Long-term quality of life and nutritional results after laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy for early gastric cancer: Secondary outcomes of a multicenter, randomized phase 3 trial (SENORITA).

person Bang Wool Eom National Cancer Center, Goyang-Si, 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, 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, South Korea, National Cancer Center, Goyang, South Korea, Dongnam Institute of Radiological and Medical Sciences, Cancer Center, Busan, South Korea, Samsung Medical Center, Seoul, South Korea, Ajou University School of Medicine, Suwon, South Korea, Gyengsang National University Hospital, Jinju, South Korea, Soonchunhyang University College of Medicine, Bucheon, South Korea, Chonnam National University Hwasun Hospital, Hwasun, South Korea, Chonnam National University Medical School, Hwasun, South Korea, Gyengsang National University College of Medicine, Jinju, South Korea, Yonsei University College of Medicine, Seoul, South Korea, Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea Abstract Disclosures Research Funding Other Grant 1110550, 1410140, 1710160, 2010150-1 Background: Laparoscopic sentinel node navigation surgery (LSNNS) has been suggested as an alternative to laparoscopic standard gastrectomy (LSG) in early gastric cancer patients to improve long-term quality of life (QOL) and nutritional outcomes. Here, we present 3-year results of patient-reported quality of life (QOL) and nutrition, secondary endpoints of SENORITA trial. Methods: SENORITA is a prospective multicenter randomized phase 3 trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS for stomach preservation or LSG. The primary endpoint was 3-year disease-free survival. In this study, we analyzed QOL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC stomach module (STO22) and nutritional parameters at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses was used to evaluate differences between the two groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned and 527 patients were included in the modified intention-to-treat analysis population (258 in LSNNS and 269 in LSG group). QOL questionnaires were available for 99.4% of patients at baseline and then for 92.2%, 83.2%, 72.8%, and 66.9% at 3, 12, 24, and 36 months after surgery, respectively. The LSNNS group had higher physical function score than the LSG group at all time points (p = 0.002). However, there were no significant differences in other scales of EORTC QLQ-C30. Regarding EORTC QLQ-STO22, pain, eating restriction, anxiety, and taste scores were lower (better QOL) at all time points in the LSNNS group than in the LSG group (p = 0.002, < 0.001, < 0.001, and < 0.001, respectively). The summary score of EORTC QLQ-STO22 was also higher in the LSNNS group representing better QOL (p < 0.001). Body mass index, hemoglobin and total protein were significantly higher in the LSNNS group compared with the LSG group. Conclusions: The LSNNS group had better physical function and less symptoms, including pain, eating restriction, anxiety, and taste change compared with the LSG group. Moreover, the nutritional parameters were better maintained in the LSNNS group than in the LSG group. These findings showed benefits of stomach preserving surgery in LSNNS and can be used to help decision making about treatment for patients with early gastric cancer. Clinical trial information: NCT01804998