PD13-10: The impact of purified protein derivative prior to intravesical bacillus Calmette-Guérin for the treatment of patients with non-muscle invasive bladder cancer: A controlled clinical trial
Introduction: To investigate the impact of the intradermal injection of purified protein derivative (PPD) and PPD skin test reactions on the oncological outcomes of patients with non-muscle invasive bladder cancer (NMIBC) treated by adjuvant intravesical bacillus Calmette-Guérin (BCG) immunotherapy. Methods: In a propensity clinical study that included 100 patients with primary NMIBC who received intradermal PPD two weeks before adjuvant BCG therapy in a prospective manner starting from January 2020. Another 100 patients with primary NMIBC not given PPD prior to BCG therapy before January 2020 were chosen as a control group. The control group was chosen to be matching with the study group regarding all the baseline characteristics. PPD skin test reactions were categorized into positive and negative reactions. Urine and blood samples were collected 2 weeks before starting BCG therapy and 4 hours after the sixth dose of BCG. Urine and blood samples were evaluated for tumor necrosis factor a (TNFa) and interleukin (IL)-6 by solid-phase enzyme-linked immunosorbent assay and quantitative reverse transcriptase-polymerase chain reaction analysis, respectively. Oncological outcomes, immunological markers changes and BCG side effects were statistically evaluated. Results: The 2-year recurrence-free survival (RFS) rates of patients who received the PPD or not were 82% and 73%, respectively, without a significant difference (P=0.128). No significant difference between both groups regarding the immunological markers changes (TNFa and IL-6) and BCG side effects. A total of 57 (57%) and 43 (43%) patients exhibited positive and negative PPD skin test reactions, respectively. The 2-year RFS rates of patients with positive and negative reactions were 89.5% and 72% respectively with a significant difference (P=0.02). The 2-year progression-free survival rates were higher in patients with positive reactions with a significant difference (P=0.038). Immunological markers increased significantly in patients with positive reactions (P <0.001). BCG side effects were significantly higher in patients with positive reactions (P <0.001). Conclusions: The intradermal injection of PPD before intravesical BCG has no impact on oncological outcomes, immunological markers and BCG side effects of patients with NMIBC treated with TURBT and adjuvant BCG. PPD skin test reactions before BCG therapy can predict the oncological outcomes, BCG side effects and the immunological outcomes of the patients. SOURCE OF Funding: None
