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Adding Pemetrexed to Cisplatin Improves Survival in Malignant Pleural Mesothelioma
Positive Trial Details : Adding Pemetrexed to Cisplatin Improves Survival in Malignant Pleural Mesothelioma
Laurie Barclay, MD
July 18, 2003 รน Adding pemetrexed (Alimta) to cisplatin improved survival for patients with malignant pleural mesothelioma, according to the results of a randomized phase III trial published in the July 15 issue of the Journal of Clinical Oncology.
"For the first time we have a therapy for mesothelioma that makes a difference," lead author Nicholas J. Vogelzang, MD, from the University of Chicago Cancer Research Center in Illinois, says in a news release. "This is a first step, a small step to be sure, but a step in the right direction. It should encourage patients to keep trying and inspire physicians to focus more attention on this frustrating disease."
Of 456 chemotherapy-naive patients who were not eligible for curative surgery, 226 received pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1, 222 received cisplatin alone, and eight never received therapy. Both treatment regimens were given intravenously every 21 days.
Median survival time was 12.1 months in the pemetrexed/cisplatin arm and 9.3 months in the cisplatin group (hazard ratio for death, 0.77; P = .02). Patients in the pemetrexed/cisplatin group also fared better in terms of median time to progression (5.7 months vs. 3.9 months; P = .001) and response rates (41.3% vs. 16.7%; P < .0001).
After 117 patients had enrolled, folic acid and vitamin B12 were added in the pemetrexed/cisplatin group, resulting in a significant reduction in toxicities including neutropenia, severe diarrhea, and severe mouth ulcers. Addition of these vitamins did not adversely affect survival time.
Study limitations include failure to control second-line therapy and lack of double-blind design, which could bias outcome measurements.
Eli Lilly and Company, the maker of Alimta, supported this study and employs one of its authors.
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