ALIMTA Improves Survival In Non-Small Cell Lung Cancer

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The type of non-small cell lung cancer (NSCLC) patients have may now influence their treatment regimen and, in turn, survival outcome according to the results of a major study published online in the Journal of Clinical Oncology. Publication of the study was announced by Eli Lilly and Company.

The 1,725-patient study, the largest Phase III clinical trial in the first-line NSCLC setting, evaluated ALIMTA (pemetrexed for injection) plus cisplatin versus GEMZAR (gemcitabine HCl for injection) plus cisplatin, a standard of treatment in this setting. The trial met its primary endpoint of non-inferiority relative to overall survival.

Additionally, in a pre-planned histological analysis, patients with either adenocarcinoma or large-cell carcinoma had a statistically superior and clinically relevant improvement in overall survival when treated with the pemetrexed regimen in the first-line setting.

In comparison, patients with squamous cell histology were found to have a more favorable overall survival when treated with the gemcitabine regimen.

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"While non-small cell lung cancer has typically been treated as one disease, this study confirms that histology, or tumor type, can provide a clue as to which treatment regimen works best for a particular tumor type," said the study's lead author, Giorgio Scagliotti, M.D., Department of Clinical and Biological Sciences Thoracic Oncology Unit, University of Torino, Orbassano, Italy. "If we can tailor the therapy for better results, we are closer to improving outcomes for this terrible disease."

The overall survival of patients treated with either the pemetrexed regimen or gemcitabine regimen was found to be non-inferior, with a median survival of 10.3 months. However, when researchers reviewed 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.

"In research, we're always looking for a new door to open - a different way of looking at the problem, in the hope of finding a better solution. That's why this study is so important. It has opened a door that points to histology as a way of helping physicians decide which lung cancer treatment may work best for a particular patient," said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader at Lilly.

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