Masaaki Iwatsuki1, Hiroyuki Orita2, Kazuma Kobayashi3, Shigekazu Hidaka4, Takaaki Arigami5, Tetsuya Kusumoto6, Hironaga Satake7, Eiji Oki8, Satoshi Tsutsumi9, Kazutoshi Tobimatsu10, Mototsugu Shimokawa11, Hiroshi Saeki12, Akitaka Makiyama13, Hideo Baba1, Masaki Mori14. 1. Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. 2. Department of Surgery, Nakatsu Municipal Hospital, Nakatsu, Japan. 3. Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan. 4. Department of Surgical Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan. 5. Department of Onco-Biological Surgery, Kagoshima University, Kagoshima, Japan. 6. Department of Gastroenterological Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan. 7. Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan. 8. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. okieiji@surg2.med.kyushu-u.ac.jp. 9. Department of Surgery, Oita Prefectural Hospital, Oita, Japan. 10. Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan. 11. Department of Biostatistics, Cancer Biostatistics Laboratory, Yamaguchi University Graduate School of Medicine, Clinical Research Institute, Yamaguchi, Japan. 12. Department of General Surgical Science, Graduate School of Medicine, Gunma University, Maebashi, Japan. 13. Cancer Center, Gifu University Hospital, Gifu, Japan. 14. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Abstract
BACKGROUND: Perioperative chemotherapy is the standard of care for locally advanced gastric cancer (LAGC). This phase II study investigated the efficacy and safety of S-1 and oxaliplatin (SOX) as neoadjuvant chemotherapy (NAC) for LAGC and esophagogastric junction cancer (EGJC). METHODS: Patients completed up to three cycles of SOX130 (oxaliplatin 130 mg/m2 on day 1, oral S-1 40-60 mg twice daily for 2 weeks every 3 weeks), followed by gastrectomy and D2 lymphadenectomy. The primary endpoint was the pathological response rate (pRR). The anastomosis leakage rate was the secondary endpoint in patients with EGJC, and other secondary endpoints were the R0 resection, overall survival (OS), and relapse-free survival (RFS) rates. RESULTS: Between April 2016 and July 2017, 47 patients (24 EGJC, 23 LAGC) were enrolled in this study. Forty-two patients (89.4%, 95% confidence interval [CI] = 76.9-96.5) underwent surgery, and R0 resection was achieved in 41 patients. The pRR was 59.5% (90% CI = 45.7-72.3). The major grade 3 or 4 toxicities were appetite loss in six patients (12.8%), thrombocytopenia in five patients (10.6%), and neutropenia and diarrhea in three patients (6.4%) each. The rate of severe anastomotic leakage (Clavien-Dindo classification grade III or higher) in 20 EGJC was 25.0% (90% CI = 10.4-45.6). The 3-year OS and RFS rate were 62.9% (95% CI = 47.2-75.1) and 53.2% (95% CI = 38.1-66.2), respectively. CONCLUSION: SOX130 demonstrated substantial benefit for LAGC and EGJC. However, special attention should be paid to anastomotic leakage during surgery for EGJC.
BACKGROUND: Perioperative chemotherapy is the standard of care for locally advanced gastric cancer (LAGC). This phase II study investigated the efficacy and safety of S-1 and oxaliplatin (SOX) as neoadjuvant chemotherapy (NAC) for LAGC and esophagogastric junction cancer (EGJC). METHODS: Patients completed up to three cycles of SOX130 (oxaliplatin 130 mg/m2 on day 1, oral S-1 40-60 mg twice daily for 2 weeks every 3 weeks), followed by gastrectomy and D2 lymphadenectomy. The primary endpoint was the pathological response rate (pRR). The anastomosis leakage rate was the secondary endpoint in patients with EGJC, and other secondary endpoints were the R0 resection, overall survival (OS), and relapse-free survival (RFS) rates. RESULTS: Between April 2016 and July 2017, 47 patients (24 EGJC, 23 LAGC) were enrolled in this study. Forty-two patients (89.4%, 95% confidence interval [CI] = 76.9-96.5) underwent surgery, and R0 resection was achieved in 41 patients. The pRR was 59.5% (90% CI = 45.7-72.3). The major grade 3 or 4 toxicities were appetite loss in six patients (12.8%), thrombocytopenia in five patients (10.6%), and neutropenia and diarrhea in three patients (6.4%) each. The rate of severe anastomotic leakage (Clavien-Dindo classification grade III or higher) in 20 EGJC was 25.0% (90% CI = 10.4-45.6). The 3-year OS and RFS rate were 62.9% (95% CI = 47.2-75.1) and 53.2% (95% CI = 38.1-66.2), respectively. CONCLUSION: SOX130 demonstrated substantial benefit for LAGC and EGJC. However, special attention should be paid to anastomotic leakage during surgery for EGJC.
Authors: Augustinas Bausys; Toomas Ümarik; Martynas Luksta; Arvo Reinsoo; Rokas Rackauskas; Giedre Anglickiene; Marius Kryzauskas; Kristina Tõnismäe; Veslava Senina; Dmitrij Seinin; Rimantas Bausys; Kestutis Strupas Journal: Ann Surg Oncol Date: 2021-07-15 Impact factor: 5.344