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Medicare Widens Drugs It Accepts for Cancer

Thursday, January 29, 2009

Source: New York Times

The New York Times is running an article on Medicare’s announcement that it has expanded its coverage policy to pay for off-label use of cancer drugs. The decision has been welcomed by most oncologists around the country, but there is concern among other physicians, as well as consumer advocates, that the decision will lead to more money being spent on treatments that have not been proven effective.

When the FDA approves a drug, it does so for the treatment of a particular disorder. However, once the drug has been approved, physicians are allowed to prescribe the drug for uses that it was not approved for. This is known as “off-label” use and is a common use for many different agents. However, off-label use has not traditionally been subsidized by Medicare, so its recent decision represents a major break with past policy. Cancer doctors are generally happy with the change, as most have lobbied for it for many years now. They see the rule change as an important step in their ability to treat their patients. While FDA approval is the gold standard for every drug, the process can take years to work through the system and for many cancer patients, years might not be an option for them. However, critics of the change fear that cancer patients may end up as guinea pigs for non-standard drug treatments and that Medicare costs will sky-rocket due to so many more drugs now being available for coverage.

To read more about this story, please see the full article: Medicare Widens Drugs It Accepts for Cancer.

Labels: cancer

posted by Joseph DiCastro at 12:01 AM
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Asbestos and Nanomaterials

Wednesday, January 28, 2009

Source: HARN report considers health risks of high aspect ratio nanomaterials in relation to asbestos

A group of scientists in the United Kingdom have recently published a paper showing that high aspect ratio nanomaterials (HARN) may have toxicological/pathological effects on the human body similar to asbestos. The report looked at certain kinds of these materials, such as carbon nanotubes, that share similar physical characteristics as asbestos fibers and it concluded that they would likely trigger the same, or similar, physiological reactions that lead to diseases such as mesothelioma. In making this analysis, the researchers conducted an extensive review of the available literature on asbestos and asbestos-related diseases, as well as prior studies of HARN and their possible health effects. The report makes a number of specific recommendations on the direction of future research into this question.

One of the difficulties associated with this kind of research is that asbestos-related diseases often take decades to develop, so the actual health effects of HARN exposure may not be seen for years to come. The report’s recommendations are directed at learning more about the pathological potential of these materials and, should this potential be confirmed, developing proper safety mechanisms to ensure the well-being of those who work with the materials.

Carbon nanotubes, and other such nanomaterials, are revolutionizing multiple industries and have the potential to remake many more, so identifying their potential health effects and developing safety precautions now will prevent problems in the future. To learn more about some of the medical research being conducted with carbon nanotubes, please read the following articles:

• ‘Smart bomb’ Nanoparticles Stop Cancer’s Spread
• Researchers Use Nanotech to Target Chemo Cancer Treatment

Labels: asbestos

posted by Joseph DiCastro at 12:56 PM
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Pleural Mesothelioma and Surgery

Tuesday, January 27, 2009

Article: Surgery for Malignant Pleural Mesothelioma

Malignant mesothelioma is one of the most difficult diseases in all of medicine to manage effectively. Median survival time typically averages only 12-14 months. For patients lucky enough to receive a diagnosis in the disease’s earliest stages, median survival can sometimes be extended two or three years, but a complete cure remains impossible and the vast majority of people who are diagnosed with pleural mesothelioma or peritoneal mesothelioma will eventually die from the disease. Because of this disappointing situation, physicians and scientists all over the world are searching for more effective treatments. In some cases, this research may focus on the investigation of a novel therapeutic strategy; in other cases, it may focus on improving a current treatment modality or on comparing the effectiveness of competing modalities when a standard-of-care has not yet been established.

One of the most controversial questions in contemporary mesothelioma treatment research concerns the choice of pleurectomy/decortication (P/D) vs. extrapleural pneumonectomy (EPP) for the surgical management of pleural mesothelioma. Both of these treatments are highly invasive procedures and both are properly considered radical surgery, but there is not yet clear guidance on which surgery should be performed for what patient. EPP is considered the more invasive of the two procedures, so some physicians will perform P/D on early-stage patients and EPP on late-stage patients, but a standard does not exist which actually specifies this. In many cases, the question of procedure will be based on a physician’s personal history in treating the disease. A number of retrospective studies have been performed, but direct comparison of their results is impossible due to differences in study design, staging guidelines, reporting and a host of other factors. However, these studies are still helpful for the working physician and many doctors will look at these studies in an attempt to draw some conclusions from their findings.

In an article recently published in the Annals of Diagnostic Pathology, David Rice, MB, BCh, FRCSI, of the MD Anderson Cancer Center, summarized much of the available literature on the treatment of pleural mesothelioma and addressed the controversy of P/D vs. EPP as well. He stated that the goal of any curative surgery should be the removal of all macroscopic evidence of disease, but that the available evidence does not indicate which procedure should be the one deployed for this purpose, because neither shows any greater long-term survival when compared to the other. EPP has demonstrated better rates of local disease control than P/D has and it more readily allows the use of radiation than does pleurectomy/decortication, which are important factors in its favor. However, EPP is also associated with a greater risk of serious side effects and of treatment-related death than is pleurectomy/decortication. It is also associated with a greater likelihood of metastatic spread of the disease. Because of this situation, the choice regarding which procedure is more effective is still an open question. Dr. Rice does say, however, that should physicians be able to stop the metastasic spread of the disease, then EPP would likely lead to longer survival in patients who are able to tolerate it.

Labels: epp, mesothelioma, pd, pleuralmesothelioma, treatments

posted by Belluck & Fox at 5:39 PM
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EPA Provides $2.1 Million Grant for Asbestos Research

Monday, January 26, 2009

Source: Hamner Institute for Health Sciences

The Hamner Institute for Health Sciences in North Carolina has signed a $2.1 million contract with EPA to conduct a long-term study of the asbestos-contaminated vermiculite ore that was once mined in Libby, MT. The mine was shut down in 1990 when the asbestos contamination first received public notice. Sadly, thousands of people were sickened or killed before this happened. The town of Libby, as well as many of the surrounding towns, has rates of mesothelioma, lung cancer and asbestosis that are much higher than the national average. Researchers from Hamner will analyze the vermiculate on a number of fronts and will attempt to quantify the toxicological nature of this mineral. The study will take three years to complete.

Labels: asbestos, mesothelioma

posted by Belluck & Fox at 4:23 PM
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Mesothelioma Specialist in Hawaii Awarded Grants to Study the Disease

Friday, January 23, 2009

Source: Honolulu Advertiser

Dr. Haining Yang, MD, PhD, a scientist and mesothelioma specialist affiliated with the Thoracic Oncology Program at the Cancer Research Center of Hawaii, was recently awarded two research grants to study the manner in which mesothelioma develops in people. Dr. Yang received a $100,000 grant from the Mesothelioma Applied Research Foundation to study the biological events triggered by asbestos exposure that lead to the development of pleural mesothelioma and peritoneal mesothelioma. Her second grant was awarded by the Hawai’i Community Foundation’s Leahi Fund. Part of this money will be applied to a study devoted to the early detection of mesothelioma that Dr. Yang is conducting in Turkey. For reasons not yet understood, there are villages in Turkey that demonstrate mesothelioma rates far, far above national and international averages of disease genesis and Dr. Yang will be investigating some of these villages.

To learn more about Dr. Yang and the important work she is conducting on mesothelioma, please read the profile of her in the Honolulu Advertiser, “Young cancer scientist receives prestigious grant awards of $200,000.”

Labels: mesothelioma, pleuralmesothelioma

posted by Joseph DiCastro at 4:31 PM
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Cancer Drug Inventor Donates $1M for Student/Faculty Research

Friday, January 16, 2009

Source: Hamilton College

Edward C. Taylor, inventor of pemetrexed (Alimta), has recently donated $1 million to his alma mater, Hamilton College, to establish The Edward and Virginia Taylor Fund for Student/Faculty Research in Chemistry. Long before Mr. Taylor become a Professor of Chemistry at Princeton , he was as student at Hamilton not sure if he should take biology or chemistry to fulfill his science requirement. He flipped a coin to decide and chemistry won the day. It soon became his passion, as well as the focus of his life’s work.

Dr. Taylor eventually joined the faculty at Princeton, where he completed his most important professional success: the invention of pemetrexed. The drug has now been approved in 92 countries for the treatment of mesothelioma and lung cancer and still represents the only FDA-approved agent for pleural mesothelioma.

To learn more about Dr. Taylor, we encourage users to read the profile of him on the Hamilton College website.

Labels: chemotherapy, mesothelioma, pemetrexed

posted by Joseph DiCastro at 12:01 AM
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Asbestos Disease Awareness Organization (ADAO) Awards

Thursday, January 15, 2009

Source: Medical News Today

The Asbestos Disease Awareness Organization (ADAO) has announced the recipients of their yearly awards that recognize individuals for their efforts in increasing awareness about asbestos and for fighting to limit its use. The ADAO is recognizing the following people for this work:

• U.S. Senator Barbara Boxer (Tribute of Hope Award)
• Margaret Seminario, AFL/CIO (Tribute of Unity Award)
• Dr. Stephen Levin (Dr. Irving Selikoff Lifetime Achievement Award)
• Pralhad Malvadkar and Raghunath Manwar Tribute of Inspiration Award)

The awards will be given out during ADAO’s conference in March.

More details about ADAO and the awards mentioned here can be found on their website: http://www.asbestosdiseaseawareness.org/.

Labels: asbestos

posted by Joseph DiCastro at 12:01 AM
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Implant Raises Cellular Army to Attack Cancer

Wednesday, January 14, 2009

Source: New Scientist

New Scientist is running a story on an investigational cancer treatment that cured 90% of the mice who received the therapy. The treatment involved “reprogramming” the mice’s immune system to identify the cancer as an antigen and then attack it as such. The study’s authors claim that variations on the therapy could also be used for other serious disorders, such as type 1 diabetes.

Therapies based on augmenting a patient’s immune system response to disease or other disorders are part of the branch of medicine known as immunotherapy. They are already used to treat a number of conditions and innovative researchers continue to expand their domain of application. One of the great hopes for immunotherapy is the development of vaccines or other treatments in the fight against cancer. Because cancer grows from within a person, the immune system rarely identifies the malignancy as an antigen and generally leaves the tumor alone, allowing it to grow and spread relatively untouched. Therapies that train the immune system to recognize the cancer have been studied and some have shown an ability to fight the cancer, but their efficacy has been limited by the manner in which the treatment is given: the patient’s immune cells are removed from the body and trained to attack the cancer and are then injected back into the person to treat the malignancy. The problem with this method is that most of the re-injected cells—some estimates are as many as 90%—die before they have an effect.

Researchers from Harvard University have developed a new system that accomplishes the same “training” of cells, but does it through an implant. The treatment involves implanting a biodegradable polymer that is encoded with the chemical signature of the cancer and a “danger signal” to tell the body to attack agents with this same signature. When the polymer begins to breakdown, it releases a signaling molecule that starts the “training” process which eventually leads to the immune system organizing T-cells to attack the underlying malignancy.

To test their treatment, the researchers studied two sets of mice infected with an aggressive form of melanoma that usually kills within 25 days. The group that did not receive treatment all developed large tumors and had to be killed, but 90% of the group that received the implant were totally cured.

As is the case with all research, more studies are needed to validate the safety and efficacy of this treatment. However, the success demonstrated by this particular study is certainly a cause for hope that better treatments for diseases such as pleural mesothelioma and peritoneal mesothelioma may be found in the future.

Labels: cancer, mesothelioma, treatments

posted by Joseph DiCastro at 11:28 AM
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Chemotherapy for Mesothelioma Treatment: Tolerability of Pemetrexed at Higher Doses

Thursday, January 8, 2009

Combination therapy with pemetrexed and cisplatin has been the standard of care for the treatment of mesothelioma since its approval in 2004 by the US FDA. The treatment’s approval was driven by the results of a large Phase III study that demonstrated greater treatment efficacy for patients with malignant mesothelioma than any other chemotherapy treatment had previously demonstrated. The currently approved treatment regimen involves 500 mg/m2 of pemetrexed and 75 mg/m2 of cisplatin in 21-day cycles, along with folic acid and vitamin B12 supplementation to reduce the potentially toxic side effects of the main agents. The latter supplements were added to this regimen after pemetrexed and cisplatin dosing levels were finalized and because they’ve been successful in reducing side effects, a number of physicians have wondered if an increase in pemetrexed levels would still be tolerable, as well as more effective, for individual patients. Some studies have looked at higher doses of single agent pemetrexed treatment, but few have looked at increasing pemetrexed levels when still used in combination with cisplatin and vitamin supplements.

To learn more about the tolerability of increased pemetrexed levels in this context, Eli Lilly—makers of Alimta, pemetrexed’s trade name—worked with a group of researchers to discover the maximum tolerated dose (MTD) of pemetrexed, as well as the highest recommended dose of the drug. The paper describing the results of this research, “Phase I and Pharmacokinetic Study of Pemetrexed plus Cisplatin in Chemonaive Patients with Locally Advanced or Metastatic Malignant Pleural Mesothelioma or Non-Small Cell Lung Cancer,” was recently published in the journal Clinical Cancer Research.

Introduction to the Study

To discover the maximum tolerated dose and highest recommended dose of pemetrexed in combination with cisplatin and vitamin supplementation, the researchers enrolled 21 chemonaive patients with locally-advanced or metastatic cases of pleural mesothelioma or non-small cell lung cancer. 12 of these patients had non-small cell lung cancer and 9 were diagnosed with pleural mesothelioma. These 21 patients were then split into 5 different pemetrexed dosing groups: 3 patients received a dose of 500 mg/m2, 3 received 600 mg/m2 and 3 more received 700 mg/m2 doses, while 6 patients received 800 mg/m2 and the final 6 received 900 mg/m2 doses. All patients received the standard cisplatin level of 75 mg/m2.

The patients were primarily evaluated on tolerability, but part of the study also included a pharmacokinetic (PK) analysis of the body’s reaction to the drug agent. PK analysis evaluates the manner in which the drug combination is broken down by the body and then absorbed, distributed and excreted from it. Results from this type of analysis can be useful in predicting the possible effects of dose escalation on treatment efficacy.

Results & Conclusion

The study found that 900 mg/m2 was the maximum tolerated dose, but was associated with a number of grade 3 toxicities and one patient experienced a grade 4 neutropenia and later died from sepsis (this is considered a Grade 5 toxicity). None of the patients who received the 800 mg/m2 dose administration experienced any dose limiting toxicities, so the researchers concluded that—in terms of tolerability—800 mg/m2 was the highest recommended dose.

However, the authors also note that the results of their own PK analysis, as well as the results of previous PK analyses and of studies that evaluated higher doses of pemetrexed in single-agent therapy, have not shown a likelihood of increased therapeutic efficacy from a larger dosing regimen. These studies have shown that the manner in which pemetrexed is metabolized by the body shows a very similar response curve over a wide range of dosing levels, so an increase from 500 mg/m2 to 800 mg/m2 would be unlikely to be show clinical benefit to the patient. Because of these findings, the authors recommend keeping the standard dosing level of pemetrexed at 500 mg/m2 for patients with pleural mesothelioma or non-small cell lung cancer.

Labels: chemotherapy, mesothelioma, pleuralmesothelioma

posted by Joseph DiCastro at 3:18 PM
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State Funding Could Help Asbestos-Related Agencies Stay Afloat

Wednesday, January 7, 2009

Source: The Western News

The Western News is running an article on the need for continued state funding of many of Montana’s most important asbestos treatment and research agencies. Unless they receive additional state funding, projects funded through the Libby Asbestos Medical Plan (LAMP) and Asbestos-Related Diseases Network (ARD-Net) are in danger of shutting down during 2009. ARD-Net will lose its funding in June and LAMP some time later, unless the State steps in and provides the needed money. Gov. Brian Schweitzer is being petitioned by regular citizens and many of the people involved with these organizations to continue to fund these programs.

Even though it’s rarely in the news these days, the tragedy associated with the asbestos contamination of the vermiculite mine in Libby, Montana continues to this day. Residents of Libby, and the surrounding areas, have the highest rates of mesothelioma and asbestosis in the nation and people will continue to be affected from these diseases for years to come. LAMP and ARD-Net coordinate resources to help provide care and resources to disease victims. These are difficult diseases to endure and the treatments they require—especially mesothelioma treatments—are expensive and difficult to endure, so there is large swell of public support to continue their funding.

Labels: asbestos, mesothelioma

posted by Joseph DiCastro at 6:04 PM
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Mesothelioma Research at the Minnesota Partnership for Biotechnology and Medical Genomics

Tuesday, January 6, 2009

Source: Post-Bulletin

The Minnesota Post-Bulletin is running an article on the Minnesota Partnership for Biotechnology and Medical Genomics, a research partnership comprised of the Mayo Clinic, the University of Minnesota, and the State of Minnesota. The Partnership’s goal is to position Minnesota as a leader in medical research by developing innovative diagnostic and treatment strategies using the latest discoveries in biotechnology and genomics research.

The Partnership is currently involved with a number of important research projects, one of which is exploring the use of virotherapy in the treatment of malignant mesothelioma. Virotherapy is a cutting-edge cancer treatment protocol that uses genetically-modified viruses to target cancerous cells, while leaving healthy ones alone. It is still in the experimental stages, but if successful, virotherapy could lead to more effective and better targeted treatments than many of the current therapeutic modalities. The particular virotherapy project the Partnership has funded is studying the use of an adapted measles virus to deliver mesothelioma treatments. The study is led by Robert Krattzke, M.D., of the University of Minnesota, and Stephen Russell, M.D., Ph.D., of the Mayo clinic, the institution where the measles virus under investigation was developed at.

Labels: mesothelioma, treatments

posted by Joseph DiCastro at 3:52 PM
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New Test Available for Mesothelioma Diagnosis

Monday, January 5, 2009

Source: Rosetta Genomics

Rosetta Genomics has recently announced the availability of miRview(TM) meso, a new test for diagnosing mesothelioma that it developed using its proprietary microRNA-based technology. The new test provides precise differentiation between malignant mesothelioma and the various forms of lung cancer by identifying molecular differences between the two cancers. This is an important development for patients with mesothelioma, as the disease is often—mistakenly—described as form of lung cancer, even thought it’s actually quite different and requires different treatment strategies to maximize a patient’s therapeutic potential.

The availability of this new test gives mesothelioma specialists one more tool in their fight against pleural mesothelioma and peritoneal mesothelioma, as well as the disease’s rarest forms.

Labels: diagnosis, mesothelioma

posted by Joseph DiCastro at 5:13 PM
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