KOL Pulse — Trial Profile

ESOPEC Trial

Resectable esophageal adenocarcinoma (cT1N+ or cT2-4a N0/+, M0) — University Hospital Schleswig-Holstein / German Research Foundation

Resectable esophageal adenocarcinoma (cT1N+ or cT2-4a N0/+, M0)FLOTASCO 2024 Plenary / NEJM 2025
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Top KOLs Discussing ESOPEC

Krishan Jethwa
Krishan Jethwa
@KrishanJethwa
144.5K impressions
Dr. Nina Niu Sanford
Dr. Nina Niu Sanford
@NiuSanford
38.7K impressions
Mark Lewis
Mark Lewis
@marklewismd
24.3K impressions
NEJM
NEJM
@NEJM
16.5K impressions
Erman Akkus
Erman Akkus
@Erman_Akkus
11.7K impressions
M. Bolton
M. Bolton
@5_utr
7.2K impressions

ESOPEC Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASCO 2024 Plenary / NEJM 2025. Click any image to expand.

Krishan Jethwa
Krishan Jethwa @KrishanJethwa
ESOPEC Data
77.4K impressions · 263 likes · Jun 2, 2024
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[Slide 1] 12 Characteristics of ESOPEC Trial Patients FLOT Group CROSS Group N 221 217 Age mean (SD) in years 63.1 (8.6) 62.6 (9.8) Sex male 89.1 % 89.4 % ECOG > 0 26.7% 28.1% Clinical T-stage cT1-2 19.5% 17.1% cT3-4 79.1% 81.9% Clinical N-stage cNO 22.2% 18.4% cN+ 77.8% 81.6% 1. Missing: 2 patients 2024 ASCO #ASCO24 PRESENTED BY: Jens Hoeppner MD FACS FEBS 2. Siewert BJS 1998 ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions @asco org 3. Tx:5 patients; Missing 2 patients KNOWLEDGE CONQUERS CANCER --- [Slide 2] 13 Overall Survival - ITT Population 100 Randomized treatment FLOT CROSS FLOT CROSS 80 Median follow-up: 55 months Events 97 121 60 Median 66 37 OS 95% CI 95% CI time 40 36 n.e 28 - 43 (months) 3-year 20 OS HR 0.70 (0.53-0.92)* p=0.012 57.4% 50.7% rate 0 5-year OS 50.6% 38.7% 0 12 24 36 48 60 72 84 rate Months from randomization FLOT 221 172 124 107 84 44 11 0 CROSS 217 146 113 92 54 32 15 0 *Two-sided 95% confidence interval; 2024 ASCO #ASCO24 PRESENTED BY: Jens Hoeppner MD FACS FEBS ASCO AMERICAN SOCIETY OF Cox regression adjusted for N stage CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco org KNOWLEDGE CONQUERS CANCER and age, stratified for trial site --- [Slide 3] 17 Progression Free Survival - ITT Population 100 Randomized treatment FLOT CROSS FLOT CROSS 80 Median follow-up: 55 months Events 107 137 60 Median PFS 38 16 95% CI 95% CI time 40 21 - n.e. 12 - 22 (months) 3-year 20 PFS 51.6% 35.0% HR 0.66 (0.51-0.85)* p=0.001 rate 0 5-year 0 12 24 36 48 60 72 84 PFS 44.4% 30.9% rate Months from randomization FLOT 221 135 101 93 73 39 11 0 CROSS 217 113 78 62 39 22 9 0 *Two-sided 95% confidence interval; 2024 ASCO #ASCO24 PRESENTED BY: Jens Hoeppner MD FACS FEBS Cox regression adjusted for N stage ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco org and age, stratified for trial site KNOWLEDGE CONQUERS CANCER --- [Slide 4] 7 ESOPEC Trial Scheme Preoperative Postoperative Chemotherapy Chemotherapy FLOT Surgery FLOT 5-FU, Leucovorin, 5-FU, Leucovorin, Oxaliplatin, Docetaxel 4-6 4-6 Oxaliplatin, Docetaxel weeks 4 cycles in 8 weeks weeks after 4 cycles in 8 weeks discharge R 1:1 Neoadjuvant Chemoradiation CROSS Surgery 41.4 Gy 4-6 Paclitaxel/Carboplatin weeks 5 cycles in 5 weeks 2024 ASCO #ASCO24 PRESENTED BY: Jens Hoeppner MD FACS FEBS ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions @asco org KNOWLEDGE CONQUERS CANCER
Krishan Jethwa
Krishan Jethwa @KrishanJethwa
ESOPEC Data
41.1K impressions · 136 likes · Jan 22, 2025
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[Slide 1] A Overall Survival 100 90 80 70 Percentage of Patients 60 FLOT 50 40 30 20 Preoperative Hazard ratio for death, 0.70 (95% CI, 0.53-0.92) chemoradiotherapy 10 P=0.01 0 0 12 24 36 48 60 72 84 Months since Randomization No. at Risk FLOT 221 172 124 107 84 44 11 0 Preoperative chemoradiotherapy 217 146 113 92 54 32 15 0 B Progression-free Survival 100 90 80 70 Percentage of Patients 60 50 FLOT 40 30 20 Preoperative Hazard ratio for disease progression or death, chemoradiotherapy 10 0.66 (95% CI, 0.51-0.85) 0 0 12 24 36 48 60 72 84 Months since Randomization No. at Risk FLOT 221 135 101 93 73 39 11 0 Preoperative chemoradiotherapy 217 113 78 62 39 22 9 0
Dr. Nina Niu Sanford
Dr. Nina Niu Sanford @NiuSanford
ESOPEC Data
19.7K impressions · 66 likes · Jan 23, 2025
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[Slide 1] Table S3. Status and Site of Failure, Overall Survival Status, Progression-free Survival Status (Intention-to-Treat Population). FLOT Preoperative Chemoradiotherapy (N=221) (N=217) Status and site of failure - no. Failure 89 118 Isolated locoregional failure 17 9 Isolated distant failure 45 71 Simultaneous locoregional and distant failure 26 27 Distant metastases detected before start of 1 11 therapy (M1) No failure 132 99 Alive without failure* 114 80 Death without failure* 18 19 Overall survival status - no. Death 97 121 Death with previous failure 72 99 Death without previous failure* 25 22 Alive (censored) 124 96 Alive with failure 17 19 Alive without failure* 107 77 Progression-free survival status - no. Event 107 137 Failure 89 118 Death 18 19 No event (censored)* 114 80
Lorenzo Ferri MD PhD
ESOPEC Data
6.6K impressions · 52 likes · Jun 2, 2024
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[Slide 1] 13 Overall Survival - ITT Population 100 Randomized treatment FLOT CROSS FLOT CROSS 80 Median follow-up: 55 months Events 97 121 Overall survival (%) 60 Median OS 66 37 95% CI 95% CI time 40 36 - n.e 28 - 43 (months) 3-year 20 HR 0.70 (0.53-0.92)* p=0.012 OS 57.4% 50.7% rate 0 5-year 0 12 24 36 48 60 72 84 OS 50.6% 38.7% rate Months from randomization FLOT 221 172 124 107 84 44 11 0 CROSS 217 146 113 92 54 32 15 0 "Two-sided 95% confidence interval; 2024 ASCO #ASCO24 PRE SENTED-BY: Jens Hoeppner MD FACS FEBS ASCO AMERICAN SOCIETY OF Cox regression adjusted for N stage CURICAL (modd/yy) ANNUAL MEETING Presentation . property of the author and ABOD Permission required for - - KNOWLEDGE CONQUERS CANCER and age, stratified for trial site
Krishan Jethwa
Krishan Jethwa @KrishanJethwa
ESOPEC Data
5.2K impressions · 21 likes · Jun 2, 2024
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[Slide 1] SANO-1 TRIAL Response assessment 10-14 weeks PET EGD/EUS + Bx Active Surveillance cCR R Esophageal Carcinoma CROSS CRT Esophagectomy (SCC or Adeno) N=309 <CR Esophagectomy X @KrishanJethwa Redrawn from: Van der Wilk ESMO 2023 @2024 Mayo Foundation for Medical Education and Research I WF1527250-67 --- [Slide 2] SANO-1 TRIAL - OVERALL SURVIVAL 1.00 0.75 Survival (%) 0.50 0.25 HR 1.14, 95% CI 0.74-1.78, P=0.55 - Active surveillance Noninferiority testing at 2 years 95% upper boundary <15% difference (P<0.01) Surgery 0.00 0 6 12 18 24 30 36 Follow-up (months) Number at risk 198 191 178 164 144 95 45 111 105 97 85 78 68 60 X @KrishanJethwa Redrawn from: Van der Wilk ESMO 2023 @2024 Mayo Foundation for Medical Education and Research I WF1996204-68

ESOPEC Top Tweets

Top tweets by impressions — click to view on X

Krishan Jethwa
Krishan Jethwa@KrishanJethwa

🚨🚨🚨 #ESOPEC🚨🚨🚨

🔥Practice shifting trial🔥

Patients with resectable, locally advanced, esophagus/GEJ adenocarcinoma

Randomized

Peri-op FLOT (FLOT4)
vs
Pre-operative chemoradiation…

👁 77.4K ♡ 263 ↻ 121 Jun 2, 2024
Krishan Jethwa
Krishan Jethwa@KrishanJethwa

🚨ESOPEC Pub has landed!🚨

See data review below!

For now, "standard" will appropriately shift to peri-operative FLOT BUT we should not be satisfied as outcomes remain suboptimal

Ongoing ❓❓
- does…

👁 41.1K ♡ 136 ↻ 44 Jan 22, 2025
Mark Lewis
Mark Lewis@marklewismd

OK, wait, something doesn&#x27;t make sense with ESOPEC
Even excluding the presumably more radio-sensitive squams, why is the adeno arm performing worse in a contemporary trial vs. the CROSS study…

👁 20.3K ♡ 80 ↻ 16 Jun 2, 2024
Dr. Nina Niu Sanford
Dr. Nina Niu Sanford@NiuSanford

Isolated locoregional failures were halved w CROSS, but unsurprisingly many more distant metastases.

Also notable that CROSS group had many more distant mets even BEFORE start of therapy (11 vs. 1),…

👁 19.7K ♡ 66 ↻ 19 Jan 23, 2025
Dr. Nina Niu Sanford
Dr. Nina Niu Sanford@NiuSanford

Big dif in OS favoring FLOT over CROSS in ESOPEC!

Look forward to details &amp; discussion in a few hours.

#ASCO24

https://t.co/csudkS1ZkP https://t.co/hC9oqG5Jq8

👁 17.1K ♡ 53 ↻ 18 Jun 2, 2024
NEJM
NEJM@NEJM

ESOPEC, a large randomized trial involving patients with resectable esophageal cancer, showed that perioperative chemotherapy improved overall survival as compared with preoperative…

👁 16.5K ♡ 74 ↻ 29 Jan 22, 2025
Erman Akkus
Erman Akkus@Erman_Akkus

❓Is CROSS out after ESOPEC?

Real-world CROSS outcomes from Nerherlands
@eClinicalMed

➡️4765 patients
✅87.5% completed full CROSS regimen
✅pCR: 20.5%
✅mOS: 33.7 mo, 3-year OS: 48.1%
❗️adjuvant…

👁 8K ♡ 54 ↻ 14 Jan 23, 2025
Lorenzo Ferri MD PhD
Lorenzo Ferri MD PhD@LFerri123

ESOPEC trial
It’s been a long 15 year journey, but so nice to see Docetaxel triplets come on top for the benefit of our patients!
CROSS just doesn’t work for GEA-EAC- radiation compensates for poor…

👁 6.6K ♡ 52 ↻ 17 Jun 2, 2024
Bishal Gyawali
Bishal Gyawali@oncology_bg

#ASCO24 plenary, ESOPEC trial asked a very important clinically relevant question and answered it the right way. Kudos to the investigators but would have loved to see QOL and toxicity data as well.…

👁 6.4K ♡ 58 ↻ 13 Jun 2, 2024
M. Bolton
M. Bolton@5_utr

Out? No. Sicker/older non-FLOT candidates, non-surgical candidates, SCC, we still don’t know CM577 OS, ~50% of failures with FLOT are locoregional

Still a LOT of unmet need here! @NiuSanford

👁 5.5K ♡ 40 ↻ 8 Jan 23, 2025

About the ESOPEC Trial

ESOPEC is the first head-to-head Phase 3 comparison of perioperative FLOT vs. neoadjuvant CROSS in pure esophageal adenocarcinoma. FLOT won on OS, PFS, pCR, and 90-day post-op mortality. Investigators concluded FLOT should be preferred. Discussant noted CROSS may have underperformed vs. prior trials (mOS 37 months here vs. 43-50 months historically), but the study nonetheless settles the question. Post-neoadjuvant adjuvant nivolumab (CheckMate-577, non-pCR) and emerging organ-preservation concepts will reshape the landscape further. 5-year OS of 50% remains suboptimal — room for further improvement.

Trial Methodology & Results

Overall Survival — Primary Endpoint (ITT)

Median: 66 months (perioperative FLOT, 95% CI 36-NE) vs. 37 months (neoadjuvant CROSS chemoradiation, 95% CI 28-43). HR 0.7 (95% CI 0.53-0.92), P=0.01 3-year OS rate: 57.4% (FLOT) vs. 50.7% (CROSS). 5-year OS rate: 50.6% (FLOT) vs. 38.7% (CROSS). FLOT conveyed a 30% survival benefit over CROSS at median 55 months follow-up. Median OS 66 months (95% CI 36-NE) with perioperative FLOT vs. 37 months (95% CI 28-43) with neoadjuvant CROSS; HR 0.70 (95% CI 0.53-0.92, P=0.01). 3-year OS 57.4% vs. 50.7%; 5-year OS 50.6% vs. 38.7%. Per-protocol analysis: mOS NR vs. 39 months, HR 0.72 (P=0.023). Median PFS 38 vs. 16 months, HR 0.66 (P=0.001). pCR 16.8% (FLOT) vs. 10.0% (CROSS). Hoeppner et al., NEJM 2025;392(4):323-335.

✓ mOS 66 vs. 37 mo (HR 0.70); 5-yr OS 50.6% vs. 38.7%

📄 Source: KOL commentary on X →

Overall Survival (OS)

Median: 66 months (FLOT) vs. 37 months (CROSS). HR 0.7 (95% CI 0.53-0.92), P=0.01 OS is the primary endpoint (see above). Practice-changing 29-month improvement in median OS.


📄 Source →

Safety & Tolerability

Grade ≥3 adverse events: 58.0% (flot) vs. 50.0% (cross). Key AEs: neutropenia (19.8% FLOT), diarrhea (6.8% FLOT), leukopenia (6.3% FLOT; 9.7% CROSS), pneumonia (5.8% FLOT; 9.2% CROSS), pleural effusion (3.1% CROSS). Grade ≥3 AEs 58.0% (FLOT) vs. 50.0% (CROSS). Serious AEs 47.3% vs. 41.8%. 90-day postoperative mortality 3.1% (FLOT) vs. 5.6% (CROSS) — notably LOWER with FLOT despite higher preoperative AE burden. Completion rates: 87.3% (FLOT) vs. 67.7% (CROSS) received full neoadjuvant dosing.

✓ 90-day post-op mortality 3.1% (FLOT) vs. 5.6% (CROSS)

📄 Source →

Clinical Implications

Practice-changing: perioperative FLOT is new SOC over CROSS for resectable esophageal adenocarcinoma. ESOPEC is the first head-to-head Phase 3 comparison of perioperative FLOT vs. neoadjuvant CROSS in pure esophageal adenocarcinoma. FLOT won on OS, PFS, pCR, and 90-day post-op mortality. Investigators concluded FLOT should be preferred. Discussant noted CROSS may have underperformed vs. prior trials (mOS 37 months here vs. 43-50 months historically), but the study nonetheless settles the question. Post-neoadjuvant adjuvant nivolumab (CheckMate-577, non-pCR) and emerging organ-preservation concepts will reshape the landscape further. 5-year OS of 50% remains suboptimal — room for further improvement.

ESOPEC in the News

Key KOL Sentiments — ESOPEC

DoctorSentimentComment
Krishan Jethwa ● POSITIVE 🚨🚨🚨 #ESOPEC🚨🚨🚨 🔥Practice shifting trial🔥 Patients with resectable, locally advanced, esophagus/GEJ adenocarcinoma Randomized Peri-op FLOT (FLOT4) vs Pre-operative chemoradiation (CROSS) Congrats to the study investigators! Let’s dive in! #ASCO24 @MayoRadOnc 1/ https://t.co/PJ8xxxNAhk
Dr. Nina Niu Sanford ● POSITIVE Big dif in OS favoring FLOT over CROSS in ESOPEC! Look forward to details &amp; discussion in a few hours. #ASCO24 https://t.co/csudkS1ZkP https://t.co/hC9oqG5Jq8
Bishal Gyawali ● POSITIVE #ASCO24 plenary, ESOPEC trial asked a very important clinically relevant question and answered it the right way. Kudos to the investigators but would have loved to see QOL and toxicity data as well. https://t.co/UXwERZm1OL
Krishan Jethwa ● POSITIVE FLOT4 Trial included pts with resectable GEJ or gastric adenocarcinoma Randomized patients to: Peri-operative ECF vs. Peri-operative FLOT 🔑 FLOT improved: ✅ OS ✅ DFS 🔥FLOT became new SOC 6/ https://t.co/V0l2irMApv
Krishan Jethwa ● POSITIVE 🔑Takeaways 🟢 FLOT should be a SOC BUT ❓Is FLOT &gt; CM-577 regimen ❓⚖️ Toxicity ❓E vs GEJ (S1/2 vs S3) ❓Poorer pCR/OS compared with CROSS ❓TNT 🔵If FLOT ineligible or not a surgical candidate, CRT is preferred 10/
Shivani Modi MD ● POSITIVE What an amazing session by @NiuSanford and Dr. Sanjay Wani! #GI25 Great discussion on ESOPEC, TOPGEAR and other trials and breakdown of current practice guidelines! Insightful @AnwaarSaeed3 @oncodaily @OncoDailyGI https://t.co/pkYZTZfKnl
Cindy M. Pabon, MD ● POSITIVE #ESOPEC at #ASCO24 plenary: perioperative FLOT shows overall survival benefit vs neoadjuvant ChemoXRT (CROSS) in esophageal adenocarcinoma. HR 0.70 #PracticeChanging -- tho not clear yet for SCC or low stage adenocarcinoma https://t.co/gbdwgPgZU8
Nicholas Hornstein ● POSITIVE ESOPEC #ASCO24 Amazing trial design Answers critical question of FLOT vs CROSS is esophageal adeno 🌠HR .7 in favor of FLOT!! Benefit in most subgroups analyzed ✅PFS 51.5% vs 34% Adherents may still point to squamous histology for CROSS? Role of immunotherapy? Practice changing! https://t.co/vvEYowL0Bk
Dr Joseph McCollom DO ● POSITIVE Dr Jens Hoeppner presents secondary endpoints for ESOPEC trial FLOT vs CROSS favoring FLOT with PFS of 38m vs 16mo with CROSS #GIonc #ASCO24 #esocsm https://t.co/WRGlKATXWa
Krishan Jethwa ● NEUTRAL 🚨ESOPEC Pub has landed!🚨 See data review below! For now, "standard" will appropriately shift to peri-operative FLOT BUT we should not be satisfied as outcomes remain suboptimal Ongoing ❓❓ - does TNT (FLOT + CRT) offer further benefit? - is it time to consider organ… https://t.co/gsMVWjbNpg https://t.co/wgY12Z76tj https://t.co/WxVM1tntZn
Dr. Nina Niu Sanford ● NEUTRAL Isolated locoregional failures were halved w CROSS, but unsurprisingly many more distant metastases. Also notable that CROSS group had many more distant mets even BEFORE start of therapy (11 vs. 1), driving down OS by ITT. #GI25 https://t.co/C5NKSKSYRJ https://t.co/hTO0IZDLbW
NEJM ● NEUTRAL ESOPEC, a large randomized trial involving patients with resectable esophageal cancer, showed that perioperative chemotherapy improved overall survival as compared with preoperative chemoradiotherapy. Full trial results: https://t.co/KcViF0c2aW Editorial: Multimodal Treatment… https://t.co/JW3aEFOLXO https://t.co/peip0PCfQt
Erman Akkus ● NEUTRAL ❓Is CROSS out after ESOPEC? Real-world CROSS outcomes from Nerherlands @eClinicalMed ➡️4765 patients ✅87.5% completed full CROSS regimen ✅pCR: 20.5% ✅mOS: 33.7 mo, 3-year OS: 48.1% ❗️adjuvant nivo: 7.5% ➡️CROSS can be still a valid option 👉https://t.co/TANOscSkFv… https://t.co/J4qnWsK2yH https://t.co/ok8RHcz813
Lorenzo Ferri MD PhD ● NEUTRAL ESOPEC trial It’s been a long 15 year journey, but so nice to see Docetaxel triplets come on top for the benefit of our patients! CROSS just doesn’t work for GEA-EAC- radiation compensates for poor surgical control (trans-hiatal) and CM577 compensates for poor systemic control https://t.co/CRa3X9BAAO
Krishan Jethwa ● NEUTRAL To ⚖️ QoL and cancer control, organ pres w/ CRT should be considered 🚨SANO🚨 EsoCa with cCR after CRT Active surveillance vs. esophagectomy AS 🔥Non-inf OS ⬆️ QoL SANO-2, ESOSTRATE, ESORES exploring Much unleashed potential with CRT + systemic tx ➡️ Organ pres 12/12 #ASCO24 https://t.co/rtM8OZnFku
Daniel Catenacci ● NEUTRAL #ESOPEC Trial: #FLOT vs #CROSS A Hill Worth Dying On #itwasjustmath HR 0.72 pp https://t.co/1oINhdSgtP Thank you to the German DFG for doing this important study https://t.co/cmdvW7ZtiQ
Dr Amol Akhade ● NEUTRAL Innovation trial. Can additon of trastuzumab With or without Pertuzumab into perioperative chemo makes a difference in OS for her2 postive stomach cancer . Answer is NO . Negative trial. May be her2 is not a strong driver pathway in stomach as it is in breast. @ASCO #GI25… https://t.co/C0jZTy7KyV https://t.co/Rn4GKVLC8z
Kristen Ciombor ● NEUTRAL Tough challenge for @NiuSanford at #GI25 -convincing a lot of med oncs of the ongoing role for RT in esophageal cancer post-ESOPEC! https://t.co/2ZT991ufk3
Erman Akkus ● NEUTRAL 📢🔥ESOPEC trial: FLOT vs CROSS in locally advanced esophageal adenocarcinoma ✅FLOT provided better OS! mOS: 66 vs 37 mo Eagerly waiting for plenary presentation ❗️Soon⏰ #ASCO24 @ASCO @JCO_ASCO @dromerdizdar @DenizCanGuven1 @OncoAlert
Krishan Jethwa ● NEUTRAL 🚨#ESOPEC🚨 Resectable, cT2+ or N+, E/GEJ adenocarcinoma Peri-op FLOT (FLOT4) vs Pre-op CRT (CROSS; no ICI if &lt; pCR) N=438 81% T3-4; 80% N+ 🔑Outcomes 🧐Only 68% completed nCRT⁉️ R0 94% vs 95% pCR: 19% vs 14% ✅ FLOT ⬆️ mOS 66m vs 37m ✅ FLOT ⬆️ OS3 57% vs 51% #ASCO24 9/ https://t.co/geR2Y0rev2
Krishan Jethwa ● NEUTRAL First… Background Both Peri-operative chemotherapy (MAGIC/FLOT4) and pre-operative chemoradiation (CROSS) are standard of care treatment options for patients with resectable, locally advanced, esophagus/GEJ adenocarcinoma. Each has demonstrated: ✅ Improved OS 2/
Krishan Jethwa ● NEUTRAL MAGIC trial included patients with GEJ or gastric adenocarcinoma Randomized patients to: Up-front surgery Vs. Peri-operative ECF chemotherapy Peri-operative ECF was associated with: ✅ Improved OS ✅ Improved DFS 3/ https://t.co/6WElNQldkh
Mark Lewis ● NEUTRAL Especially given interim therapeutic advances! https://t.co/k2T2e1TvkU
Krishan Jethwa ● NEUTRAL CROSS trial included pts with resectable, LA esophagus/GEJ cancer Randomized patients to: Up-front surgery Vs Pre-operative carbo-taxol based CRT, 41.4 Gy/23 CRT Improved: ✅ OS ✅ DFS ✅ Locoregional control ✅ 29% pCR 4/ https://t.co/XPQdB59q2z
Mark Lewis ● NEGATIVE OK, wait, something doesn't make sense with ESOPEC Even excluding the presumably more radio-sensitive squams, why is the adeno arm performing worse in a contemporary trial vs. the CROSS study reported in 2012? #ASCO24 https://t.co/zfaylRA0Be
M. Bolton ● NEGATIVE Out? No. Sicker/older non-FLOT candidates, non-surgical candidates, SCC, we still don’t know CM577 OS, ~50% of failures with FLOT are locoregional Still a LOT of unmet need here! @NiuSanford @KrishanJethwa https://t.co/5GgkGzCLpJ
M. Bolton ● NEGATIVE 🔑 To summarize: mOS 49.4 months all histo on CROSS, adeno ~48 months, and separately, NeoAEGIS replicated this at 49.2 months These are not even in the 0.95 compatibility interval (28-43) in CRT arm on ESOPEC - literally not compatible! Something is very wrong here
Mark Lewis ● NEGATIVE @drkiwikate You're too self-effacing! Thanks for raising the potential PS imbalance (and I will now self-flagellate for my sin of cross-study comparison)
M. Bolton ● NEGATIVE @TonyFelefly Few thoughts: CROSS alone is not enough. We know that; response based adjuvant Nivo is standard. Also, CRT outcomes here on ESOPEC are surprisingly poor; I would love to see adjusted K-M (Cox-Kalbfleisch-Prentice) that would be ideal here HT @f2harrell https://t.co/cwXV8e14Yx
Prof. Chris Jackson ● NEGATIVE @marklewismd @drkiwikate The 68% completion rate for CROSS is stunningly low in this trial too. Can't remember the last pt W CROSS who didnt make it thru at our institution. Still, FLOT for the W