Survival Outcomes of Two Phase 2 Studies of Adjuvant Chemotherapy with S-1 Plus Oxaliplatin or Capecitabine Plus Oxaliplatin for Patients with Gastric Cancer After D2 Gastrectomy
- National Cancer Center Hospital East, Department of Gastroenterology and Gastrointestinal Oncology (Japan)
- Yokohama City University, Department of Biostatistics (Japan)
- Cancer Institute Hospital of Japanese Foundation for Cancer Research, Department of Gastroenterology (Japan)
- Kanagawa Cancer Center, Department of Gastrointestinal Surgery (Japan)
- National Cancer Center Hospital, Division of Gastric Surgery (Japan)
- Shizuoka Cancer Center, Division of Gastric Surgery (Japan)
- Aichi Cancer Center Hospital, Department of Gastroenterological Surgery (Japan)
- National Hospital Organization Osaka National Hospital, Department of Surgery (Japan)
- Gifu University, Department of Surgical Oncology, Graduate School of Medicine (Japan)
- Kyushu University Hospital, Department of Surgery and Science, Graduate School of Medical Sciences (Japan)
- Hyogo College of Medicine, Department of Surgery (Japan)
- Saiseikai Fukuoka General Hospital, Department of Surgery (Japan)
- Saitama Cancer Center, Department of Gastroenterological Surgery (Japan)
- St. Marianna University School of Medicine, Department of Gastroenterological and General Surgery (Japan)
- Osaka Medical College, Cancer Chemotherapy Center (Japan)
- Yokohama City University Hospital, Center for Novel and Exploratory Clinical Trials (Japan)
Background: Two phase 2 trials of oxaliplatin-containing adjuvant therapy for patients with gastric cancer (GC) after D2 gastrectomy were conducted in Japan. The SOXaGC trial evaluated the tolerability and safety of adjuvant therapy with S-1 plus oxaliplatin (SOX), whereas the J-CLASSIC trial evaluated the feasibility of adjuvant therapy with capecitabine plus oxaliplatin (CAPOX). Because both were studies that did not evaluate survival results as study end points, the authors evaluated the survival outcomes for the patients in the two trials. Methods: All 62 and 100 patients in the full analysis set of the SOXaGC and J-CLASSIC trials, respectively, were included in the current study. Their information about survival outcome was collected. The primary end point was relapse-free survival (RFS), and the secondary end point was overall survival (OS). Results: For the pathologic stage (pStage 2) patients treated with CAPOX, the 3-year RFS rate was 87.8% and the 3-year OS rate was 92.7%. For the pStage 3 patients treated with SOX and CAPOX, the 3-year RFS rates were respectively 70.9% and 67.8% (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.50–1.72), whereas the 3-year OS rates were respectively 75.7% and 79.3% (HR, 1.10; 95% CI, 0.54–2.26). Subgroup analysis showed significant interactions between the treatment (SOX vs. CAPOX) and both sex (male vs. female; P = 0.024) and histologic type (diffuse vs. other, P = 0.069). Conclusions: This exploratory analysis demonstrated that SOX and CAPOX are suggested to have similar efficacy for pStage 3 GC patients after D2 gastrectomy. Differences in the treatment effect according to sex and histologic type warrant further evaluation.
- OSTI ID:
- 22927886
- Journal Information:
- Annals of Surgical Oncology (Online), Vol. 26, Issue 2; Other Information: Copyright (c) 2019 Society of Surgical Oncology; Country of input: International Atomic Energy Agency (IAEA); ISSN 1534-4681
- Country of Publication:
- United States
- Language:
- English
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