Phase II Trial of Adjuvant S-1 Following Neoadjuvant Chemotherapy and Surgery in Patients with Locally Advanced Esophageal Squamous Cell Carcinoma: The PIECE Trial
2024

Adjuvant S-1 After Surgery for Esophageal Cancer

Sample size: 50 publication 10 minutes Evidence: moderate

Author Information

Author(s): Nomura Motoo MD, PhD, Yamaguchi Toshifumi MD, PhD, Chin Keisho MD, Hato Shinji MD, PhD, Kato Ken MD, PhD, Baba Eishi MD, PhD, Matsubara Hisahiro MD, PhD, Mukaida Hidenori MD, PhD, Yoshii Takako MD, PhD, Tsuda Masahiro MD, PhD, Tsubosa Yasuhiro MD, PhD, Kitagawa Yuko MD, PhD, Oze Isao MD, PhD, Ishikawa Hideki MD, PhD, Muto Manabu MD, PhD

Primary Institution: Kyoto University Hospital, Kyoto, Japan

Hypothesis

The addition of adjuvant S-1 after neoadjuvant chemotherapy and surgery improves outcomes in patients with locally advanced esophageal squamous cell carcinoma.

Conclusion

Adjuvant S-1 after neoadjuvant chemotherapy and surgery showed promising efficacy and a manageable safety profile for patients with resectable esophageal squamous cell carcinoma.

Supporting Evidence

  • The 3-year relapse-free survival rate was 72.3%.
  • The overall survival rate was 85.0%.
  • Grade ≥3 adverse events included neutropenia and anorexia.

Takeaway

This study tested a new medicine called S-1 after surgery for esophageal cancer and found it helps patients live longer without their cancer coming back.

Methodology

Patients received four cycles of S-1 after R0 resection following neoadjuvant chemotherapy, with the primary endpoint being 3-year relapse-free survival.

Potential Biases

Potential biases due to the open-label design and lack of randomization.

Limitations

The study had a small sample size and lacked a control group.

Participant Demographics

{"age":{"median":62,"range":"40-72"},"sex":{"male":38,"female":12},"performance_status":{"0":46,"1":4}}

Statistical Information

P-Value

0.02

Confidence Interval

{"RFS":"90% CI 59.9–81.5","OS":"90% CI 73.9–91.6"}

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1245/s10434-024-16325-2

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