The oncologist
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Multicenter Study
Approval summary: pemetrexed in the initial treatment of advanced/metastatic non-small cell lung cancer.
On September 26, 2008, the U. S. Food and Drug Administration approved pemetrexed injection (Alimta Injection; Eli Lilly and Company, Indianapolis, IN) for use in combination with cisplatin for the initial treatment of patients with stage IIIB/IV nonsquamous non-small cell lung cancer (NSCLC). ⋯ However, in the squamous cell histology subgroup, the median survival times were 9.4 versus 10.8 months in the AC and GC groups, respectively (unadjusted HR, 1.22; 95% CI, 0.99-1.50). This unfavorable effect of squamous histology on overall survival was also noted in a retrospective analysis of a trial that compared pemetrexed with docetaxel in NSCLC patients who received prior chemotherapy. No new pemetrexed safety signals were observed.