Management of early rectal cancer: Any role for adjuvant ... · SURGERY AND ADJUVANT CT IN MRI...
Transcript of Management of early rectal cancer: Any role for adjuvant ... · SURGERY AND ADJUVANT CT IN MRI...
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Management of early rectal cancer:Any role for adjuvant chemotherapy?
Andrés CervantesProfessor of Medicine
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DISCLOSURE SLIDE
Employment: None; Stock Ownership: None
Consultant or Advisory Role: Merck Serono, Roche, Beigene, Bayer, Servier, Lilly, Novartis, Takeda, Astelas.
Research Funding: Genentech, Merck Serono, Roche, Beigene, Bayer, Servier, Lilly, Novartis, Takeda, Astelas, Fibrogen, Amcure, Sierra Oncology, Astra Zeneca, Medimmune, BMS, MSD
Speaking: Merck Serono, Roche, Angem, Bayer, Servier, Foundation Medicine. Grant support: Merck Serono, Roche.
Others: Executive Board member of ESMO, Chair of Education ESMO, General and Scientific Director INCLIVA, Associate Editor: Annals of Oncology and ESMO Open, Editor in chief: Cancer Treatment Reviews.
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ESMO PRECEPTORSHIP PROGRAM
� TME surgery
� Optimal staging by MRI
� Pathological assessment of the quality of surgery
� Preoperative radiation or chemoradiation
� Integration of knowledge in a multidisciplinary team approach
� Selective approach for preoperative treatment
� Non surgical approach for patient with complete remision
CURRENTS CONCEPTS IN RECTAL CANCERDIAGNOSIS AND THERAPY
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ESMO PRECEPTORSHIP PROGRAM
IMPROVEMENT IN RECTAL CANCER TREATMENT
OUTCOMES IN NORWAY
Local Recurrence Distant Metastases
Distant metastases 4x greater risk than local recurrence
Guren MG, et al Acta Oncol 2015; 54:1714-1722.
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ADJUVANT THERAPY FOR LOCALIZED RECTAL CANCER
Ann Oncol 2017; 28(suppl 4):iv22-iv40.
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ESMO PRECEPTORSHIP PROGRAM 7
� MRI Staging
� MDT discussion
� Preoperative treatment if indicated
� TME Surgical resection
� Pathology assessment and estimation of risk
� Postoperative chemotherapy if indicated
CURRENT APPROACH TO RECTAL CANCER
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THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
• The pre-TME/preoperative RT or ChRT data• The TME/preoperative RT or ChRT data• How to integrate ChT in patients with locally
advanced disease?
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ESMO PRECEPTORSHIP PROGRAM
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE IN THE PRE-TME PRE-
RT/CHRT PREOPERATIVE ERA?
� American Intergroup
� Quasar
� Japanese Society of Colon and Rectal Meta-analysis on individual data
� Cochrane Meta-analysis on individual data
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ESMO PRECEPTORSHIP PROGRAM
THE ROLE OF SYSTEMIC CHEMOTHERAPY IN LOCALISED RECTAL CANCER:
Gunderson et al. J Clin Oncol 2004
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED
RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
The American Intergroup* Pooled Analysis
* NSABP, NCCTG and US-GI Intergroup
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THE ROLE OF SYSTEMIC CHEMOTHERAPY IN LOCALISED RECTAL CANCER:
The QUASAR Collaborative Group. Lancet 2007; 370:2020.
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED
RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
The QUASAR TRIAL
UK QUASAR uncertain indication trial Approx 30% rectal.
5yr survival 5 yr recurrence
Chemo No chemo
P-value
Chemo No chemo
P-value
Whole cohort 80.3% 77.4% 0.02 22.2% 26.2%, 0.001
Rectal subgroup p=0.05 19.6% 26.8%, 0.005
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The QUASAR Collaborative Group. Lancet 2007; 370:2020.
WHAT IS THE EVIDENCE WE HAVE?
The Quasar trial
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Sakamoto et al. Br J Cancer 2007
WHAT IS THE EVIDENCE WE HAVE?
The Japanese Society of Cancer of Colon
and Rectum Meta-analysis on UFT trials
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2012
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED
RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
The Cochrane Meta-analysis
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Petersen et al, Cochrane Data Base of Systenatic Rev 2012; CD004078
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Petersen et al, Cochrane Data Base of Systenatic Rev 2012; CD004078
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17
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
• The pre-TME/preoperative RT or ChRT data• The TME/preoperative RT or ChRT data• How to integrate ChT in patients with locally
advanced disease?
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THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE IN THE TME/PREOPERATIVE RT OR CHRTERA?
• Chronicle trial • Proctor/script trial • Meta-analysis by Breugomon
individual data from 4 trials and 1200 pts
• Adore trial• CAO/ARO/AIO -04 trial
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CHRONICLE TRIAL: ASSESSING THE VALUE OF ADJUVANT CHEMOTHERAPY IN THE TREATMENT OF RECTAL CANCER AFTE R
PREOPERATIVE CHEMORADIATION
Glynne Jones et al. Ann Oncol 2014; 25:1356
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Glynne Jones et al. Ann Oncol 2014; 25:1356
� Target population 800 pts
� Primary end point: DFS at 3 years (HR:0.75)
� Accrued nr. Patients 113
� Underpowered to detect any potential benefit of Chemotherapy
� HR for DFS: 0.80 (95%CI: 0.38-1.69; p:0.56)
� HR for OS: 1.18 (95%CI: 0.43-3.26; p:0.75)
WHAT IS THE EVIDENCE WE HAVE?
The Chronicle trial
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Breugom et al, Ann Oncol 2015; 26:696-701
PROCTOR/SCRIPT TRIAL: ASSESSING THE VALUE OF ADJUVANT CHEMOTHERAPY IN THE TREATMENT OF
RECTAL CANCER AFTER PREOPERATIVE CHEMORADIATION OR 5X5 RADIATION
� Target population 840 pts� Primary end point: OS at 5 years improved from60 to 70%� Accrued nr. Patients 437 over 14 years� Underpowered to detect any potential benefit of
Chemotherapy� 5 year OS for observation: 79.2%� 5 year OS for adj therapy: 80.4%
� HR for DFS: 0.80 (95%CI: 0.60-1.07; p:0.13)� HR for OS: 0.93 (95%CI: 0.61-1.29; p:0.73)
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Breugom et al. Lancet Oncol 2015; 16:200-207.
WHAT IS THE EVIDENCE WE HAVE?
The Breugom’s Meta-analysis
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Adding Oxaliplatin to 5-FU based adjuvant therapy in localised colon/rectal cancer
Trial N Control Exp. Stag
e
DFS HR
P value
OS HR
P value
Absolute
Gain in OS
G3
Neur
o
Tox
MOSAIC1 2246 FULV2 FOLFOX4 II/III 0.80
0.003
0.84
0.046
4,2% at 6 y
stage III
12%
NSABP-C072 2407 FULV
Roswell
FLOX II/III 0.80
0.0034
0.82
0.002
2,7 at 5 y
Stage III
8,2%
XELOXA3 1886 FULV
Mayo
CAPEOX III 0.80
0.0038
0.83
0.04
6 % at 7 y 11%
1André T, et al. J Clin Oncol 2007; 27:3109-3116. 2Kuebler JP, et al. J Clin Oncol 2007; 25:2198-2204.3Schmoll HJ et al. J Clin Oncol 2015; 33:3733-3740.
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Adding Oxaliplatin to 5-FU based adjuvant therapy in localised colon/rectal cancer
Trial N Control Exp. Stag
e
DFS HR
P value
OS HR
P value
Absolute
Gain in OS
G3
Neur
o
Tox
MOSAIC1 224
6
FULV2 FOLFOX4 II/III 0.80
0.003
0.84
0.046
4,2% at 6 y
stage III
12%
NSABP-C072 240
7
FULV
Roswell
FLOX II/III 0.80
0.0034
0.82
0.002
2,7 at 5 y
Stage III
8,2%
XELOXA3 188
6
FULV
Mayo
CAPEOX III 0.80
0.0038
0.83
0.04
6 % at 7 y 11%
AIO044 123
3
FU mFOLFOX
6
II/III 0.79
0.030
0.96
NS
0.7 at 3 y 9%
NSABP R045 128
4
FU/Cap
e
+ Oxali II/III 0.94
NS
0.94
NS
NR 6%
PETACC66 898 Cape + Oxali II/III 1.04
NS
NR NR 8%1André T, et al. J Clin Oncol 2007; 27:3109-3116. 2Kuebler JP, et al. J Clin Oncol 2007; 25:2198-2204.3Schmoll HJ et al. J Clin Oncol 2015; 33:3733-3740. 4Roedel C et al. Lancet Oncol 2015; 16:979-989. 5Allegra CJ et al. J Natl Cancer Inst 2015; 107: pii: djv248.
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Hong YS et al. Lancet Oncol 2014; 15:1245-1253.
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED
RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
THE ADORE TRIAL
BOLUS 5FU-LV
Mayo Clinic Schedule
FOLFOX
Rectal Cancer
patients who
completed
preoperative
Long course
chemoradiation
and Surgery with
free margins
ypT3-4N0
or
anyTN1-2
1:1 Randomization
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Hong YS et al. Lancet Oncol 2014; 15:1245-1253.
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED
RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
THE ADORE TRIAL
� No observational arm
� Randomised phase II trial 80% Power
� Unilateral hypothesis
� Target population 320 pts
� Primary end point: DFS at 3 years improved by8% from 70 to 78%
� Accrued nr. Patients 322 over 3.5 years
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ADORE TRIAL: ADJUVANT CHEMOTHERAPY IN STAGE II/III RECTAL
CANCER AFTER PREOPERATIVE CHEMORADIATION
DISEASE FREE AND OVERALL SURVIVAL
Hong YS et al. Lancet Oncol 2014; 15:1245-1253.
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28
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
• The pre-TME/preoperative RT or ChRT data• The TME/preoperative RT or ChRT data• How to integrate ChT in patients with locally
advanced disease?
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ESMO Rectal Cancer Guidelines: Staging
SoC
TME alone
AVOID RT
TME alone if
high quality or
plus
SCPRT/CRT
SCPRT
or
CRT
Then TME
CRT or
SCPRT +
FOLFOX
then TME
Key
Messages
cT1-2; cT3a/b if
middle or high cN0
(cN1 ig high) MRF
clear; no EMVI
cT3a/b very low
levators clear. MRF
clear, cT3a/b in mid or
high rectum, cN1-2 (not
extranodal), no EMVI
cT3c/d or very low,
levators not threatened,
MRF clear. cT3c/d mid
rectum, cN1-N2
(extranodal), EMVI +ve
cT3 with MRF involved
cT4b,
levators threatened,
lateral node +ve
Glynne Jones, R et al. Ann Oncol 1017;28 (Supplement 4): iv22–iv40.
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George TG , et al. Curr Colorectal Cancer Rep 2015; 11:275-280
DOWNSTAGING AFTER NEOADJUVANTTREATMENT : NEOADJUVANT RECTAL SCORE
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NEOADJUVANT RECTAL SCOREA SERIES OF 158 LOCALLY ADVANCED RECTAL CANCER
PATIENTS TREATED WITH CT-RT
Log Rang Test p: 0.004
(Mantel Cox)
Roselló S, et al. Clin Colorectal Cancer 2018; 17:104-112
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NEOADJUVANT RECTAL SCORE IN CAO/ARO/AIO04 TRIAL
Fokas E, et al, Ann Oncol 2018; 29:1521-1527
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NEOADJUVANT CT PLUS CT-RT VERSUS CT-RT FOLLOWED BY SURGERY AND ADJUVANT CT IN MRI DEFINED HIGH RISK RE CTAL
CANCER: THE PHASE II RADOMIZED VALENCIAN EXPERIENCE
Fernández-Martos et al. Ann Oncol 2015; 26: 1722-1728
Concurrent CRT with
CAPOX
CAPOX x 4
MRI defined
Locally advanced
Rectal Cancer
patients
N=108
1:1 Randomization
S Adjuvant
CAPOX
Concurrent CRT with
CAPOXS
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POLISH PHASE III TRIAL CRT VS 5X5 AND FOLFOX
S
5x5 FOLFOX 4 x 3
S
RT+5FU LV wk1,5
Ox weekly
34
Primary end point R0 resectionLocally advanced
Unresectable
Locally recurrent
• MRI defined 66%
• Oxaliplatin became
optional
• Short duration FOLFOX
• Weekly Ox single agent
wk 2,3,4
Bujko et al Ann Oncol. 2016;27:834-842.
Primary end point R0 resection
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Bujko K, et al. Ann Oncol 2016; 27:834-842
POLISH TRIAL: OVERALL SURVIVAL FAVORS PREOPERATIVE
SCPRT + CHRT VERSUS PREOPERATIVE CHEMORADIATION IN
LOCALLY ADVANCED RECTAL CANCER
HR: 0.73 p: 0.046
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THE WAY FORWARD: THE PHASE III RADOMIZED RAPIDO TRI AL
PI: Prof. C. van de Velde
CRT with
CAPECITABINE
Week 1-6
5x5 RT
Week 1
MRI defined
Locally advanced
Rectal Cancer
patients
N=920
1:1 Randomization
SURGERY
Week12
Adjuvant
CT
OPTIONAL
Neoadjuvant XELOX x6
Week 3-16SURGERY
Week 24-28
DFS at 3 years improved by 10% from 50 to 60%
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ESMO PRECEPTORSHIP PROGRAM
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: CONCLUSIONS
� Adjuvant Chemotherapy is not standard of care for all localized
rectal cancer patients
� Adjuvant Chemotherapy should be considered for patients at risk after direct surgery without neoadjuvant therapy
� Adjuvant Chemotherapy should be also considered after neoadjuvant Chemoradiation for patients with stage ypIII and high risk stage ypII. LoE: II GoR: C
� The decision on postoperative Chemotherapy (FU alone or combined with oxaliplatin) should be risk balanced, taking into account both the predicted toxicity for a particular patient and the risk of relapse, and should be made jointly by the individual and the clinician
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ESMO PRECEPTORSHIP PROGRAM
Thank you