LA-ESCC: presurgery CRT extends survival in Chinese trial

  • Yang H & al.
  • J Clin Oncol
  • 8 Aug 2018

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Neoadjuvant chemoradiotherapy (NCRT) followed by surgery improves survival over surgery alone in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).

Why this matters

  • NCRT + surgery is the preferred option with manageable adverse events.

Study design

  • Phase 3, multicenter, open-label, randomized controlled trial (NEOCRTEC5010) of NCRT plus surgery (CRT group; n=224) vs surgery alone (n=227) for potentially resectable thoracic ESCC staged as T1-4N1M0/T4N0M0.
  • NCRT consisted of vinorelbine 25 mg/m2 and cisplatin 75 mg/m2 with a total concurrent radiation dose of 40.0 Gy.
  • Surgery consisted of the McKeown or Ivor Lewis esophagectomy.
  • Primary outcome was OS.
  • Funding: Health Ministry of China; National Science Foundation of China; Major Science and Technology Special Fund for Projects of Zhejiang Province.

Key results

  • The CRT group had a pathologic complete response rate of 43.2%.
  • The CRT group outperformed the surgery-alone group on these outcomes:
    • Higher R0 resection rate (no gross or microscopic tumor remains) of 98.4% vs 91.2% (P=.002);
    • Better median OS of 100.1 vs 66.5 months (HR, 0.71; P=.025); and
    • Longer DFS of 100.1 vs 41.7 months (HR, 0.58; P<.001>
  • The most common grade 3 or 4 adverse events with NCRT were leukopenia (48.9%) and neutropenia (45.7%).

Limitations

  • Open-label design.

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