Efficacy and safety of short-term intravesical gemcitabine vs. long-term intravesical epirubicin in the treatment of moderate to high-risk non-muscle-invasive bladder cancer: a pilot study

Long-term bladder instillation therapy will bring more infusion side effects and economic consumption to patients. This study aims to compare short-term gemcitabine vs. long-term epirubicin for intravesical chemotherapy in patients diagnosed with moderate- to high-risk NMIBC treated using transurethral resection of bladder tumor (TURBT).

This randomized controlled trial enrolled patients diagnosed with pT1 bladder cancer who underwent TURBT at Tianjin Medical University Cancer Institute from (01/2015- 07/2018), randomized 1:1 to gemcitabine vs. epirubicin. Recurrence-free survival (RFS) and progression-free survival (PFS) were monitored by cystoscopy. Side-effects after intravesical instillation and QLQ-C30 questionnaire were collected.

Finally, 208 patients were enrolled. The median follow-up was 50.6 (6–69) months. The median RFS of the gemcitabine vs. epirubicin groups were 46.7 (6–69) vs. 47.2 (8–69) months, respectively (P > 0.05); the median PFS was 51.3 (9–69) vs. 50.9 (27–69) months, respectively (P > 0.05). The incidence rates of lower urinary tract symptoms, dysuria, hypo gastralgia, and gastrointestinal symptoms in the epirubicin group were 33.3%, 6.7%, 17.7%, and 18.3%, compared with 8.5%, 3.4%, 8.5% and, 1.2%, respectively, for gemcitabine. The gemcitabine group had a better quality of life than epirubicin in global health status (82.8 ± 8.5 vs. 79.6 ± 4.2, P = 0.01) and pain symptom domain (1.1 ± 2.8 vs. 2.4 ± 3.8, P = 0.04).

There are no significant differences in efficacy between gemcitabine and epirubicin for intravesical chemotherapy in patients with moderate to high-risk NMIBC to prevent tumor recurrence or progression for patients intolerant to BCG or those for whom BCG is not accessible. Patients with gemcitabine suffer fewer adverse events and have a better health status than with epirubicin.