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Colorectal Cancer: Critical review
AIOM POST-ASCO 2018
Updates and Review from Chicago
Milano, June 15-16, 2018
Alfredo Falcone, MD Department of Oncology and Translational Medicine
University of Pisa and Azienda Ospedaliero Universitaria Pisana
PISA- ITALY
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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As an Oncologist: What am I going to do?
Presented By Weijing Sun at 2018 ASCO Annual Meeting
Colon adiuvante: 3 vs 6 mesi
Educational Session
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Jeanne Tie et al. abst. #3516 (poster discussion)
Circulating tumor DNA as a prognostic marker
in stage III colon cancer: DFS
4-10 wks after surgery After adjuvant CT
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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Historic Oxaliplatin-based XRT studies
Presented By Cathy Eng at 2018 ASCO Annual Meeting
Oxaliplatin-based RT in Rectal Cancer
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Slide 7
Presented By Hans-Joachim Schmoll at 2018 ASCO Annual Meeting
PETACC-6
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Overall survival (ITT)
Presented By Hans-Joachim Schmoll at 2018 ASCO Annual Meeting
PETACC-6
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Disease Free Survival
Presented By Yanhong Deng at 2018 ASCO Annual Meeting
FOWARC
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Overall survival
Presented By Yanhong Deng at 2018 ASCO Annual Meeting
FOWARC
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Study design and Rationale
Presented By Yong Sang Hong at 2018 ASCO Annual Meeting
ADORE
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Disease-free survival, ITT population
Presented By Yong Sang Hong at 2018 ASCO Annual Meeting
ADORE
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Slide 16
Presented By Yong Sang Hong at 2018 ASCO Annual Meeting
ADORE
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TAKE HOME MESSAGES: MALATTIA LOCALIZZATA
Nel colon III stadio 3 mesi di CAPOX adiuvante “si può fare” se basso rischio, ma più strategico definire più accuratamente il rischio!
Nel retto II-III stadio l’aggiunta dell’oxali alla RT + fluoropirimidina neoadiuvante non migliora DFS e OS
Nel retto II-III stadio patologico dopo CT+RT considerare FOLFOX adiuvante x 8 cicli (o XELOX)
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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Slide 4
Presented By Filippo Pietrantonio at 2018 ASCO Annual Meeting
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Slide 11
Presented By Filippo Pietrantonio at 2018 ASCO Annual Meeting
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600
RAS and BRAF
wt
mCRC pts
R 1:1
FOLFIRI +
cetuximab
x 8 cycles
FOLFIRI +
cetuximab until
PD
cetuximab until
PD
FOLFIRI +
cetuximab
x 8 cycles
Anti-EGFR maintenance – trials ongoing
ERMES
Phase III trial
Primary endpoint:
• PFS for non-inferiority
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280 pts
SD or better
after 3 mos of
FOLFOX +
panitumumab in
RAS wt mCRC
R 1:1
FUFA +
panitumumab
FUFA
FOLFOX +
panitumuma
b until PD or
unacceptabl
e toxicity
PD
PANAMA
Phase II trial
Primary endpoint:
• PFS
Anti-EGFR maintenance – trials ongoing
USC trial
Phase III trial
Primary endpoint:
• PFS
450
RAS wt
mCRC pts
R 1:1
FUFA +
panitumumab
Capecitabine
FOLFOX +
panitumumab x 6
cycles
FOLFOX +
panitumumab x 6
cycles
Sponsor: AIO Cooperative Group
Sponsor: Amgen
PD
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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mCRC pts
RAS and BRAF wt
FOLFIRI/
FOLFOXIRI
+ Cetuximab
FOLFOX/XELOX
/
FOLFOXIRI
+ Bevacizumab
Irinotecan
+ Cetuximab
Target accrual: 27 pts
Study Design
PD PD
Phase II, non comparative, study
• At least a RECIST 1.1 partial response
• 1st-line PFS ≥6 months • PD to 1st-line cetuximab
within 4 weeks after the last cetuximab administration
• Time between the end of 1st-line therapy and the start of 3rd-line ≥4 months
Study treatment: Irinotecan 180 mg/sqm iv Cetuximab 500 mg/sqm iv
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Patients RAS status on
ctDNA
Objective
Response
#1 Wild-type Confirmed PR
#2 KRAS G12D PD
#3 Wild-type Confirmed PR
#4 Wild-type PD
#5 Wild-type SD
#6 KRAS G12D PD
#7 Wild-type SD
#9 Wild-type Confirmed PR
#10 Wild-type Unconfirmed
PR
#11 Wild-type PD
#12 KRAS G12D PD
#13 KRAS G12V PD
#15 NRAS Q61L SD
Patients RAS status
on ctDNA
Objective
Response
#16 Wild-type SD
#17 KRAS G12V/
Q61H
PD
#18 KRAS G12V PD
#19 Wild-type Confirmed
PR
#21 KRAS G12D SD
#22 KRAS G12V SD
#23 KRAS G12V PD
#24 KRAS G12D Unconfirme
d PR
#25 KRAS G12D SD
#26 Wild-type SD
#27 Wild-type PD
#28 Wild-type SD
Predictive Role of ctDNA
No RAS mutations were detected in samples from patients who achieved a confirmed PR
• RAS mutations were found in liquid biopsies collected at the rechallenge baseline in 12 (48%) out of 25 evaluable patients
• No BRAF or PI3KCA mutations were found
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How do RAS and EGFR mut alleles decay?
Parseghian et al, ASCO Ann Meeting 2018; abst #3511
Discovery Set
N=135 pts
RAS/BRAF/EGFRwt
treated with anti-EGFRs
Validation Set
N=267 pts
RAS/BRAF/EGFRwt
treated with anti-EGFRs
Exponential decay:
median estimated
t/2: 4-5 months
RAS and EGFR mutations testing on ctDNA [Guardant360®]
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Liquid biopsy: potential applications
Use of liquid biopsy for treatment strategy in various stages of cancer
REFRACTORY DISEASE
Monitoring response and
tracking resistance;
Identification of mechanisms
of acquired resistance.
METASTATIC DISEASE
Molecular profiling and
replacement of tumor
tissue analyses;
Prognostication.
LOCALIZED DISEASE
Prognostication;
Detection of residual disease
and treatment
personalization in
macroscopically resected
patients.
EARLY DETECTION
Diagnosis of cancer
or pre-cancer earlier
through screening.
adapted from Wan et al, Nature Rev 2017;
adapted from Heitzer et al, Precision Oncology 2017
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Slide 17
Presented By Giulia Siravegna at 2018 ASCO Annual Meeting
Plasma HER-2 copy number to predict response in HERACLES
ctDNA NGS assay GUARDANT360
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Slide 6
Presented By Katherine Clifton at 2018 ASCO Annual Meeting
Detection of gene fusions in plasma
ctDNA NGS assay GUARDANT360
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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Unicancer Prodige 7 trial design
Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
265 pts with isolated perioteneal mets and Peritoneal Cancer Index (PCI) < 25
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Overall survival (ITT)
Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
Primary Enpoint: OS
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Overall survival and PCI
Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
Overall Survival in PCI 11-15 subgroup
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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mFOLFOXIRI+pan N=63
FOLFOXIRI N=33
OR p
Response Rate 87.3% 60.6% 4.47 0.004
Left-sided tumors N=53 N=25
4.52 0.02 90.6% 68.0%
Right-sided tumors N=10 N=8
3.89 0.34 70.0% 37.5%
RAS/BRAF wt N=43 N=17
3.36 0.08 86.0% 64.7%
BRAF mut N=7 N=9
21.0 0.04 85.7% 22.2%
mFOLFOXIRI+Pani in VOLFI trial: RECIST RR
Geissler et al, ASCO Ann Meeting 2018; abstr #3508
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To improve tumor shrinkage: TRIPLETE study by G.O.N.O.
R
RAS and BRAF wt
mCRC pts
1st line
unresectable
mFOLFOX6+pani (up to max 12 cycles)
mFOLFOXIRI+pani (up to max 12 cycles)
5-FU/LV +Pani
5-FU/LV +Pani
PD
INDUCTION MAINTENANCE
Phase III random
Stratification factors: • PS 0-1 vs 2; • primary tumor location (right vs left or rectum); • previous adjuvant chemotherapy; • liver-only metastases.
Primary endpoint: Response Rate
Target accrual: 432 pts
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OUTLINE
MALATTIA LOCALIZZATA
Colon
Retto
MALATTIA METASTATICA
Mantenimento dopo I linea anti-EGFR
Rechallange anti-EGFR e biopsia liquida
HIPEC
FOLFOXIRI+anti-EGFR
Sequenza Regorafenib/anti-EGFR
Immunoterapia nei MSS
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TAKE HOME MESSAGES: MALATTIA METASTATICA
Considerare dopo induzione con comboCT+anti-EGFR mantenimento con anti-EGFR+5FU/LV (in attesa di nuovi dati)
Rechallange con anti-EGFR da considerare nella pratica clinica in alcuni casi, ma previa rivalutazione di RAS
La biopsia liquida sarà uno strumento importante nel management dal carcinoma del colon-retto
Chirugia su mets peritoneali SI, ma HIPEC?
FOLFOXIRI+anti-EGFR, sequenza Rego/anti-EGFR ed immunotx nei MSS: aspettiamo i risultati di nuovi studi