Optimal adjuvant intravesical therapy for intermediate risk non-muscle invasive bladder cancer; oncological and patient-reported outcomes of randomized controlled trial.

BACKGROUND

Adjuvant Intravesical BCG and chemotherapy are utilized viables options for intermediate-risk (IR) NMIBC. We are lacking well-designed evidence for superiority of any in terms of effectiveness, toxicity, and patient tolerability.

OBJECTIVES

We compared the oncological outcomes, treatment-related adverse events (AEs) and Health-related quality of life (HRQoL) in IR NMIBC patients who received intravesical BCG vs. intravesical Epirubicin.

MATERIALS AND

METHODS

After institutional review board (IRB) approval, 134 patients were randomly allocated into two groups; adjuvant intravesical BCG and intravesical Epirubicin. Patients were followed every 3 to 6 months by cystourethroscopy and urine cytology. The primary end points were recurrence, progression, and disease-free survivals. The secondary end points comprised treatment-related AEs and quality of life using HRQoL-EORTC QLQ-30 questionnaire.

RESULTS

Of the 134 patients, 122 were followed for a mean of 19 months and included in the final analysis. There were no statistically significant differences between the two groups in terms of baseline demographic/tumor criteria. The tumor recurrence and progression rates were comparable between BCG vs. Epirubicin groups, (19.4% vs. 28.5%), (6.5% vs. 5%), respectively. Mean time to recurrence and RFS were significantly prolonged in BCG group (18 vs. 16.7 months, Log rank P = 0.02) While time to progression and PFS were statically comparable between the two groups (18.5 vs. 18.3 months, Log rank P = 0.76). Local treatment-related AEs as dysuria/urgency/frequency were significantly more reported in BCG group (19.5% vs. 10%, P = 0.03). BCG group experienced significantly worse HRQoL in terms of urinary symptoms and treatment-related future worries domains (P = 0.008, 0.001, respectively).

CONCLUSIONS

In patients with IR NMIBC, adjuvant intravesical therapy with BCG and Epirubicin are equivalent in terms of recurrence and progression rates. Nevertheless, RFS was significantly prolonged in patient receiving intravesical BCG. On the contrary, patients treated with BCG experienced significantly more local bladder symptoms and worse HRQoL in terms of bothering urinary symptoms and negative treatment-related future worries.