OUTCOMES OF IMMUNOTHERAPY BY INTRAVESICAL BCG VACCINE INSTILLATION ON TUMOR RECURRENCE OF NON-MUSCLE-INVASIVE UROTHELIAL BLADDER CANCER

Maher Hmedan*, Hassan Naser and Mohammad Kanaan

ABSTRACT

Background: In 1976 Morales et al were the first to prove the effectiveness of intravesical BCG on the bladder cancer and reported a remarkable decrease in the rates of recurrence of superficial bladder cancer. In 1990, BCG was approved by the Food and Drug Administration (FDA) as a primary treatment for the bladder carcinoma in situ (CIS) and as a preventive treatment for papillary tumors, thus BCG became essential in complementary treatment for NMIBC. Objective: This study aims to evaluate the effectiveness of the immunotherapy by intravesical BCG vaccine instillation in reducing recurrence rates in non-muscle-invasive urothelial bladder cancer patients
(NMIBC). Methods and materials: Patients diagnosed with bladder transitional cell carcinoma by transurethral resection with no muscular invasion in pathology and who had a high or intermediate risk for tumor recurrence were included. BCG immunotherapy Onco TICE (CFU=2-8×108) was given as an induction course of 6 weekly instillations. Maintenance treatment 3 weekly instillations every 3 months for 1 year, was given as a single standard. The follow-up program included a cystoscopy every 3 months with biopsies from the site of the previous curettage or new recurrence. Results: Our study reported recurrence in 26 (43.7%) cases. Tumors ≥3 cm and T1 tumors were more common (73.1%) and (80.8%) in the recurrence group respectively, however there was no important significance (p>0.05). On the other hand: high grade tumors, multifocal tumors, tumors with previous recurrence and tumors without concomitant CIS, each was more common in the recurrence group with an important significance(p<0.05) (88.5%,76.9%,92.3% and80.8%)respectively. Conclusion: We support the previous studys that intravesical BCG vaccine instillation reduces the recurrence rates in non-muscle-invasive urothelial bladder cancer ptients(NMIBC), especially when a maintenance treatment program is used. This study also supports the recommendation of using BCG as the frst-line supportive treatment in patients with high-risk NMIBC.

Keywords: Non-muscle-invasive bladder cancer, BCG, Recurrence.