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ANKI- GI > Pancreas > Flashcards

Pancreas Flashcards

1
Q

What was the clinical relevance of GITSG 91-73 for pancreatic cancer?

A

Showed that adjuvant chemoRT after surgery improves OS over observation for resected pancreatic cancer.

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2
Q

What population was studied in GITSG 91-73 for pancreatic cancer?

A

43 pts with Resected pancreatic cancer with negative margins<br></br><br></br>28% were LN+, 95% pancreatic head

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3
Q

What regimen was studied in GITSG 91-73 for pancreatic cancer?

A

“→Surgery alone <br></br>vs. <br></br><span>→Surgery → 40 Gy split course + </span><span>concurrent bolus 5FU –> maintanence 5FU x 2y</span>”

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4
Q

What were the results of GITSG 91-73 for pancreatic cancer?

A

“<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>”

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5
Q

What was the clinical relevance of EORTC 40891 for pancreatic cancer?

A

In contrast to GITSG 91-73, adjuvant CRT led to no OS or PFS benefit over observation.

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6
Q

What population was studied in EORTC 40891 for pancreatic cancer?

A

“218 pts with Resected <span>pancreas or periampullary </span>cancer”

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7
Q

What regimen was studied in EORTC 40891 for pancreatic cancer?

A

“→Split-course 40 Gy <span>conc 5-FU</span> <br></br>vs. <br></br>→obs”

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8
Q

What were the results of EORTC 40891 for pancreatic cancer?

A

“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>”

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9
Q

What was the clinical relevance of ESPAC-1 for pancreatic cancer?

A

This trial showed that adjuvant chemo improved OS, and adjuvant chemoRT worsened OS.

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10
Q

What was the population studied in ESPAC-1 for pancreatic cancer?

A

289 pts with Resected pancreatic cancer, R0/R1

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11
Q

What was the regimen studied in ESPAC-1 for pancreatic cancer?

A

→40 Gy split conc 5FU (EORTC) vs. <br></br>→5FU alone vs.<br></br>→chemoRT → chemo (GITSG) vs.<br></br>→obs

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12
Q

What were the results of ESPAC-1 for pancreatic cancer?

A

<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>

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13
Q

What are concerns about ESPAC-1 for pancreatic cancer?

A

“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””.”

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14
Q

What was the clinical relevance of the EORTC-FFCD-GERCOR study for pancreatic cancer?

A

Showed a LC benefit to adding RT to Gem adjuvantly for resected pancreatic cancer.

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15
Q

What population was studied in the EORTC-FFCD-GERCOR study for pancreatic cancer?

A

90 pts with resected pancreatic cancer

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16
Q

What regimen was studied in the EORTC-FFCD-GERCOR study for pancreatic cancer?

A

“Phase II: <br></br>→50.4 Gy <span>conc Gem</span> <br></br>vs. <br></br>→Gem alone”

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17
Q

What were the results of the EORTC-FFCD-GERCOR study for pancreatic cancer?

A

“<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>”

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18
Q

What is the clinical relevance of RTOG 9704 for pancreatic cancer?

A

Showed that adding perioperative Gemcitabine to adjuvant regimen of chemoRT for pancreatic trends towards improved OS.

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19
Q

What population was studied in RTOG 9704 for pancreatic cancer?

A

451 pts with Gross total resection of adenoCA<br></br>35% with positive margins (highest among trials)

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20
Q

What regimen was studied in RTOG 9704 for pancreatic cancer?

A

“<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”

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21
Q

What were the results of RTOG 9704 for pancreatic cancer?

A

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

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22
Q

What was the clinical relevance of CONKO-001 for pancreatic cancer?

A

Showed that adjuvant gemicitabine improves OS.

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23
Q

What population was studied in CONKO-001 for pancreatic cancer?

A

368 pts with pancreas R0/R1, no patients with CEA >2.5 ULN

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24
Q

What regimen was studied in CONKO-001 for pancreatic cancer?

A

“→obs <br></br>vs. <br></br><span>→gemcitabine 6 cycles</span>”

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25
Q

What were the results of CONKO-001 for pancreatic cancer?

A

<div>Adjuvant Gem improved OS and DFS</div>

<div><br></br></div>

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>

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26
Q

What was the clinical relevance of ESPAC-4 for pancreatic cancer?

A

Showed that adding adjuvant capecitabine to gemcitabine improves OS.

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27
Q

What population was studied in ESPAC-4 for pancreatic cancer?

A

730 pts with pancreatic cancer patients who underwent surgery, R0 or R1

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28
Q

What regimen was studied in ESPAC-4 for pancreatic cancer?

A

→adj gem + capecitabine <br></br>vs. <br></br>→gem alone

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29
Q

What were the results of ESPAC-4 for pancreatic cancer?

A

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>

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30
Q

What was the clinical relevance of the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?

A

Showed that adjuvant mFOLFIRINOX improves DFS, DMFS, and OS compared to gemcitabine.

31
Q

What population was studied in the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?

A

493 pts with resected pancreatic cancer

32
Q

What regimen was studied in the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?

A

“→adj gem <br></br>vs. <br></br><span>→mFOLFIRINOX</span>”

33
Q

What were the results of the PRODIGE 24 / CCTG PA.6 study for pancreatic cancer?

A

“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>”

34
Q

What was the clinical relevance of the LAP07 trial for pancreatic cancer?

A

This trial assessed the value of adding EBRT and Erlotinib to Gemcitabine for unresectable pancreatic cancer.

35
Q

What population was studied in the LAP07 trial for pancreatic cancer?

A

Pts with locally advanced pancreatic cancer

36
Q

What regimen was studied in the LAP07 trial for pancreatic cancer?

A

“→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>”

37
Q

What were the results of the LAP07 trial for pancreatic cancer?

A

“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>”

38
Q

What were the concerns about the LAP07 trial for pancreatic cancer?

A

IMRT was not used. 18% of pts had major deviations.

39
Q

What was the clinical relevance of the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?

A

This trial showed worse OS for chemoRT over Gemcitabine alone for unresectable pancreatic cancer.

40
Q

What was the population studied in the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?

A

119 pts with locally advanced pancreatic cancer

41
Q

What was the regimen studied in the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?

A

“60 Gy + <span>5FU/</span><span>cis</span> vs. <span>Gem</span> alone<br></br><br></br>maintenance Gem in both arms”

42
Q

What were the results of the FFCD-SFRO trial for unresectable pancreatic cancer (Chauffert et al. Ann Onc)?

A

<div>Worse OS and toxicity with chemoRT.</div>

<div><br></br></div>

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%

43
Q

What was the clinical relevance of the GITSG unresectable pancreatic cancer trial?

A

<b>Old trial </b>that showed that CRT with 5FU->SMF resulted in improved OS over SMF alone.

44
Q

What was the population studied in the GITSG unresectable pancreatic cancer trial?

A

43 pts with unresectable, surgically staged pancreatic cancer

45
Q

What was the regimen studied in the GITSG unresectable pancreatic cancer trial?

A

SMF (streptozocin, mitomycin, 5FU) vs. 54 Gy conc 5FU then SMF

46
Q

What were the results of the GITSG unresectable pancreatic cancer trial?

A

Improved OS with addition of chemoRT to SMF chemotherapy<div><br></br></div><div>1-yr OS 19% vs. 42% with RT</div>

47
Q

What was the clinical relevance of the ECOG 4201 trial for unresectable pancreatic cancer?

A

This trial showed that chemoRT with gem seems to result in improved OS over gem alone. The trial is likely underpowered.

48
Q

What population was studied in the ECOG 4201 trial for unresectable pancreatic cancer?

A

74 pts with unresectable pancreatic cancer

49
Q

What regimen was studied in the ECOG 4201 trial for unresectable pancreatic cancer?

A

“→gem alone <br></br>vs. <br></br>→50.4 Gy<span> RT + gem then consolidation gem</span>”

50
Q

What were the results of the ECOG 4201 trial for unresectable pancreatic cancer?

A

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>

51
Q

What was the clinical relevance of the SCALOP trial for unresectable pancreatic cancer?

A

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.

52
Q

What population was studied in the SCALOP trial for unresectable pancreatic cancer?

A

74 pts with locally advanced pancreatic, size ≤7 cm

53
Q

What regimen was studied in the SCALOP trial for unresectable pancreatic cancer?

A

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

54
Q

What were the results of the SCALOP trial for unresectable pancreatic cancer?

A

“<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>”

55
Q

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)?

A

This trial showed chemoRT with 5FU results in improved OS over RT alone.

56
Q

What population was studied in the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?

A

194 pts with unresectable pancreatic cancer

57
Q

What regimen was studied in the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?

A

60 Gy vs. 40 Gy + 5FU vs. 60 Gy + 5FU<br></br><br></br>Split course RT

58
Q

What were the results of the GITSG trial analyzing the addition of 5FU to RT for unresectable pancreatic cancer (Moertel et al. Cancer 1981)?

A

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>

59
Q

What was the clinical relevance of the PREOPANC study for pancreatic cancer?

A

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.

60
Q

What population was studied in the PREOPANC study for pancreatic cancer?

A

246 pts with borderline resecatble pancreatic cancer

61
Q

What regimen was studied in the PREOPANC study for pancreatic cancer?

A

“→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”

62
Q

What were the results of the PREOPANC study for pancreatic cancer?

A

<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>

<div><br></br></div>

<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>

63
Q

What was the clinical relevance of the Italian analysis of SBRT for inoperable pancreatic cancer?

A

Showed that SBRT seems to show favorable outcomes. Randomized trials are needed.

64
Q

What population was included in the Italian analysis of SBRT for inoperable pancreatic cancer?

A

1009 pts with inoperable pancreatic cancer

65
Q

What regimen was included in the Italian analysis of SBRT for inoperable pancreatic cancer?

A

Review and pooled analysis of 19 SBRT studies

66
Q

What were the results of the Italian analysis of SBRT for inoperable pancreatic cancer?

A

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>

67
Q

What was the clinical relevance of the T Gen trial for metastatic pancreatic cancer?

A

Showed that Nab-paclitaxel improves OS in metastatic pancreatic cancer.

68
Q

What population was studied in the T Gen trial for metastatic pancreatic cancer?

A

861 pts with metastatic pancreatic cancer

69
Q

What regimen was studied in the T Gen trial for metastatic pancreatic cancer?

A

“<span>→nab-paclitaxel then gem <br></br></span>vs. <br></br>→gem alone”

70
Q

What were the results of the T Gen trial for metastatic pancreatic cancer?

A

OS benefit with nabpaclitaxel<div><br></br>Median OS 8.5 mos vs. 6.7 mos<br></br><br></br><br></br></div>

71
Q

What was the clinical relevance of the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?

A

This trial showed that FOLFIRINOX improves OS and has lower toxicity than gemcitabine in metastatic pancreatic cancer.

72
Q

What population wa sstudied in the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?

A

242 pts with metastatic pancreatic cancer

73
Q

What regimen was studied in the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?

A

“<span>→FOLFIRNOX</span> <br></br>vs. <br></br>→gem”

74
Q

What were the results of the Intergroup study (GTDU and PRODIGE) for metastatic pancreatic cancer?

A

Benefit with FOLFIRINOX over Gemcitabine in Median OS<br></br>11.1 mos vs. 6.8<div><br></br><br></br></div>

ANKI- GI (8 decks)

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