Celebrex Slows Lung Cancer Development

[Christine]

http://www.cancerwise.org/july_2008/dis ... &color=red

Precancerous Cells Respond to High Doses

Celecoxib, an anti-inflammatory medication sold under the brand name Celebrex®, is suggested to be safe and effective in slowing growth of precancerous cells in the lungs of current and former smokers, according to a new study.

Significance of results

This was the first large study of the use of celecoxib to slow growth of precancerous cells in the lungs, say M. D. Anderson researchers, who presented the results at the American Society for Clinical Oncology annual meeting in June.

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID), like aspirin or ibuprofen, which works by blocking chemical enzymes that cause inflammation.

It inhibits cyclooxygenase-2 (COX-2), an enzyme that researchers believe helps tumor growth. COX-2 is found at high levels in precancerous lung tissue.

"This study showed the importance of COX-2 and its possible relationship to lung cancer,” says the study's lead author Edward Kim, M.D., assistant professor in M. D. Anderson's Department of Thoracic/Head and Neck Medical Oncology. "It also affirmed the safety of this drug class. As we move forward in researching how to prevent lung cancer, these drugs may be important."

Research methods

From November 2001 to September 2006, 212 people enrolled in the study.

Participants:

Were current or former smokers

Had at least a 20-pack-a-year smoking habit

Had been cancer-free at least six months

The study examined levels of KI-67, a biomarker associated with precancerous lung lesions.

Before the study, each participant underwent a bronchoscopy, a procedure in which a small viewing instrument is inserted down the throat. Biopsies, which involve the removal of tissue samples, can be conducted during the test.

Participants also took one of two different kinds of pills twice a day.

Participants took either:

400 milligrams of celecoxib

A placebo

After three months, each participant underwent a second bronchoscopy and was given the option to continue on the trial for three more months. Those who continued had a third bronchoscopy at six months.

Primary results

KI-67 production decreased in current and former smokers treated with celecoxib, and there were no adverse cardiac side effects.

Additional results

“These findings are also important because they show it is acceptable to patients to have more than one bronchoscopy, thus allowing us to measure important markers in the tissue,” Kim says. "Other imaging tools are important, but in lung cancer it is beneficial to be able to analyze the actual tissue.”

Background

In December 2004, M. D. Anderson voluntarily stopped this trial at the request of Pfizer, the manufacturer of celecoxib, and the National Cancer Institute, the funding source for the study, until celecoxib's risk for heart problems could be studied.

Months later, advisors to the U.S. Food and Drug Administration recommended that the drug continue to be studied for the treatment and prevention of cancer. After adding stringent guidelines to further reduce cardiac risk, M. D. Anderson investigators reopened the study in May 2005.

Jonathan Kurie, M.D., professor in the Department of Thoracic/Head and Neck Medical Oncology, was the principal investigator on the clinical trial, and Waun Ki Hong, M.D., head of M. D. Anderson's Division of Cancer Medicine, was principal investigator on the trial grant.

What’s next?

“Our next steps include evaluating other important markers in lung tissue and conducting a similar study in high-risk patients,” Kim says.

— Adapted by Dawn Dorsey from an M. D. Anderson news release