To investigate the efficacy and safety of Nocardiarubra cell wall skeleton (N-CWS)bladder irrigation in prevention of recurrence after transurethral resection for the treatment of non-muscle invasive bladder cancer (NMIBC).

The clinical data of patients with NMIBC treated by N-CWS and epirubicin collected between October 2013 and November 2018 at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed. All patients underwent TURBT. Among the 118 NMIBC patients, the average age was (65.1±11.9)years, and the sex ratio (male/female) was 1.9∶1 (77/41). Patients were divided into two group: N-CWS group (n=55) and epirubicin group (n=63) according to different instillation regimens. N-CWS was given as an instillation of 800 μg in 50 ml of saline and maintained in the bladder for 2 h in the N-CWS group. Epirubicin was given as an instillation of 50 mg in 50 ml of saline and maintained in the bladder for 1 h in the epirubicin group. In the N-CWS group, mean age was (64.9±12.1) years and 37 (67.3%) were male. Multiple tumors were present in 17(69.1%) patients. Tumor size was ≤3 cm in 49(89.1%) and 7(12.7%) had a history of NMIBC. Stage was T_a and T₁ in 36(65.5%) and 19(34.5%), respectively. Grade 1, Grade 2 and Grade 3 were the primary grades in 38(69.1%), 13(23.6%) and 4(7.3%), respectively. Low risk, intermediate risk and high risk were present in 14 patients(25.5%), 16(29.1%)and 25(45.5%), respectively. In the epirubicin group, mean age was (65.3±11.2) years and 40(63.5%)were male. Multiple tumors were present in 19(30.2%) patients. Tumor size was ≤3 cm in 56(88.9%) and 11(17.5%) had a history of NMIBC. Stage was Ta and T₁ in 37(58.7%) and 26(41.3%), respectively. Grade 1, Grade 2 and Grade 3 were the primary grades in 44(69.8%), 12(19.0%)and 7(11.1%), respectively. Low risk, intermediate risk and high risk were present in 13(20.6%), 19(30.2%)and 31(49.2%), respectively. The tumor recurrence, progression and adverse reactions after Intravesical Instillation in both groups were followed up and recorded. No significant differences were found between the two groups.

A total of 118 patients were followed up.Mean follow-up time was (33.7±5.4) months. 25.5%(14/55) in the N-CWS group vs. 42.8%(27/63) in the epirubicin group had recurrence after 5 years (χ²=3.922, P=0.048). The five-year RFS was higher in the N-CWS group than in the epirubicin group (74.2% vs. 56.5%, P=0.044). No significant difference was found in the progression rate between the two groups(5.5% vs. 7.9%, P=0.867). The incidences of adverse events in the two groups were 16.4%(9/55) and 19.0% (12/63), respectively. The N-CWS group had significantly fewer cases with urinary frequency and dysuria than the epirubicin group. No significant differences were found in other side effects.

Intravesical instillation of N-CWS after NMIBC TURBT was found to be a promising procedure to prevent recurrence and prolong the recurrence-free survival with less side effects.

Non-muscle invasive bladder cancer; Nocardiarubra cell wall skeleton; Intravesical Instillation