ESOFAGO E STOMACO
Dott.ssa Eleonora Lai
Specialista in Oncologia Medica
Corso di Dottorato in medicina molecolare e traslazionale
Sperimentazioni cliniche SC Oncologia Medica Università degli studi di Cagliari
AOU Cagliari
CARCINOMA GASTRICO LOCALIZZATO 1. LBA41- PRODIGY
2. LBA42- RESOLVE
3. 674PD- ICONIC TRIAL
CARCINOMA GASTRICO ED ESOFAGEO AVANZATO 1. LBA11- ATTRACTION-3
2. LBA44, LBA45 - KEYNOTE-062 3. LBA43- ANGEL
Quali novità?
CARCINOMA GASTRICO LOCALIZZATO 1. LBA41- PRODIGY
2. LBA42- RESOLVE
3. 674PD- ICONIC TRIAL
Quali novità?
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA41 – PRODIGY (Kang et al.)
LBA42 – RESOLVE (Ji et al.)
Perioperative chemotherapy of oxaliplatin combined with S-1 (SOX) versus postoperative chemotherapy of SOX or oxaliplatin with capecitabine (XELOX) in locally advanced gastric adenocarcinoma with D2 gastrectomy:
A randomized phase III trial (RESOLVE trial)
ARM A
D2 surgery → CAPOX ×8 cycles n = 345
ARM B
D2 surgery → SOX ×8 cycles n = 340
cT4aN+ M0 or cT4bNxM0
gastric or gastro- esophageal
junction
adenocarcinoma
Primary endpoint: 3-year disease-free survival rate (3yDFS%) in the mITT population
R 1:1:1
ARM C
SOX ×3 → D2 surgery →SOX ×5 followed by S1 ×3 cycles
n = 337
LBA42 – RESOLVE: results
1094 patients randomized between August 2012 and February 2017 454 recurrences/deaths observed by July 2019
Similar baseline characteristics between 3 arms
75.2% Male
Median age: 60.0 years
GEJ 36.5%
LBA42 – RESOLVE: conclusions
Peri-operative SOX (ARM C) improved 3yDFS% compared with post-operative CAPOX (ARM A)
3yDFS% 62.0% in Arm C vs 54.8% in Arm A; HR 0.79, 95%CI [0.62-0.99]; p=0.045)
Post-operative SOX was non-inferior to post-operative CAPOX (ARM A)
3yDFS%, 60.3% in Arm B, 54.8% in Arm A; HR 0.85, 95%CI [0.67-1.07]; p =0.162)
Resection rate: 90.4% in Arm A vs 92.7% in Arm B vs 85.5% in Arm C
Thirty-day mortality rate was all 0.9% for Arms A, B and C
PRODIGY and RESOLVE
Cambia la pratica clinica?
PRODIGY and RESOLVE
Ian Chau - Congress Highlights 2 - The best of ESMO 2019 GI (non colorectal) cancers
PRODIGY and RESOLVE
Ian Chau - Congress Highlights 2 - The best of ESMO 2019 GI (non colorectal) cancers
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
674PD – ICONIC TRIAL (Davidson et al.)
CARCINOMA GASTRICO LOCALIZZATO 1. LBA41- PRODIGY
2. LBA42- RESOLVE
3. 674PD- ICONIC TRIAL
CARCINOMA GASTRICO ED ESOFAGEO AVANZATO 1. LBA11- ATTRACTION-3
2. LBA44, LBA45 - KEYNOTE-062 3. LBA43- ANGEL
Quali novità?
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
LBA11 – ATTRACTION-3 (Cho et al.)
Practice changing!
LBA11 – ATTRACTION-3 (Cho et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA44 – KEYNOTE-062 (Shitara et al.)
LBA45 – KEYNOTE-062 (Van Cutsem et al.)
LBA44 and LBA45 – KEYNOTE-062
CONCLUSIONS
PEMBRO VS CHEMO
Non-inferior OS pembro vs chemo
Clinically meaningful improved OS with pembro VS chemo in CPS ≥10
PEMBRO+ CHEMO VS CHEMO
NO OS improvement pembro + chemo vs chemo
Clinical benefit substantially enhanced in MSI-H tumour patients treated with pembrolizumab
Similar HRQoL pembro vs chemo
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
LBA43 – ANGEL (Ryu et al.)
Why did Apatinib fail to demonstrate the superiority in OS?
LBA43 – ANGEL (Ryu et al.)
Cambia la pratica clinica?
LBA43 – ANGEL (Ryu et al.)
CONCLUSIONI
Al momento non novità con impatto immediato nella pratica clinica in futuro Nivolumab in II linea nel carcinoma esofageo squamocellulare
Studi soprattutto su popolazioni asiatiche applicabilità sulla popolazione occidentale?
Immunoterapia
Necessità di identificazione di biomarcatori predittivi ruolo di MSI
Grazie dell’attenzione
