ALIMTA^® Available on a Limited Basis to Pleural Mesothelioma Patients

Mesothelioma News

Pemetrexed (ALIMTA^®) Plus Cisplatin Shows Continuing Promise in Pleural Mesothelioma Treatment

August 22, 2003 — CHICAGO, IL— Mesothelioma treatment using pemetrexed (ALIMTA^®, Lilly) plus cisplatin improved survival times for pleural mesothelioma patients as compared to treatment with cisplatin alone, according to a study published recently in the Journal of Clinical Oncology. ALIMTA^® is a drug that works by inhibiting the enzymes necessary for the synthesis of thymidine and purine. The more traditional chemotherapy agent, cisplatin, is a platinum compound used in treating mesothelioma and other cancers.

Four hundred fifty–six pleural mesothelioma patients took part in the study, with 226 receiving ALIMTA^® plus cisplatin and 222 receiving cisplatin alone. Eight patients did not receive any mesothelioma treatment. All patients were in advanced stages of mesothelioma and ineligible for surgery.

The median survival time for those taking the ALIMTA^®/cisplatin combination was 12.1 months, as compared to 9.3 months for those taking only cisplatin. The one–year survival rate was 56.5 percent among pleural mesothelioma patients receiving ALIMTA plus cisplatin versus a 41.9 percent rate for patients receiving cisplatin alone. The time to further progression of pleural mesothelioma was 5.7 months in those taking the combination therapy versus 3.9 months in those receiving only cisplatin. The combination of ALIMTA^®/cisplatin was also more effective in reducing pain and shortness of breath.

During the course of the study, the researchers began to give folic acid and vitamin B12 to the ALIMTA/cisplatin group. The result was a decrease in toxicity and side–effects such as fatigue. They concluded that mesothelioma treatment with ALIMTA^®, cisplatin, and vitamins could help pleural mesothelioma patients.

Other Clinical Trials Using ALIMTA^® As a Pleural Mesothelioma Treatment

The ALIMTA^®/cisplatin study was a Phase III clinical trial. A Phase III clinical trial occurs after earlier clinical trials (Phases I and II) have provided some information about a drug’s safety and effectiveness for patients. A phase III trial gathers more details about the drug’s overall benefits and risks. It usually involves a larger sample group than earlier clinical trials do.

A Phase II clinical trial suggested that ALIMTA^® could be useful in treating pleural mesothelioma. Another study showed the value of ALIMTA^® combined with vitamin supplements as a mesothelioma treatment (J Clin Oncol. 2003 Apr 15; 21(8): 1556–61). The drug is now being considered for treating non–small cell lung cancer. Clinical trials also suggest that ALIMTA^® may help patients with breast, colorectal, and gastric cancers.

ALIMTA^® Available to Pleural Mesothelioma Patients on a “Compassionate Use” Basis

Because of ALIMTA^®’s ability to reduce tumors and prolong survival, it is now available to some pleural mesothelioma patients on a “compassionate use” basis. This means that patients who have not yet received mesothelioma treatment may be eligible to obtain ALIMTA^® free of charge before the federal Food and Drug Administration completes its formal review of the drug, an event scheduled for 2004. Your physician can obtain more information about ALIMTA^® availability at 1–866–347–9503.