evaluation of the celecoxib effect against radiotherapy induced acute toxicities in the patients with prostate cancer compared with placebo group

Background: acute toxicities in patients with prostate cancer who accede to radiation therapy usually affect the patients’ quality of life and these toxicities are sometimes dose limiting. objectives: this study was performed to determine the efficacy and safety of celecoxib together with radiation therapy. methods: forty prostate cancer patients undergoing external beam radiotherapy (ebrt) were enrolled to receive either placebo or celecoxib. the patients received external-beam radiotherapy up to 70 gy daily fractions of 1.8 - 2 gy. the patients received oral celecoxib or placebo 200mg twice daily. the first celecoxib or placebo was administered 3 hours before each radiotherapy fraction and the second, 12 hours after the first consumption. rtog based gastrointestinal (gi) and genitourinary (gu) acute toxicity scoring were performed pre-treatment, at least once weekly during radiotherapy and once 1 month after the end of the treatment. results: celecoxib was well tolerated. thirty-nine patients (39/40) fully completed treatment according to protocol. no grade 4 toxicity was seen in two groups. a significant reduction in gu  2 toxicity was observed in the celecoxib group (p = 0. 006). no significant difference was found between the two groups with respect to gi 2 toxicity (p = 0. 621). conclusions:we demonstrated that the combination of celecoxib with radiotherapy is well toleratedanddecreased acute toxicities especially gu toxicity in patients with prostate cancer.