Celebrex shows benefit in first-of-its-kind lung cancer chemoprevention trial

Edward Kim, M.D., assistant professor in M. D. Anderson's Department of Thoracic Head and Neck Medical Oncology. Click here for more information.

HOUSTON - Celecoxib, the anti-inflammatory medication also known by the trade name Celebrex, has proven to be safe and reduces a specific proliferation measurement of precancerous lesions in the lung, according to a study from The University of Texas M. D. Anderson Cancer Center. This finding demonstrates the significance of COX-2 inhibition toward preventing lung cancer in individuals at higher risk of developing the disease.

The study is the first large randomized trial of Celebrex in lung cancer prevention; the findings will be presented at the American Society for Clinical Oncology's (ASCO) upcoming annual meeting as an oral presentation.

"With this study, in principal, we've been able to demonstrate the importance of COX-2 and the implications on inflammation pathway in lung cancer development," said Edward Kim, M.D., assistant professor in M. D. Anderson's Department of Thoracic Head and Neck Medical Oncology. "We've also been able to demonstrate that this drug class is safe and tolerable for this patient population. As we move forward in lung cancer chemoprevention, the importance of this class of drugs cannot be ignored."

From November 2001 to September 2006, the M. D. Anderson study enrolled 212 individuals, all of whom were current or former smokers with at least a 20-pack-year smoking habit. Most participants did not have any history of cancer; however, patients with a history of cancer who had been disease-free for six months could participate. The median age of participants was 53. The study examined levels of KI-67, a biomarker associated with precancerous lung lesions.

Participants underwent a baseline broncoscopy in which six predetermined biopsies were performed. They then were randomized to receive Celebrex at either 200 milligrams (low dose) or 400 milligrams (high dose) twice a day or placebo. After three months, participants received a second broncoscopy, the primary endpoint of the trial. Patients had the option to continue on the trial for three more months per their prior randomized arm; for those participants, a third and final broncoscopy was conducted at six months.