This is one of the most famous studies for pleural mesothelioma. This was the clinical trial that helped pemetrexed and cisplatin get FDA approval and become the standard of care in the treatment of pleural mesothelioma. It was published in 2003 and the lead author was Dr. Nicholas Vogelzang.
In this phase III study the researchers compared two groups of mesothelioma patients. One group was given the drug cisplatin only. The other group was given a combination of cisplatin and pemetrexed (Alimta). None of the patients had a surgery because their tumors were considered inoperable.
A total of 456 patients were involved in the study. Two hundred and twenty-six received pemetrexed and cisplatin and 222 received cisplatin alone. Eight never received therapy. Median survival in the pemetrexed plus cisplatin group was 12.1 months. Median survival in the cisplatin only group was 9.3.
Folic acid and vitamin B12 were also added (after 117 patients had joined the trial) to reduce the side effects. The researchers concluded that “treatment with pemetrexed plus cisplatin and vitamin supplementation resulted in superior survival time…compared with treatment with cisplatin alone.”
Today, more than 15 years later this regiment is still the standard of care for pleural mesothelioma patients.
|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 A received two chemotherapy drugs, pemetrexed and cisplatin (platinol). In addition, most patients were supplemented with folic acid and vitamin B12.
Toxicity: Fourteen patients in Group A died while on the study or within 30 days of the last dose of the study drugs. Three deaths were thought to be possibly related to the drugs. (These deaths occurred before folic acid and vitamin B12 supplementation was initiated.) Other toxicities included grade 3-4 hematologic, nausea, fatigue, vomiting, diarrhea, dehydration, stomatitis, anorexia, febrile neutropenia, infection, and rash.
Results: Median survival for patients in Group A was 12.1 months. (Median survival was 13.3 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
|Hospital:||University of Chicago, Cancer Research Center|
See all conventional treatment results for mesothelioma.