Acute toxicity of cyclooxygenase-2 inhibitor rofecoxib as a radiosensitizer for concurrent chemoradiation in the treatment of uterine cervical cancer

Objective: To evaluate the acute toxicity of rofecoxib during concurrent use with cisplatin-based chemoradiotherapy (CCRT) in patients with cervical cancer. Methods: We evaluated 67 FIGO stage IB2-IVA cervical cancer patients treated with CCRT between June 2002 and July 2004. The study group included patients who received rofecoxib (N=30) and the control group included patients who received CCRT only (N=37). The patients' medical records were retrospectively reviewed for patient characteristics, toxicity related to CCRT and treatment results. Results: There were no significant differences in toxicity between the two groups. The most common acute grade 3/4 toxicity was neutropenia (13.3% in the study group and 21.6% in the control group). Grade 3/4 late toxicity was observed in 2 (6.6%) patients in the study group and 3 (8.1%) in the control group. There was no treatment-related deaths in either group. Six (20.0%) patients in the study group had treatment failure. In the control group, 6 (16.2%) patients experienced treatment failure. Progression-free and overall survival was 55.8±4.2 and 59.0±2.8 months, respectively, in the study group, and 69.7±4.3 and 71.6±3.6 months, respectively, in the control group. There were no differences in progression-free and overall survival between the 2 groups. Conclusion: Our data indicate that rofecoxib, at a dose of 25 mg twice daily, has acceptable acute toxicity as a radiosensitizer during CCRT. Although rofecoxib was not efficacious as a radiosensitizer in the present study, the benefit of rofecoxib as a radiosensitizer should be further evaluated in a prospective study.