Survival:9.3 months
Toxicity Grade:4
Country:United States
City/State/Province:Chicago, Illinois
Hospital:University of Chicago, Cancer Research Center
Patients: This Phase III study involved a total of 448 patients with malignant pleural mesothelioma. Patients were divided into two groups. Group A was comprised of 226 patients and Group B was comprised of 222 patients.

Treatment: Patients in Group B received the chemotherapy drugs cisplatin. In addition, most patients were supplemented with folic acid and vitamin B12.

Toxicity: Eight patients in Group B died while on the study or within 30 days of the last dose of the study drugs. Three deaths were thought to be disease related. (These deaths occurred before folic acid and vitamin B12 supplementation was initiated.) Other toxicities included grade 3-4 hematologic, nausea, fatigue, vomiting, dehydration, anorexia, febrile neutropenia, infection, and rash.

Results: Median survival for patients in Group B was 9.3 months. (Median survival was 10.0 months for those patients who were fully supplemented with folic acid and vitamin B12).

Support: The study was supported by a grant from Eli Lilly and Company. Eli Lilly markets pemetrexed.

Correspondence: Nicholas J. Vogelzang, MD