Pancreatic Cancer. BIOLOGY: Not well defined (genetic and enviromental factors) CLINICAL PRESENTATION: Abd pain, jaundice, weight loss.

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1 EloreMed Editor: Le Wang, MD, PhD Date of Update: 2/6/2018 UpToDate: Liposomal irinotecan (Onivyde) plus FU/LV is now approved for gemcitabine-refractory metastatic pancreatic cancer and recommended by NCCN as category 1 second line therapy. INTRODUCTION: 4th leading cause of cancer-related deaths in US. 60% of pancreatic cancers are unsectable at presentation. Only 15-20% are candidate for surgery at diagnosis. RISK FACTORS: A. Non-hereditary risk factor: Chronic pancreatitis, pancreatic cyst Diabetic, insulin resistance Smoking, obesity, physical inactive Diet: high fat/cholesterol (NOT high protein) Ethinicity: black > white B. Hereditary risk factors: Peutz-Jegher syndrome: STK11 gene mutation, RR=132 Familial atypical multiple mole melanoma syndrome (FAMMM ): CKDN2A mutation, RR = HNPCC: DNA-mismatch gene mutations, RR =8.6 Hereditary breast ovarian cancer syndrome (HBOC): BRCA1/2. RR = Familial pancreatic cancer: RR = 4-6 BIOLOGY: Not well defined (genetic and enviromental factors) CLINICAL PRESENTATION: Abd pain, jaundice, weight loss. DIAGNOSIS: A. Pancreatic Mass Evaluation: Multiphase CT with pancreatic protocol or MRI. Page 1 of 5

2 CT chest If no distant metastasis on CT scan, the patient should be immeidately evaluated for surgical resection. * If surgery has to delayed due to jaundice, fever or cholangitis, then consider stent placement and ERCP for biopsy. * If metastatic disease is present, biopsy of the metastatic sites is preferred. B. Other evaluation: CA 19-9: often elevated * CA19-9 can be negative in lewis antigen-negative patient. Live function tests Genetic testing: indicated for young patients, family history of pancreatic cancers or Ashkenazi Jew PATHOLOGY: A. Classification: Invasive ductal adenocarcinoma Pancreatic intraepithelial neoplasma (PanINs): precursor for invasive cancer Intraductal papillary mucinous neoplasm of the pancreas (IPMN): * non-invasive: cystic tumor, cured by surgery alone * invasive, frequently recur after "complete" curative surgery, poor prognosis, treated as invasive pancreatic cancer B. Staging (Key Points): T1: limited to pancreas, <2cm T2: limited to pancreas, >2cm T3: extend beyond pancreas, but no involvment of celiac axis or superior mesenteric vein (SMA) resectable T4: involve celiac axis or SMA unresectable. N1: regional lymph node mets M1: distant metastasis Stage IA T1 N0 M0; IB T2 N0 M0 Stage IIA T3 N0 M0; IIB T1-3 N1 M0 Stage III T4 any N M0 Stage IV anyt anyn M1 PREDICTION AND PROGNOSIS: Page 2 of 5

3 The prognosis remains dismal. Five- year survial even after complete resection is only 25-30% for node-negative and 10% for node positive disease. TREATMENT RECOMMENDATION: A. Resectable (stage I-II): potentially curative 1) Criteria for resectability: Resectable: No distant mets, no radiographic encasement of superior menseteric vein (SMV) or portal vein, no arterial tumor contact with celiac axis (CA) or common hepatic artery (CHA) or superior menseteric artery (SMA). Bordline Resectable: no distant mets; venous involvment (SMV/portal vein); no artery involvement Unresectable: * Mets in liver, peritoneum, omentum, or any extra-abdominal sites; * Encasement or occlusion/thrombous of SMV; * Direct involvement with celiac axis, SMA, hepatic artery, inferior vena cava, aorta. 2) Pre-op Evaluation: Laproscopic staging to rule out occult mets (<1cm) on the surface of liver, peritoneum. * Indicated for high-risk patients based on CT scan: pancreas body or tail tumor, primary tumor >3cm, high CA19.9 (>100units/ml). 3) Treatment Guideline: Surgery (whipple), followed adjuvant chemoradiation (for all patients, even T1N0). 3.1 Surgery: Endoscopic stent for some patients with obstructive jaundice prior to surgery. Tumor in pancreas head surgery if resectable (whipple procedure) followed by adj chemoradiation (see below). Tumor in pancreas body or tail distal subtotal pancreatectomy ± splenectomy (short survival, high perioperative mortality, poor prognosis) followed by adj chemoradiation. Neoadj therapy if borderline resectable (limited evidence) surgery adj therapy 3.2 Adjuvant Therapy: Use adjuvant chemoradiation, rather then chemotherapy alone, for all resected pancreatic cancers. Common protocol: RTOG improve PFS and OS. * Concurrent chemoradiation with 5FU, followed by 4-6 months of chemotherapy. For fit patient, prefer Gemcitabine/Capcitabine combination, rather than Gemcitabine alone. Neoadjuvant therapy remains investigational. Page 3 of 5

4 B. Unresectable : locally advanced without systemic metastasis: Guideline: Induction chemotherapy (4-6 months) chemoradiation for patients with good and total bilirubin <1.5 of upper normal limit. Chemotherapy regimen: * FOLFIRINOX (preferred) * Gemcitabine plus abraxane (commonly used, preferred) * Gemcitabine plus Capcitabine Chemoradiation: * RTOG protocol C. Metastatic : 1) 1st line therapy: Good performance status * FOFIRINOX (category 1) * Gemcitabine/Abraxane (category 1) Poor performance status * Gemcitabine (single agent): superior to infusional 5-FU ( survival 24% vs 5%). Poor liver function (T. bil > 1.5 xunl): * FOLFOX, rather than Gemcitabine (because gemcitabine is metabolized through liver.) 2) 2nd line therapy: Liposomal irinotecan (Onivyde)/FU/LV: if previously treated with gemcitabine-based therapy. FOLFOX6, CapeOx. Gemcitabine +/- abraxane if not used before. Keytruda for MSI-high patient. FOLLOW-UP: Resected Disease: * q3-6 months for 2 yrs, then annually with H&P, CA19.9, CT Metastaric Disease: * CA19.9 at the start of treatment and q 1-3 mos during therapy. * series CT for rising CA19.9. CHEMOTHERAPY AND REGIMEN: 1. RTOG protocol: concurrent ChemoRT plus Chemotherapy Regimen: Gemcitabine 1000mg/m2/week, x 3, followed by concurrent chemoradiation with infusion 5FU, then (wait for 3-5 wk post RT) start chemotherapy Page 4 of 5

5 * For fit patient, prefer Gemcitabine/Capcitabine combination, rather then Gemcitabine alone. Clinical trials: * RTOG 9704 trial: " Gemcitabine vs infusional 5-FU, after chemort arm" improve survival (20.6 mos vs 15.9 mos, HR=0.75) for pancrearic HEAD tumor, but not pancrearic tail/body tumor. * Adj chemort improves 3-yr OS from 30% to 45% compared to surgery alone. 2. FOLFIRINOX: Regimen: Oxaliplatin 85mg/m2 d1, followed by Leukovorin 400mg/m2 over 2hrs, Ironotecan 180mg/m2 d1 over 90 min, concurrent with last 90min of leukovorin, then followed by 5-FU, 400mg/m2 bolus, then 2400mg/m2 as 46hrs continuous infuction. Clinical trial: * ACCORD 11 trial: FOLFIRINOX vs Gemcitabine ORR (32% vs 9%), PFS (6.4 vs 3.3mos), median OS (11.1 vs 6.8 mos), delayed the time to degradation of QoL 3. Gemcitabine/Abraxane: Gemcitabine 1000mg/m2, plus Abraxane 125mg/m2, 3 weeks on and 1 week off. 4. Gemcitabine/Capcitabine: Gemcitabine 1000mg/m2, 3 weeks on and 1 week off, plus capcitabine 830mg/m2 Bid, days 1-21, q 4 weeks, x 4-6 cycles. 5. Liposomal irinotecan/fu/lv: Liposomal irinotecan 70mg/m2, plus LV 400mg/m2, FU 2400mg/m2, IV, q 2 weeks 6. Capcitabine single agent: Capcitabine 1250mg/m2, orally, twice daily for 14 of every 21 days. Page 5 of 5

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