Giuseppe Aprile

AULSS8 Vicenza

I N U M E R I D E L C A N C R O A I O M - A I R T U M 2 0 1 7

I N U M E R I D E L C A N C R O A I O M - A I R T U M 2 0 1 7

T C G A N E T W O R K . N A T U R E 2 0 1 7

Qualche conferma (unpublished)

FLOT4 Study Design

Presented By Salah-Eddin Al-Batran at 2017 ASCO Annual Meeting

FLOT4: Overall Survival

Presented By Salah-Eddin Al-Batran at 2017 ASCO Annual Meeting

F O R N A R O L , E T A L . S U B M I T T E D

Cavetas

• Toxicity

• Need for postop

• Optimal preop duration

• ….

Chemo Related Toxicity 1

Presented By Salah-Eddin Al-Batran at 2017 ASCO Annual Meeting

Pay attention to toxicity profile

Cambio demografico

D A T I S S P R E G I O N E V E N E T O , 2 0 1 8 .

STUDY Regimen Eso/GOJ R0 pCR pN0 LF

UK MRC OE 05 ECX x 4 451 66% 7% 30% 10%

CF x 2 446 59% 1% 39% 13%

STO3 (Magic-B) ECX/Bev 680 69% 9% NR NR

FLOT ECX 201 77% 6% 41% NR

FLOT 200 84% 16% 49% NR

POET CF 59 70% 2% 37% 41%

CF—EP/RT 60 72% 16% 68% 23%

CROSS Surgery 141 69% 0% 24% 34%

Carbo/P/R

T

134 92% 23% 64% 14%

Ilson D et Al, Gastrointestinal Cancers Symposium 2018

Ongoing Randomized Trials of Preop

Chemo/RT

As time goes by….

Qualche delusione (sistemica e peritoneale)

Statistical Considerations:

Presented by: Charles S. Fuchs, MD

Endpoints PFS (Primary) Investigator-

assessed OS (Secondary)

Sample Size 508 645

Power 90% 80%

Assumptions HR=0.70 HR=0.77

Events 346 467

Analyses – Observed

Events

Primary efficacy analysis (PFS): 359 PFS events

Final OS analysis: 470 OS events

Presented by: Charles S. Fuchs, MD

Primary Endpoint – Investigator-Assessed Progression-Free Survival:

N=508 RAM Placebo p-value

Median (mos) 5.72 5.39 0.011

HR (95% CI) 0.75 (0.61-0.94)

Benefit (HRs) from antiangiogenics in GC

Perioperative HR 1.06 STO3/MAGIC-B

First-line HR 0.9 AVAGAST

HR 1.0 Yoon (ram) HR 1.1 AVATAR

HR 0.96 (RAINFALL)

Second-line HR 0.8 REGARD

HR 0.8 RAINBOW

Third-line HR 0.7 Li (apatinib)

HR 0.73 INTEGRATE (rego)

T3/T4 or N+ localized GC

FLOT

FLOT + Primary endpoint: OS

R 1:1

the new German philosophy

C L I N I C A L T R I A L S . G O V

RAM (Ramses)

3 randomized phase II/III studies

ATEZO (Dante)

TRAST/PERT (Petrarca)

Catumaxomab prolunga significativamente la sopravvivenza senza paracentesi

Tempo all’evento (giorni)

Sop

ravv

iven

za m

edia

lib

era

da

par

acen

tesi

(%

)

Catumaxomab (n=170)

Controllo (n=88)

10

0

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210

Popolazione raggruppata (endpoint primario)

Preop Catumaxumab

Molta speranza

Overall Survival

K A N G Y K , E T A L . L A N C E T 2 0 1 7

Nivolumab vs BSC in Asians

Overall Survival

Presented By Yelena Janjigian at 2017 ASCO Annual Meeting

Nivolumab + Ipilimumab in Caucasians

M O H L E R M . A S C O G I 2 0 1 6

Qualche dubbio

110 patients in almost 5 years Less complications, no difference in outcome

Any HTA evaluation?

A non-randomized study HIPEC pts 11 yrs younger and more preop chemo

(63% vs 35%) No info on tx lines at disease progression

Una riflessione

Ho sognato di essere mammella

Ho sperato di essere colon

Ma sono un tumore dello stomaco (Aho nun è che so’ un pò ppancreas?)

Giuseppe Aprile

AULSS8 Vicenza