Introduction

The association between the purified protein derivative (PPD) skin test reaction before intravesical BCG therapy and clinical outcomes of patients with non-muscle invasive bladder cancer (NMIBC) has not been adequately investigated.

Methods

A total of 288 patients with NMIBC who underwent complete TURBT and adjuvant intravesical BCG therapy between 1987 and 2015 were included. In all patients, skin reactivity to a PPD of mycobacterium tuberculosis was tested before BCG therapy. The PPD skin test reaction was classified into 3 categories; negative, erythema or induration. Erythema reaction of 10 mm or less in diameter was considered to be negative. We evaluated the association between the PPD skin test reaction and tumor recurrence as well as the occurrence of major side effects due to BCG.

Results

The PPD skin test results were induration in 66 (23%) patients, erythema in 149 (52%), and negative in 73 (25%). The 5-year recurrence-free survival rates in patients with induration, erythema, and negative to PPD skin test were 89.4%, 65.5%, and 56.4%, respectively, with significant differences between the 3 groups. Univariate analysis demonstrated that tumor multiplicity (p=0.025) and induration to PPD skin test (p<0.001) were significantly associated with tumor recurrence. On multivariate analysis only induration to PPD skin test was independently associated with tumor recurrence (Hazard ratio: HR of 0.321, p=0.002). Seventy two (25%) patients experienced major side effects, including macrohematuria in 16 patients, high grade fever in 28, severe lower urinary tract symptoms in 19, and others in 19. Major side effects were observed in 22 (33%) patients with induration, in 40 (27%) with erythema, and in 10 (14%) with negative to PPD skin test, with significant difference between the 3 groups. On multivariate analysis only erythema to PPD skin test was independently associated with occurrence of major side effect (HR of 2.309, p=0.03)

Conclusions

The PPD skin test reaction before BCG therapy was highly associated with clinical outcome of tumor recurrence and occurrence of major side effects in patients with NMIBC treated with BCG therapy.

Funding

none