Pancreatic Cancer - JTL 2012
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Epidemiology
Risk Factors
Anatomy
Staging, Prognosis
Lymphatics / Pattern ofSpread Pathogenesis/Genetics and Histology
Presentation
Workup
Labs, Imaging
Management Surgical, Peioperative Resectable
Unresectable
Metastatic Disease
Palliation
Outline
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Epidemiology
4th leading cause of cancer death in M&F (43K in 2010 in US) 9th most common Ca Western>Eastern AA>Whites
OS Resection: 48% (1-yr)
Unresectable: 23% (1-yr)
Incidence peaks @70-80s
5-year O
Sis lowestof any cancer
Most diagnosed at unresectable stage
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Age Gender: M>F Race: AA>W Smoking
Ionizing Radiation Chemotherapy Obesity and Diet: animal fats Possible link to EtOH, Coffee use, Diabetes Family History (BRCA2)
Chronic pancreatitis Exposure to pesticides, benzene, dyes (2-
Naphthylamine, petrochemicals (gasloine)
Risk Factors
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Pathogenesis/Genetics
7590%FTIs
EGFRRTKi
mOS +1mo
SHHi
8590%
50%
85% Ductal Adeno
Subtypes
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Anatomy
75%
15% 10%
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Anatomy
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Anatomy
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Anatomy
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Staging/AnatomyAJCC 7th Edition (2009)
Primary Tumor:T1 - confined to pancreas, 2 cm or lessT2 - confined to pancreas, > 2 cmT3 - extends beyond pancreas
T4 - invades SMA or celiac axis
Regional Lymph Nodes:N0 - noN1 - yes
Distant Metastases:M0 - noneM1 - yes
Stage Grouping:IA - T1 N0IB - T2 N0
IIA - T3 N0IIB - T1-3 N1III - T4Any NIV - M1
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Pattern ofSpread: LymphaticDrainage
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Pattern ofSpread: Distant Disease 30% Liver and Peritoneum
Lung most common extra-abdominal Major sites of recurrence:
50-86% operative bed (local) Liver 20-60%
Peritoneal 23-36%
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Silent Disease
Most present as painless masses w/obstructive jaundice
Classic Triad- pain + jaundice + weight loss
Symptoms:
Jaundice
Pain in upper abdomen or back (dull or burning)
Floating stools w/especially abd odor
Weakness, Loss ofAppetite, N/V
Diabetes diagnosed 2 yrs prior to dx in >50%
PE findings (late): Palpable L SCV = Virchows node,
Periumbilical LN = Sister Mary Josephs node,
Palpable Gallbladder = Courvoisiers sign,
Migratory thrombophlebitis = Trousseaus sign
Presentation
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Physical Exam Labs: CBC, CMP, LFTs w/GGT, Amylase, Lipase, Direct and
Indirect bilirubin, CA19-9, CEA
Biopsy: ERCP
EUS Sens 75%Spec 75% CT guided FNA
Laparoscopy
Imaging CT Triphasic thin slice
MRI w/w/o contrast
PET/CT 87%Sens for Mets Octereotide imaging if NE
MRCP
FDG-PET
Consider Angiogram
Workup
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Workup Staging Studies
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Preop Biliary drainage for obstructive lesions?
Presence of jaundice preop +s complications Does preop drainage reduce post op comp?
Randomized Multicenter Trial
1o Outcome: Complications w/in 120d
Results:
Complication Rate: Preop Decompression: 47%
Surgery Alone: 37% (SS)
No Difference in OS, hospital stay
Preop Jaundice Empiric antibiotics if concern forcholangitis
Management
Preoperative biliary drainage for cancer of the head of the pancreas. van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der HarstE,Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM,Gouma DJ. NEJM. 2010 Jan 14;362(2):129-37.
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Chronic Pancreatitis Autoimmune Pancreatitis
Differentiate w/Ig levels
Islet cell/neuroendocrine cancer
Cystic adenomas, papillary cystic neoplasms (e.g.,intraductal papillary mucinous tumor)
Lymphoma
Acinar cell carcinoma
Metastatic cancer.
CA 19-9 may be elevated in bengin pancreatic pathology
Differential Diagnosis
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NCCN criteria for resectability:
Resectable - no distant mets, clear fat plane around celiac/SMA,patentSMV
Borderline Resectable - severe unilateral SMV/portal impingement,abutSMA (
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Imaging Resectability
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Imaging Resectability
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Surgical Evaluation: Head/Body
Head/Body lesions
Pancreaticoduodenectomy/Whipple Procedure:
Resected: Pylorus sparing antrectomy vs. classic antrectomy >40% removed
Cholecystectomy, Choledochectomy, Parrtial Pancreatectomy
Reconstructed:
Pancreaticojejunostomy, choledochojejunostopmy, gastrojejunostomy
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Surgical Evaluation: Tail
Tail lesions:
Distal pancreatectomy and splenectomy
Cholecystectomy
Roux-en-Y hepaticojejunostomy
Vol (- )s
morbidity
R0: No evidence of microscopic or macroscopic tumor
R1: 1 cell w/in 1mm is considered + margin
R2: gross residual disease
Margins
Volume
Lieberman MD, Lilburn H, Lindsey M, Brennan MF. Relation of perioperative deaths to hospital volume among patients undergoing pancreaticresection for malignancy. Ann Surg 1995; 222:638-645.
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Vein Reconstruction
- Results are varied
- Likely that small selected population of patients will benefit
- Japan improves OS, US/UKshows opposite
- Ongoing study @ Hopkins w/299 patients:
- no SS diff @ 1,3,5 yrs
- Should not be considered routine
Tseng,JF, Raut CP, Lee JE, et al. Pancreaticoduodenectomy w/vascular resection: margin status & OS . J GastrointestSurg 2004:8;935-949.
Extended Lymphadenectomy
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Should only be carried out if possibility for R0 resection
No benefit to extended lymphadenectomy Definitive CRT is not equivalent
Resectable
Pancreaticoduodenectomy with or without distal gastrectomy and extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma--part3: update on 5-year survival. Riall TS, Cameron JL, Lillemoe KD, Campbell KA, Sauter PK, Coleman J, Abrams RA, Laheru D, Hruban RH, Yeo CJ.J GastrointestSurg. 2005 Dec;9(9):1191-204; discussion 1204-6.
Surgery versus radiochemotherapy for resectable locally invasive pancreatic cancer: final results of a randomized multi-institutional trial.Doi R, Imamura M, Hosotani R, Imaizumi T, Hatori T, Takasaki K, FunakoshiA, Wakasugi H, Asano T, Hishinuma S, Ogata Y, Sunamura M, Yamaguchi K,Tanaka M, Takao S, Aikou T, Hirata K, Maguchi H, Aiura K, Aoki T, Kakita A, Sasaki M, Ozaki M, Matsusue S, Higashide S, Noda H, Ikeda S, Maetani S, YoshidaS; Japan Pancreatic Cancer Study Group.
Surg Today. 2008;38(11):1021-8. Epub 2008 Oct 29.
Prognosis s/p Definitive Resection
1o predictor: Lymph Node Ration = # LN+ / Total # LN LNR = 0 25 mo
LNR < 0.2 22 mo
LNR 0.2-0. 4 15 mo
LNR > 0.4 12 mo
Margin status
Grade of lesion
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Pattern of Failure s/p Definitive Resection Local failure: 50-80%, sole site of failure ~25% Regional Failure: para-aortic LN 21%
Distant Failure: Liver failure ~50%, commonly together with local failure, rarely as
sole site Peritoneal failure ~30% Nearly always concurrent w/local failure
US has been centered on management of local disease Cant see the forest for the trees
Europes care has been focused on management of distant disease
Cant see the trees for the forest
Prognostic relevance of lymph node ratio following pancreaticoduodenectomy for pancreatic cancer. (Pawlik TM, Surgery. 2007 May;141(5):610-8.
US & European Management
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Treatment ParadigmResectable
Definitive Resection Obs vs. Adj CRT + Maint
Definitive Resection CRT+Maint (Gem vs. 5FU)
Defintive Resection Obs vs. Adj CRT (no Maint)
Definitive Resection Obs vs. Adj Chemo vs. Adj CRT+/-Maint
Definitive Resection Obs. Vs. Adj Gem
Borderline Resectable
Neoadjuvant CRT Reassessment for resection
UnresectableConsider prophylactic duodenal bypass, stenting
Locally Advanced: Definitive CRT
Metastatic
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Treatment Paradigm: ResectableResectable
Definitive Resection Obs vs. Adjuvant CRT + Maint
1985 GITSG 9173
Definitive Resection CRT+Maint (Gem vs. 5FU)
RTOG 97-04
Definitive Resection Obs vs. Adj CRT (no Maint)
EORTC 40891
Definitive Resection Obs vs. Chemo vs. CRT+/-Maint
ESPAC-1Definitive Resection Obs. Vs. Adj Gem
CONKO-001
Definitive ResectionAdj 5FU vs. Gem
ESPAC-3
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Resectable
GITSG- Kalser, Arch Surg 1985;120:899-903
Randomized No
Stratification
Early
Comparison: R
Concurrent Adj CRT
(5FU) + Maint vs. Obs
Patients
43
ECOG
0-3
T Stage
35%T2,
37%T3
Location
95% Head
5% Body
LN Status
28% LN+
Surgery
68% Whipple
R0v.R1 NR
RT
40Gy Split
Course
Chemo
5FU Bolus 500mg/m2
d1-3 qWkly x 2 yrs 2yr OS:43%/20 movs.
18%/11 mo
OS
43%/20mo
vs.
18%/11mo
DFS
11mo vs. 9mo
Recurrence
LR: 86% vs. 71%
Hepatic: 50% vs. 32%
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Null: 1 doesn't equal 2
Null: 1 isnt less than 2
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Meanwhile in Europe.
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Resectable
EORTC 40891 - Klinkenbijl, Ann Surg 1999;230:776-84
2yr OS:
43%/20 movs.
18%/11 mo
Randomized Stratification
by Inst &
Location
Comparison: R
Concurrent Adj CRT
(5FU) vs. Observation
Patients
218
ECOG
0-2
T Stage
T1-T2
Location
55% Head
45% Periamp
LN Status
23% LN+
Surgery
25% R1
75% R0
RT
40Gy Split
Course
Chemo
5FU Bolus 500mg/m2
d1-3 qWkly
2yr OS (A v. O)
51%/24.5mo vs. 41%/19mo
Panc:34%/17 vs. 26%/13mo
PeriAmp:67%/39.5 vs. 63%/40.1mo
DFS
NR
Recurrence
NR
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Resectable
EORTC 40891 - Klinkenbijl, Ann Surg 1999;230:776-84
PeriAmp- 2yr OS:
67%/39.5vs.
63%/40.1mo
Panc- 2 yr OS:
34%/17vs.
26%/13mo
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Sample Size Calculation:
Type 1 Error: .025Power = .8Survival Rate Group 1: 43%Survival Rate Group 2: 18%
1:1 Randomization
= Sample Size Needed 119
If one-sided only need 98
https://biostatistics.mdanderson.org/SoftwareDownload/
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Resectable
ESPAC1 Neoptolemos, Lancet 2001;358:1576
NEJM 2004;350:1200-1210
(+/-)
Randomized
2 x 2 factorial
Stratified by R,
T, N stage
Comparison: R
Chemo vs. CRT vs.
CRT+Maint vs. Obs
Patients
289
ECOG
NR
T Stage
NR
Location
NR
LN Status
78% LN+
Surgery28% R1
72% R0
RT40Gy Split
Course
Chemo5FU Bolus 500mg/m2
d1-3 qWkly x 2 yrs
OS
43%/20mo
vs.
18%/11mo
DFS
11mo vs. 9mo
Recurrence
LR: 86% vs. 71%
Hepatic: 50% vs. 32%
Chemo vs. No Chemo - 5yr OS21%/20.1mo vs. 8%/15.5mo
CRT vs. No CRT - 5yr OS10%/15.0mo vs. 20%/17.9mo)
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ResectableESPAC1 Neoptolemos, Lancet 2001;358:1576 NEJM 2004;350:1200-1210
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ResectableESPAC1 Neoptolemos, Lancet 2001;358:1576 NEJM 2004;350:1200-1210
72
CRT+Maint
103
CRT
166
Chemo
200
Obs
The Plan
How things shouldof been compared
How thingswere compared
>35% randomized toNo tx got tx that wasunspecified
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Factorial Clinical Trial DesignIntention: + Efficiency of trials
Assumption: No interactions b/n arms (+ or -)Comparisons:1 vs. 2, 1 vs. 3, 1 vs. 42 vs. 3, 2 vs. 43 vs. 4
If 1 has any component of 2ness or visa versathen needs to be re-powered!
i.e. Chemo vs. ChemoRadiationAdj Chemo vs. Adj Chemo + MaintChemoRT vs. ChemoRT + Maint
Bayesian Design and Analysis of 2x2 Factorial Clinical Trials Biometrics Vol 53, No 2 1997 pp. 456-
464Factoriaol design for Randomized Clinical Trials. Bria. Ann Oncol (2006) 17 (10): 1607-1608.
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Who knows what actually happened?
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Resectable
CONKO-001 Oettle, JAMA. 2007;297(3):267
Randomized
Phase 3
Stratified by R,
T, N stage
Comparison:
R Adj Gem vs. Obs
Patients368
KPS>50%
T Stage86%
T3-4
LocationNR
LN Status72% LN+
Surgery
80% RO,
20% R1
RT
NA
Chemo x 6C (q4wkC)
- Gem 1gm/m2 qWkly x 3/4wks
3yrOS (Gem v Obs)34%/22.1mo vs.
22.5%/20.2mo
DFS+'d SS in all
subsets
RecurrenceLR: 34 v. 41%
DM: 56% v. 49%
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Resectable
RTOG 9704 Regine JAMA. 2008;299(9):1019
Randomized
Phase 3
Stratified by R,
T, N stage
Comparison:
R CRT (5FU vs. Gem)
Patients451
KPS>60%
T StageT1-4
Location85% Head
15% Bod/Tail
LN Status65% LN+
Surgery
35% R1
65% R0
RT
45Gy/25fx
to tumor bed
& regional
LNs; 5.4Gy/3
boost to
tumor bed
Chemo
- 5-FU(250mg/m2/d) CI qd
concurrentw/RT
- 5FU 250mg/m2/d CI x 3wk
pre ChRT & x12wk post
- Gem 1gm/m2 wkly x 3wks
pre ChRT & post x12wk
3yr OS Head
Gem 31%/20.5mo
vs.
5FU 22%/16.9mo
DFS
11mo vs.
9mo
Recurrence
LR: 23-28%
RF: 8%
DM: 71-77%
3yr OSGem vs. 5FU31%/20.5mo
vs5FU 22%/16.9mo
15x more likely to have G4 Tox, 5x more Heme tox
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Resectable
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Resectable
ESPAC3 Neoptolemos , ASCO 09Abstr, Vol27, No18S
Randomized
Phase 3
Stratified by R
, Country
Comparison:
Chemo (5FU vs. Gem) vs.
Obs (closed)
Patients1088
KPSNR
T StageT1-4
LocationNR
LN Status72% LN+
Surgery
R0 65%
R1 35%
RT
NONE
Chemo X 6mo
- 5FU 425mg/m2/d bolus d1-
5 x 4wk
- Gem 1gm/m2 d1,8,15 x 4wks
mOS (5FU vs. Gem)23.0mo vs 23.6mo
NS
DFSNR
RecurrenceNR
More GI side effects w/5FU, More hematologic Tox w/Gem
Toxicity
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Resectable
EORTC 40013 Van Laethem, JCO 2010 28(29):4450
Randomized
Phase 2
Stratified by
Inst, LN, PS
Comparison:
Adj Gem vs. Gem CRT
Patients90
KPS0-2
T StageT3>2>
1
LocationHead only
LN Status70% LN+
Surgery
R0 only
RT
50.4Gy
/ 28fx
Chemo
-Gem 1gm/m2 qWk 3/4wk q4wk x 4C
-Gem 1gm/m2x2C300mg/m2w/RT
mOS 2yr G v. GCRT
50.2%/23.4mo vs50.6%/24.3mo NS
DFS
10.9 v.12.4mo
Recurrence
Gem v. GemCRTLR: 24 v. 11%
L&DM: 13 v.20%
DM: 40 v. 42%
G4 tox4.7% in GemCRT arm v. 0% in Gem aloneToxicity
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RTOG 0848/EORTC-40084-22804
1000mg/m2 qwk 3/4wkq4wk C x5C
1000mg/m2 qwk 3/4wkq4wk C x5C
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Retrospective Analysis of GERCOR Phase 2/3
Huguet JCO 2007, 25:326-331
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Treatment Paradigm: Borderline Resectable
Borderline ResectableSurgery
Neoadjuvant CRT
Reassess for RClinical Trial
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BorderlineResectable
MD And Evans, JCO 08, Vol26, No21Single
Arm
Phase 2
Stratified
NA
Gem Concurrent w/30Gy/10fx
Restaging Whipple
Patients86 KPS>70% T StageT1-3 LocationHead LN Status*38% LN+
Surgery R0 or R1:(11%)
87% Rsctbl, 13% UnR
75% R, 4% off protocol
20% Progressed
RT
30Gy
/ 10fx
Chemo
- Gem 400mg/m2
qwk x 7 wks
5 yr mOS27%/22.7mo ALL,36%/34mo Rsctd,
0%/7.1moUnRsctd
DFS15.4mo
RecurrenceLR: 11%
DM: 60% (41% liver)
No CRT deaths, 9% Periop Death
Toxicity
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BorderlineResectable
MD And Evans, JCO 08, Vol26, No21
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BorderlineResectable
MD And Evans, JCO 08, Vol26, No21
71% 74%
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Treatment Paradigm: Unresectable
UnresectableConsider prophylactic duodenal bypass, stenting
Locally Advanced: Consider Definitive CRT vs. Chemo
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Treatment Paradigm: Metastatic
Metastatic:Management based on KPS/ECOG
Best supportive care
Palliative stenting/surgery Chemo:
Gem
GemOx
FOLFIRINOX
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Metastatic
ECOG 6201 Poplin JCO 2009;27(23):3778
Randomized
Phase 3
Stratified by
PS, R, T, N stage
Comparison:
Chemo
(Gem, Gem FDR, GemOx)
Patients832
KPS0-2
T StageAll
Location>90%
Metastatic
LN StatusNR
Surgery
NA
RT
NA
Chemo
- GEM 1gm/m2 wkly for 7/8wks x 1C
wkly x 3-4C
- GEM FDR 1.5gm/m2 d1,8,15 q4wks
-GEM1gm/m2 + Ox 100mg/m2 d2 q2wks
mOS & 1 yr OS%
GEM vs. GEMFDR vs. GEMOX
16%/4.9mo vs. 21%/6.2mo vs.
21%/5.7mo (SS)
DFS Recurrence
Toxicity
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Metastatic
ACCORD4 Conroy NEJM 2011;364(19):1817
Randomized
Phase 2/3
Stratified by
Center, PS, T
location
Comparison:
Chemo
(Gem v. FOLFIRINOX)
Patients342
KPS0-1
T StageAll
LocationMetastatic
60% body/tail
LN StatusNR
Surgery
NA
RT
NA
Chemo
- GEM 1gm/m2 wkly for 7/8wks wkly -
FOLFIRINOX q2wks x 6mo
FOL vs. Gem
mOS 11.1mo v. 6.8mo
DFS
mPFS 6.4 v.3.3mo
Recurrence
ORR 31.6% v.9.4%
Toxicity
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Treatment RadiationGTV define by Preop imaging
CTV -1-1.5cm extension of : Celiac axis, SMA and PV ROIs should be expanded by 1.0-1.5 cm in all directions.
Aortic ROI should be expanded asymmetrically to include the prevertebral nodal regions from the top of the PJ, PV, or CA (whichever ismost superior) to the bottom of L2 (or L3 if GTV location low, see above section). 2.5 to 3.0 cm to the R, 1.0 cm to the L, 2.0 to 2.5 cmanteriorly, 0.2 cm posteriorly.
Delineated clips may be expanded by 0.5 1.0 cm in all directions or used without expansion.
Merge the above ROI/ROI expansions (CA, SMA, PV, GTV, Aortic, PJ, , clips) with the following constraints and notes:
The post margin should follow the contour of the ant aspect of the vertebral body w/o actually including more than 0.10 cm of the anteriorvertebral body ant edge.
If the PJ cannot be identified, the CTV should be generated without it.
If the surgeon has created a pancreaticogastrostomy, do not include it into the CTV.
If the CTV with the noted expansions protrudes into a dose limited normal organ such as the liver or stomach, the CTV should be edited tobe adjacent (may touch the edge of) the relevant structure.
di i
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Treatment RadiationTolerances
Kidney L&R D50%
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Post Tx Management
Consider pancreatic enzyme replacementPalliative care consult
LMWH for concern for thromboembolic disease
E d
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End
ESPAC3 t i it
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ESPAC3 toxicity
ECOG 6201 T
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ECOG 6201 Tox
L h ti D i
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Lymphatic Drainage
2/24
24/1
11/16
19/10
22/10
7/10
53/3
36/3
8/8
1/42/36
4/10
10/15
23/1
13/10
A
B/CA : JPS LN Station #B: Head Ca % LN Met
C: Body/Tail Ca % LN Met
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Hunter, Ben Josef IJROBP- Dec 2011
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