AUA 2018: High Risk BCG Recurrent/Refractory Disease: Secondary Intravesical Therapy

San Francisco, CA ( Dr. Sima Porten from UCSF provided a discussion of secondary intravesical therapy for patients with high-risk BCG recurrence/refractory disease at the SUO bladder cancer session. Dr. Porten started by noting several important definitions:

  • BCG refractory: patients who do not reach a disease-free state at 6 months after starting BCG (at least induction + maintenance) for high risk NMIBC (Ta/T1/CIS)
  • BCG relapsing: patients who reach a disease-free state at 6 months, and continue on BCG, but later recur within 6 months of the last dose of BCG
As Dr. Porten notes, the reason we don’t do immediate cystectomy on everyone with BCG recurrent/refractory disease is secondary to many of these patients being frail, old and incredibly comorbid. As follows is a representation of level of comorbidities by age, highlighting the 60-64 age group, which commonly falls into the BCG recurrent/refractory disease category:

Enhanced recovery pathways after surgery (ERAS) help, but it doesn’t change the comorbidity level of these patients. ERAS has decreased length of stay, but hasn’t changed complication rates (15%) or readmissions/mortality (15-30%). So, is there a “window of safety” with which to continue with bladder sparing therapy without missing oncologic cure? Dr. Porten thinks that there is, with a combination of treatment/therapies: (i) blue light/narrow band imaging, (ii) adequate prostatic urethra and upper tract evaluation to identify possible sanctuary sites for tumors, (iii) improved cross sectional imaging, and (iv) new biomarkers/genomics.

There are several single-agent salvage intravesical chemotherapy options that are available now that Dr. Porten highlighted1:

  • Valrubicin: 6 weekly instillations. Has reported 1 year complete response rates of 14% and 8% complete response rates at 30 months.
  • Gemcitabine: 6 weekly instillations and monthly x 12 months. Reported 28% 1-year complete response rates.
  • Docetaxel: 6 weekly instillations and monthly x 9 months. Reported 40% 1-year complete response rates.
  • Nab-paclitaxel: 6 weekly instillations and monthly x 6 months. Reported 36% 1-year complete response rates.
Dr. Porten concluded by highlighting the importance of clinical trials in this space. One trial highlighted in the paper by Li et al.1, is with Nadofaragene firadenovec (Adstiladrin®) (rAD-IFN/Syn3) which is currently rolling into a single arm phase III trial. The phase II trial showed 35% of patients free of high grade recurrence at 1 year, and 50% of patients free of recurrence free of any papillary tumors at 1 year2.


Presented by: Sima Porten, UCSF Department of Urology, San Francisco, CA

Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, @zklaassen_md at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA

Read the Rebuttal Presentation: High Risk BCG Recurrent/Refractory Disease: Immediate Cystectomy