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