K Misawa1, Y Mochizuki2, M Sakai3, H Teramoto4, D Morimoto5,6, H Nakayama7, N Tanaka5,8, T Matsui9, Y Ito1, S Ito1, K Tanaka5, K Uemura10, S Morita11, Y Kodera5. 1. Department of Gastroenterological Surgery, Aichi Cancer Centre Hospital, Nagoya, Japan. 2. Department of Surgery, Komaki Municipal Hospital, Komaki, Japan. 3. Department of Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan. 4. Department of General Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan. 5. Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. 6. Department of Surgery, JA Kainan Hospital, Yatomi, Japan. 7. Department of Surgery, National Hospital Organization Nagoya Medical Centre, Nagoya, Japan. 8. Department of Surgery, JA Aichi Konan Kosei Hospital, Konan, Japan. 9. Department of Gastroenterological Surgery, Aichi Cancer Centre, Aichi Hospital, Okazaki, Japan. 10. Department of Biostatistics and Bioinformatics, Interfaculty Initiative in Information Studies, University of Tokyo, Tokyo, Japan. 11. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Abstract
BACKGROUND: A survival benefit of extensive intraoperative peritoneal lavage (EIPL) has been reported in patients with gastric cancer with positive peritoneal cytology. The hypothesis of this study was that EIPL may reduce peritoneal recurrence in patients with advanced gastric cancer who undergo surgery with curative intent. METHODS: This was an open-label, multi-institutional, randomized, phase 3 trial to assess the effects of EIPL versus standard treatment after curative gastrectomy for resectable gastric cancer of T3 status or above. The primary endpoint was disease-free survival (DFS); secondary endpoints were overall survival, peritoneal recurrence-free survival and incidence of adverse events. RESULTS:Between July 2011 and January 2014, 314 patients were enrolled from 15 institutions and 295 patients were analysed (145 and 150 in the EIPL and no-EIPL groups respectively). The 3-year DFS rate was 63·9 (95 per cent c.i. 55·5 to 71·2) per cent in the EIPLgroup and 59·7 (51·3 to 67·1) per cent in the control group (hazard ratio (HR) 0·81, 95 per cent c.i. 0·57 to 1·16; P = 0·249). The 3-year overall survival rate was 75·0 (67·1 to 81·3) per cent in the EIPL group and 73·7 (65·9 to 80·1) per cent in the control group (HR 0·91, 0·60 to 1·37; P = 0·634). Peritoneal recurrence-free survival was not significantly different between the two groups (HR 0·92, 0·62 to 1·36; P = 0·676). No intraoperative complications related to EIPL were observed. CONCLUSION:EIPL did not improve survival or peritoneal recurrence in patients who underwent gastrectomy for advanced gastric cancer. Registration number: 000005907 (http://www.umin.ac.jp/ctr/index.htm).
RCT Entities:
BACKGROUND: A survival benefit of extensive intraoperative peritoneal lavage (EIPL) has been reported in patients with gastric cancer with positive peritoneal cytology. The hypothesis of this study was that EIPL may reduce peritoneal recurrence in patients with advanced gastric cancer who undergo surgery with curative intent. METHODS: This was an open-label, multi-institutional, randomized, phase 3 trial to assess the effects of EIPL versus standard treatment after curative gastrectomy for resectable gastric cancer of T3 status or above. The primary endpoint was disease-free survival (DFS); secondary endpoints were overall survival, peritoneal recurrence-free survival and incidence of adverse events. RESULTS: Between July 2011 and January 2014, 314 patients were enrolled from 15 institutions and 295 patients were analysed (145 and 150 in the EIPL and no-EIPL groups respectively). The 3-year DFS rate was 63·9 (95 per cent c.i. 55·5 to 71·2) per cent in the EIPL group and 59·7 (51·3 to 67·1) per cent in the control group (hazard ratio (HR) 0·81, 95 per cent c.i. 0·57 to 1·16; P = 0·249). The 3-year overall survival rate was 75·0 (67·1 to 81·3) per cent in the EIPL group and 73·7 (65·9 to 80·1) per cent in the control group (HR 0·91, 0·60 to 1·37; P = 0·634). Peritoneal recurrence-free survival was not significantly different between the two groups (HR 0·92, 0·62 to 1·36; P = 0·676). No intraoperative complications related to EIPL were observed. CONCLUSION: EIPL did not improve survival or peritoneal recurrence in patients who underwent gastrectomy for advanced gastric cancer. Registration number: 000005907 (http://www.umin.ac.jp/ctr/index.htm).
Authors: Katarzyna Gęca; Karol Rawicz-Pruszyński; Jerzy Mielko; Radosław Mlak; Katarzyna Sędłak; Wojciech P Polkowski Journal: Cells Date: 2020-09-25 Impact factor: 6.600