Elsevier

Urology

Volume 71, Issue 5, May 2008, Pages 947-951
Urology

Medical Oncology
Etoricoxib and Intermittent Androgen Deprivation Therapy in Patients with Biochemical Progression After Radical Prostatectomy

https://doi.org/10.1016/j.urology.2007.09.033Get rights and content

Abstract

Objectives

To verify whether in patients with biochemical progression after radical prostatectomy (RRP), the administration of a cyclooxygenase-2 (COX-2) inhibitor during the off-phases of intermittent androgen deprivation (IAD) may increase the effectiveness and off-therapy time of intermittent therapy.

Methods

This is a comparative, prospective study. A total of 44 patients with biochemical progression after RRP were included in a clinical protocol for IAD once prostate-specific antigen (PSA) levels progressed over 0.4 ng/mL. The 44 cases were randomly assigned to receive two different treatment strategies: group A received IAD therapy using bicalutamide 150 mg once daily in the on-phases and no therapy in the off-phases; group B received IAD therapy using bicalutamide 150 mg once daily in the on-phases and etoricoxib 60 mg once daily in the off-phases.

Results

Median follow-up was 62 weeks. In group A 5 of 22 (22.7%) cases and in group B 2 of 22 (9.1%) cases failed to respond to IAD (P >0.05). Comparing the two groups, in all three cycles of IAD the time of the cycles and the time of the off-phases were significantly (P <0.0001) longer in group B than in group A. The highest PSA value reached during the off-phases in each cycle was significantly (P <0.001) lower in group B than in group A. Withdrawal from treatment owing to side effects was not necessary in any of the 44 patients.

Conclusions

In patients with biochemical progression after RRP, we showed that the use of a COX-2 inhibitor in the off-phases of IAD is able to increase the off-treatment time significantly.

Section snippets

Patients

This was a comparative, prospective, single-center study. Inclusion into this study was based on the following criteria: histologically proven adenocarcinoma of the prostate at surgery, clinically localized prostate cancer, no preoperative hormone therapy, radical prostatectomy at our institution, and biochemical failure after surgery. Between April 2004 and September 2005, a total of 44 patients fulfilled the inclusion criteria and were included in the study. After RRP, serum PSA measurements

Results

A total of 44 patients with PSA progression from an undetectable PSA after RRP were evaluated and randomized in the two groups of treatment. All patients responded to their first 12 weeks of treatment with bicalutamide and serum PSA dropped to a median level of 0.20 ng/mL in group A and 0.15 ng/mL in group B (P = 0.4117). At present, 7 of 44 (15.9%) patients have failed to respond to reinstitution (on-phase) of treatment. All these cases had subsequently been withdrawn from IAD and are

Discussion

To our knowledge, this study represents the first experience in the literature using a COX-2 inhibitor during the off-phases of IAD therapy for prostate adenocarcinoma. Our hypothesis was to use a COX-2 inhibitor to improve the whole response to IAD and, in particular, to prolong the time of the off-phases. The intermittent administration of IAD therapy is not modified and its rationale is respected. Our aims in the administration of the COX-2 inhibitor in association with androgen deprivation

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