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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