- In patients with T2-4a muscle-invasive bladder cancer (MIBC), both fluorouracil+cisplatin+twice daily radiotherapy (FCR) and gemcitabine+once daily radiotherapy (GR) showed favorable outcomes and safety profile in phase 2 study.
- Both regimens showed high bladder preservation and complete response rates.
Why this matters
- GR is an acceptable alternative to established FCR.
- Findings call for larger phase 3 trial.
- Phase 2 randomized trial of 70 patients with cT2-4a MIBC who received either FCR or GR.
- Primary endpoint: 3-year distant metastasis-free survival (DMFS) rate ≥75%.
- Funding: National Cancer Institute.
- Median follow-up was 5.1 years.
- In the FCR and GR groups:
- 3-year DMFS rate was 78% and 84%, respectively (P=.73).
- 3-year bladder-intact DMFS rate was 67% and 72%, respectively (P=.62).
- Postinduction complete response rates were 88% and 78%, respectively.
- In the FCR vs GR group (n=33 each), 64% vs 55% experienced treatment-related grade 3/4 toxicities: hematologic, 55% vs 42%; gastrointestinal, 6% vs 9%; and genitourinary, 6% vs 6%.
- Trial was underpowered to compare the 2 regimens.