The results of a phase II clinical trial suggest that daily treatment with Celebrex® (celecoxib) may effectively treat high-grade precancerous changes to the cervix. These results were published in the journal Gynecologic Oncology.
Cancerous and precancerous changes in cervical cells are often first detected by a Pap test, wherein a sample of cells is removed from the cervix using a small wooden or plastic spatula and a brush. The cells are then examined under a microscope in a laboratory. If Pap test results are abnormal, a physician may perform a colposcopy, using a microscope called a colposcope to better see the cervix. The physician applies a mild vinegar solution to the cervix, which makes abnormal cells appear more white than pink. If abnormal areas are identified, the physician may remove samples of tissue so that the cells can be further evaluated-a procedure called a biopsy.
The results of the biopsy allow the physician to diagnose cancer or precancerous conditions. Precancerous changes to the cervix are called cervical intraepithelial neoplasia (CIN). The severity of CIN is graded on a scale of 1 to 3, with 3 being the most severe. CIN2 and CIN3 are considered “high-grade” CIN and may progress to cancer if not treated.
Celebrex belongs to the class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Celebrex inhibits the COX-2 enzyme, which plays a role in inflammation. Though studies have suggested that Celebrex may reduce the risk of certain types of cancer, it has also been linked with an increased risk of serious cardiovascular problems.
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To evaluate the safety and efficacy of Celebrex in the treatment of high-grade CIN, researchers conducted a phase II clinical trial among 25 patients with CIN2 or CIN3. Patients were treated with either Celebrex 200 mg twice a day or a placebo.
All patients underwent follow-up colposcopy and pap testing every two months for six months. Patients who still had severe CIN after six months, or who experienced a worsening of their CIN, were treated with loop electrosurgical excision procedure (LEEP).
- Cervical abnormalities improved in 75% of patients treated with Celebrex and 31% of patients treated with placebo.
- A complete disappearance of detectable cervical abnormalities was experienced by 33% of patients treated with Celebrex and 15% of patients treated with placebo.
The researchers conclude that Celebrex could offer a noninvasive approach to treating precancerous cervical changes. Larger studies are needed to confirm these findings and to provide additional information about cardiovascular risks.
Reference: Farley JH, Truong V, Goo E et al. A Randomized Double-blind Placebo-controlled Phase II Trial of Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Cervical Dysplasia. Gynecologic Oncology. 2006;103:425-430.