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Title: Pemetrexed as Effective as Docetaxel, but Less Toxic, as Second-Line Therapy in Non-Small-Cell Lung Cancer: Presented at ECCO

"Pemetrexed as Effective as Docetaxel, but Less Toxic, as Second-Line Therapy in Non-Small-Cell Lung Cancer: Presented at ECCO"

By Michael Smith COPENHAGEN, DENMARK -- September 23, 2003 -- The experimental antifolate drug pemetrexed confers similar efficacy to docetaxel as second-line therapy for non-small-cell lung cancer (NSCLC), researchers said here September 22nd at the ECCO 12: The European Cancer Conference. But pemetrexed was significantly less toxic than docetaxel, the current standard of care, said Christian Manegold, MD, Heidelberg University, Heidelberg, Germany. Dr. Manegold reported the final results of the largest-ever phase III study of second-line therapy for NSCLC -- a multicentre trial that randomised 571 patients into its 2 arms. "Pemetrexed has certainly the potential to be the new standard in second-line treatment of non-small-cell lung cancer," Dr. Manegold said, adding that the drug is not yet registered, which makes a widespread change in practice problematic. But he noted that the drug has shown promise in earlier phase I and II studies as first-line therapy, so "it makes sense to compare the 2 drugs for second-line treatment." In the study, patients were given either 500 mg/m2 of pemetrexed on the first day of a 21-day cycle or the standard dose of docetaxel 75 mg/m2 on the same cycle. Patients in the pemetrexed arm were supplemented with vitamin B and folic acid, since the drug inhibits folic acid production. Patients in both arms were given the steroid dexamethasone to forestall rashes. The main factors the researchers examined were median survival, time to progression, and toxicity, Dr. Manegold said. Median survival was similar between the 2 arms, he said -- 8.3 months for pemetrexed and 7.9 for docetaxel. As well, disease-free survival was identical: 2.9 months. However, side effects were markedly different, he said: the docetaxel arm had significantly more serious adverse events. "There was a clear advantage for pemetrexed as far as neutropaenia, febrile neutropaenia, and infections," Dr. Manegold said. The advantage was clearly demonstrated in the percentage of patients hospitalised due to febrile neutropaenia: 1.5% for pemetrexed and 13.4% for docetaxel. [Study title: Pemetrexed Versus Docetaxel: A Phase III Study in Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Were Previously Treated with Chemotherapy. Abstract 57]

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