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Bladder-Sparing Treatment Regimens for Muscle-Invasive Bladder Cancer

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Key Points

  • 3-year distant metastasis–free survival was 78% in the FCT group and 84% in the GD group.
  • Bladder-intact 3-year distant metastasis–free survival was 67% and 72%, respectively.

In a phase II trial (NRG/RTOG 0712) reported in the Journal of Clinical Oncology, Coen et al found that bladder-sparing treatment with twice-daily radiation plus fluorouracil/cisplatin (FCT) or once-daily radiation plus gemcitabine (GD) produced similar distant metastasis-free survival in patients with muscle-invasive bladder cancer. The GD regimen was associated with less toxicity.

Study Details

In the study, 66 eligible patients with cT2–4a muscle-invasive bladder cancer enrolled between December 2008 and April 2014 were randomly assigned to receive FCT (n = 33) or GD (n = 33). Patients underwent transurethral resection and induction chemoradiation to 40 Gy. Patients with a complete response received consolidation chemoradiation to 64 Gy, and all others underwent cystectomy. Patients received adjuvant therapy consisting of gemcitabine/cisplatin chemotherapy.

The primary endpoint was freedom from distant metastasis at 3 years, with the main assessment being whether either group had a rate greater than a benchmark figure of 75%.

Survival and Toxicity

Median follow-up was 5.1 years among surviving patients. Distant metastasis–free survival at 3 years was 78% in the FCT group and 84% in the GD group. Bladder-intact distant metastasis–free survival at 3 years was 67% and 72%, respectively. Postinduction complete response was observed in 88% and 78% of patients.

A prompt cystectomy was performed in 3 of 4 patients without complete response in the FCT group and in 5 of 7 in the GD group. Of the 10 vs 8 patients with documented treatment failure, 5 vs 3 had distant metastasis, 3 vs 2 died, and 2 vs 3 underwent cystectomy as the first failure event.

Treatment-related grade 3 or 4 toxicities occurred in 64% of the FCT group vs 55% of the GD group, including hematologic (55% vs 42%), gastrointestinal (6% vs 9%), and genitourinary (6% vs 6%) adverse events. Grade 4 adverse events, all hematologic, occurred in 21% vs 6% of patients.

The investigators concluded, “Both regimens demonstrated [3-year distant metastasis–free survival] greater than 75%. There were fewer toxicities observed in the GD arm. Either gemcitabine and once daily radiation or a cisplatin-based regimen could serve as a base for future trials of systemic therapy.”

John J. Coen, MD, of 21st Century Oncology, Providence, Rhode Island, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by grants from the National Cancer Institute. See the study authors’ full disclosures at jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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