esophagus and gastric cancer: poster...
TRANSCRIPT
Chemo Related Toxicity 1
Presented By Salah-Eddin Al-Batran at 2017 ASCO Annual Meeting
Pay attention to toxicity profile
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
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)
Overall Survival
Presented By Yelena Janjigian at 2017 ASCO Annual Meeting
Nivolumab + Ipilimumab in Caucasians
A non-randomized study HIPEC pts 11 yrs younger and more preop chemo
(63% vs 35%) No info on tx lines at disease progression
Ho sognato di essere mammella
Ho sperato di essere colon
Ma sono un tumore dello stomaco (Aho nun è che so’ un pò ppancreas?)