ALIMTA (pemetrexed disodium) as second-line treatment of XXXX : a phase II study.

@entity1 @entity137 @entity1149 @entity8642 @entity902
BACKGROUND: The purpose of this study was to evaluate ALIMTA (pemetrexed disodium, @entity8642 ), a multi-targeted antifolate with first-line activity against @entity1149 ( @entity1149 ), in a second-line setting. @entity1 AND METHODS: @entity1 with @entity1149 were eligible for this phase II study if they had progressive disease within 3 months after first-line chemotherapy or progression while being treated with first-line chemotherapy. In 81 @entity1 studied, two cohorts of @entity1 were assigned based on whether the first-line therapy had included a @entity902 regimen. ALIMTA was administered at 500 mg/m2 by 10-min intravenous infusion once every 21 days. RESULTS: The response rate in the 79 evaluable @entity1 with poor prognostic features was 8.9% [95% confidence interval (CI) 2.6% to 15.1%]. The response rate in the @entity902 -pretreated group was 4.5% and 14.1% in the non- @entity902 -pretreated group. The median duration of response was 6.8 months (95% CI 3.4-7.8 months, 0% censoring). The median survival time was 5.7 months (95% CI 4.0-8.3 months, 7.6% censoring). The probability of survival for at least 6 months was estimated to be 48%. The median time to disease progression was 2 months (95% CI 1.4-2.8 months, 0% censoring). The principal @entity137 was myelosuppression, which was reversible. CONCLUSIONS: ALIMTA is active in a second-line setting in non- @entity902 -pretreated @entity1149 @entity1 progressing within 3 months of first-line chemotherapy. This study demonstrates that it is possible to evaluate new drugs against @entity1149 in a second-line setting.
