Pancreas Flashcards
(74 cards)
What was the clinical relevance of GITSG 91-73 for pancreatic cancer?
Showed that adjuvant chemoRT after surgery improves OS over observation for resected pancreatic cancer.
What population was studied in GITSG 91-73 for pancreatic cancer?
43 pts with Resected pancreatic cancer with negative margins<br></br><br></br>28% were LN+, 95% pancreatic head
What regimen was studied in GITSG 91-73 for pancreatic cancer?
“→Surgery alone <br></br>vs. <br></br><span>→Surgery → 40 Gy split course + </span><span>concurrent bolus 5FU –> maintanence 5FU x 2y</span>”
What were the results of GITSG 91-73 for pancreatic cancer?
“<div>Improved survival with adjuvant chemoRT</div><div><br></br></div>Median OS 21.0 months vs. 10.9 months<br></br>2-yr OS 46% vs. 18%<span><br></br></span><br></br>”
What was the clinical relevance of EORTC 40891 for pancreatic cancer?
In contrast to GITSG 91-73, adjuvant CRT led to no OS or PFS benefit over observation.
What population was studied in EORTC 40891 for pancreatic cancer?
“218 pts with Resected <span>pancreas or periampullary </span>cancer”
What regimen was studied in EORTC 40891 for pancreatic cancer?
“→Split-course 40 Gy <span>conc 5-FU</span> <br></br>vs. <br></br>→obs”
What were the results of EORTC 40891 for pancreatic cancer?
“No significant difference in 2-yr PFS or OS. Trend to benefit with RT.<br></br><br></br>2-yr OS 37% vs. 23%, p=0.09<br></br>LR 20% both arms<br></br><span>Summary: LF 20%, MS 17 mos, +M 19%</span>”
What was the clinical relevance of ESPAC-1 for pancreatic cancer?
This trial showed that adjuvant chemo improved OS, and adjuvant chemoRT worsened OS.
What was the population studied in ESPAC-1 for pancreatic cancer?
289 pts with Resected pancreatic cancer, R0/R1
What was the regimen studied in ESPAC-1 for pancreatic cancer?
→40 Gy split conc 5FU (EORTC) vs. <br></br>→5FU alone vs.<br></br>→chemoRT → chemo (GITSG) vs.<br></br>→obs
What were the results of ESPAC-1 for pancreatic cancer?
<div>OS improved with chemo. OS worse with chemoRT.</div>
<div><br></br></div>
5-yr OS 10% chemoRT vs. 20% without<br></br>5-yr OS 21% chemo vs. 8% without<br></br><br></br>
What are concerns about ESPAC-1 for pancreatic cancer?
“In original design, not all patients were randomized. No RT quality assurance. Option of up to 60 Gy instead of 40. Only 70% had full dose. Optional ““background therapy””.”
What was the clinical relevance of the EORTC-FFCD-GERCOR study for pancreatic cancer?
Showed a LC benefit to adding RT to Gem adjuvantly for resected pancreatic cancer.
What population was studied in the EORTC-FFCD-GERCOR study for pancreatic cancer?
90 pts with resected pancreatic cancer
What regimen was studied in the EORTC-FFCD-GERCOR study for pancreatic cancer?
“Phase II: <br></br>→50.4 Gy <span>conc Gem</span> <br></br>vs. <br></br>→Gem alone”
What were the results of the EORTC-FFCD-GERCOR study for pancreatic cancer?
“<div>LC benefit to adding RT to Gem</div><div><br></br></div><div>Median OS 24 mos in both arms<br></br></div><span>LR 11% vs. 24%, improved with RT</span><div><span><br></br></span><span></span></div>”
What is the clinical relevance of RTOG 9704 for pancreatic cancer?
Showed that adding perioperative Gemcitabine to adjuvant regimen of chemoRT for pancreatic trends towards improved OS.
What population was studied in RTOG 9704 for pancreatic cancer?
451 pts with Gross total resection of adenoCA<br></br>35% with positive margins (highest among trials)
What regimen was studied in RTOG 9704 for pancreatic cancer?
“<span>→pre and post gem</span> <br></br>vs. <br></br>→pre and post 5FU <br></br><br></br>50.4 Gy to elective nodes and post-op bed with concurrent 5FU for all”
What were the results of RTOG 9704 for pancreatic cancer?
Gem arm trended to improved OS<br></br>panc head 3-yr OS 31% vs. 22%, p=0.09<br></br><br></br>Grade 3+ heme 58% gem vs. 9% 5FU
What was the clinical relevance of CONKO-001 for pancreatic cancer?
Showed that adjuvant gemicitabine improves OS.
What population was studied in CONKO-001 for pancreatic cancer?
368 pts with pancreas R0/R1, no patients with CEA >2.5 ULN
What regimen was studied in CONKO-001 for pancreatic cancer?
“→obs <br></br>vs. <br></br><span>→gemcitabine 6 cycles</span>”
OS 23% vs. 12%
10 yr DFS 14% vs. 6%
vs.
→gem alone
MS 28.0 mos with cape+gem vs. 25.5 gem alone
vs.
→mFOLFIRINOX"
Median DFS 12.8 mos vs. 21.6 mos
Median OS 35 mos vs. 54 mos
Median DMFS 17.7 mos vs. 30.4 mos
vs.
→induction gem + erlotinib
if disease controlled →
→further chemo
vs.
→54 Gy 3DCRT conc cape"
Median OS 16.5 mos chemo vs. 15.2 mos chemoRT, p=0.83
RT improved LC, 32% vs. 46%, p=0.03
No increase in Grade 3-4 toxicity with RT except for nausea
Erlotinib did not improve OS and increased toxicity
maintenance Gem in both arms"
Grade 3-4 toxicity 65% vs. 40%
Completion of 75% of therapy: 42% vs. 73%
vs.
→50.4 Gy RT + gem then consolidation gem"
Median OS 9.2 mos vs. 11 mos CRT (p=0.017)
Grade 4-5 toxicity worse with CRT 9% vs. 41%
→Gem + 50.4 Gy RT
vs.
→Cape + 50.4 Gy RT
Median PFS 12.0 mos vs. 10.4 mos, p=.11
Split course RT
vs.
→gem → 36 Gy/ 15 fx at 2.4 Gy with concurrent gemcitabine 1000 mg/m2 → surgery → adjuvant gem"
Subanalysis of those who had surgery and started adjuvant gem: OS 19.8 mos vs. 35.2 mos
Resection rate 72% vs. 61%, p=0.058
DFS and LRF also improved
Severe adverse effects <10%
Borderline resected in 50-56% and unresectable removed in 0-20%
LRC correlated to dose and # fractions
vs.
→gem alone"
Median OS 8.5 mos vs. 6.7 mos
vs.
→gem"
11.1 mos vs. 6.8
