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Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer
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Medical Students 2011 - A. Cervantes - GASTROINTESTINAL CANCER - Pancreatic Cancer

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    • 1. PANCREATIC CANCER A CHALLENGE FOR MODERN MEDICINE IN THE 21 ST CENTURY
    • 2. ETHIOLOGICAL FACTORS <ul><li>TOBACCO 2:1 </li></ul><ul><li>CRONIC PANCREATITIS </li></ul><ul><li>OBESITY </li></ul><ul><li>Not related </li></ul><ul><ul><li>Coffee </li></ul></ul><ul><ul><li>Alcohol </li></ul></ul><ul><ul><li>colelitiasis </li></ul></ul>
    • 3.  
    • 4.  
    • 5.  
    • 6.  
    • 7. EARLY SYMPTOMS Y SIGNS OF PANCREATIC CANCER <ul><li>COMMON </li></ul><ul><ul><li>VISCERAL PAIN </li></ul></ul><ul><ul><li>WEIGHT LOSS </li></ul></ul><ul><ul><li>JAUNDICE (PANCREATIC HEAD) </li></ul></ul><ul><li>LESS FREQUENT </li></ul><ul><ul><li>GLUCOSE INTOLERANCE </li></ul></ul><ul><ul><li>PALPABLE GALLBLADDER </li></ul></ul><ul><ul><li>TROMBOFLEBITIS MIGRANS </li></ul></ul><ul><ul><li>GASTROINTESTINAL BLEEDING </li></ul></ul><ul><ul><li>SPLENOMEGALY </li></ul></ul>
    • 8. CASE 3 A 65 YEAR OLD WOMAN WITH UNRESECTABLE PANCREATIC CANCER <ul><li>DIABETES MELLITUS DIAGNOSED ONE YEAR AGO </li></ul><ul><li>CONSULTED FOR WEIGHT LOSS OF 10KG IN 6 MONTHS, </li></ul><ul><li>ANOREXIA, </li></ul><ul><li>DEPRESSION AND </li></ul><ul><li>BACK PAIN INCREASING AT NIGHTS AND AT SUPINE POSITION THAT ONLY RELIEVES PARTIALLY WITH MOVEMENTS </li></ul>
    • 9. CASE 3 A 65 YEAR OLD WOMAN WITH UNRESECTABLE PANCREATIC CANCER <ul><li>PHYSICAL EXAMINATION: </li></ul><ul><ul><li>NO HEPATOMEGALY </li></ul></ul><ul><ul><li>NO ASCITIS </li></ul></ul><ul><ul><li>NO JAUNDICE </li></ul></ul><ul><ul><li>RETROPERITONEAL PAIN ELICITED BY SOME SPECIFIC MANIOUVERS </li></ul></ul><ul><ul><li>NO EDEMA </li></ul></ul><ul><ul><li>NO PALLOR </li></ul></ul><ul><ul><li>PERFORMANCE STATUS 2 </li></ul></ul>
    • 10. LABORATORY DATA IN PANCREATIC CANCER <ul><li>NONE OF THE IS SPECIFIC </li></ul><ul><li>OBSTRUCTIVE JAUNDICE </li></ul><ul><li>HYPERGLYCEMIA </li></ul><ul><li>CA 19.9 > 600 mU/ml </li></ul>
    • 11. IMAGING FOR DIAGNOSIS AND STAGING PANCREATIC CARCINOMA <ul><li>ABDOMINAL ULTRASONOGRAPHY </li></ul><ul><li>HELYCAL CT-SCAN </li></ul><ul><li>RETROGRADE ENDOSCOPIC COLANGIOGRAPHY </li></ul><ul><li>ENDOSCOPIC ULTRASONOGRAPHY </li></ul><ul><li>MAGNETIC RESONANCE </li></ul><ul><li>ANGIOGRAPHY </li></ul>
    • 12. CASE 3 A 65 YEAR OLD WOMAN WITH UNRESECTABLE PANCREATIC CANCER <ul><li>LABORATORY DATA: </li></ul><ul><ul><li>No anemia </li></ul></ul><ul><ul><li>No liver test alterations </li></ul></ul><ul><ul><li>Glucose: 210 mg/dl </li></ul></ul><ul><ul><li>CA19.9: 1200 IU/ml </li></ul></ul><ul><li>HELICAL CT SCAN OF THE ABDOMEN AND THORAX </li></ul><ul><ul><li>No liver or lung mets </li></ul></ul><ul><ul><li>Tumor located at the pancreatic body infiltrating retroperitoneal tissues and vascular structures (superior mesenteric artery) </li></ul></ul><ul><ul><li>Lymph nodes of significant size in retroperitoneal area </li></ul></ul><ul><li>BIOPSY </li></ul>
    • 13. CLINICAL STAGING OF PANCREATIC CANCER <ul><ul><li>RESECTABLE </li></ul></ul><ul><ul><ul><li>T1-2 NX M0 </li></ul></ul></ul><ul><ul><ul><li>NO CELIAC AXIS INVOLVEMENT </li></ul></ul></ul><ul><ul><ul><li>NO SUPERIOR MESETERIC ARTERIAL INVOLVEMENT </li></ul></ul></ul><ul><ul><ul><li>NO EXTRAPANCREATIC INVOLVEMENT </li></ul></ul></ul><ul><ul><li>LOCALLY AVANCED UNRESECTABLE </li></ul></ul><ul><ul><ul><li>T3 NX-1 M0 </li></ul></ul></ul><ul><ul><ul><li>CELIAC AXIS OR MESENTERIC INVOLVEMENT </li></ul></ul></ul><ul><ul><li>METASTATIC </li></ul></ul><ul><ul><ul><li>METASTASES </li></ul></ul></ul><ul><ul><ul><ul><li>LIVER </li></ul></ul></ul></ul><ul><ul><ul><ul><li>PERITONEAL </li></ul></ul></ul></ul><ul><ul><ul><ul><li>LUNG </li></ul></ul></ul></ul><ul><ul><ul><ul><li>BONE </li></ul></ul></ul></ul>
    • 14.  
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    • 18.  
    • 19.  
    • 20.  
    • 21.  
    • 22.  
    • 23.  
    • 24.  
    • 25. <ul><li>CURE IS SOMEHOW EXCEPTIONAL </li></ul><ul><li>PALLIATIVE THERAPY </li></ul><ul><li>SYMPTOMS CONTROL </li></ul><ul><li>INDUCE OBJECTIVE RESPONSES </li></ul><ul><li>AVOID OR DELAY TUMOR PROGRESSION </li></ul><ul><li>IMPROVE OR MAINTAIN QUOALITY OF LIVE </li></ul><ul><li>PROLONG SURVIVAL </li></ul>AIMS OF TREATMENT FOR PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
    • 26. CASE 3 A 65 YEAR OLD WOMAN WITH UNRESECTABLE PANCREATIC CANCER <ul><li>Therapeutic plan </li></ul><ul><ul><li>Control pain and anorexia-caquexia </li></ul></ul><ul><ul><li>Palliative chemotherapy with gemcitabine </li></ul></ul><ul><ul><li>Do consider experimental approaches </li></ul></ul>
    • 27. CLINICAL BENEFIT USE OF ANALGESICS PAIN INTENSITY PAIN PERFORMANCE STATUS RESPONSE STABLE NO RESPONSE RESPONSE NO RESPONSE WEIGHT
    • 28. GEMCITABINE 5-FU NR PATIENTS 63 63 TIME TO PROGRESSION p median 2.33 m .0002 0.92 m 6 months 22% 5% 12 months 9% 5% SURVIVAL median 5.65 m .0025 4.41 m 6 months 46% 31% 12 months 18% 2% CLASICAL PARAMETERS : 5FU BOLUS VS GEMCITABINE IN ADVANCED PANCREATIC CANCER
    • 29. GEMCITABINE 5-FU Nr. Patients 63 63 Pain improvement 23.8% 4.8% Pain improvement With improved or stable PS 23.8% 4.8% Clinical benefit 23.8% 4.8% p=0.0022 CLINICAL BENEFIT: 5FU BOLUS VS GEMCITABINE IN ADVANCED PANCREATIC CANCER
    • 30. GEMCITABINE 5-FU Nr. Patients 63 63 Pain improvement 23.8% 4.8% Pain improvement With improved or stable PS 23.8% 4.8% Clinical benefit 23.8% 4.8% p=0.0022 CLINICAL BENEFIT: 5FU BOLUS VS GEMCITABINE IN ADVANCED PANCREATIC CANCER BURRIS et al, J Clin Oncol 1997 .
    • 31. STATHIS et al. Nat Rev Clin Oncol 2010
    • 32. Heinemann V, et al BMC Cancer 2008
    • 33. Heinemann V, et al BMC Cancer 2008
    • 34. STATHIS et al. Nat Rev Clin Oncol 2010
    • 35.  
    • 36.  
    • 37. Stratified by: - Center - PS (0/1 vs 2) - Stage of disease (locally advanced vs distant metastases) RANDOM I ZE Gemcitabine 1000 mg/m 2 IV + ERLOTINIB 100/150 mg po daily Gemcitabine 1000 mg/m 2 IV + Placebo 100/150 mg po daily GEMCITABINE +/- ERLOTINIB IN ADVANCED PANCREATIC CANCER : Design of PA.3 trial
    • 38. GEMCITABINE +/- ERLOTINIB IN ADVANCED PANCREATIC CANCER : Overall Survival
    • 39.  
    • 40. A MULTIDISCIPLINARY APPROACH IS NEEDED TO TREAT PANCREATIC CANCER PANCREATIC CANCER IS RARELY CURED WITH SURGERY RESECTABILITY R0 RATE: 10-15% MEDIAN SURVIVAL: 11-13 MontHs 5-YR SURVIVAL: 15-20%
    • 41. A MULTIDISCIPLINARY APPROACH FOR PANCREATIC CANCER TREATMENT PANCREATIC CANCER IS A A SYSTEMIC DISEASE ROLE OF ADJUVANT THERAPY CONTROL OF MICROMETASTATIC DISEASE REDUCE LOCAL AND SYSTEMIC RELAPSES DELAY RELPASES INCREASE SURVIVAL IMPROVE QUALITY OF LIFE
    • 42. Signal transduction pathways via Ras and PI3K/Akt that cause cell proliferation and survival ■ EGFR ■ IGF‑1R ■ HGFR ■ VEGFR Developmental signaling pathways that can cause tumor progression and resistance to chemotherapy ■ Hedgehog ■ Notch ■ Wnt Tissue invasion and neovascularization ■ MMP DNA damage control and impaired apoptosis ■ p53 ■ p14 ARF/p16INK4A ■ SMAD4/TGF‑b PATHWAYS INVOLVED IN PANCREATIC CANCER
    • 43. <ul><li>THE ABILITY TO UNDERGO SELF RENEWAL </li></ul><ul><li>THE DEVELOPMENTAL POTENTIAL TO RECAPITULATE ALL THE CELL TYPES FOUND IN A GIVEN TISSUE </li></ul><ul><li>SURFACE MARKERS: CD34+, CD44+, CD133+, ABCB5 </li></ul><ul><li>RESISTANCE TO CONVENTIONAL CT AND RT </li></ul>THE CANCER STEM CELLS : MAIN PROPERTIES Jordan CT. Cell Stem Cell 2009; 4:203.
    • 44. THE CANCER STEM CELL HYPOTHESIS: THERAPEUTIC STRATEGIES TO TARGET TUMOUR-INITIATING CELLS Sergeant G., et al Nature Rev Clin Oncol 2009; 6:580.
    • 45. THE CANCER STEM CELL HYPOTHESIS: THERAPEUTIC STRATEGIES TO TARGET TUMOUR-INITIATING CELLS Zhou BS. Nature Rev Drug Discov 2009; 8:806.
    • 46. THE CANCER STEM CELL HYPOTHESIS: THERAPEUTIC STRATEGIES TO TARGET TUMOUR-INITIATING CELLS Zhou BS. Nature Rev Drug Discov 2009; 8:806.
    • 47. A MULTIDISCIPLINARY APPROACH IS NEEDED TO TREAT PANCREATIC CANCER PANCREATIC CANCER IS RARELY CURED WITH SURGERY RESECTABILITY R0 RATE: 10-15% MEDIAN SURVIVAL: 11-13 MontHs 5-YR SURVIVAL: 15-20%
    • 48. Adjuvant treatment in resected Pancreatic Cancer ESPAC-1 <ul><li>Pancreatic or ampullary adenocarcinoma, R0 or R1 </li></ul>Observation N=69 Chemoradiation N=73 Chemotherapy N=75 CRT and chemotherapy N=72 Treatment comparison Chemoradiotherapy vs. no CRT (144 vs. 145) Chemotherapy vs. no chemotherapy (142 vs. 147) R Neoptolemos et al, NEJM 2004
    • 49. Survival rates 2-year 5-year No CRT: 41.4% 19.6% CRT: 28.5% 10.0% HR=1.28 (0.99, 1.66), p=0.053 ESPAC-1 NEJM 2004 ; 350:1200-10 ESPAC-1 NEJM 2004 : No benefit for Chemoradiation confirmed
    • 50. Survival rates 2-year 5-year No CT: 30.0% 8.4% CT: 39.7% 21.1% HR=0.71 (0.55, 0.92), p=0.009 ESPAC-1 NEJM 2004; 350:1200-10 ESPAC-1 NEJM 2004 : Benefit for Chemotherapy confirmed
    • 51. Adjuvant treatment in resected Pancreatic Cancer CONKO-001 Trial Design R0 or R1 resected Pancreatic Ca N=368 R Gemcitabine 1000mg/m 2 d1,8,15 q28d x6 Observation <ul><li>Stratified by: </li></ul><ul><li>R0 v R1 </li></ul><ul><li>T1/2 v T3/4 </li></ul><ul><li>N+ v N- </li></ul><ul><li>Primary Endpoint: </li></ul><ul><li>Disease free survival </li></ul><ul><li>Secondary Endpoints: </li></ul><ul><li>Toxicity, Quality of life, Overall survival </li></ul>Oettle JAMA 2007
    • 52. Adjuvant treatment in resected Pancreatic Cancer CONKO-001- Results (ITT) Oettle JAMA 2007
    • 53. Adjuvant treatment in resected Pancreatic Cancer CONKO-001- Results (ITT) Oettle JAMA 2007
    • 54. ESPAC-3(v1) Trial Design Patients with ductal adenocarcinoma undergoing ‘curative’ resection Target N=990 RANDOMISE 5FU/ FA 5-FU 425mg/m 2 & FA 20mg/m 2 for 5 days every 28 days for 6 cycles Target N=330 GEMCITABINE 1000mg/m 2 once a week for 3 of 4 weeks for 6 cycles Target N=330 OBSERVATION Target N=330 330 per group to detect 10% difference in 2y survival rate (  = 5%, 1-  = 80%) Trial opened July 2000
    • 55. ESPAC-3(v2) Trial Design Patients with ductal adenocarcinoma undergoing ‘curative’ resection Target N=1030* RANDOMISE 5FU/ FA Target N=515 Actual=551 GEMCITABINE Target N=515 Actual N=537 3-monthly follow-up to death 515 per group to detect 10% difference in 2y survival rate (  = 5%, 1-  = 90%) *Actual N=1088
    • 56. Br J Cancer 2009; 100 :246-50 No. at risk Gemcitabine Observation Cumulative survival % Months Disease free survival Observation Gemcitabine Oettle et al JAMA, 2007 17;297:267-77 CONK01 Adjuvant Trial: Gemcitabine vs Observation ESPAC Adjuvant Trials: 5FU/FA vs Observation Survival rates 2-year 5-year Obs: 37% 14% 5FU/FA: 49% 24% Overall survival N = 458 N = 354 Log rank p < 0.001 Cumulative survival % HR= 0.68 (0.50, 0.92) p = 0.001 In the meantime!
    • 57. Survival by Treatment Median S(t)= 23.0 months (95%CI:21.1, 25.0) Median S(t)= 23.6 months (95%CI:21.4, 26.4)  2 LR =0.74, p=0.39, HR GEM VS 5FU/FA =0.94 (95%CI: 0.81, 1.08) ESPAC 3 RESULTS REPORTED AT ASCO 2009
    • 58. PFS by Treatment Median PFS(t)= 14.1months (95%CI:12.5, 15.3) Median PFS(t)= 14.3months (95%CI:13.5, 15.7)  2 LR =0.59, p=0.44, HR GEM VS 5FU/FA =0.95 (95%CI: 0.83, 1.09) ESPAC 3 RESULTS REPORTED AT ASCO 2009
    • 59. Reported Toxicity Number of patients with at least one NCI CTC v2. grade 3/4 event * Exploratory analysis: sig level p<0.005 using Bonferroni adjustment p=0.013 p=0.94 p=0.0034* p=0.37 p=0.34 p<0.001* p=1.0 p=0.16 p<0.001* p=0.027 5FU/FA GEM CTC 3/4 (% of 551 pts) CTC 3/4 (% of 537 pts) WBC 32 (6%) 53 (10%) Neutrophils 121 (22%) 119 (22%) Platelets 0 8 (1.5%) Nausea 19 (3.5%) 13 (2.5%) Vomiting 17 (3%) 11 (2%) Stomatitis 54 (10%) 1 (0%) Alopecia 1 (0%) 1 (0%) Tiredness 45 (8%) 32 (6%) Diarrhoea 72 (13%) 12 (2%) Other 67 (12%) 43 (8%)
    • 60. Adjuvant treatment in resected Pancreatic Cancer ESPAC-4 proposal Gemcitabine + Capecitabine Gemcitabine Primary Outcome: Overall Survival Resected pancreatic cancer Secondary Outcomes: DFS, Toxicity, QOL
    • 61. Adjuvant Chemotherapy for Resected Pancreatic Cancer <ul><ul><li>We have information from two well designed positive randomized studies showing survival benefit </li></ul></ul><ul><ul><li>Better staging system and optimal surgical centers with high volume and good experience should be a priority </li></ul></ul><ul><ul><li>FU/LV or gemcitabine are useful agents </li></ul></ul><ul><ul><li>Gemcitabine is preferred for its more favourable profile </li></ul></ul><ul><ul><li>It is a well established standard of care with evidence level I recommendation grade A </li></ul></ul>

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