Pancreatic cancer: S-1-based neoadjuvant chemoradiation ups survival

  • Eguchi H & al.
  • Ann Surg Oncol
  • 22 Aug 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • A neoadjuvant combination of full-dose gemcitabine, the fluorouracil-based chemotherapy agent S-1, and radiotherapy showed "outstanding" clinical efficacy in resectable pancreatic ductal adenocarcinoma.

Why this matters

  • Survival was "strikingly better" than previously observed with neoadjuvant therapy.

Study design

  • Prospective, single-arm, multicenter phase 2 trial (n=63).
  • Patients received:
    • Intravenous gemcitabine (1000 mg/m2) on days 1, 8, 22, and 29.
    • Oral S-1 twice daily (80 mg/m2/day) on days 1-5, 8-12, 22-26, and 29-33. 
    • Conformal 3D radiotherapy (5 times per week, 1.8 Gy/day).
  • In the absence of liver metastasis or peritoneal implantation, patients underwent pancreatectomy 4-7 weeks after beginning radiotherapy.
  • Patients with adequate performance status underwent 6 months of adjuvant therapy with gemcitabine or S-1.
  • Funding: None disclosed.      

Key results

  • Completion rate, 98%.
  • 79% of patients experienced grade ≥3 leukopenia. 56% experienced grade ≥3 neutropenia.
  • 54 of 63 patients underwent resection (29 pancreaticoduodenectomy, 25 distal pancreatectomy).
    • All 54 achieved R0 status.
  • Over a median follow-up of 27.2 months:
    • Intention-to-treat: OS, 1 year (83.3%); 3 years (51.6%); 5 years (41.2%).
    • 5-year OS among neoadjuvant/adjuvant completers, 56.6%.
    • Median recurrence-free survival was 29.2 months (noncompleters, 13.2 months; P=.02).

Limitations

  • Japanese population.
  • Small sample size.