Legal entity responsible for the study: Cumhuriyet University Faculty of Medicine. Funding: Has not received any funding.
Disclosure: All authors have declared no conflicts of interest.
694P Differences in presentation and outcomes among young and old patients with gastric cancer
M. Al Otaibi1 , J. Al Barak2
, J. Al Abbad1 , A. Akbar3 1
Medical Oncology Department, Kuwait Cancer Control Centre Al Sabah Hospital, Shuwaikh, Kuwait,2
Medical Oncology, Kuwait Cancer Control Center, Kuwait, 3
Histopathology Department, Kuwait Cancer Control Centre Al Sabah Hospital, Shuwaikh, Kuwait
Background: The worldwide incidence of gastric cancer (GC) has been increasing in young patients (YP) over the past few decades. It is unclear whether there are differen-ces in disease characteristics and prognosis between YP and older patients (OP). This review examines the differences in presentation and outcomes between YP and OP. Methods: A retrospective review of all cases of sporadic GC referred to the Kuwait Cancer Control Center (KCCC) between 2008 and 2016 was conducted. We collected data on patients’ demographics, risk factors, disease clinicopathologic characteristics, stage at diagnosis and survival. Patients at the age of 50 years or younger at the time of diagnosis were designated as YP. Continuous variables were summarized with mean and standard deviation, or median and interquartile range (IQR) as appropriate and compared with Mann-Whitney U test. Categorical variables were described as frequen-cies (percent) and compared with Fisher’s exact test. A level of 0.05 was defined as stat-istically significant.
Results: Evaluable data were available for 167 patients. 52 (31.1%) where YP. The mean age was 43.2 (65.7) years for YP compared with 64.3 (68.4) years for OP. In YP 63.5% were males compared to 72.2% in EG, p¼ 0.28. YP tends to present more with epigas-tric pain as opposed to OP who presented with GI bleed (hematemesis, melena or symptomatic anemia). There were less smokers in YP (23.1%) relative to OP (42.5%), p¼ 0.009. We found no difference with regards to family history, H. Pylori status, his-tological subtype, grade or stage at diagnosis. The overall survival was 78.8% for YP ver-sus 63.5% for OP, p¼ 0.051.
Conclusions: Compared to their older counter parts, YP with GC tend to present with more epigastric pain and less likely to be smokers. No significant differences were found in disease characteristics or outcomes between YP and OP. More research is needed to further understand the raise of GC among YP.
Legal entity responsible for the study: Ministry of Health of Kuwait. Funding: Has not received any funding.
Disclosure: All authors have declared no conflicts of interest.
695P Prospective observational cohort study of oesophagogastric cancer patients (POCOP): A Dutch nationwide cohort
J.J. van Kleef1 , L.V. van de Poll-Franse2 , R.H. Verhoeven3 , M. Slingerland4 , J.P. Ruurda5 , J. Heisterkamp6 , C. Rosman7 , J.W.B. de Groot8 , E.A. Kouwenhoven9
, M.A. van Dijk10
, E. de Graaf11 , T. van Voorthuizen12 , F. Daams13 , S. Lagarde14 , G.A.P. Nieuwenhuijzen15 , J. Vincent16
, M. van Berge Henegouwen17
, M.G.H. van Oijen1
, M.A.G. Sprangers18
, H.W.M. van Laarhoven1
1
Department of Medical Oncology, Academic Medical Center (AMC), Amsterdam, Netherlands,2
Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands,3
Department of Research, Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands,4
Department of Medical Oncology, Leiden University Medical Center (LUMC), Leiden, Netherlands,
5
Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands,
6
Department of Surgery, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands,
7
Department of Surgery, Radboud University Medical Center, Nijmegen, Netherlands,
8
Department of Medical Oncology, Isala Hospital, Zwolle, Netherlands,9
Department of Surgery, HospitalGroup Twente (ZGT), Almelo, Netherlands,10
Department of Medical Oncology, ZorgSaam Hospital, Terneuzen, Netherlands,11
Department of Medical Oncology, Reinier de Graaf Hospital, Delft, Netherlands,12
Department of Medical Oncology, Rijnstate Hospital, Arnhem, Netherlands,13
Department of Surgery, VU Medical Center, Amsterdam, Netherlands,14
Department of Surgery, Erasmus Medical Center, Rotterdam, Netherlands,15
Department of Surgery, Catharina Cancer Institute, Catharina Hospital, Eindhoven, Netherlands,16
Department of Medical Oncology, Elkerliek Hospital, Helmond, Netherlands,17
Department of Surgery, Academic Medical Center, Amsterdam, Netherlands,18
Department of Medical Psychology, Academic Medical Center (AMC), Amsterdam, Netherlands
Background:POCOP is a novel prospective scientific database including oesophago-gastric cancer patients, initiated by the Dutch Upper GI Cancer Group (DUCG) to stimulate multidisciplinary research. Within POCOP treatment and diagnostic strat-egies as well as prognostic and predictive factors for outcome can be evaluated on a population-based level. We present the design and current proceedings. Methods:All patients with oesophagogastric cancer in the Netherlands are eligible. Patients need to provide consent for: 1) the reuse of clinical data collected by the Netherlands Cancer Registry (NCR), 2) longitudinal collection of patient reported
outcomes (PROs), receiving future information on new interventional studies (includ-ing cohort multiple randomized controlled trials (cmRCT)), and/or 3) linkage with Dutch databases e.g. the Dutch Upper GI Cancer Audit, the biobank of The Parelsnoer Institute and general practitioner databases. Funding: Dutch Cancer Society (UVA 2014-7000).
Results:Thus far, clinical data is being collected from almost all Dutch patients with oesophagogastric cancer diagnosed from 2015 onwards. Clinical data mainly consist of patient, tumour and multidisciplinary sequential treatment characteristics. The collec-tion of longitudinal PROs started in 2016. Of all patients who gave consent (N¼ 1000), 92% also participated in the PRO-registry. PRO compliance was 87%, 67% and 46% (not accounted for death or drop-out) at diagnosis, 3 and 6 months follow-up, respec-tively. 81% of patients consented to receive future information on new interventional studies, including cmRCTs. Collaborations with phase II/III trials and other cohort studies were established to reduce patient burden regarding completion of PROs and trial registration burden. Obtained data is governed by the DUCG scientific committee which includes members of participating hospitals, the study team and the NCR. Conclusions:POCOP provides real world population-based data to stimulate (inter-)national multidisciplinary research and provides the opportunity to perform novel tri-als within the established infrastructure. Researchers can acquire data by submitting a research proposal to the scientific committee of the DUCG (www.ducg.nl). Legal entity responsible for the study:Dutch Upper GI Cancer Group. Funding:Dutch Cancer Society.
Disclosure:J.W.B. de Groot: Advisory role: BMS and MSD. T. van Voorthuizen: Travel, accomodations, expenses: Ipsen, Astellas M. van Berge Henegouwen: Consulting/advisory: Olympus, Covidien; Research funding: Olympus; Travel, accom-odations, expenses: Johnson&Johnson M.G.H. van Oijen: Research funding: Bayer, BMS, Celgene, Lilly, Merck Serono, MSD, Nordic, Roche. H.W.M. van Laarhoven: Consultancy: Celgene, Lilly, Nordic. Research funding: Bayer, Lilly, Merck Serono, Roche. All other authors have declared no conflicts of interest.
697P A phase I, open-label, multi-center, dose-escalation study of codrituzumab, an anti-glypican-3 monoclonal antibody, in combination with atezolizumab in patients with locally advanced or metastatic hepatocellular carcinoma
A-L. Cheng1 , C-J. Yen2 , T. Okusaka3 , M. Ikeda4 , C-H. Hsu1 , S-Y. Wu2 , C. Morizane3 , Y. Hashimoto5 , K. Ueshima6 , T. Ohtomo7 , T. Tanaka8 , M. Kudo6 1
Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan, 2
Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan,3
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan,4
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan,5
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan,6
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan,7
Oncology Lifecycle Management Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan,8
Translational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
Background: Codrituzumab (Cod) is a recombinant humanized monoclonal antibody against Glypican-3 (GPC3). GPC3 is over-expressed in hepatocellular carcinoma (HCC). Cod elicits antibody-dependent cellular cytotoxicity against human HCC cell lines and shows more potent tumor activity when combined with PD-L1 anti-body in syngeneic mouse model. This is a phase I dose-escalation study to evaluate safety/tolerability and pharmacokinetics in combination with the anti-PD-L1 antibody, atezolizumab (Atezo) in advanced HCC patients.
Methods: This study is composed of a 3þ 3 dose-escalation part and an expansion part. Patients with advanced or metastatic HCC who had failed prior systemic therapy, GPC3 high expression, ECOG PS 0-1, Child-Pugh A-B7 were eligible. Cod given intra-venously 800 or 1600 mg on Day 1, 4, then weekly from Day 8 combined with 1200 mg every 3 weeks dosing of Atezo until disease progression/toxicity. The objectives were to determine MTD of Cod and Atezo combination primarily, to assess safety, antitumor effect (RECIST 1.1) and pharmacokinetics secondarily, and to assess biomarkers exploratory.
Results: Ten patients each were enrolled in dose-escalation and expansion parts, respectively. There were 16 men/4 women, median age 58, all Asian, HBV/HCV/neither 11/4/5, ECOG 0/1 15/5. No dose limiting toxicities were observed in dose-escalation part. The most frequently observed adverse events (AEs) were pyrexia (80%), fatigue (50%), decreased appetite (30%), aspartate aminotransferase increased, lymphocyte count decreased (25%), constipation, cough, nasopharyngitis (20%). Grade 3 or higher AEs ( 2 patients) were aspartate aminotransferase increased, lymphocyte count decreased (20%), anemia (15%), and ascites (10%). There was 1 confirmed PR, 10 SD (including 1 unconfirmed PR) among 18 evaluable patients and 6 of them had SD for more than 6 months before progression.
Conclusions: Codþ Atezo combination was well-tolerated and showed antitumor activity in this advanced, previously treated and GPC3 highly expressed HCC patients. Clinical trial identification: JapicCTI-163325 Registered date: 22/07/2016. Legal entity responsible for the study: Chugai Pharmaceutical Co., Ltd. Funding: Chugai Pharmaceutical Co., Ltd.
