Esophagus Flashcards

1
Q

What is the clinical relevance of RTOG 8501?

A

This trial showed a benefit to adding chemo to definitive RT for unresectable esophageal cancer.

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2
Q

What population was studied in RTOG 8501?

A

129 pts; T1-3, N0-1, mostly squamous

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3
Q

What regimens were studied in RTOG 8501?

A

“<span>50 Gy/25 fx + 5FU/cisplatin <br></br></span>vs. <br></br>64 Gy alone”

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4
Q

What were the outcomes of RTOG 8501?

A

<div>All outcomes improved with addition of CHT.</div>

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

<b>5-yr OS 26% CRT vs. 0% RT alone<br></br>Median OS 14.1 vs. 9.3 mos</b><br></br>5-yr LRF 53% vs. 38%<br></br>5-yr DM 16% vs. 30%

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5
Q

What is the clinical relevance of RTOG 9405/INT 0123 (esophageal trial)?

A

This trial examined whether dose escalation is beneficial for definitive chemoradiation for inoperable pts with esophageal cancer.

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6
Q

What population was studied in RTOG 9405/INT 0123 (esophageal trial)?

A

236 pts; inoperable SCCa or adeno

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7
Q

What regimens were studied in RTOG 9405/INT 0123 (esophageal trial)?

A

“<span>→50.4 Gy + 5FU/cisplatin <br></br></span>vs. <br></br>→64.8 Gy + 5FU/cisplatin”

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8
Q

What were the results of RTOG 9405/INT 0123 (esophageal trial)?

A

Closed and reached futility early due to deaths in high dose arm (but prior to recieving 50.4 Gy).<div><br></br>No difference in any outcomes<br></br><br></br></div>

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9
Q

What is the clinical relevance of the ARTDECO trial (esophageal trial)?

A

This trial examined whether dose escalation would be helpful or pts with unresectable/inoperable esophageal cancer. This trial utilized IMRT for escalating dose.

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10
Q

What population was studied in the ARTDECO trial (esophageal trial)?

A

260 pts; T2-4, N0-3 esophageal cancer, inoperable (either medically or anatomically)

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11
Q

What regimens were studied in the ARTDECO trial (esophageal trial)?

A

“<span>→50.4 Gy + carbo/taxol<br></br></span>vs.<br></br>→61.6/50.4 Gy SIB + carbo/taxol”

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12
Q

What were the results of the ARTDECO trial (esophageal)?

A

No improvement in outcomes with IMRT dose escalation for unresectable/inoperable esophageal cancer.

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13
Q

What regimens were studied in the Japanese cervical esophageal cancer study?

A

60 Gy and concurrent cisplatin and 5FU

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14
Q

What was the outcome of the Japanese cervical esophageal cancer study?

A

Favorable results:<div><br></br></div><div>3 yr OS 67% and 3 yr laryngectomy free survival 53%</div><div><br></br></div><div>(Outcomes worse for T4 tumors)</div>

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15
Q

What is the clinical relevance of the Japanese cervical esophageal cancer study?

A

This study showed that definitive chemoRT is feasible and has relatively favorable outcomes.

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16
Q

What is the clinical relevance of the CROSS trial?

A

This trial showed the neoadjuvant chemoRT improves outcomes for resectable esophageal cancer.

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17
Q

What population was studied in the CROSS trial?

A

368 pts with resectable T1N1 and T2/3 N0/1 adeno (75%) or squamous (25%) of esophagus (75%) or GEJ (25%)

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18
Q

What regimens were studied in the CROSS trial?

A

“→surgery alone <br></br>vs. <br></br><span>→pre-op chemoRT to 41.4 Gy + carbo/paclitaxel weekly</span><br></br><br></br>RT did not include SCV or celiac”

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19
Q

What were the results of the CROSS trial?

A

“<span>Improved OS with chemoRT<br></br>Median OS 49 vs. 24 mos <br></br>Median OS SCC 82 vs. 21 mos<br></br>Median OS adeno 43 vs. 27 mos<br></br>5-yr OS 47% vs. 34%</span><br></br><br></br><div><br></br></div>”

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20
Q

What were the findings at surgery after chemoRT in the CROSS trial?

A

R0 resections better with chemoRT: 92% vs. 69%<br></br><br></br><div>pCR rate of 29% (23% in adeno, 49% in SCC)</div>

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21
Q

What were the recurrence patterns from the CROSS trial?

A

Pre-op chemoRT reduced LRR and peritoneal carcinomatosis.<br></br><br></br>Most LRRs were concominant with outfield recurrences.

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22
Q

What is the clinical relevance of NEOCRTEC5010 (esophageal study)?

A

It provided additional evidence that neoadjuvant chemoRT improves outcomes.

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23
Q

What population was studied in NEOCRTEC5010?

A

451 pts; Resectable esophageal cancer T1-4N1M0 or T4N0M0

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24
Q

What regimens were studied in NEOCRTEC5010?

A

→surgery alone <br></br>vs. <br></br>→pre-op RT to 40 Gy/2 Gy fx + cisplatin vinorelbine q3 wks

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25
Q

What were the results of NEOCRTEC5010?

A

Improved OS and DFS<div><br></br></div><div>Median OS 67 mos vs. 100 mos<br></br>Median DFS 42 mos vs. 100 mos<br></br></div>

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26
Q

What was the clinical relevance of CALGB 9781 (esophageal study)?

A

Provided additional evidence that preop chemoRT improves outcomes for esophageal cancer

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27
Q

What population was studied in CALGB 9781 (esophageal study)?

A

56 pts with adeno or SCC<br></br>thoracic esophagus to GEJ with less than 2 cm to cardia<br></br>T1-3, N0-1. Nodes <1.5 cm

28
Q

What regimens were studied in CALGB 9781?

A

“→sugery alone <br></br>vs<br></br><span>→pre-op RT to 50.4 Gy + cis/5FU</span><br></br><br></br>Optional inclusion of SCV or celiac <br></br><br></br>Surgery in 3-8 weeks, Ivor-Lewis”

29
Q

What were the outcomes of CALGB 9781?

A

Improved OS and PFS<div><br></br></div><div>Median OS 4.5 yrs vs. 1.8<br></br>5-yr OS 39% vs. 16%<br></br>PFS 3.5 yrs vs. 1<br></br></div>

30
Q

What was the clinical relevance of the Irish esophageal study (Walsh et al.)?

A

Provided additional evidence that preop chemoRT improves outcomes for esophageal cancer.

31
Q

What population was studied in the Irish esophageal study (Walsh et al.)?

A

113 pts with adenocarcinoma

32
Q

What regimen was studied in the Irish esophageal study (Walsh et al.)?

A

“→surgery alone <br></br>vs. <br></br><span>→pre-op chemoRT</span> to 40 Gy/15 fx + cis/5FU”

33
Q

What were the results of the Irish esophageal study (Walsh et al.)?

A

Improved OS<div><br></br></div><div>ChemoRT improved 1-yr OS 52% vs. 32%<br></br>3-yr OS 6% vs. 32%<br></br>Median OS 16 vs. 11 mos<br></br></div>

34
Q

What is the clinical relevance of the Michigan and French studied of preop chemoRT for esophageal cancer?

A

They showed no OS benefit (unlike other trials such as CROSS, CALGB 9781, Irish, etc.).

35
Q

What populations were studied in the Michigan and French studied of preop chemoRT for esophageal cancer?

A

Michigan: Localized adeno and SCC<div><br></br></div><div>French: Esophageal SCC (70%) or adeno (29%), T1-T2N0-1 or T3N0. Celiac and SCV LN excluded</div>

36
Q

What regimens were studied in the Michigan and French studied of preop chemoRT for esophageal cancer?

A

<div>Michigan:</div>

<div>→surgery alone vs. <br></br>→pre-op 45 Gy 1.5 BID + cisplatin/vinblastine/5FU<br></br></div>

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

French:<div>→Transthoracic surgery<div>vs. <br></br>→pre-op RT 45 Gy + cis/5FU</div></div>

37
Q

What were the results of the Michigan and French esophageal studies?

A

No significant OS benefit to preop chemoRT.

38
Q

What is the clinical relevance of the Stahl II study?

A

This study showed a trend to improved OS for neoadjuvant chemoRT over neoadjuvant chemo alone for GEJ tumors.

39
Q

What population was studied in the Stahl II study?

A

119 pts with T3-4Nx GE junction adenocarcinoma Type I-III

40
Q

What regimen was studied in the Stahl II study?

A

“<span>→pre-op cisplatin/5FU/leucovorin then 30 Gy concurrent cis/etop </span>vs. <br></br>→pre-op chemo alone<br></br><br></br>RT to cardiac, gastric, celiac, splenic, hepatic nodes”

41
Q

What were the results of the Stahl II study?

A

Trend to improved OS for neoadjuvant chemoRT. Better pCR rate.<div><br></br></div>pCR 16% vs. 2% <br></br>3-yr OS 47% vs. 28%, p=0.07<br></br><br></br>

42
Q

What was the problem with the Stahl II study?

A

Closed early. Underpowered.

43
Q

What is the clinical relevance of the POET study for esophageal cancer?

A

This showed a significant PFS benefit to neoadjuvant chemoRT over chemo alone.

44
Q

What population was studied in the POET study for esophageal cancer?

A

119 pts; T3/T4 GEJ adeno

45
Q

What regimen was studied in the POET study for esophageal cancer?

A

→pre-op cis/5FU/LV x2 then cis/etop x1c + 30 Gy RT<br></br>vs. <br></br>→pre-op cis/5FU/LV x2.5

46
Q

What were the results of the POET study for esophageal cancer?

A

Trend toward OS benefit with chemoRT (HR 0.65; P=0.055)<div>Significant PFS benefit (HR 0.37)</div>

47
Q

What is the clinical relevance of the FFCD 9102 France esophageal cancer study?

A

Showed LC benefit to adding surgery to chemoRT for esophageal cancer.

48
Q

What was the population studied in the FFCD 9102 France esophageal cancer study?

A

259 pts; operable T3N0-1 thoracic esophageal Ca. 90% SCC. 94% transthoracic surgery

49
Q

What was the regimen studied in the FFCD 9102 France esophageal cancer study?

A

→Pre-op RT 46 Gy (or split course) + 5FU/cis x2 –> surgery vs. <br></br>→chemoRT (total dose 66 Gy)

50
Q

What were the results of the FFCD 9102 France esophageal cancer study?

A

Benefit in LC but not OS<div><br></br></div><div>Median OS 18 vs. 19 mos (NS)<br></br>2-yr LC 65% vs. 57% (ss)<br></br><br></br><br></br>Also more stents with chemoRT:<br></br>stents 5% vs. 32%<br></br><div><br></br></div><div><br></br></div></div>

51
Q

What is the clinical relevance of the Stahl I esophageal cancer study?

A

Showed a LC benefit to adding surgery to chemoRT.

52
Q

What population was studied in the Stahl I esophageal cancer study?

A

172 pts; T3-4 SCC

53
Q

What regimen was studied in the Stahl I esophageal cancer study?

A

→Pre-op chemo → RT 40 Gy → surgery vs. <br></br>→chemoRT (HDR or EBRT boost to 64-65 Gy)

54
Q

What were the results of the Stahl I esophageal cancer study?

A

“<div>LC benefit but no OS benefit. Also higher mortality with surgery.</div><div><br></br></div>MS (16 mos vs. 15 mos) and 3-yr OS (31% vs. 24%)<br></br><span>2-yr FFLP 64% surgery vs. 41% chemoRT</span>.<br></br>Treatment mortality 4% vs. 13%”

55
Q

What is the clinical relevance of the London study of salvage vs planned esophagectomy?

A

Salvage esophagectomy showed favorable outcomes compared to planned.

56
Q

What population was studied in the London study of salvage vs planned esophagectomy?

A

848 pts from 30 different centers in Europe

57
Q

What regimen was studied in the London study of salvage vs planned esophagectomy?

A

Retrospective review comparing salvaged vs. planned esophagectomy

58
Q

What rwere the outcomes of the London study of salvage vs planned esophagectomy?

A

“No difference in OS and slightly better DFS.<div><br></br><span>3-yr OS 43% vs. 40%, p=0.542</span><br></br><span>3-yr DFS 39% salvage vs. 33% planned, p=0.046</span><br></br>If persistent disease, OS and DFS were worse</div>”

59
Q

What is the clinical relevance of RTOG 0246 for esophageal cancer?

A

This trial showed that selective esophagectomy after chemoRT leads to good outcomes (although not as good as historical controls getting trimodality therapy).

60
Q

What population was studied in RTOG 0246 for esophageal cancer?

A

43 pts; operable nonmetastatic esophageal cancer

61
Q

What regimen was studied in RTOG 0246 for esophageal cancer?

A

Phase II: Induction 5FU/cis/paclitaxel → 50.4 Gy + concurrent 5-FU/cis<br></br>→ eval response with CT, EUS, and optional PET → observe CR and resect PR or PD

62
Q

What were the results of RTOG 0246 for esophageal cancer?

A

Overall: 5-yr OS 37%<br></br>If CR: 5-yr OS 53%<br></br><br></br><div>These are pretty good but the overall number is lower than the CROSS trial 5 yr OS of 47%</div>

63
Q

What is the clinical relevance of the MDACC proton therapy for esophageal cancer study?

A

It showed that protons improved total toxicity burden and reduced postop complications.

64
Q

What population was studied in the MDACC proton therapy for esophageal cancer study?

A

145 pts with locally advanced esophageal cancer

65
Q

What regimen was studied in the MDACC proton therapy for esophageal cancer study?

A

Phase IIB<br></br>IMRT 50.4 Gy<br></br>vs. <br></br>protons 50.4 Gy<br></br><br></br><div><br></br></div>

66
Q

What were the results of the MDACC protons for esophageal cancer study?

A

<div>-Mean TTB 2.3x more with IMRT<br></br></div>

-Post-op complications 7.6x more with IMRT<br></br><br></br><div>No survival differences</div>

67
Q

What are the criticisms of the MDACC protons for esophageal cancer study?

A

VMAT was not required for IMRT arm.<div>The total toxicity burden endpoint was made up by MDACC and never validated.</div>