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Pemetrexed Shows Promise in Treating Peritoneal Mesothelioma: Presented at ECCO
Pemetrexed, used alone or in tandem with a platinum agent, shows good response and disease control rates in patients diagnosed with peritoneal mesothelioma, according to data presented at the 14th European Cancer Conference (ECCO).
109 patients were enrolled in the study with a histologic or cytologic diagnosis of peritoneal mesothelioma where curative surgery was not recommended and were treated with pemetrexed alone or in combination with a platinum agent.
Study presenter Giacomo Carteni, MD, Director, Oncology Division, Cardarelli Hospital, Naples, Italy said "Malignant peritoneal mesothelioma is a rare cancer, having a yearly incidence of about one or two cases per million in the US and Europe. The incidence of pleural mesothelioma is 3- to 30-fold higher in other countries."
There are few large studies that have examined peritoneal mesothelioma, so treatment has for the most part been based on protocols used in patients with pleural mesothelioma, said Dr. Carteni during a poster presentation on Sept. 24th, 2007.
Access to the drug before and during regulatory agency review was provided through The international Expanded Access Program (EAP) for pemetrexed in mesothelioma.
Throughout the trial, pemetrexed 500 mg/m2 alone or in combination with cisplatin 75 mg/m2 or carboplatin AUC 5 was given on the first day of each 21-day treatment cycle as part of the EAP. All patients involved in the trial took standard supplementation with vitamin B12 and folic acid, and dexamethasone.
Treatment continued until patients developed progressive disease or unacceptable toxicity, or until the trial investigator and/or patient decided to stop treatment.
The combination of Pemetrexed and platinum resulted in a 20% or greater response rate and a 76% or greater control rate for the disease.
Patients taking the single-agent platinum showed a 12.5% overall response rate, a 50% disease control rate, and a 41.5% survival rate at one year. Dr. Carteni said "this is in line with their worse prognostic factors including higher median age, higher percent of patients who had undergone prior chemotherapy, and lower performance status at baseline".
He also said that hematologic toxicity was manageable in all groups and in agreement with phase 3 findings.
The results reported from this study for peritoneal mesothelioma are comparable with the pemetrexed EAP in the US, which involved 98 patients with peritoneal mesothelioma. In that report, there was a 26% overall response rate and median survival was generally greater than thirteen months.
This is an Eli Lilly and Company sponsored study.