Pleural mesothelioma patients treated with both cisplatin and raltitrexed may survive longer than patients who receive cisplatin alone, according to a recent study conducted in Europe and Canada (J Clin Oncol. 2005 Oct 1; 23(28): 6881?9). Raltitrexed (Tomudex) works by interfering with the ability of tumor cells to multiply and make deoxyribonucleic acid or DNA. Cisplatin is a traditional chemotherapy drug.
Two hundred fifty pleural mesothelioma patients took part in a clinical trial to determine the safety and effectiveness of raltitrexed. One hundred twenty?four patients took cisplatin and the rest took cisplatin plus raltitrexed. Most were men with an average age of 58 who had not received other chemotherapy treatments.
The raltitrexed study was a ?phase III? clinical trial, as defined by the European Organization for Research and Treatment of Cancer. A phase III trial compares a new cancer treatment with a standard treatment, and requires a large number of participants. It follows a phase II clinical trial, which is concerned with the safety of a new treatment and how to administer it, and a basic phase I clinical trial, which tests the drug?s effectiveness on a small number of patients.
Survival Increased in Patients Treated with Raltitrexed The researchers looked at survival, progression of pleural mesothelioma, safety, tumor response rates, and the patient?s quality of life. They found the following:
? Forty?six percent of pleural mesothelioma patients in the cisplatin/raltitrexed group survived at least one year, compared to 40% of those in the cisplatin group.
? The average survival was 11.4 months for patients in the cisplatin/raltitrexed group, but only 8.8 months for patients in the cisplatin group.
? Twenty?four percent of patients treated with cisplatin/raltitrexed had a positive response against pleural mesothelioma compared to 14% of patients treated with cisplatin.
? The overall quality of life was about the same in the cisplatin group as compared to the cisplatin/raltitrexed group.
A small number of patients in both the cisplatin and cisplatin/raltitrexed groups developed low white blood cell counts (neutropenia). Other side effects included fatigue, nausea, and vomiting, which were more common in the combined drug group.
Raltitrexed Is Related to the Pleural Mesothelioma Drug Alimta? Raltitrexed is in the class of chemotherapy drugs called antifolates. It blocks the production of thymidylate synthase, which in turn decreases the mesothelioma cell?s ability to make DNA, the basic genetic material involved in cell reproduction. It is registered in Europe for the treatment of advanced colorectal cancer.
Raltitrexed is closely related to pemetrexed (Alimta?), another antifolate. Currently, pemetrexed/cisplatin is the only chemotherapy drug combination that the US Food and Drug Administration has approved to treat pleural mesothelioma.
The authors of the raltitrexed study concluded that combining cisplatin with an antifolate such as raltitrexed or pemetrexed is more helpful in treating pleural mesothelioma than using cisplatin alone. They also felt that cisplatin plus raltitrexed did not have a harmful effect on the patient?s quality of life.
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