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

Abstract

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 200 mg 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 tolerated and decreased acute toxicities especially GU toxicity in patients with prostate cancer.