Fluorouracil plus cisplatin and radiation twice a day (FCT) appears to produce similar benefits compared with gemcitabine and once-daily radiation (GD) for selective bladder-sparing treatment of muscle-invasive bladder cancer, according to the results of arandomized phase 2 trial published in The Journal of Clinical Oncology.1 Researchers looked at the rate of freedom from distant metastasis at 3 years (DMF3) and determined if either regimen exceeded a DMF3 benchmark of 75%. They found DMF3 was 78% for FCT and 84% GD.
John J. Coen, MD, 21st Century Oncology, Providence, Rhode Island, and colleagues compared 33 patients receiving FCT to 33 patients receiving GD. All the patients were treated between December 2008 and April 2014 and had cT2-4a muscle-invasive bladder cancer.
The trial was not statistically powered to compare the 2 regimens, but with a median follow-up of 5.1 years, the researchers found both regimens were well tolerated and had high complete response (CR) rates and high bladder preservation rates. The findings suggestedthat both regimens should be further studied. However, the authors noted that concurrent low-dose gemcitabine may be a reasonable alternative to a cisplatin-based regimen. “Once-per-day radiation is a reasonable alternative to accelerated twice-a-day radiation, which may allow for the wider adoption of bladder preservation,” the authors wrote.
The study showed fewer toxicities in the GD arm, with 64% in the FCT arm experiencing treatment-related grade 3/4 toxicities compared with 55% in the GD arm. The CR rates were 88% for FCT and 78% for GD. The researchers looked at the CR rates and bladder-intact distant metastasis-free survival at 3 years (BI-DMFS3) and found similar rates (67% for the FCT arm and 72% for the GD arm).
- Coen JJ, Zhang P, Saylor PJ, et al. Bladder preservation with twice-a-day radiation plus fluorouracil/cisplatin or once daily radiation plus gemcitabine for muscle-invasive bladder cancer: NRG/RTOG 0712—a randomized phase 2 trial [published online November 15, 2018]. J Clin Oncol. doi: 10.1200/JCO.18.00537