Pancreas Flashcards
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>
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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>”
What were the results of CONKO-001 for pancreatic cancer?
<div>Adjuvant Gem improved OS and DFS</div>
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Median OS 22 mos gem vs. 20 mos<br></br>OS 23% vs. 12%<br></br>10 yr DFS 14% vs. 6%<div><br></br><br></br></div>
What was the clinical relevance of ESPAC-4 for pancreatic cancer?
Showed that adding adjuvant capecitabine to gemcitabine improves OS.
What population was studied in ESPAC-4 for pancreatic cancer?
730 pts with pancreatic cancer patients who underwent surgery, R0 or R1
What regimen was studied in ESPAC-4 for pancreatic cancer?
→adj gem + capecitabine <br></br>vs. <br></br>→gem alone
What were the results of ESPAC-4 for pancreatic cancer?
Improved OS with Gem/Capecitabine compared to Gem.<div><br></br>MS 28.0 mos with cape+gem vs. 25.5 gem alone<br></br><br></br></div>
What was the clinical relevance of the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?
Showed that adjuvant mFOLFIRINOX improves DFS, DMFS, and OS compared to gemcitabine.
What population was studied in the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?
493 pts with resected pancreatic cancer
What regimen was studied in the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?
“→adj gem <br></br>vs. <br></br><span>→mFOLFIRINOX</span>”
What were the results of the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?
“Adjuvant mFOLFIRINOX improves DFS, DM, and OS over adjuvant Gem<div><br></br>Median DFS 12.8 mos vs. 21.6 mos<br></br>Median OS 35 mos vs. <span>54 mos</span><br></br>Median DMFS 17.7 mos vs. 30.4 mos<br></br><br></br><div><br></br></div></div>”
What was the clinical relevance of the LAP07 trial for pancreatic cancer?
This trial assessed the value of adding EBRT and Erlotinib to Gemcitabine for unresectable pancreatic cancer.
What population was studied in the LAP07 trial for pancreatic cancer?
Pts with locally advanced pancreatic cancer
What regimen was studied in the LAP07 trial for pancreatic cancer?
“→induction gem <br></br>vs. <br></br>→induction gem + erlotinib<br></br><br></br>if disease controlled → <br></br><br></br>→further chemo <br></br>vs. <br></br>→54 Gy 3DCRT <span>conc cape</span>”
What were the results of the LAP07 trial for pancreatic cancer?
“No OS benefit to adding EBRT or Erlotinib to Gemcitabine<div><br></br></div><div><span>No difference in OS</span><br></br>Median OS 16.5 mos chemo vs. 15.2 mos chemoRT, p=0.83<br></br><span>RT improved LC, 32% vs. 46%, p=0.03<br></br></span><br></br><br></br>No increase in Grade 3-4 toxicity with RT except for nausea <br></br>Erlotinib did not improve OS and increased toxicity<br></br></div>”
What were the concerns about the LAP07 trial for pancreatic cancer?
IMRT was not used. 18% of pts had major deviations.
What was the clinical relevance of the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?
This trial showed worse OS for chemoRT over Gemcitabine alone for unresectable pancreatic cancer.
What was the population studied in the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?
119 pts with locally advanced pancreatic cancer
What was the regimen studied in the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?
“60 Gy + <span>5FU/</span><span>cis</span> vs. <span>Gem</span> alone<br></br><br></br>maintenance Gem in both arms”
What were the results of the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?
<div>Worse OS and toxicity with chemoRT.</div>
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8.6 mos RT vs. 13 mos chemo alone<br></br>Grade 3-4 toxicity 65% vs. 40%<br></br>Completion of 75% of therapy: 42% vs. 73%
What was the clinical relevance of the GITSG unresectable pancreatic cancer trial?
<b>Old trial </b>that showed that CRT with 5FU->SMF resulted in improved OS over SMF alone.
What was the population studied in the GITSG unresectable pancreatic cancer trial?
43 pts with unresectable, surgically staged pancreatic cancer
What was the regimen studied in the GITSG unresectable pancreatic cancer trial?
SMF (streptozocin, mitomycin, 5FU) vs. 54 Gy conc 5FU then SMF
What were the results of the GITSG unresectable pancreatic cancer trial?
Improved OS with addition of chemoRT to SMF chemotherapy<div><br></br></div><div>1-yr OS 19% vs. 42% with RT</div>
What was the clinical relevance of the ECOG 4201 trial for unresectable pancreatic cancer?
This trial showed that chemoRT with gem seems to result in improved OS over gem alone. The trial is likely underpowered.
What population was studied in the ECOG 4201 trial for unresectable pancreatic cancer?
74 pts with unresectable pancreatic cancer
What regimen was studied in the ECOG 4201 trial for unresectable pancreatic cancer?
“→gem alone <br></br>vs. <br></br>→50.4 Gy<span> RT + gem then consolidation gem</span>”
What were the results of the ECOG 4201 trial for unresectable pancreatic cancer?
Underpowered, terminated early but results showed:<div><br></br>Median OS 9.2 mos vs. 11 mos CRT (p=0.017)<br></br>Grade 4-5 toxicity worse with CRT 9% vs. 41%</div>
What was the clinical relevance of the SCALOP trial for unresectable pancreatic cancer?
Analyzed induction Gem/Cape then concurrent chemoRT for unresectable pancreatic cancer. The chemoRT was either Gem/RT or Cape/RT. There is a trend to PFS with Cape/RT, though results were nonsignificant.
What population was studied in the SCALOP trial for unresectable pancreatic cancer?
74 pts with locally advanced pancreatic, size ≤7 cm
What regimen was studied in the SCALOP trial for unresectable pancreatic cancer?
12 wks induction gem+cape then if stable disease or response, more chemo, then randomized: <br></br><br></br>→Gem + 50.4 Gy RT <br></br>vs. <br></br>→Cape + 50.4 Gy RT
What were the results of the SCALOP trial for unresectable pancreatic cancer?
“<span>No benefit in OS</span><div><span>Trend to PFS improved with Capecitabine</span></div><div><b>Worse toxicity with Gem<br></br></b><br></br>Median PFS 12.0 mos vs. 10.4 mos, p=.11<br></br><br></br></div>”
What was the clinical relevance of the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?
This trial showed chemoRT with 5FU results in improved OS over RT alone.
What population was studied in the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?
194 pts with unresectable pancreatic cancer
What regimen was studied in the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?
60 Gy vs. 40 Gy + 5FU vs. 60 Gy + 5FU<br></br><br></br>Split course RT
What were the results of the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?
1-yr OS 40% CRT vs. 10% without chemo.<div><br></br></div><div>No significant difference b/w dose levels.</div><div><br></br></div>
What was the clinical relevance of the PREOPANC study for pancreatic cancer?
This trial analyzed use of chemoRT prior to resection for borderline resectable pancreatic cancer. Showed improved resection rates with chemoRT and a trend to OS benefit.
What population was studied in the PREOPANC study for pancreatic cancer?
246 pts with borderline resecatble pancreatic cancer
What regimen was studied in the PREOPANC study for pancreatic cancer?
“→Surgery → adjuvant gem<br></br>vs.<span> <br></br>→gem → 36 Gy/ 15 fx at 2.4 Gy with concurrent gemcitabine 1000 mg/m2</span> → surgery → adjuvant gem”
What were the results of the PREOPANC study for pancreatic cancer?
<div>Trend to OS benefit for intention to treat population. Per protocol analysis showed significant OS benefit. More R0 resections with chemoRT and improved DFS and LRF.</div>
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<div>Median OS 14.3 vs. 16.0 mos, p=0.096<br></br>Subanalysis of those who had surgery and started adjuvant gem: OS 19.8 mos vs. 35.2 mos<br></br></div>
R0 40% vs. 71%<br></br>Resection rate 72% vs. 61%, p=0.058<br></br>DFS and LRF also improved<br></br><br></br>
What was the clinical relevance of the Italian analysis of SBRT for inoperable pancreatic cancer?
Showed that SBRT seems to show favorable outcomes. Randomized trials are needed.
What population was included in the Italian analysis of SBRT for inoperable pancreatic cancer?
1009 pts with inoperable pancreatic cancer
What regimen was included in the Italian analysis of SBRT for inoperable pancreatic cancer?
Review and pooled analysis of 19 SBRT studies
What were the results of the Italian analysis of SBRT for inoperable pancreatic cancer?
1-yr LRC 72%, 1-yr OS 52%, Median OS 17 mos (range 5.7-47 mos)<div><br></br>Severe adverse effects <10%</div><div><br></br>Borderline resected in 50-56% and unresectable removed in 0-20%</div><div><br></br>LRC correlated to dose and # fractions</div>
What was the clinical relevance of the T Gen trial for metastatic pancreatic cancer?
Showed that Nab-paclitaxel improves OS in metastatic pancreatic cancer.
What population was studied in the T Gen trial for metastatic pancreatic cancer?
861 pts with metastatic pancreatic cancer
What regimen was studied in the T Gen trial for metastatic pancreatic cancer?
“<span>→nab-paclitaxel then gem <br></br></span>vs. <br></br>→gem alone”
What were the results of the T Gen trial for metastatic pancreatic cancer?
OS benefit with nabpaclitaxel<div><br></br>Median OS 8.5 mos vs. 6.7 mos<br></br><br></br><br></br></div>
What was the clinical relevance of the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?
This trial showed that FOLFIRINOX improves OS and has lower toxicity than gemcitabine in metastatic pancreatic cancer.
What population wa sstudied in the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?
242 pts with metastatic pancreatic cancer
What regimen was studied in the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?
“<span>→FOLFIRNOX</span> <br></br>vs. <br></br>→gem”
What were the results of the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?
Benefit with FOLFIRINOX over Gemcitabine in Median OS<br></br>11.1 mos vs. 6.8<div><br></br><br></br></div>
