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278 Oral Abstract Session, Thu, 1:30 PM-3:00 PM Results of The ESOPHAGEAL AND GASTRIC CANCER 278 Oral Abstract Session, Thu, 1:30 PM-3:00 PM Results of the JAVELIN Gastric 100 phase 3 trial: avelumab maintenance following first-line (1L) chemotherapy (CTx) vs continuation of CTx for HER22 advanced gastric or gastroesophageal junction cancer (GC/GEJC). Markus H. Moehler, Mikhail Dvorkin, Mustafa Ozguroglu, Min-hee Ryu, Alina Simona Muntean, Sara Lonardi, Marina Nechaeva, Arinilda Silva Campos Bragagnoli, Hasan Senol Coskun, Antonio Cubillo Graci´an, Toshimi Takano, Rachel Wong, Howard Safran, Gina M. Vaccaro, Narikazu Boku, Ilaria Conti, Janet Hong, Huiling Xiong, Julien Taieb, Yung-Jue Bang; Johannes Gutenberg-University Clinic, Mainz, Germany; Omsk Regional Clinical Centre of Oncology, Omsk, Russian Federation; Cerrahpas¸a School of Medicine, Istanbul University-Cerrahpas¸a, Istanbul, Turkey; Department of Oncology, Asan Medical Center, Seoul, South Korea; "Prof. Dr. Ion Chiricut¸a"˘ Institute of Oncology, Cluj-Napoca, Romania; Medical Oncology Unit 1, Clinical and Experimental Oncology Department, Veneto Institute of Oncology IOV–IRCCS, Padua, Italy; Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Barretos Cancer Hospital, Barretos, Brazil; Akdeniz University, Antalya, Turkey; HM Universitario Sanchinarro, Madrid, Spain; Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan; Eastern Health, Monash University, Melbourne, Australia; Brown University Oncology Research Group, Providence, RI; Oregon Health & Science University, Portland, OR; National Cancer Center Hospital, Tokyo, Japan; EMD Serono, Billerica, MA; Merck Serono, Beijing, China; Hopitalˆ Europ´een Georges-Pompidou, Sorbonne Paris Cite/Paris Descartes University, Paris, France; Seoul National University Hospital, Seoul, South Korea Background: We report the primary analysis of JAVELIN Gastric 100, which compared avelumab (anti–PD-L1) maintenance after 1L CTx vs continued CTx in patients (pts) with GC/GEJC. Methods: In this global, open-label, phase 3 trial (NCT02625610), eligible pts had previously untreated, unresectable, locally advanced/metastatic (LA/M) HER22 GC/GEJC. Pts without progressive dis- ease (PD) after 12 weeks of 1L oxaliplatin/fluoropyrimidine induction were randomized 1:1 to avelumab 10 mg/kg Q2W switch maintenance or continued CTx, stratified by region (Asia vs non-Asia). Primary endpoint was overall survival (OS) post induction in all randomized or PD-L1+ ($1% of tumor cells, 73- 10 assay) pts. Results: 805 pts received induction CTx and 499 pts were randomized (avelumab, n = 249; CTx, n = 250). At data cutoff (Sep 13, 2019), minimum follow-up was 18 months. In the avelumab and CTx arms, median OS post induction/randomization was 10.4 months (95% CI 9.1-12.0) vs 10.9 months (95% CI 9.6-12.4), hazard ratio (HR) 0.91 (95% CI 0.74-1.11; p = 0.1779); 24-month OS rates were 22.1% (95% CI 16.8-28.0) vs 15.5% (95% CI 10.8-20.9), respectively. The HR for OS in PD-L1+ pts (n = 54) was 1.13 (95% CI 0.57-2.23). No OS trend was seen in Asian pts (n = 114; HR 0.90 [95% CI 0.59-1.36]) or other subgroups, except for a potential benefit with avelumab in pts with no metastatic sites at randomization (n = 60; HR 0.52 [95% CI 0.28-0.98]). Progression-free survival was similar between arms (HR 1.04 [95% CI 0.85-1.28]). In the avelumab vs CTx arms, objective response rates (post randomization only) were 13.3% (95% CI 9.3-18.1) vs 14.4% (95% CI 10.3-19.4), and 12-month rates for duration of response were 62.3% (95% CI 40.9-77.9) vs 28.4% (95% CI 13.2-45.7), respectively. Treatment-related adverse event rates (all grades/grade $3) were 61.3%/12.8% with avelumab and 77.3%/32.8% with CTx. Conclusions: Avelumab maintenance showed clinical activity and favorable safety vs continued CTx in pts with LA/M GE/GEJC; however, JAVELIN Gastric 100 did not meet its primary objective of demonstrating superior OS in the randomized or PD-L1+ population. Clinical trial information: NCT02625610. Research Sponsor: Merck KGaA, Darmstadt, Germany and Pfizer Inc. © 2020 American Society of Clinical Oncology. Visit gicasym.org and search by abstract for disclosure information. ESOPHAGEAL AND GASTRIC CANCER 279 Oral Abstract Session, Thu, 1:30 PM-3:00 PM Extensive peritoneal lavage after curative gastrectomy for gastric cancer study (EXPEL): An international multicenter randomized controlled trial. Jimmy Bok Yan So, Jiafu Ji, Sang Uk Han, Masanori Terashima, Guoxin Li, Hyung-Ho Kim, Simon Law, Asim Shabbir, Kyo Young Song, Woo Jin Hyung, Nik Ritza Kosai, Koji Kono, Kazunari Misawa, Hiroshi Yabusaki, Takahiro Kinoshita, Peng Choong Lau, Young Woo Kim, Jaideepraj Rao, Bee Choo Tai, Han-Kwang Yang, EXPEL Study Group; Department of Surgery, National University Health System, Singapore, Singapore; Peking University Cancer Hospital and Institute, Beijing, China; Ajou University School of Medicine, Suwon, South Korea; Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan; Nanfang Hospital/ Southern Medical University, Guangzhou, China; Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Hong Kong University, Hong Kong, China; National University Health System, Singapore, Singapore; Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea; Yonsei University College of Medicine, Seoul, South Korea; The National University of Malaysia, Kuala Lumpur, Malaysia; Fukushima Medical University, Fukushima, Japan; Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan; Niigata Cancer Center Hospital, Niigata, Japan; Gastric Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan; University of Malaya Medical Centre, Kuala Lumpur, Malaysia; National Cancer Center, Goyang, South Korea; Tan Tock Seng Hospital, Singapore, Singapore; Saw Swee Hock School of Public Health, National University Health System, Singapore, Singapore; Cancer Research Institute and Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea Background: Peritoneal recurrence of gastric cancer after curative surgical resection is common and portends a poor prognosis. Preliminary studies suggest extensive intraoperative peritoneal lavage (EIPL) may reduce the risk of peritoneal recurrence and improve survival. We sought to perform a randomized phase III study to definitively establish the role of performing EIPL after gastrectomy. Methods: This is a prospective, open-label, phase 3 multicentre randomised con- trolled trial involving 22 hospitals from Korea. China, Japan, Malaysia and Singapore. Patients aged between 21 to 80 years with cT3/4 stomach cancer undergoing curative resection were random- ized to either surgery and EIPL (lavage with 10 litres of saline) or surgery alone. Comparison of DFS and OS were made via log-rank test. The cumulative incidence of peritoneal recurrence was compared using competing risks approach. All analyses were performed based on intention-to- treat. Results: Between March 2015 to August 2018, 800 patients were randomly assigned to surgery alone (n= 402) or EIPL (n= 398). Based on a median follow-up duration of 29 months, the 3- year cumulative incidence of all-cause mortality was 23.1% and 23.3% for EIPL and surgery alone respectively (hazard ratio [HR] = 1.09, 95% CI: 0.78 to 1.52, p = 0.615). Similarly, the 3-year cumulative incidence of recurrence were 28.0% and 25.9% respectively (HR = 1.01, 95% CI: 0.74 to 1.37, p = 0.947), and 7.9% and 6.6% respectively for peritoneal recurrence (Subdistribution HR = 1.33, 95% CI: 0.73 to 2.42, p = 0.347). Overall, the risk of adverse events was higher in EIPL as compared to surgery alone (relative risk = 1.58, 95% CI 1.07 to 2.33, p = 0.019). The most common adverse events were anastomotic leak, bleeding and intra-abdominal abscess. At the planned third interim analysis on 28 August 2019, the predictive probability of achieving even a 5% difference in 3-year OS in favour of EIPL at final analysis was , 0.4%. The trial was thus recommended to terminate on the basis of futility. Conclusions: EIPL does not show any survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for cancer. Clinical trial information: NCT02140034. Research Sponsor: National Medical Research Council Singapore. © 2020 American Society of Clinical Oncology. Visit gicasym.org and search by abstract for disclosure information. ESOPHAGEAL AND GASTRIC CANCER 280 Oral Abstract Session, Thu, 1:30 PM-3:00 PM Early results of the randomized, multicenter, controlled evaluation of S-1 and oxaliplatin as neoadjuvant chemotherapy for Chinese advanced gastric cancer patients (RESONANCE Trial). Xinxin Wang, Shuo Li, Tianyu Xie, Yixun Lu, Xin Guo, Chen Lin; Chinese PLA General Hospital, Beijing, China; Chinese People’s Liberation Army General Hospital, Beijing, China Background: Perioperative chemotherapy brings potential benefits to growing patients with gastric cancer based on several clinical trials including MAGIC, ACTS-GC, CLASSIC and INT- 0116. However, the effect of neoadjuvant therapy before D2 gastrectomy remains pending. According to phase II clinical trials, SOX regimen as neoadjuvant chemotherapy is associated with increased rate of D2 lymph nodes dissection and R0 resection. We hypothesize that SOX regimen can improve survival of patients with gastric cancer. Methods: Through CT, EUS and laparoscopic exploration, patients with gastric cancer on the stage IIA-IIIC were included in the study and divided into 2 groups randomly. Patients in neoadjuvant group received 2-4 cycles of SOX before surgery and 4-6 cycles after surgery, while patients in no neoadjuvant group received 8 cycles after surgery. The primary endpoint was 3-y DFS and the secondary endpoint were 5-y OS, ORR, D2/R0 resection rate and side effect. Results: A total of 772 patients were enrolled in the study between September 2012 and July 2019. After neoadjuvant therapy, the downstaging was found in neoadjuvant group (261/386, 67.6%). The pathological efficiency rate and pCR rate of neoadjuvant group were 67.8% and 23.6% respectively.
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