MIBC: dose-dense gemcitabine/cisplatin shows promise as NAT

  • Iyer G & al.
  • J Clin Oncol
  • 9 May 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Neoadjuvant dose-dense gemcitabine and cisplatin (6 cycles) was well-tolerated and effective in patients with muscle-invasive bladder cancer (MIBC).
  • The presence of deleterious DNA damage response (DDR) gene alterations strongly predicted chemosensitivity.

Why this matters

  • These findings challenge the standard 3-4 cycles of neoadjuvant therapy (NAT).
  • Detection of deleterious DDR gene alterations may help identify patients most likely to benefit from neoadjuvant chemotherapy.

Study design

  • Multicenter phase 2 study of 49 patients with MIBC who received gemcitabine (2500 mg/m2 on day 1) and cisplatin (35 mg/m2 on days 1 and 2) every 2 weeks for 6 cycles, followed by radical cystectomy (RC).
  • Funding: Zena and Michael A. Wiener Research and Therapeutic Program in Bladder Cancer.

Key results

  • Median follow-up, 25.6 months.
  • 57% of 46 evaluable patients downstaged to
  • Pathological response rate was 62% in patients who underwent RC.
  • Median recurrence-free survival (RFS) and OS were not reached.  
  • 39% of patients required toxicity-related dose modifications or discontinuation.
  • 37% of patients experienced treatment-related grade 3-4 toxicities; anemia was the most common (12%).
  • Positive predictive value of deleterious DDR gene alteration for response was 89%.
  • 2-year RFS was higher in patients with deleterious DDR gene alterations vs those without (100% vs 61%; Plog-rank=.07).

Limitations

  • Single-group study.

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