Alimta

Treatment for Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer

FDA Approves Alimta for use with cisplatin, for the treatment of Malignant Pleural Mesothelioma

Estimates are between 10,000 and 15,000 people worldwide are diagnosed annually with malignant pleural mesothelioma, a figure that is increasing. Most people do not learn they have malignant pleural mesothelioma until the disease has progressed to an advanced stage when treatment with surgery or radiation is not an option.

Clinical Trials
This drug regimen was compared to cisplatin alone in a trial of 448 patients from 19 countries - the largest trial to date among patients with malignant pleural mesothelioma. Results showed overall survival was increased 30 percent (12.1 months for Alimta/cisplatin versus 9.3 months for cisplatin alone), and that 50.3 percent of patients treated with Alimta/cisplatin were alive a year later compared to 38.0 percent treated with cisplatin alone1. Both the median and one-year rates of survival were of these findings were statistically significant.

In addition, according to research findings, there was an improvement in lung function (forced vital capacity) on the Alimta/cisplatin arm compared to the cisplatin (or control) arm.2

Important Safety Information
The hematolgoic and non-hematologic side effects associated with Alimta are neutropenia, thrombocytopenia, anemia, nausea, vomiting, fatigue, diarrhea, skin rash and pain. To reduce the severity of treatment-related toxicities, all patients on Alimta must receive daily doses of folic acid and intramuscular injections of vitamin B12. As with many chemotherapies, the dose-limiting toxicity of Alimta is usually myelosuppression. Specific dose-modification may be required for patients who experience grade 3 or 4 toxicities. Patients with kidney impairment should not receive Alimta therapy. Patients should also inform their doctors if they are taking NSAIDs like ibuprofen. It is recommended that frequent blood tests be performed on all patients receiving Alimta.

References:

  1. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21:2636-2644, 2003
  2. Pistolesi M, Symanowski J, Gatzemeier U, et al. Improving pulmonary function in patients with malignant pleural mesothelioma: results from the phase III trial of pemetrexed + cisplatin vs. cisplatin. Lung Cancer 41:(Suppl 2) S220 (abstr P-513)

Source: Eli Lilly and Company

Posted: February 2004

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