Esophagus Flashcards
What is the clinical relevance of RTOG 8501?
This trial showed a benefit to adding chemo to definitive RT for unresectable esophageal cancer.
What population was studied in RTOG 8501?
129 pts; T1-3, N0-1, mostly squamous
What regimens were studied in RTOG 8501?
“<span>50 Gy/25 fx + 5FU/cisplatin <br></br></span>vs. <br></br>64 Gy alone”
What were the outcomes of RTOG 8501?
<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%
What is the clinical relevance of RTOG 9405/INT 0123 (esophageal trial)?
This trial examined whether dose escalation is beneficial for definitive chemoradiation for inoperable pts with esophageal cancer.
What population was studied in RTOG 9405/INT 0123 (esophageal trial)?
236 pts; inoperable SCCa or adeno
What regimens were studied in RTOG 9405/INT 0123 (esophageal trial)?
“<span>→50.4 Gy + 5FU/cisplatin <br></br></span>vs. <br></br>→64.8 Gy + 5FU/cisplatin”
What were the results of RTOG 9405/INT 0123 (esophageal trial)?
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>
What is the clinical relevance of the ARTDECO trial (esophageal trial)?
This trial examined whether dose escalation would be helpful or pts with unresectable/inoperable esophageal cancer. This trial utilized IMRT for escalating dose.
What population was studied in the ARTDECO trial (esophageal trial)?
260 pts; T2-4, N0-3 esophageal cancer, inoperable (either medically or anatomically)
What regimens were studied in the ARTDECO trial (esophageal trial)?
“<span>→50.4 Gy + carbo/taxol<br></br></span>vs.<br></br>→61.6/50.4 Gy SIB + carbo/taxol”
What were the results of the ARTDECO trial (esophageal)?
No improvement in outcomes with IMRT dose escalation for unresectable/inoperable esophageal cancer.
What regimens were studied in the Japanese cervical esophageal cancer study?
60 Gy and concurrent cisplatin and 5FU
What was the outcome of the Japanese cervical esophageal cancer study?
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>
What is the clinical relevance of the Japanese cervical esophageal cancer study?
This study showed that definitive chemoRT is feasible and has relatively favorable outcomes.
What is the clinical relevance of the CROSS trial?
This trial showed the neoadjuvant chemoRT improves outcomes for resectable esophageal cancer.
What population was studied in the CROSS trial?
368 pts with resectable T1N1 and T2/3 N0/1 adeno (75%) or squamous (25%) of esophagus (75%) or GEJ (25%)
What regimens were studied in the CROSS trial?
“→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”
What were the results of the CROSS trial?
“<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>”
What were the findings at surgery after chemoRT in the CROSS trial?
R0 resections better with chemoRT: 92% vs. 69%<br></br><br></br><div>pCR rate of 29% (23% in adeno, 49% in SCC)</div>
What were the recurrence patterns from the CROSS trial?
Pre-op chemoRT reduced LRR and peritoneal carcinomatosis.<br></br><br></br>Most LRRs were concominant with outfield recurrences.
What is the clinical relevance of NEOCRTEC5010 (esophageal study)?
It provided additional evidence that neoadjuvant chemoRT improves outcomes.
What population was studied in NEOCRTEC5010?
451 pts; Resectable esophageal cancer T1-4N1M0 or T4N0M0
What regimens were studied in NEOCRTEC5010?
→surgery alone <br></br>vs. <br></br>→pre-op RT to 40 Gy/2 Gy fx + cisplatin vinorelbine q3 wks
What were the results of NEOCRTEC5010?
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>
What was the clinical relevance of CALGB 9781 (esophageal study)?
Provided additional evidence that preop chemoRT improves outcomes for esophageal cancer
What population was studied in CALGB 9781 (esophageal study)?
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
What regimens were studied in CALGB 9781?
“→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”
What were the outcomes of CALGB 9781?
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>
What was the clinical relevance of the Irish esophageal study (Walsh et al.)?
Provided additional evidence that preop chemoRT improves outcomes for esophageal cancer.
What population was studied in the Irish esophageal study (Walsh et al.)?
113 pts with adenocarcinoma
What regimen was studied in the Irish esophageal study (Walsh et al.)?
“→surgery alone <br></br>vs. <br></br><span>→pre-op chemoRT</span> to 40 Gy/15 fx + cis/5FU”
What were the results of the Irish esophageal study (Walsh et al.)?
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>
What is the clinical relevance of the Michigan and French studied of preop chemoRT for esophageal cancer?
They showed no OS benefit (unlike other trials such as CROSS, CALGB 9781, Irish, etc.).
What populations were studied in the Michigan and French studied of preop chemoRT for esophageal cancer?
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>
What regimens were studied in the Michigan and French studied of preop chemoRT for esophageal cancer?
<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>
What were the results of the Michigan and French esophageal studies?
No significant OS benefit to preop chemoRT.
What is the clinical relevance of the Stahl II study?
This study showed a trend to improved OS for neoadjuvant chemoRT over neoadjuvant chemo alone for GEJ tumors.
What population was studied in the Stahl II study?
119 pts with T3-4Nx GE junction adenocarcinoma Type I-III
What regimen was studied in the Stahl II study?
“<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”
What were the results of the Stahl II study?
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>
What was the problem with the Stahl II study?
Closed early. Underpowered.
What is the clinical relevance of the POET study for esophageal cancer?
This showed a significant PFS benefit to neoadjuvant chemoRT over chemo alone.
What population was studied in the POET study for esophageal cancer?
119 pts; T3/T4 GEJ adeno
What regimen was studied in the POET study for esophageal cancer?
→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
What were the results of the POET study for esophageal cancer?
Trend toward OS benefit with chemoRT (HR 0.65; P=0.055)<div>Significant PFS benefit (HR 0.37)</div>
What is the clinical relevance of the FFCD 9102 France esophageal cancer study?
Showed LC benefit to adding surgery to chemoRT for esophageal cancer.
What was the population studied in the FFCD 9102 France esophageal cancer study?
259 pts; operable T3N0-1 thoracic esophageal Ca. 90% SCC. 94% transthoracic surgery
What was the regimen studied in the FFCD 9102 France esophageal cancer study?
→Pre-op RT 46 Gy (or split course) + 5FU/cis x2 –> surgery vs. <br></br>→chemoRT (total dose 66 Gy)
What were the results of the FFCD 9102 France esophageal cancer study?
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>
What is the clinical relevance of the Stahl I esophageal cancer study?
Showed a LC benefit to adding surgery to chemoRT.
What population was studied in the Stahl I esophageal cancer study?
172 pts; T3-4 SCC
What regimen was studied in the Stahl I esophageal cancer study?
→Pre-op chemo → RT 40 Gy → surgery vs. <br></br>→chemoRT (HDR or EBRT boost to 64-65 Gy)
What were the results of the Stahl I esophageal cancer study?
“<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%”
What is the clinical relevance of the London study of salvage vs planned esophagectomy?
Salvage esophagectomy showed favorable outcomes compared to planned.
What population was studied in the London study of salvage vs planned esophagectomy?
848 pts from 30 different centers in Europe
What regimen was studied in the London study of salvage vs planned esophagectomy?
Retrospective review comparing salvaged vs. planned esophagectomy
What rwere the outcomes of the London study of salvage vs planned esophagectomy?
“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>”
What is the clinical relevance of RTOG 0246 for esophageal cancer?
This trial showed that selective esophagectomy after chemoRT leads to good outcomes (although not as good as historical controls getting trimodality therapy).
What population was studied in RTOG 0246 for esophageal cancer?
43 pts; operable nonmetastatic esophageal cancer
What regimen was studied in RTOG 0246 for esophageal cancer?
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
What were the results of RTOG 0246 for esophageal cancer?
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>
What is the clinical relevance of the MDACC proton therapy for esophageal cancer study?
It showed that protons improved total toxicity burden and reduced postop complications.
What population was studied in the MDACC proton therapy for esophageal cancer study?
145 pts with locally advanced esophageal cancer
What regimen was studied in the MDACC proton therapy for esophageal cancer study?
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>
What were the results of the MDACC protons for esophageal cancer study?
<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>
What are the criticisms of the MDACC protons for esophageal cancer study?
VMAT was not required for IMRT arm.<div>The total toxicity burden endpoint was made up by MDACC and never validated.</div>
