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Study: Maintenance Treatment w/Premetrexed

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http://www.oncolink.upenn.edu/resources ... &year=2008


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The first randomized double-blind placebo-controlled trial to evaluate pemetrexed (Alimta) as maintenance therapy for non-small cell lung cancer (NSCLC) shows that the drug significantly prolongs progression-free survival, with patients with non-squamous histology faring best.

The findings were reported Thursday at a press conference hosted by the American Society of Clinical Oncology, ahead of ASCO's annual meeting, which begins May 30 in Chicago.

In the study, Dr. Tudor E. Ciuleanu of the University of Medicine and Pharmacy Iuliu Hatieganu in Romania and colleagues tested the safety and efficacy of pemetrexed against placebo in 663 patients with stage IIIB/IV NSCLC whose cancer had not progressed after four cycles of standard platinum-based first-line chemotherapy. Three to 6 weeks after completion of induction chemotherapy, 441 patients were randomized to pemetrexed and 222 to placebo.

Pemetrexed is currently approved by the U.S. Food and Drug Administration for treating NSCLC that has progressed despite previous chemotherapy.

Post-induction maintenance therapy with pemetrexed was "very well tolerated," Dr. Ciuleanu said, "and the data revealed remarkably statistically significant 40% reduction in the risk of progression with pemetrexed and a doubling of median progression-free survival," from 2.6 months with placebo to 4.3 months with pemetrexed.

Preliminary survival analysis revealed a 20% reduction in the risk of death with pemetrexed therapy. Median survival was 13 months with pemetrexed and 10.2 months with placebo. But Dr. Ciuleanu cautioned that "the overall survival data are preliminary and require careful interpretation at this time. The final survival analysis is expected to occur in the next 6 to 12 months."

An analysis of efficacy based on histology showed a "consistent improvement in progression-free survival with pemetrexed therapy in the non-squamous histology," Dr. Ciuleanu reported. "Conversely, in the squamous population there was little change in progression-free survival with pemetrexed therapy, consistent with previous phase III trials."

Based on this study, "we recommend giving pemetrexed after a patient completes initial induction therapy, but before cancer progression occurs," Dr. Ciuleanu said in an ASCO-issued statement. "This approach affords the greatest chance of killing stray cancer cells before they have a chance to contribute to tumor growth."

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(Oncolink, Abramson Cancer Center, University of Pennsylvania, By Megan Rauscher, Reuters Health, May 16, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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