Raltitrexed (Tomudex®) in Combination With Cisplatin in the Treatment of MPM Improves Overall Survival Compared to Treatment With Cisplatin Alone

Tuesday, October 12th, 2010.

Raltitrexed (Tomudex®) in Combination With Cisplatin in the Treatment of MPM Improves Overall Survival Compared to Treatment With Cisplatin Alone1MPM is a Rare Cancer, but its Incidence is Expected to Double Over the Next 20 Years in Many Countries2Raltitrexed is Currently Licensed for the Treatment of MPM in Portugal, Czech Republic and Hungary; Further Marketing Authorisations are Expected Across Europe in Late 2010

Raltitrexed (Tomudex®) in combination with cisplatin in the treatment of MPM improves median overall survival compared to treatment with cisplatin alone.1 With incidence rates expected to double over the next 20 years in many countries2, new and effective treatments are a welcome addition, concluded an eminent panel of international speakers at a symposium sponsored by Hospira at the 35th congress of the European Society for Medical Oncology (ESMO), Milan.

Mesothelioma is a form of cancer that affects the mesothelium, a thin membrane that lines the inner surface of the chest wall where it is known as the pleura. It also surrounds the organs found within this cavity, for example the heart and lungs.3 Speakers at the symposium highlighted that whilst MPM – most commonly caused by exposure to asbestos – is a rare disease (the incidence is estimated to be 1.1-1.25 cases per 100,000 people), its incidence is expected to double over the next 20 years in many countries.2

Historically MPM has been treated with radiotherapy or surgery, despite minimal evidence to support these treatment options and both being associated with low success rates.4,5,6 Speakers highlighted that over recent years the treatment of MPM has been simplified with the development of chemotherapy regimens as first-line treatment options.

Speakers referred to a clinical trial of first-line raltitrexed in combination with cisplatin, which showed that overall response rates in the raltitrexed group were higher compared to patients treated with cisplatin alone (23.6% vs. 13.6%; p=0.056).1 Raltitrexed improved median overall survival by 2.8 months compared to patients treated with cisplatin alone (11.4 vs. 8.8 months; p=0.0483).1 In addition, raltitrexed was associated with improved progression-free survival (5.3 vs. 4.0 months; p=0.058) compared to treatment with cisplatin alone.1

"MPM is a hard to treat, rare cancer with a poor prognosis. New treatment options such as a combination of cisplatin and raltitrexed, which improve patient outcomes with no detrimental effect on quality of life as compared to cisplatin alone are a welcome addition to our therapeutic portfolio," said Professor JP van Meerbeeck, professor of Thoracic Oncology at Ghent University, Belgium.

Treatment of MPM with chemotherapy regimens, including those that are cisplatin-based, is associated with a high incidence of neutropenia and anaemia. Neutropenia is the most serious haematological toxicity that occurs as a result of cancer chemotherapy and can lead to chemotherapy dose reductions and/or dose delays compared with the prescribed schedule.7 Anaemia is associated with fatigue and poor quality of life. Supportive care to treat neutropenia and anaemia is therefore very important. Hospira has a broad oncology portfolio including supportive care drugs: Nivestim™ (filgrastim) and Retacrit™ (epoetin zeta), which are licensed for the treatment of chemotherapy-induced neutropenia and anaemia respectively.

Tomudex (Raltitrexed) is currently licensed for the treatment of malignant pleural mesothelioma (MPM) in Portugal, Czech Republic and Hungary; further marketing authorisations are expected across Europe late 2010. Mesothelioma is a form of cancer that affects the mesothelium, a thin membrane that lines the inner surface of the chest wall where it is known as the pleura.

Nivestim (filgrastim) was recently approved by the European Commission for the reduction in the duration of neutropenia and incidence of febrile neutropenia in patients undergoing established chemotherapy for malignancy. Neutropenia is a condition where the number of neutrophils (a type of white blood cell) in the blood is abnormally low. A reduced number of neutrophils increases a patient’s susceptibility to bacterial and fungal infections.

Retacrit (epoetin zeta) is indicated for the treatment of chemotherapy-induced anaemia, and anaemia associated with chronic renal failure. Epoetins such as Retacrit, are forms of erythropoietin, a hormone produced by the kidneys which acts within the bone marrow to stimulate red blood cell production. There are many causes of anaemia, including chemotherapy treatment for cancer (which indiscriminately inhibits all fast-growing cells, including red blood cells), renal failure (which can cause a deficiency in production of erythropoietin) or a decrease in bone marrow function. A decrease in red blood cell number or function may lead to anaemia. Retacrit has been available in Europe since 2008.

Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States and has approximately 13,500 employees. The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK. Learn more at http://www.hospira.com.

van Meerbeeck JP, Gaafar R, Manegold C, et al. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol. 2005;23(28):6881-9Stahel RA, Weger W, Lievens Y, Felip E. Malignant pleural mesothelioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010; 21:v126-8Mesothelioma UK website. http://www.mesothelioma.uk.com/mesothelioma-information-support.htm. Accessed 15 September 2010Borasio P, et al. Malignant pleural mesothelioma: clinicopathologic and survival characteristics in a consecutive series of 394 patients. Eur J Cardiothorac Surg 2008;33:307-13Lee C, et al. Prophylactic radiotherapy to intervention sites in mesothelioma: A systematic review and survey of UK practice. Lung Cancer 2009;66:150-6Scherpereel P, et al. Guidelines of the European Respiratory Society and the European Society of Thoracic Surgeons for the management of malignant pleural mesothelioma. Eur Respir Journal 2010;35:479-495Crawford J, Dale DC, Lyman GH. Chemotherapy-Induced Neutropenia: Risks, Consequences, and New Directions for Its Management. Cancer, 2004; 100(2): 228-37

For further information please contact: Hannah Stacey, Athena, +44(0)20-8956-2289 or +44(0)7984-496-441

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Posted: Tuesday, October 12th, 2010 at 3:37 pm; filed under Cisplatin (Platinol ®), Drug Companies, Novel Treatments & Drugs, Raltitrexed (Tomudex®).

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Smoking and Lung Cancer Not the End of the Story: Asbestos and Smoking Create an Incredibly Deadly Combination

Tuesday, March 22nd, 2011.

Lung cancer is the most common type of cancer worldwide, resulting in 1.4 million deaths annually1. In the US, more than 150,000 deaths resulted from lung cancer in 20102. Although lung cancer can have numerous causes, smoking is a huge and well-known contributor to lung cancer deaths, with some 90% of all lung cancer cases a result of smoking tobacco.

While there can be no discounting smoking’s ill health effects, the flood of information on smoking’s risks can drown out other causes of lung cancer. A recent study in The Annals of Occupational Hygiene, a research journal on hazards and risks to health resulting from work, highlights another contributor to lung cancer: asbestos.

Asbestos as a cause of lung cancer is often ignored because of smoking. One reason for this is readily revealed in “The effect of smoking on the risk of lung cancer mortality for asbestos workers in Great Britain (1971-2005)”: among asbestos workers, smoking is more common than in the general population. The study followed asbestos workers from 1971 until 2005, at which point some 53% of asbestos workers were still active smokers. In contrast, 45% of the general population in Great Britain smoked in 1971, and that number dropped to 24% by 2005.

While either cigarette smoking or asbestos may be the cause of lung cancer, together, they create an exceptionally high risk. One cannot simply add the risk associated with each carcinogen together and determine the risk that the two create in individuals exposed to both.

This synergistic connection between asbestos and smoking is well known among researchers who specialize in studies like the one cited above. In fact, a September 2010 journal article covering asbestos workers in China (“Lung cancer mortality from exposure to chrysotile asbestos and smoking: a case control study within a cohort in China”) found that the total risk of lung cancer was one and a half times what would be expected if the risk associated with smoking and the risk associated with asbestos exposure were added together3.

In the Chinese study, no completely unexposed control group was compared to asbestos exposed and/or smoking groups studies. Other studies that have compared non-asbestos exposed, non-smoking workers to asbestos exposed, smoking workers found the latter group fifty or more times likely to develop lung cancer over the former group4.

While researchers may be aware of this deadly mix, many primary care physicians are unaware of these connections. Without a thorough patient history, the connection between a patient’s lung cancer and their asbestos exposure may never be made, especially if they smoked. Unfortunately, with a smoker, many people, doctors included, stop looking at other culprits for a patient’s lung cancer. It’s important to note, however, that although smoking is a great risk factor in a lung cancer diagnosis, only 10% of smokers will develop lung cancer.

Asbestos attorneys see thousands of people diagnosed with lung cancer each year, and Dave Chervenick is no exception. A shareholder at Goldberg, Persky, and White, a law firm that has specialized in asbestos cases for more than 30 years, Chervenick notes “If there was one thing I could impress upon our clients with lung cancer, it’s that smoking doesn’t negate your asbestos exposure, and in fact, it’s an important factor related to it.”

Many of Chervenick’s asbestos lung cancer clients were already suffering from another asbestos-related disease, such as asbestosis, before being diagnosed. “When one of our asbestosis clients later develops lung cancer, it’s a little easier for them to see the connection,” Chervenick explains, “however, you don’t have to have asbestosis to develop lung cancer.”

Asbestosis is a scarring of the lung tissues resulting from breathing in asbestos fibers. The small, sharp, and indestructible asbestos bodies lodge in the lungs, causing a buildup of scar tissue that makes it hard for the lungs to expand and contract and complete their job of exchanging carbon dioxide for oxygen.

Asbestosis definitively reveals that you’ve been exposed to asbestos, and because of that, indicates you’re at increased risk of developing an asbestos-related lung cancer. The number of lung cancer cases attributable to asbestos exposure each year in the US is estimated at 3,400 to 8,500. It is likely higher however, thanks to poor tracking mechanisms and a lack of complete worker histories.

It is also not unusual for a worker to be unaware they worked with asbestos. “I’ve had people tell me they don’t believe they ever handled asbestos products,” Chervenick says, “however, after I mention a particular brand of insulation, or a type of sealer, they’ll say ‘well, yes, I worked with that.’ Well, that item contained 10%, or 30%, or even 50% asbestos.”

In order to reduce the risk among asbestos workers and smokers, eliminating exposure to both is recommended. Some studies indicate a reduction in the risk of lung cancer within five years of smoking cessation. The numbers associated with removing asbestos exposure vary, but researchers note “that even if the risk of lung cancer does not decrease following cessation of asbestos exposure, removal from exposure would prevent cumulative dosage.” 1

In Great Britain, researchers estimate that smoking and/or asbestos exposure result in 96% of lung cancer deaths. Using that guideline on worldwide deaths, that could mean more than 1.3 million lives could be saved from lung cancer if smoking and asbestos were eliminated.

Gillian Frost, Andrew Darnton, and Anne-Helen Harding. “The effect of smoking on the risk of lung cancer mortality for asbestos workers in Great Britain (1971–2005).” The Annals of Occupational Hygiene. First published online January 20, 2011 doi:10.1093/annhyg/meq089.SEER Stat Fact Sheets: Lung and Bronchus. Surveillance Epidemiology and End Results; National Cancer Institute.
Accessed March 22, 2011.Eiji Yano, Xiaorong Wang, Mianzhen Wang, Hong Qiu, and Zhiming Wang. "Lung cancer mortality from exposure to chrysotile asbestos and smoking: a case control study within a cohort in China." Occupational and Environmental Medicine. 2010;67:867e871. doi:10.1136/oem.2009.051615 Hammond, E. C., Selikoff, I. J. and Seidman, H. (1979). “Asbestos Exposure, Cigarette Smoking and Death Rates.” Annals of the New York Academy of Sciences, 330: 473-790. doi: 10.1111/j.1749-6632.1979.tb18749.x « Mesothelioma News Main Page.

Posted: Tuesday, March 22nd, 2011 at 4:34 pm; filed under Asbestos & Mesothelioma Studies.

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