Download with previously treated advanced gastric or

AIOM POST ASCO
Update and News from Gastrointestinal Cancer Symposium in San Francisco, Ca USA
Roma, 5-6 Febbraio 2016
Critical Review
Francesco Di Costanzo
SC Oncologia Medica
Azienda Ospedaliero Universitaria Careggi
Firenze
Gastic Cancer
New Options
Clinical PracticeMAY
WE REFINE OUR CLINICAL PRACTICE?
Multicenter double-blind randomized phase II:
FOLFOX + ziv-aflibercept/placebo for patients
(pts) with chemo-naive metastatic
esophagogastric adenocarcinoma (MEGA).
New Options
AGC
A randomized, open-label, multicenter, adaptive
phase 2/3 study of trastuzumab emtansine (T-DM1)
versus a taxane (TAX) in patients (pts) with
previously treated HER2-positive locally advanced
or metastatic gastric/gastroesophageal junction
adenocarcinoma (LA/MGC/GEJC).
Safety and activity of nivolumab monotherapy in
advanced and metastatic (A/M) gastric or
gastroesophageal junction cancer (GC/GEC):
Results from the CheckMate-032 study.
Abstract 4: FOLFOX + aflibercept/placebo
Presented By Daniel Catenacci at TBD
First Line Management of Advanced Gastroesophageal Cancer
Presented By Daniel Catenacci at TBD
Antiangiogenesis for EGA IV
Presented By Daniel Catenacci at TBD
Antiangiogenesis for EGA
Presented By Daniel Catenacci at TBD
Predictive Biomarkers of Antiangiogenesis?
Presented By Daniel Catenacci at TBD
Summary Anti-VEGF/R for EGA IV
Presented By Daniel Catenacci at TBD
Future Anti-VEGF/R for EGA IV
Presented By Daniel Catenacci at TBD
RAINFALL Phase III 1L
Presented By Daniel Catenacci at TBD
Slide 66
Presented By Daniel Catenacci at TBD
Next-Generation Trials: PANGEA<br />
Presented By Daniel Catenacci at TBD
Multicenter double-blind randomized phase II:
FOLFOX + ziv-aflibercept/placebo for patients
(pts) with chemo-naive metastatic
esophagogastric adenocarcinoma (MEGA).
New Options
AGC
A randomized, open-label, multicenter, adaptive
phase 2/3 study of trastuzumab emtansine (T-DM1)
versus a taxane (TAX) in patients (pts) with
previously treated HER2-positive locally advanced
or metastatic gastric/gastroesophageal junction
adenocarcinoma (LA/MGC/GEJC).
Safety and activity of nivolumab monotherapy in
advanced and metastatic (A/M) gastric or
gastroesophageal junction cancer (GC/GEC):
Results from the CheckMate-032 study.
GATSBY 2L phase III
Presented By Daniel Catenacci at TBD
Slide 71
Presented By Daniel Catenacci at TBD
Anti-HER2 Therapy for EGA IV
Presented By Daniel Catenacci at TBD
Failures x 3 after TOGA: WHY?
Presented By Daniel Catenacci at TBD
Slide 19
Presented By Yoon-Koo Kang at TBD
Failures x 3 after TOGA: WHY?
Presented By Daniel Catenacci at TBD
Reassessment of HER2 status in AGC with initially HER2 negative primary tumor: GASTHER-1
Presented By Yoon-Koo Kang at TBD
Summary: Anti-HER2 therapy EGA
Presented By Daniel Catenacci at TBD
Future: Anti-HER2 therapy EGA
Presented By Daniel Catenacci at TBD
Multicenter double-blind randomized phase II:
FOLFOX + ziv-aflibercept/placebo for patients
(pts) with chemo-naive metastatic
esophagogastric adenocarcinoma (MEGA).
New Options
AGC
A randomized, open-label, multicenter, adaptive
phase 2/3 study of trastuzumab emtansine (T-DM1)
versus a taxane (TAX) in patients (pts) with
previously treated HER2-positive locally advanced
or metastatic gastric/gastroesophageal junction
adenocarcinoma (LA/MGC/GEJC).
Safety and activity of nivolumab monotherapy in
advanced and metastatic (A/M) gastric or
gastroesophageal junction cancer (GC/GEC):
Results from the CheckMate-032 study.
Immunogenicity in Esophagogastric Cancer
Presented By Markus Moehler at TBD
Immunogenicity in Esophagogastric Cancer
Presented By Markus Moehler at TBD
Slide 3
Presented By Dung Le at TBD
Patient Demographics and Disease Characteristics
Presented By Dung Le at TBD
Assessment of PD-L1 Expression: Dako Assay
Presented By Markus Moehler at TBD
CheckMate-032: PD-L1 Expression and Response
Presented By Markus Moehler at TBD
Best Overall Response
Presented By Dung Le at TBD
Conclusions
Presented By Dung Le at TBD
Current Trials for Esophagogastric Cancer
Presented By Markus Moehler at TBD
Avelumab: First-Line Maintenance Global Ph III
Presented By Markus Moehler at TBD
Slide 29
Presented By Markus Moehler at TBD
Sarcopenia with modified Glasgow prognostic score as a
predictor of long-term survival in patients with gastric
cancer.
Characterizing tumor responses from RAINBOW, a
randomized phase III trial of ramucirumab (RAM) plus
paclitaxel (PAC) vs placebo (PBO) plus PAC in patients (pts)
with previously treated advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Clinical Practice
Second-line chemotherapy with paclitaxel for elderly patients
with advanced gastric cancer.
Role of palliative resection in patients with incurable
advanced gastric cancer unfit for chemotherapy.
Sarcopenia with modified Glasgow prognostic score as a
predictor of long-term survival in patients with gastric
cancer.
Characterizing tumor responses from RAINBOW, a
randomized phase III trial of ramucirumab (RAM) plus
paclitaxel (PAC) vs placebo (PBO) plus PAC in patients (pts)
with previously treated advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Clinical Practice
Second-line chemotherapy with paclitaxel for elderly patients
with advanced gastric cancer.
Role of palliative resection in patients with incurable
advanced gastric cancer unfit for chemotherapy.
What is malnutrition?
A state of nutrition in which a deficiency, excess, or imbalance of
energy, protein, and other nutrients causes measurable adverse
effects on body function and clinical outcome.1
Up to 1 in 2 adults admitted to hospital or
care homes is or at risk of malnutrition.
– Somanchi M, et al. JPEN. Mar 2011;35(2):209-216
Estimated up to 80% of advanced patients
with cancer have malnutrition.
– Poole K, Froggatt K. Palliative medicine. 2002;16(6):499-506
1. Elia M, ed. Guidelines for Detection and Management of Malnutrition: A Report of the Malnutrition Advisory Group.
43Maidenhead, UK: British Association for Parenteral and Enteral Nutrition (BAPEN); 2000.
GDS_80000_Title_v1
43
Cancer Nutrition Therapy
Malnutrition and weight loss are common in cancer
patients
• At cancer diagnosis,
approximately 50% of patients
present with some nutritional
issues1
• In certain cancers, up to 85% of
patients will develop
malnutrition/weight loss2,3 during
treatment
• Involuntary weight loss of just 5%
results in decreased survival5
Most common secondary diagnosis
for cancer patients is malnutrition4
1. Halpern-Silveira D, et al. Support Care Cancer. 2010;18(5):617-625; 2. Laviano A, Mequid MM. Nutrition. 1996;12(5):358-371; 3. Bozzetti F. In: PayneJames J, Grimble G, Silk D, eds. Artificial Nutrition Support in Clinical Practice. 2nd ed. London: GMM; 639-680; 4. National Cancer Institute. Nutrition in
Cancer Care. www.cancer.gov/cancertopics/pdq/supportivecare/nutrition/HealthProfessional/page1. 5. Dewys WD, et al. Am J Med 1980;69(4):491-7
Cancer Nutrition Therapy
44
GDS_80000_Title_v1
44
Type of Weight Loss is Critical to Outcomes and
Survival in Cancer Patients
Malnutrition
Weight Loss
Muscle Mass Loss
Muscle mass functions include:
• Skin integrity
• Immune function
• Healing/Repair
• GI integrity/Digestion
45
Wardlaw GM, Kessel M. Perspectives in Nutrition. 5th ed. New York, NY: McGraw-Hill; 2002.
GDS_80000_Title_v1
45
Cancer Nutrition Therapy
Progressive Muscle Loss Can Be Associated with
Severe Complications
46
Loss of Total Muscle
Mass (%)
Complications
Associated
Mortality (%)
10
Decreased immunity,
increased infections
10
20
Decreased healing,
weakness, infections
30
30
Too weak to sit,
pressure ulcers,
pneumonia, no
healing
50
40
Death, usually from
pneumonia
100
Demling RH. Eplasty. 2009;9:65-94.
GDS_80000_Title_v1
46
Cancer Nutrition Therapy
Cancer Nutrition Therapy
47
GDS_80000_Title_v1
47
Sarcopenia with modified Glasgow prognostic score as a
predictor of long-term survival in patients with gastric
cancer.
Characterizing tumor responses from RAINBOW, a
randomized phase III trial of ramucirumab (RAM) plus
paclitaxel (PAC) vs placebo (PBO) plus PAC in patients (pts)
with previously treated advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Clinical Practice
Second-line chemotherapy with paclitaxel for elderly patients
with advanced gastric cancer.
Role of palliative resection in patients with incurable
advanced gastric cancer unfit for chemotherapy.
Slide 29
Characterizing tumor responses from RAINBOW, a randomized phase III trial of
ramucirumab (RAM) plus paclitaxel (PAC) vs placebo (PBO) plus PAC in patients
(pts) with previously treated advanced gastric or gastroesophageal junction
(GEJ) adenocarcinoma.
PAC +RAM
PAC+PCBO
ORR
28%
16%
Median TTR
6,7
6,6
Responding at 12 mos
11%
6%
Median DoR
4,4
2,8
Sarcopenia with modified Glasgow prognostic score as a
predictor of long-term survival in patients with gastric
cancer.
Characterizing tumor responses from RAINBOW, a
randomized phase III trial of ramucirumab (RAM) plus
paclitaxel (PAC) vs placebo (PBO) plus PAC in patients (pts)
with previously treated advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Clinical Practice
Second-line chemotherapy with paclitaxel for elderly patients
with advanced gastric cancer.
Role of palliative resection in patients with incurable
advanced gastric cancer unfit for chemotherapy.
Second-line chemotherapy with
paclitaxel for elderly patients with
advanced gastric cancer.
Elderly (31)
Non-Elderly (241)
RRs
6,2%
12,7%
16%
PFS
2,4 mos
3,6 mos
2,86
OS
5,1 mos
6,1 mos
7.36
PPS
2,2
2,6
na
Gr 3-4 Tox
38,7%
41,1%
~
3° line CT
19,4%
35,3%
na
PPS: post progression Survival
RAIMBOW
Algorithm for allocating second-line
treatment of advanced-stage gastric
cancer
{
Lordick, F. (2014) Over the RAINBOW—renaissance in antiangiogenesis
Nat. Rev. Clin. Oncol. doi:10.1038/nrclinonc.2014.195
Sarcopenia with modified Glasgow prognostic score as a
predictor of long-term survival in patients with gastric
cancer.
Characterizing tumor responses from RAINBOW, a
randomized phase III trial of ramucirumab (RAM) plus
paclitaxel (PAC) vs placebo (PBO) plus PAC in patients (pts)
with previously treated advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Clinical Practice
Second-line chemotherapy with paclitaxel for elderly patients
with advanced gastric cancer.
Role of palliative resection in patients with incurable
advanced gastric cancer unfit for chemotherapy.
Slide 39
Presented By Ulysses Ribeiro at TBD
Palliative Gastrectomy - Systematic Review and<br />Meta-analysis
Presented By Ulysses Ribeiro at TBD
Slide 24
Presented By Ulysses Ribeiro at TBD
Surgical Palliation - Resection
Presented By Ulysses Ribeiro at TBD