Postresection intravesical gemcitabine cuts recurrence in nonmuscle-invasive urothelial cancer
Administering intravesical gemcitabine immediately after tumour resection leads to a significant reduction in the long-term risk of recurrence in patients with suspected low-grade nonmuscle-invasive urothelial cancer, a study has shown.
A total of 406 patients (median age 66 years; 84.7 percent male) were randomized to receive intravesical instillation of gemcitabine (2 g in 100 mL of saline; n=201) or saline (100 mL; n=205) for 1 hour immediately following transurethral resection of bladder tumour (TURBT). None of the patients had any high-grade or >2 low-grade urothelial cancer episodes within 18 months before TURBT.
Evaluations were performed every 3 months with cystoscopy and cytology for 2 years and then semi-annually for 2 years. Patients were monitored for the occurrence of tumour recurrence, progression to muscle invasion, survival and toxic effects.
The primary outcome of recurrence of cancer occurred in 67 patients (35 percent) in the gemcitabine group and in 91 (47 percent) in the saline group within 4.0 years (hazard ratio [HR], 0.66; 95 percent CI, 0.48–0.90; p<0.001).
On the other hand, no significant between-group differences were observed in secondary endpoints. Specifically, five and 10 patients in the gemcitabine and saline groups had tumours that progressed to muscle invasion (p=0.22), while 17 and 25 patients, respectively, died of any cause (p=0.12).
No grade 4 or 5 adverse events (AEs) occurred, and AEs of grade ≤3 were comparable between the gemcitabine and saline groups.
Despite the presence of limitations, the present data support the use of intravesical gemcitabine in patients with suspected low-grade nonmuscle-invasive urothelial cancer, researchers said. However, additional research is needed to compare gemcitabine with other intravesical agents.