Primary source: BMJ

Source reference:

Johansson M, et al “Prostate specific antigen for early detection of prostate cancer: longitudinal study” BMJ 2009; DOI: 10.1136/bmj.b3537.

Additional source: BMJ

Source reference:

Stark J, et al “Screening for prostate cancer remains controversial” BMJ 2009; DOI: 10.1136/bmj.b3537.

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• Prostate Cancer: Overdiagnosed and Overtreated

The goal of tailoring radiation therapy to individual patient sensitivity has moved a step closer to reality with the creation of a tissue bank to help identify hypersensitive patients, investigators reported at an international cancer meeting.

The tissue bank has accumulated specimens from 33 “overreacting” patients, whose genetic makeup can be compared with that of patients who respond normally to radiation therapy, according to a presentation at the ECCO/ESMO combined European cancer congress.

“A major problem for radiation oncologists at present is that we are bound by the need to avoid damage to normal tissues,” Dirk de Ruysscher, MD, of Maastricht University Medical Center in Maastricht, the Netherlands, said in a statement.

“This means that the dose of radiation generally used is governed by the response of the most radiosensitive patients, and this may lead to many patients receiving lower than optimal doses, hence affecting the ability to deliver a higher dose that may result in better local tumor control.”

A dose-response relationships has been demonstrated for radiation therapy, meaning that higher doses provide better tumor control. However, radiation’s toxic effects on normal tissue surrounding a tumor complicate efforts to deliver the optimal dose to the tumor.

Generally accepted parameters for radiotherapy include no more than a 5% incidence of severe, late irreversible tissue damage, de Ruysscher said. As a result, the 5% most radiosensitive individuals determine the radiation dose for all patients.

“Identifying the most radiosensitive group would therefore have huge implications,” said de Ruysscher and colleagues.

To examine genetic pathways that lead to radiosensitivity, investigators in Canada and Europe established the GENEPI database, an integration of biological samples and clinical data from more than 8,000 patients.

The GENEPI tissue bank includes skin fibroblasts, whole blood, lymphocytes, plasma, and lymphoblastic cells lines.

Investigators have thus far identified 33 hypersensitive patients.

As compared with a control group drawn from the tissue bank, hypersensitive patients developed severe side effects that occurred with low doses of radiation, that lasted more than four weeks after completion of radiotherapy and/or required surgery, or that occurred late or persisted for more than 90 days after radiotherapy ended.

Closer inspection of the data showed that 11 of the 33 patients (two men and nine women) exhibited true radiosensitivity.

Six of the 11 patients had breast cancer and the remaining patients had non-small cell lung cancer, head and neck cancer, and lymphoma.

In all cases, the radiation dose, treatment time, and follow-up fell within normal parameters.

Side effects observed in the 11 patients included acute skin reactions, skin thickening or fibrosis, lung inflammation, and blindness caused by optic-nerve damage.

“We believe that, if we can understand what is going on at a molecular level, we may be able to develop a blood test that will allow us to know precisely how an individual patient will react to radiotherapy and to target the dose accordingly,” said de Ruysscher.

“Such personalized treatment will allow us to minimize both radiotherapy doses and unpleasant side effects while treating the tumor in the most effective way possible. Perhaps even more importantly, it will enable us to give higher doses to many patients and hence improve control of their tumors.”

Primary source: European Journal of Cancer Supplements

Source reference:
De Ruysscher D, et al “First report on the patient database of the identification of genetic pathways involved in patients overreacting to radiotherapy: GENEPI-II” Eur J Cancer Suppl 2009; 7(2): Abstract O-2007.

Scientists label cells with coloured or glowing chemicals to observe how basic cellular activities differ between healthy and cancerous cells. Existing techniques for labelling cells are either too slow or too toxic to perform on live cells. Now, a study reviewed by Philip Dawson, a member of Faculty of 1000 Biology and leading authority in chemistry and cell biology, describes a novel labelling technique that uses a chemical reaction to make live cancer cells light up quickly and safely.

Researchers at Massachusetts General Hospital developed a two-step process to specifically tag cancer cells. First, chemically modified antibodies home in on cancer cells. Then a chemical reaction called cycloaddition transfers a dye onto the antibody making the cancer cells glow when viewed through a microscope.

The novel cycloaddition reaction is fast, very specific, and requires minimal manipulation of the cells. Dawson comments that, in combining antibody binding with the cycloaddition, “low signal-to-noise ratios are achieved”. This new labelling technique could be used to track the location and activity of anti-cancer drugs, the location of cancer-specific proteins within the cell, or to visualize cancer cells inside a living organism.

Dawson concludes that cycloaddition will allow scientists to observe live cancer cells in the body, leading to a better understanding of cancer’s basic processes.

The full text of this article is available at http://f1000biology.com/article/nztqpbh7bsrf6vb/id/1164570

Source:
Steve Pogonowski

Faculty of 1000: Biology and Medicine

This conference and networking event will present a fresh and original perspective on communicating the value and cost-effectiveness of high-value oncology drugs with payers, HTA assessors and other key stakeholders.

Unlike other general pricing & reimbursement meetings which broadly discuss many therapeutic areas, this event will be focused specifically on the oncology marketplace. This conference will look at the latest innovative market access techniques such as value-based pricing schemes, risk sharing, as well as satisfying HTA requirements to build the right dossier.

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• Benchmark, network and co-operate with pharma & non-pharma decision makers.
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• Learn what data makes the difference for HTA agencies and payers and how to present it.
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• Hear multi-stakeholder perspectives from: pharmaceutical industry, academia, public insurers, HTA, policy makers, patient groups.
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Screening programs for colorectal cancer could cut the costs of future treatment in half, assuming that the price of chemotherapeutic agents continues to rise, researchers said.

Average treatment savings over the course of a lifetime were higher than average screening costs for multiple screening strategies, with the exception of colonoscopy, according to a simulation performed by Iris Lansdorp-Vogelaar, PhD, of Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues.

“Screening is a desirable approach not only to reduce colorectal cancer incidence and mortality but also to control the costs of colorectal cancer treatment,” they concluded in an online report in the Journal of the National Cancer Institute.

• Explain to interested patients that this study found all screening strategies for colorectal cancer, beginning at age 50, except for colonoscopy, would ultimately save money in the long run, considering the increasing costs of chemotherapy.
• Note that the savings from screening programs would take decades to accrue — in some cases close to half a century — which limits their attractiveness to insurance companies.

Lansdorp-Vogelaar and her colleagues said finding out whether screening programs would ultimately save money was important in order to justify government and insurance company expenditures on them.

This is particularly critical when policymakers consider the approval of expensive new cancer treatments, they said.

For example, they noted that recent, randomized controlled trials have found 50% survival improvements for metastatic colorectal cancer with the newer agents, but also a 340-fold increase in treatment costs.

To explore how these cost increases would affect the cost savings of various screening methods, the researchers used a validated microsimulation model — called the MISCAN-Colon model.

They assessed screening with guaiac fecal occult blood testing (FOBT) with Hemoccult II, annual immunochemical FOBT, sigmoidoscopy every five years, colonoscopy every 10 years, and the combination of sigmoidoscopy every five years and annual guaiac FOBT.

Chemotherapy treatment options were classified as past (1990-1994), present (1998-2003), and near future (using recent clinical trial results).

The simulation was run for a cohort of 50-year-olds, with average risk of cancer, who received screening with 100% adherence to age 80.

The primary assumption was that the costs of screening would remain flat, whereas treatment costs would increase over time.

When the researchers ran the simulation, they found that treatment savings increased for all screening methods, from past to near-future scenarios.

On average, total savings increased by 43% from the past to the present and by 56% from the present to the near future.

Compared to past methods, treatment saving were nearly double in the near-future scenario for all screening methods because the more expensive treatments of the future can be avoided by early diagnosis.

The lifetime average treatment savings were larger than the lifetime average screening costs for all methods except for colonoscopy, as follows:

• Guiaic FOBT with Hemoccult II ($1,398 versus $859)
• Immunochemical FOBT ($1,756 versus $1,565)
• Sigmoidoscopy ($1,706 versus $1,575)
• Sigmoidoscopy combined with Hemoccult II ($1,931 versus $1,878).

Although colonoscopy did not result in an overall cost savings, total net costs decreased from $1,317 to $296 per patient.

One drawback to implementation of screening programs appears to be lead time necessary to start saving money.

The time-to-cost-saving was shortest for a screening program with Hemoccult II (26 years), followed by immunochemical FOBT (37 years), sigmoidoscopy (40 years), and the combination of Hemoccult II and sigmoidoscopy (47 years).

As a result, researchers said, insurance companies might still be reluctant to implement screening programs, especially considering that many beneficiaries will not stay with their company beyond five years.

Another question is who gains and who loses. In the U.S. at least, private insurance companies would pay to establish the programs, but most of the benefits would accrue to the Medicare program.

For this reason, the researchers said it would make sense for Medicare to help pay for establishing screening programs for individuals younger than 65.

The authors said the increase in treatment costs from the present to the future scenario may have been underestimated because therapies other than chemotherapy were not included in the analysis.

The study was additionally limited in that it was assumed all patients with advanced disease would get the newer treatments, even though certain patient groups, including older individuals and those with comorbidities, might not.