Phase-3 trial on NSCLC treatment closed early

Editor's note: This blog entry was updated on March 24, 2008, after it was brought to our attention that an error was made in discussing data on the ECOG trial. Dr. Campbell and HemOncToday.com regret the error.

Bayer announced yesterday that it was closing early its phase-3 ESCAPE (Evaluation of Sorafenib, Carboplatin, And Paclitaxel Efficacy) trial evaluating the role of sorafenib in combination with chemotherapy in metastatic non-small cell lung cancer. The closing is the result of a planned interim analysis during which their data monitoring committee concluded the study would not reach its primary endpoint of improved overall survival.

Interestingly, they also report a higher mortality rate was observed in patients with squamous cell carcinoma on the sorafenib arm when compared with the chemotherapy-alone arm but no statistical information was provided. They do not mention if any of those deaths were related to bleeding.

This continues to add to the slowly growing body of evidence suggesting squamous cell cancers of the lung may have a different risk profile in the era of targeted agents. In some phase 2 trials small differences have been seen in morbidity and mortality. In one case (ECOG 4599 carboplatin/paclitaxel ± bevacizumab), this led to the exclusion of squamous cell carcinoma patients.

In addition, data presented at the International Association for the Study of Lung Cancer in Seoul, Korea this year suggested that pemetrexed may be less effective in squamous histology than in adenocarcinoma.

These suggested differences are no more than hypothesis generating and I suspect some future studies will stratify for squamous versus non-squamous histology in an attempt to continue to explore these potential differences and optimize the therapy for different patients in lung cancer.

Other than bevacizumab, I wonder if any of you are altering your therapy choices based on histology in non-small cell lung cancer?