms of effectiveness, the ICER of FOLFOX4 in comparison with capecitabine may be greater than pound30,000 per QALY.
CONCLUSIONS: The evidence suggests that both capecitabine and FOLFOX4 are clinically effective and cost-effective in comparison with 5-FU/LV regimens (Mayo Clinic and de Gramont schedules). Further research is suggested into the effectiveness, tolerability, patient acceptability and costs of different oxaliplatin/fluoropyrimidine schedules in the adjuvant setting; the effects of treatment duration on efficacy; adverse events; resource data collection strategies and reporting of summary statistics; subgroups benefiting most from adjuvant chemotherapy; and methods for estimating mean survival.

[Наталья П.]

Всесторонняя борьба с раком шейки матки: основные практические рекомендации
(Comprehensive cervical cancer control: a guide to essential practice) (2006) (на англ.яз.)

Автор: ВОЗ

Описание: “Настоящее руководство сосредоточено на знаниях и навыках, необходимых лицам, оказывающим медицинскую помощь на различных уровнях, для обеспечения качественного оказания помощи в целях профилактики, скрининга, лечения рака шейки матки и паллиативных мероприятий. Оно представляет современные, доказательные рекомендации, затрагивающие весь спектр оказания помощи. Четыре уровня оказания помощи, о которых говорится в руководстве, включают в себя: сообщество, медицинский центр, или первичный уровень оказания медицинской помощи; районную больницу, или вторичный уровень оказания помощи; и центральную, или консультативную больницу, или третичный уровень. Руководство не рассматривает вопросы управления программой, мобилизации ресурсов, а также политические, юридические и связанные с политикой мероприятия, относящиеся к борьбе с раком шейки матки.”

Как получить: Через Интернет в формате PDF [282 с.] Ограниченное число печатных экземпляров доступно через Департамент репродуктивного здоровья и исследований
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[Наталья П.]

Cancer Control Opportunities in Low- and Middle-Income Countries

Board on Global Health (BGH) Report Brief • February 2007- US Institute of Medicine IOM

Available online at: [Ссылки доступны только зарегистрированным пользователям ]

“….. in most of the world’s low- and middle-income countries (LMCs), where cancer is generally low or absent on the health agenda even as it is growing as a share of these countries’ overall disease burden.

Each year, for example, six million new cases of cancer occur in LMCs—more than half of the eleven million cases occurring worldwide. And each year, four million people in LMCs die from cancer—one million more than die in these countries from AIDS.

….. this situation has not received much attention or focus from the global health community or even from most of the LMCs themselves. Instead, concern about cancer in LMCs has been limited mainly to organizations already interested in the disease.In light of this situation, the National Cancer Institute and the American Cancer Society asked the Institute of Medicine (IOM) to study the issue and provide an assessment and recommendations:

- Cancer prevention

- Cancer treatment

- Palliative Care

- Assessing and Monitoring the Cancer Burden

- Developing Cancer-control Plans

[Belousoff]

European Group on Tumor Markers.
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Information, guidelines, presentations etc/

[Dr.]

"Palliative Care:
symptom management and end-of-life care" -

INTEGRATED
MANAGEMENT OF
ADOLESCENT AND ADULT
ILLNESS
INTERIM GUIDELINES FOR
FIRSTLEVEL FACILITY HEALTH WORKERS

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Palliative Care in Pancreatic Cancer
Frank J. Brescia, MD, MA, FACP - [Ссылки доступны только зарегистрированным пользователям ]

Паллиативная помощь для пациентов - [Ссылки доступны только зарегистрированным пользователям ]
tients/patient_gls/_english/pdf/NCCN%20Palliative%20Care%20Guidelines.pdf

[Наталья П.]

Будущие тенденции и проблемы онкологических служб Англии: обзор литературы и нормативно-правового регулирования (Future Trends and Challenges for Cancer Services in England: A Review of Literature and Policy) (на англ.яз)

Автор: Ребекка Розен [Rebecca Rosen], Алекс Смит [Alex Smith], Энтони Харрисон [Anthony Harrison]. Фонд короля [King’s Fund]
Описание: “Обзор литературы был проведен для оценки текущего состояния онкологических служб и эпидемиологических и технологических тенденций, наиболее вероятно отражающихся на количестве людей, живущих с раком, а также услугах, которые они будут получать.”
Как получить: Имеется в режиме online в формате PDF [68 стр.]
URL: [Ссылки доступны только зарегистрированным пользователям ]

[nastassia]

сегодня случайно наткнулась. оч доступно
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[Наталья П.]

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Oncology

[Наталья П.]

ONIX - New Online Portal for Cancer Researchers
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The National Cancer Research Institute's free online cancer research portal, ONIX, has launched to the public today. ONIX (ONcology Information eXchange) enables scientists and clinicians to search through and access international research data held online - to improve the flow of cancer research information between individuals, institutions and organisations.
The portal is free-to-use and uses powerful search technology - which significantly reduces the time it currently takes for scientists and clinicians to find cancer-related data and information across the spectrum of research from genomics to clinical trials. This reduces duplication of research effort across the globe and makes it easier for researchers to collaborate on similar studies. It will speed up the development of new
therapies, and could potentially improve prognosis and diagnosis. It provides a unique integrated research environment online - the gateway to cancer research.

Scientists and clinicians can simultaneously search through multiple cancer-related databases, and track the latest developments in the field - what research is being carried out by which researchers - and where. Most importantly, when users carry out a search on ONIX, they receive the search results in a clear usable format.
The demand for a system such as ONIX is greater than ever. In the last 10 years the amount of health-related data available in electronic format has ballooned due to the vast volumes of data generated by modern molecular research techniques.

The scale of this data and the fact that - to date - it has been stored in many different formats and locations has meant that it is almost impossible for individual researchers to use this information effectively.

Professor Sir Alex Markham, who has been leading the development of ONIX, on behalf of NCRI, said: "ONIX represents a major advance for cancer research in the UK. I urge all cancer researchers, whether basic scientists, clinical researchers or pre-clinical medical students, to register with ONIX, explore the system in depth and continue to use it over the coming months and years.


"Researchers can use it to pull out specific, relevant data from the haystack of information out there - really saving them valuable time. As a result researchers will be better connected with the latest projects, data and updates from institutions in the field of cancer. What you see now is just the beginning - the system will eventually become a one-stop resource for online cancer research."

ONIX will be further refined - driven by user feedback. The NCRI will continue to develop the system - by adding more content, including databases, information about cancer-related organisations and resources. And improved functionality of ONIX will enable researchers to do more with these resources and information.

An 'Intelligent' search feature is being developed which interprets the language used in search terms - called semantic searching. This enables researchers to find highly specific cancer-related information whilst eliminating irrelevant search results.

The NCRI Informatics project is collaborating with a number of UK projects including the National Cancer Intelligence Network (NCIN) and the NHS Connecting for Health Research Capability Programme (RCP). The collaboration will allow researchers to access electronic summaries of the data held by these organisations in a secure way - and with appropriate authorisation researchers will be able to access and retrieve protected data.

Professor Sir Kenneth Calman, chair of the NCRI, said: "The NCRI partners are pleased to support the launch and continued development of ONIX. The role of ONIX in connecting resources and information, and streamlining research supports the key principles of high-level coordination that the NCRI aims to achieve. I am optimistic that ONIX will provide a research tool of significant benefit to both cancer researchers and cancer patients alike."

For further information, please visit:
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About the Oncology Information Exchange (ONIX)

The NCRI ONIX is an internet portal aimed at clinical cancer researchers, clinicians, bioinformaticians and health informaticians from both public and private sectors. It provides resources and information on all aspects of global cancer research - from genomics to clinical trials.
The initiative is managed by the National Cancer Research Institute (NCRI), through the NCRI Informatics Initiative, established in 2003, to ensure that all research data generated achieves impact and is put to maximum use by the cancer research community.
The Oncology Information Exchange is funded by the NCRI Partners and Industry.
The service will launch in summer 2009 and be further developed until at least March 2010.

About the NCRI
The National Cancer Research Institute (NCRI) was established in April 2001. It is a UK-wide partnership between the government, charity and industry which promotes co-operation in cancer research among the 21 member organisations for the benefit of patients, the public and the scientific community.

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NCRI members are: the Association of the British Pharmaceutical Industry (ABPI); Association for International Cancer Research; Biotechnology and Biological Sciences Research Council; Breakthrough Breast Cancer; Breast Cancer Campaign; Cancer Research UK; CHILDREN with LEUKAEMIA, Department of Health; Economic and Social Research Council; Leukaemia Research; Ludwig Institute for Cancer Research; Macmillan Cancer Support; Marie Curie Cancer Care; Medical Research Council; Northern Ireland Health and Social Care (Research & Development Office); Roy Castle Lung Cancer Foundation; Scottish Government Health Directorates (Chief Scientist Office); Tenovus; Welsh Assembly Government (Wales Office of Research and Development for Health &
Social Care); The Wellcome Trust; and Yorkshire Cancer Research.

[Наталья П.]

A Foundation for Evidence-Driven Practice:
A Rapid Learning System for Cancer Care

Workshop Summary

Sharon Murphy and Margie Patlak, Rapporteurs;

IOM (Institute of Medicine). 2010. Washington,DC: The National Academies Press

ISBN: 0-309-15127-9, 124 pages, 6 x 9, (2010)

Available online at: [Ссылки доступны только зарегистрированным пользователям ]


“…..Evidence of what is effective in clinical practice, especially evidence of what is appropriate for specific individual patients, is often lacking. In addition, if such evidence is available, it is often not translated rapidly into standard clinical practice, nor is it followed uniformly across healthcare practices. Our current healthcare system is plagued by overuse, underuse, and misuse, leading a recent Institute of Medicine (IOM) committee to conclude there is an urgent need to “know what works” (IOM, 2008).

This is problematic and challenging given the rapidity with which medical advances render standard care obsolete. A delay in translation or inappropriate care can shorten the life span of patients with life-threatening diseases.

Regrettably, much of the information that could improve care is not currently collected or distributed at the point of care, despite recent advances in information technology that make this possible….”

“…..There is a compelling public interest to advance the evidence base for cancer treatment and control measures, and to transform the way evidence is aggregated and applied in real-time, driving the process of discovery as a natural outgrowth of patient care, to ensure innovation, quality, safety, and value. A learning health care system for cancer would take full advantage of private and public sector databases and emerging information technology, including electronic medical records, to advance clinical cancer data, both as a public utility and a point-of-care patient-centered clinical decision support system. In light of substantial public investments in health information technology and comparative effectiveness research, this workshop is both timely and topical.



The promise of personalized cancer medicine and targeted therapies for cancer add further urgency to foster development of rapid learning systems to know what works and deliver higher value cancer care.

The goal of this workshop is to foster progress toward this vision for a rapid learning health care system for cancer. The workshop will examine the foundation stones upon which to build such a system and explore aspects of information technology which will enable such a system to operate seamlessly.

The impact on oncology providers and policy challenges will be examined with the aim of stimulating collaboration and action…”