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Study Showed ALIMTA(R) (pemetrexed for injection) Improved Survival in Certain Types of Non-Small Cell Lung Cancer
Date:5/28/2008

survival rates according to histological analysis, it was found that patients with adenocarcinoma achieved 12.6 months of overall median survival when treated with the pemetrexed regimen compared to 10.9 months for those treated with the gemcitabine regimen. Patients with large cell carcinoma who were treated with the pemetrexed regimen achieved 10.4 months of overall median survival versus 6.7 months for those treated with the gemcitabine regimen. Both findings are statistically significant.

Comparatively, patients with squamous cell histology were found to have a more favorable rate of survival when treated with the gemcitabine regimen, achieving 10.8 months of median survival, compared to the 9.4 months for those treated with the pemetrexed regimen. This finding also was statistically significant.

The Phase III, randomized study compared the overall survival between pemetrexed+cisplatin versus gemcitabine+cisplatin in 1,725 chemonaive patients with stage IIIB or IV NSCLC who also exhibited a performance status of 0-1. Patients on the pemetrexed arm (n = 862) were treated with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day one every three weeks for up to six cycles. Patients on the gemcitabine arm (n = 863) were treated with cisplatin (75 mg/m2) on day one and gemcitabine (1250 mg/m2) on days one and eight every three weeks for up to six cycles.

Hematologic grade 3/4 drug-related toxicities - neutropenia, anemia and thrombocytopenia - were significantly lower for patients on the pemetrexed arm (p less than or equal to 0.001). Drug-related grade 3/4 febrile neutropenia (p = 0.002) and alopecia (all grades; p < 0.001) were also significantly less on the pemetrexed arm. However, drug-related grade 3/4 nausea (p = 0.004) was more common in patients treated with pemetrexed. Safety data by histology was generally consistent with the overall safety results.

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SOURCE Eli Lilly and Company
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