MIBC: gemcitabine with daily radiotherapy is an acceptable option

  • Coen JJ & al.
  • J Clin Oncol
  • 15 Nov 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%.

Limitations

  • Trial was underpowered to compare the 2 regimens.

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