A. Casadei Gardini

A. Passardi

A. Zaniboni

C. Manai

F. Bergamo

F. Nappo

G. Orsi

G. Pugliese

K. Andrikou

L. Procaccio

M. Libertini

M. Puzzoni

M. Scartozzi

M. Schirripa

M.L. Riggi

N. Silvestris

S. Cascinu

S. Vallarelli

V. Zagonel

English

Open Access Repository

using N- cases was performed to determine which nodal cut-offs and variables best pre-dicted survival.Results: 613 cases of non-metastatic SBA (183 N- and 430 Nþ) diagnosed from 2004 to2014 were analyzed. T stage and nodal sampling were the only two variables that dif-fered statistically between N- and Nþ cases (Table). Using the Log-rank test, a statisti-cal separation in survival curves was identified at a minimum of>¼13 NNE(p¼ 0.0136), a maximum of>¼21 NNE (p¼ 0.0142), and with the greatest statisticalseparation at>¼17 NNE (p¼ 0.0003). Out of age, gender, race, grade,>¼13NNE,>¼17 NNE,>¼ 21 NNE, and T stage, only age, node cut-off of>¼17 (HR0.47, p¼.0032) and T stage remained after stepwise selection of variables for Coxregression modelling. ROC’s for Cox Regression models at 60 months, which includedAge, T stage and either>¼ 13 NNE,>¼ 17 NNE, or>¼ 21 NNE were associated withAUC’s of 0.700, 0.717 and 0.667, respectively.Table: 773PNode - Node þ pMedian Nodes Sampled 9 12 0.0008Proportion of Cases by T StageT1 10.9% 0.7% <.0001T2 11.5% 1.6% <.0001T3 60.7% 45.4% 0.0006T4 16.9% 52.3% <.0001Conclusions: N- SBAs are associated with decreased nodal sampling compared to NþSBAs. Low sampling is associated with decreased survival, possibly related to the pres-ence of occult nodal disease. While further work is needed to determine what is consid-ered adequate nodal sampling in N- SBA’s, this analysis suggests that N- cases whereless than 17 nodes have been examined have a poorer outcome.Legal entity responsible for the study: Maclean Thiessen.Funding: Has not received any funding.Disclosure: All authors have declared no conflicts of interest.774P The role of adjuvant therapy in resectable SBA: A different cliniciansattitude with a relevant impact on outcomeG. Orsi1, K. Andrikou1, F. Bergamo2, F. Nappo3, C. Manai2, A. Passardi4, M. Puzzoni5,S. Vallarelli6, M. Libertini7, M.L. Riggi1, G. Pugliese8, A. Zaniboni7, M. Schirripa9,L. Procaccio3, N. Silvestris10, M. Scartozzi5, A. Casadei Gardini4, V. Zagonel2, S. Cascinu81Department of Oncology/Hematology, University of Modena and Reggio Emilia, ModenaCancer Center, Modena, Italy, 2Medical Oncology Unit 1, Department of Clinical andExperimental Oncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy,3Medical Oncology 1, Department of Clinical and Experimental Oncology, IstitutoOncologico Veneto IRCCS, Padua, Italy, 4Medical Oncology, Istituto Scientifico Romagnoloper lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy, 5University of Cagliari,Department of Medical Oncology, Cagliari, Italy, 6Istituto Tumori "Giovanni Paolo II",Medical Oncology Unit, National Cancer Research Centre, Bari, Italy, 7FondazionePoliambulanza, Oncology Department, Brescia, Italy, 8Oncologia, Azienda Ospedaliero -Universitaria Policlinico di Modena, Modena, Italy, 9Medical Oncology, IstitutoOncologico Veneto IRCCS, Padua, Italy, 10Istituto Tumori "Giovanni Paolo II", MedicalOncology Unit and Scientific Direction, National Cancer Research Centre, Bari, ItalyBackground: Small bowel adenocarcinoma (SBA) is a rare malignancy that accountsfor 1-2% of gastrointestinal tumours. We evaluated the clinico-pathological character-istics, outcomes and prognostic factors of patients who underwent surgery for SBA.Methods: We retrospectively analysed the features and outcome parameters of 54 SBApatients from 6 italian institutions between 2005 and 2017.Results: The primary tumour was in the duodenum, jejunum and ileum in 30 (55.6%), 18(33.3%) and 6 (11.1%) patients, respectively. Among the 54 patients studied, adjuvantchemotherapy were performed in 35.2 % of patients with stage II and in 27.8 % of patientswith stage III. Relapse rates were higher for chemonaive patients compared to treatedpatients (50% vs 23.5%). Median overall (OS) and progression-free survival (PFS) were26.98 and 19.78 months, respectively. Duodenal adenocarcinoma (p¼ 0.022), lymphnode metastases (p¼ 0.00269), long-term treatment with metformin (p¼ 0.0095), noadjuvant treatment (p¼ 0.0006) and PLR>0,1766 (p¼ 0,0137) were associated withpoor overall survival outcomes. The factors associated with PFS were patients with olderage (>75 years) (p¼ 0.04) and T4 according to TNM system (p¼ 0.02).Conclusions: The lack of well-defined guidelines for treatment of SBA justifies the het-erogeneity of therapeutic choices resulting in negative impact on patient outcomes.Thus, there is an urgent need for prognostic and predictive biomarkers to guide therapydecisions for these patients. Our results suggest that the site, lymph node metastases,metformin and PLR>0,1766 could be novel prognostic markers for SBA patients whoundergo curative surgery. However, prospective studies are necessary to confirm therole of these factors and identify new potential biomarkers of treatment efficacy, thatcould improve the selection of the right treatment for the right patient.Legal entity responsible for the study: Modena University Hospital.Funding: Has not received any funding.Disclosure: All authors have declared no conflicts of interest.775TiP A phase III, randomized, open-label study to compare the efficacy oftislelizumab versus chemotherapy as second-line therapy foradvanced unresectable/metastatic esophageal squamous cellcarcinoma (ESCC)L. Shen1, J.A. Ajani2, S-B. Kim3, E. Van Cutsem4, B. Guo5, J. Song6, V. Paton7, K. Kato81GI Oncology, Peking University Cancer Hospital & Institute, Beijing, China, 2MDAnderson Cancer Center, The University of Texas, Houston, TX, USA, 3Oncology, AsanMedical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea,4Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium, 5MedicalOncology, BeiGene (Beijing) Co., Ltd., Beijing, China, 6Biometry, BeiGene USA, Inc., Fort Lee,NJ, USA, 7Clinical Development, BeiGene USA, Inc., Emeryville, CA, USA, 8GastrointestinalMedical Oncology Division, National Cancer Center Hospital, Tokyo, JapanBackground: Approximately 40% of patients (pts) with esophageal cancer are diagnosedwith advanced unresectable or metastatic disease; the 5-year survival rate for advanced dis-ease is< 5%. Inhibition of PD-1 has demonstrated antitumor activity and was generallywell tolerated in pts with advanced unresectable or metastatic ESCC. Tislelizumab, ahumanized IgG4 monoclonal antibody, has high affinity and specificity for PD-1.Tislelizumab was specifically engineered to minimize Fc!R binding on macrophages that,based on preclinical evidence, is believed to minimize potentially negative interactionswith other immune cells. A first-in-human study (NCT02407990) demonstrated that sin-gle-agent tislelizumab was generally well tolerated and had preliminary antitumor effectsin pts with solid tumors, including ESCC. A recommended phase 3 dose of 200 mg admin-istered IV every 3 weeks (Q3W) has been established for tislelizumab.Trial design: This phase 3, randomized study (NCT03430843) was designed to evaluatethe efficacy, safety, and tolerability of tislelizumab compared with chemotherapy for sec-ond-line treatment of advanced unresectable/metastatic ESCC. Adult pts, aged18 years,with histologically or cytologically confirmed ESCC that has progressed with first-linetherapy, have1 measurable/evaluable lesion, and have an Eastern CooperativeOncology score1 will be enrolled. Approximately 450 pts will be randomized (1:1) toreceive either tislelizumab 200 mg IV Q3W or investigator-chosen chemotherapy (pacli-taxel 135–175 mg/m2 IV Q3W or 100 mg/m2 IV weekly for 6 weeks with 1 week of rest[Japan only], docetaxel 75 mg/m2 or 70 mg/m2 IV Q3W, or irinotecan 125 mg/m2 IVQ3W). Overall survival is the primary endpoint; secondary endpoints include objectiveresponse rate, progression free survival, duration of response, and health-related quality-of-life outcomes. Safety/tolerability will be assessed by monitoring adverse events (AEs),including immune-related AEs, as well as physical examinations, vital signs, and electro-cardiograms. As of 11 April 2018, 6 patients have been enrolled.Clinical trial identification: NCT03430843.Editorial acknowledgement: Medical writing and editorial assistance was provided byRegina Switzer, PhD (SuccinctChoice Medical Communications, Chicago, IL).Legal entity responsible for the study: BeiGene, Ltd.Funding: BeiGene, Ltd.Disclosure: J.A. Ajani: Honoraria, research funding: BWS, Five Prime Therapeutics,Medscape, Celgene, Taiho Pharmaceutical, Merck, Delta-Fly, Gilead. E. Van Cutsem:Consulting role, research funding: Baxter, Lilly, Roche, Servier, Amgen, Bayer,Boehringer, Celgene, MSO, Merck, Novartis, Ipsen, Roche, Sanofi. B. Guo: Employee,ownership interest: BeiGene. J. Song, V. Paton: Employee: BeiGene. K. Kato:Consulting role, speakers’ bureau, research funding: Beigene, MSD, OnoPharmaceutical, BMS, Eli Lilly, Shionogi, Merck Serono. All other authors havedeclared no conflicts of interest.776TiP Global phase III study of tislelizumab versus sorafenib as first-linetreatment in patients with advanced hepatocellular carcinoma (HCC):A trial-in-progressS. Qin1, R.S. Finn2, M. Kudo3, T. Meyer4, A. Vogel5, M.P. Ducreux6, T.M. Macarulla7,G. Tomasello8, F. Boisserie9, J. Hou10, C. Li11, J. Song12, A.X. Zhu131Medical Oncology, People’s Liberation Army (PLA) 81 Hospital, Nanjing, China, 2Schoolof Medicine, University of California Los Angeles, Los Angeles, CA, USA, 3Department ofGastroenterology and Hepatology, Kindai University School of Medicine, Osaka, Japan,4Medical Oncology, University College London Cancer Institute, London, UK, 5MedicalOncology, Medizinische Hochschule Hannover, Hannover, Germany, 6MedicalOncology, Gustave Roussy, Villejuif, France, 7Vall d’Hebron Institute of Oncology (VHIO),Vall d’Hebron University Hospital (HUVH), Barcelona, Spain, 8Medical Oncology,Azienda Istituti Ospitalieri di Cremona, Cremona, Italy, 9Clinical Science, BeiGene USA,Inc., Fort Lee, NJ, USA, 10Immuno-Oncology, BeiGene USA, Inc., Emeryville, CA, USA,11Medical Oncology, BeiGene (Beijing) Co., Ltd., Beijing, China, 12Biometry, BeiGene USA,Inc., Fort Lee, NJ, USA, 13Harvard Medical School, Massachusetts General HospitalCancer Center, Boston, MA, USABackground: Unresectable HCC accounts for 70% of diagnosed HCC. Tislelizumab isa humanized IgG4 monoclonal antibody with high affinity and specificity for pro-grammed cell death receptor-1 (PD-1). Tislelizumab was specifically engineered toabstracts Annals of Oncologyviii264 | Gastrointestinal tumours, non-colorectal Volume 29 | Supplement 8 | October 2018Downloaded from https://academic.oup.com/annonc/article-abstract/29/suppl_8/mdy282.157/5142179 by guest on 05 January 2019

the role of adjuvant therapy in resectable sba a different clinicians attitude with a relevant impact on outcome

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the role of adjuvant therapy in resectable sba a different clinicians attitude with a relevant impact on outcome

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