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GI SLIDE DECK 2018 ESDO
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Letter from ESDO, DEAR COLLEAGUES, It is our pleasure to present this ESDO slide set which has been designed to highlight and summarise. key findings in digestive cancers from the major congresses in 2018 This slide set specifically focuses. on the 20th World Congress on Gastrointestinal Cancer and is available in English French. Japanese and Chinese, The area of clinical research in oncology is a challenging and ever changing environment Within this. environment we all value access to scientific data and research which helps to educate and inspire. further advancements in our roles as scientists clinicians and educators I hope you find this review of. the latest developments in digestive cancers of benefit to you in your practice If you would like to share. your thoughts with us we would welcome your comments Please send any correspondence to. info esdo eu, Finally we are also very grateful to Lilly Oncology for their financial administrative and logistical support. in the realisation of this activity, Yours sincerely. Eric Van Cutsem Ulrich G ller, Thomas Seufferlein Thomas Gr nberger.
C me Lepage Tamara Matysiak Budnik, Wolff Schmiegel Jaroslaw Regula. Phillippe Rougier hon Jean Luc Van Laethem, ESDO Governing Board. ESDO Medical Oncology Slide Deck, Editors 2018, COLORECTAL CANCERS. Prof Eric Van Cutsem Digestive Oncology University Hospitals Leuven Belgium. Prof Wolff Schmiegel Department of Medicine Ruhr University Bochum Germany. Prof Thomas Gruenberger Department of Surgery Kaiser Franz Josef Hospital Vienna Austria. Prof Jaroslaw Regula Department of Gastroenterology and Hepatology Institute of Oncology Warsaw Poland. PANCREATIC CANCER AND HEPATOBILIARY TUMOURS, Prof Jean Luc Van Laethem Digestive Oncology Erasme University Hospital Brussels Belgium. Prof Thomas Seufferlein Clinic of Internal Medicine I University of Ulm Ulm Germany. Prof Ulrich G ller Medical Oncology Hematology Kantonsspital St Gallen St Gallen Switzerland. GASTRO OESOPHAGEAL AND NEUROENDOCRINE TUMOURS, Prof C me Lepage University Hospital INSERM Dijon France.
Prof Tamara Matysiak Hepato Gastroenterology Digestive Oncology Institute of Digestive Diseases. Nantes France, BIOMARKERS, Prof Eric Van Cutsem Digestive Oncology University Hospitals Leuven Belgium. Prof Thomas Seufferlein Clinic of Internal Medicine I University of Ulm Ulm Germany. 1 2 3L first second third line m FOLFOXIRI modified leucovorin PD L1 programmed death ligand 1. 5FU 5 fluorouracil 5 fluorouracil oxaliplatin PI3KCA phosphatidylinositol 3 kinase. AE adverse event irinotecan m PFS median progression free survival. AFP alpha fetoprotein GEJ gastro oesophageal junction PPES palmar plantar erythrodysesthesia. ALP alkaline phosphatase GI gastrointestinal syndrome. ALT alanine aminotransferase GIST gastrointestinal stromal tumour PR partial response. AST aspartate aminotransferase HBV hepatitis B virus PS performance status. BCLC Barcelona clinic liver cancer HCC hepatocellular carcinoma q 2 3 4 6 w every 2 3 4 6 week s. BICR blinded independent central review HCV hepatitis C virus QoL quality of life. bid twice daily HIF 1 hypoxia inducible factor 1 R randomised. BOR best overall response HR hazard ratio RCT randomised controlled trial. BSC best supportive care IHC immunohistochemistry RECIST Response Evaluation Criteria In. CI confidence interval IQR interquartile range Solid Tumors. CPS combined positive score ITT intent to treat RT radiotherapy. CR complete response iv intravenous SAE serious adverse event. CRC colorectal cancer KM Kaplan Meier SD stable disease. CT chemotherapy LV leucovorin Tid three times daily. ctDNA circulating tumour DNA mAb monoclonal antibody TRAE treatment related adverse event. DCR disease control rate mCRC metastatic colorectal cancer TRK tropomyosin receptor kinase. DFS disease free survival met metastasis TRR tumour resection rate. dMMR deficient mismatch repair mPDAC metastatic pancreatic ductal TTP time to progression. m DoR median duration of response adenocarcinoma m TTR median time to response. ECOG Eastern Cooperative Oncology Group MSI H high microsatellite instability tx treatment. EGFR epidermal growth factor receptor Mut mutant VEGF vascular endothelial growth factor. ESCC oesophageal squamous cell cancer NA not available WT wild type. ESMO European Society of Medical NE not evaluable, Oncology NR not reached. FAS full analysis set OR odds ratio, FOLFIRINOX leucovorin 5 fluorouracil irinotecan ORR overall objective response rate. oxaliplatin m OS median overall survival, FOLFOX leucovorin 5 fluorouracil PCR polymerase chain reaction. oxaliplatin PD progressive disease, Cancers of the oesophagus and stomach 6.
Cancers of the pancreas small bowel and hepatobiliary tract 15. Pancreatic cancer 16, Hepatocellular carcinoma 21, Cancers of the colon rectum and anus 30. Note To jump to a section right click on the number and Open Hyperlink. CANCERS OF THE, OESOPHAGUS AND STOMACH, LBA 002 Overall survival results from a phase III trial of trifluridine tipiracil. vs placebo in patients with metastatic gastric cancer refractory to standard. therapies TAGS Tabernero J et al, Study objective, To assess the efficacy and safety of trifluridine tipiracil vs placebo in patients with. metastatic gastric cancer refractory to standard therapies TAS 102 trial. Trifluridine tipiracil, Key patient inclusion criteria. 2 prior regimens n 337, Refractory to last prior, Stratification.
therapy R ECOG PS 0 vs 1, Age 18 years 20 years in 2 1 Region Japan vs rest of world. Prior ramucirumab Y N, ECOG PS 0 1 Placebo BSC, n 507 n 170. PRIMARY ENDPOINT SECONDARY ENDPOINTS, OS PFS ORR DCR QoL time to ECOG PS 2. 35 mg m2 bid orally D1 5 8 12 of each 28 day cycle Tabernero J et al Ann Oncol 2018 29 suppl 5 abstr LBA 002. LBA 002 Overall survival results from a phase III trial of trifluridine tipiracil. vs placebo in patients with metastatic gastric cancer refractory to standard. therapies TAGS Tabernero J et al, Key results, Trifluridine tipiracil Placebo. Primary endpoint OS n 337 n 170, Events n 244 72 140 82.
80 Median months 5 7 3 6, HR 95 CI 0 69 0 56 0 85, 60 1 sided p value 0 0003. Trifluridine tipiracil, 12 month OS 21 Placebo, 12 month OS 13. 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25. Time months, No at risk, Trifluridine tipiracil 337 328 282 240 201 161 124 102 80 66 51 40 31 22 16 11 9 7 7 7 4 4 4 3 1 0. Placebo 170 158 131 101 71 60 47 40 34 29 17 12 10 9 7 5 2 2 0 0 0 0 0 0 0 0. Stratified log rank test Tabernero J et al Ann Oncol 2018 29 suppl 5 abstr LBA 002. LBA 002 Overall survival results from a phase III trial of trifluridine tipiracil. vs placebo in patients with metastatic gastric cancer refractory to standard. therapies TAGS Tabernero J et al, Key results cont. Trifluridine tipiracil Placebo, n 355 n 168, Any AE 97 93.
Grade 3 AEs 80 58, AEs leading to discontinuation 13 17. TRAEs 81 57, Treatment related death 0 3 0 6, The most common haematological laboratory abnormality observed in patients treated with. trifluridine tipiracil n 328 was grade 3 4 neutropenia 38 compared with none in the. placebo arm, In 2 of patients treated with trifluridine tipiracil grade 3 febrile neutropenia was. Treated patients with 1 baseline measurement Tabernero J et al Ann Oncol 2018 29 suppl 5 abstr LBA 002. LBA 002 Overall survival results from a phase III trial of trifluridine tipiracil. vs placebo in patients with metastatic gastric cancer refractory to standard. therapies TAGS Tabernero J et al, Conclusions, In heavily pre treated patients with metastatic gastric cancer trifluridine tipiracil. was associated with a clinically meaningful and statistically significant. improvement in survival vs placebo, No new safety signals were noted and the safety profile was consistent with that.
previously seen in other patient populations, Tabernero J et al Ann Oncol 2018 29 suppl 5 abstr LBA 002. O 010 Cisplatin 5 fluorouracil panitumumab for patients with non. resectable advanced or metastatic esophageal squamous cell cancer. A randomized phase III AIO EORTC trial with an extensive biomarker. program Moehler M et al, Study objective, To assess the efficacy and safety of cisplatin 5FU with or without panitumumab in. patients with ESCC in an AIO EORTC study, Panitumumab. cisplatin 5FU PD, Key patient inclusion criteria n 73. Unresectable locally, advanced or metastatic R, ECOG PS 0 1.
n 146 Cisplatin 5FU, BOR OS PFS and safety, Study stopped early due to futility and potential safety concerns. panitumumab 9 mg kg D1 of each cycle prior to CT q3w cisplatin. 100 mg m2 iv infusion over 2 hours D1 5FU 1000 mg m2 iv infusion. over 24 hours D1 4 q3w Moehler M et al Ann Oncol 2018 29 suppl 5 abstr O 010. O 010 Cisplatin 5 fluorouracil panitumumab for patients with non. resectable advanced or metastatic esophageal squamous cell cancer. A randomized phase III AIO EORTC trial with an extensive biomarker. program Moehler M et al, Key results, 1 0 PFS 1 0 OS. mPFS 5 3 vs 5 8 months mOS 9 4 vs 10 2 months, Survival probability. Survival probability, HR 1 21 95 CI 0 85 1 73 p 0 29 HR 1 17 95 CI 0 79 1 75 p 0 43. 0 6 Cisplatin 5FU panitumumab 0 6, Cisplatin 5FU, Cisplatin 5FU panitumumab.
0 0 0 0 Cisplatin 5FU, 0 200 400 600 800 0 250 500 750 1000 1250. No at risk PFS days No at risk OS days, 68 49 29 15 7 5 4 3 2 72 64 46 31 22 15 12 9 8 6 2 1 0. 68 39 22 12 8 3 2 1 0 73 49 42 30 24 14 9 2 1 1 0 0 0. Moehler M et al Ann Oncol 2018 29 suppl 5 abstr O 010. O 010 Cisplatin 5 fluorouracil panitumumab for patients with non. resectable advanced or metastatic esophageal squamous cell cancer. A randomized phase III AIO EORTC trial with an extensive biomarker. program Moehler M et al, Key results cont, 1 0 CFP arm EGFR 1 0 Serum EGFR. Negative weak Low serum marker, 0 8 Moderate strong 0 8 High serum marker. Survival probability, Survival probability, Censored Censored.
0 200 400 600 0 200 400 600 800 1000, Time days Time days. Panitumumab cisplatin 5FU demonstrated a trend for improved OS in patients who. were EGFR positive compared with cisplatin 5FU alone. An improved PFS was observed in patients with low vs high serum EGFR or HIF 1. p 0 014 and p 0 109 respectively, Moehler M et al Ann Oncol 2018 29 suppl 5 abstr O 010. O 010 Cisplatin 5 fluorouracil panitumumab for patients with non. resectable advanced or metastatic esophageal squamous cell cancer. A randomized phase III AIO EORTC trial with an extensive biomarker. program Moehler M et al, Key results cont, At least one SAE was observed in 83 3 vs 78 6 of patients in the panitumumab. cisplatin 5FU vs cisplatin 5FU arms respectively, The most common grade 3 AEs were low neutrophils 21 vs 24 and anaemia 13. vs 16 in panitumumab cisplatin 5FU vs cisplatin 5FU arms respectively. Conclusions, In patients with locally advanced or metastatic ESCC the addition of panitumumab.
to cisplatin and 5FU was not associated with improved OS compared with cisplatin. EGFR 1 HIF 1 and serum EGFR under EGFR 1 inhibition may be potential. biomarkers in locally advanced or metastatic ESCC, Moehler M et al Ann Oncol 2018 29 suppl 5 abstr O 010. CANCERS OF THE PANCREAS, SMALL BOWEL AND, HEPATOBILIARY TRACT. GI SLIDE DECK 2018 Selected abstracts from Letter from ESDO DEAR COLLEAGUES It is our pleasure to present this ESDO slide set which has been designed to highlight and summarise key findings in digestive cancers from the major congresses in 2018 This slide set specifically focuses on the 20th World Congress on Gastrointestinal Cancer and is available in English French Japanese and Chinese

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