PDAC: RCT hints at neoadjuvant efficacy

  • Versteijne E & al.
  • J Clin Oncol
  • 27 Feb 2020

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Neoadjuvant chemoradiotherapy (nCRT) shows superiority to up-front surgery in secondary outcomes, but not OS, in resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).

Why this matters

  • This study is the first randomized clinical trial of nCRT in this population.

Study design

  • Randomized, phase 3 clinical trial (16 centers, N=246).
  • Funding: Dutch Cancer Society.

Key results

  • No significant difference in median OS between the nCRT and up-front surgery groups (16.0 vs 14.3 months; P=.096).
  • The nCRT group had better secondary outcomes:
    • R0 resection rate: 71% vs 40% (P<.001>
    • Median DFS: HR, 0.73 (P=.032).
    • Median locoregional failure-free interval (LFFI): HR, 0.56 (P=.0034).
  • Patients who underwent an R0 resection had better OS than those who underwent non-R0 resection: HR, 0.47 (P<.001>
  • The nCRT group had lower rates of:
    • Pathologic lymph nodes: 33% vs 78% (P<.001>
    • Perineural invasion: 39% vs 73% (P<.001>
    • Venous invasion: 19% vs 36% (P=.024).
  • In a predefined subgroup of patients with suspected borderline resectable PDAC, nCRT was associated with better median:
    • OS: 17.6 vs 13.2 months (HR, 0.62; P=.029).
    • DFS: 6.3 vs 6.2 months (HR, 0.59; P=.013). 
    • LFFI: 27.7 vs 11.8 months (HR, 0.54; P=.022).

Limitations

  • Possibly underpowered.