Long-term quality of life and nutritional results of stomach-preserving surgery after sentinel node evaluation in patients with early gastric cancer: A multicenter, randomized phase 3 trial (SENORITA).

person Bang Wool Eom National Cancer Center, Goyang-Si, Gyeonggi-do, South Korea info_outline Bang Wool Eom, Hong Man Yoon, Young-Woo Kim, Jae Seok Min, Ji Yeong An, Hoon Hur, Young Joon Lee, Gyu Seok Cho, Young-Kyu Park, Mi Ran Jung, Ji-Ho Park, Woo Jin Hyung, Sang-Ho Jeong, Myeong-Cherl Kook, Mira Han, Byung-Ho Nam, Keun Won Ryu

Authors person Bang Wool Eom National Cancer Center, Goyang-Si, Gyeonggi-do, South Korea info_outline Bang Wool Eom, Hong Man Yoon, Young-Woo Kim, Jae Seok Min, Ji Yeong An, Hoon Hur, Young Joon Lee, Gyu Seok Cho, Young-Kyu Park, Mi Ran Jung, Ji-Ho Park, Woo Jin Hyung, Sang-Ho Jeong, Myeong-Cherl Kook, Mira Han, Byung-Ho Nam, Keun Won Ryu Organizations National Cancer Center, Goyang-Si, Gyeonggi-do, South Korea, National Cancer Center, Goyang-Si, South Korea, National Cancer Center, Goyang-Si, Korea, Republic of (South), Dongnam Institute of Radiological & Medical Sciences Cancer Center, Busan, South Korea, Samsung Medical Center, Seoul, South Korea, Ajou University School of Medicine, Suwon, South Korea, Gyeongsang National University College of Medicine, Jinju, South Korea, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea, Chonnam National University Hwasun Hospital, Hwasun, Korea, Republic of (South), Chonnam National University Hwasun Hospital, Hwasun, South Korea, Gyeongsang National University, Jinju-Si, South Korea, Yonsei University College of Medicine, Seoul, South Korea, Gyeongsang national university, Changwon-Si, South Korea, National Cancer Center, Korea, Goyang, South Korea, Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea, Research Institute and Hospital, National Cancer Center, Goyang-Si, South Korea Abstract Disclosures Research Funding Other This research was supported by the National Cancer Center, Republic of Korea (Grant 1110550, 1410140, 1710160, 2010150) Background: In the SENORITA trial, laparoscopic sentinel node navigation surgery (LSNNS) showed no significant difference in overall and disease specific survivals compared with laparoscopic standard gastrectomy (LSG). Here, we present the effect of stomach preservation surgery on QoL and nutritional outcomes, and identify risk factors affecting QoL in stomach preservation surgery. Methods: SENORITA was a prospective multicenter randomized trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS or LSG. The primary endpoint was 3-year disease-free survival. This analysis focuses on long-term quality of life and nutritional outcomes of patients who finally underwent stomach-preservation surgery in the LSNNS group. QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses were used to evaluate differences between treatment groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned in the SENROTA trial. Among them, 258 patients underwent sentinel node navigation surgery and 198 finally underwent stomach preservation surgery. QoL data was available in 194 patients and compared with those of 257 patients who underwent standard gastrectomy. The stomach-preservation group had better QoL in physical function, dyspnea, and appetite loss of C30 and dysphagia, pain, reflux symptoms, eating restriction, anxiety, taste change, body image, and total score of STO22. Regarding nutritional outcomes, body mass index, hemoglobin, protein, and albumin levels were significantly higher in the stomach-preservation group than in the gastrectomy group. In multivariate analyses, tumor location (greater curvature) was an independent favorable factor affecting global health status, reflux symptoms, eating restriction, and total score of STO22 at 3 months in the stomach-preservation group. Segmental resection was a risk factor for diarrhea and eating restriction at postoperative 3 year. Conclusions: The stomach-preservation surgery had better long-term QoL and nutritional outcomes compared with standard gastrectomy. These findings can help decision making about treatment for patients with early gastric cancer, especially or elderly or nutritionally high risk patients. Clinical trial information: NCT01804998.

Clinical