Novel 4-drug combination proves safe for lung cancer...(ancer patients 99 of whom were able to b...),Health

The study met its primary endpoint, safety, defined by frequency of pulmonary hemorrhage, or bleeding, a concern related to Avastin. There were four treatment-related deaths and two due to bleeding, which is consistent with prior Avastin studies, explained Kim. Adverse events such as low blood counts and neuropathy were reported in 40 patients, also consistent with standard chemotherapy.

Secondary endpoints included response rate, progression-free survival and overall survival. Of patients enrolled, 53 percent had shrinkage of their tumors and 24 percent had stable disease. The median progression-free survival rate was seven months and overall survival was 14 months. In contrast, previous SWOG studies showed an average progression-free survival rate of five-and-a-half months and overall survival of 12 months.

"These findings were certainly compelling, and are the best results ever for a SWOG-based study for advanced lung cancer. While early, this four-drug combination seems to show promising, yet modest improvement in efficacy without compromising patients' safety," said Kim. "Our next priority will be to analyze the tissue from this to study to help find appropriate biomarkers for the disease to best understand who might benefit from this drug regimen."

A biomarker analysis of this study is ongoing and a randomized Phase III study is planned, with the trial scheduled to open in 2009.

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