ASCO GU 2018: Primary Results of NRG/RTOG 0712—A Randomized Phase 2 Multicenter Trial - Selective Bladder Preservation

San Francisco, CA (UroToday.com) While radical cystectomy has historically been the standard of care for patients with muscle-invasive urothelial carcinoma of the bladder, there has recently been increased interest in evaluating bladder-sparing treatment modalities. 

Bladder-sparing regimens typically include up-front maximal transurethral resection (TUR) followed by induction radiation and concomitant chemotherapy.  Cystoscopy is later utilized to evaluate for treatment response.  If a patient shows a complete response then consolidative chemoradiation would be administered, however if there is residual disease, a patient would be considered for radical cystectomy with or without adjuvant chemotherapy.

Dr. John J Coen, from 21st Century Urology presented the results of the NRG/RTOG 0712 study during the bladder cancer session at the 2018 Genitourinary Cancers Symposium.  In this Phase II, multi-center trial, patients with muscle-invasive urothelial carcinoma of the bladder who elected to pursue bladder-sparing treatment were randomized to one of two treatment groups.  The first group received cisplatin/5-flurouracil (5-FU) as well as twice-daily radiotherapy.  The second group received low-dose gemcitabine and daily radiotherapy.  70 patients with cT2-cT4aN0 disease were randomized between the two groups from 12/2008 to 2/2014.  The primary endpoint of the study was the rate of distant metastases (DM) at 3 years.  Secondary endpoints included acute and late toxicities, tumor response, and 3-year bladder-intact distant metastasis free survival. The median follow-up length for the study was 5.1 (0.4 – 7.8) years. 

Patients in the cisplatin/5-FU group with twice-daily radiation were noted to have a 77.8% (21/28) rate of DM-free survival at 3 years.  The group who received low-dose gemcitabine and daily radiation had an 84% (21/25) DM-free survival at 3 years. Acute and long-term toxicities were felt to be acceptably low and were similar between the two groups. There were impressive complete response (CR) rates at 3 years, with 87.9% of patients in the cisplatin/5/FU twice-daily radiation group showing a CR, and 75% of patients in the low-dose gemcitabine and daily radiation group showing a CR. Finally, they found that 66.7% of patients in the cisplatin/5-FU and twice-daily radiation group had a remained disease free and retained their bladder at 3 years, while 69% of patients in the low-dose gemcitabine and daily radiation group were disease free and with their native bladder. 

Dr. Coen concluded that the DM rate at 3 years was similar in both arms of the trial and were comparable to that of previously published surgical series.  Both bladder-sparing regimens were well tolerated and complete response rates were high in both arms. This study lends more weight to the argument that bladder-sparing regimens are a viable option option for appropriately selected, highly motivated patients who wish to avoid radical cystectomy for muscle-invasive urothelial carcinoma of the bladder. 


Presented by: John J. Coen, MD, 21st Century Urology

Written by: Brian Kadow, MD, Fox Chase Cancer Center, Philadelphia, PA at the 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, February 8-10, 2018 - San Francisco, CA
E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe