The role of adjuvant chemotherapy in localized rectal cancer · Andrés Cervantes The role of...
Transcript of The role of adjuvant chemotherapy in localized rectal cancer · Andrés Cervantes The role of...
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ESMO Preceptorship Programme
Andrés Cervantes
The role of adjuvant chemotherapy in
localized rectal cancer
Rectal cancer– Singapur – November 2017
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ESMO PRECEPTORSHIP PROGRAM
Disclosures
Consulting and advisory services, speaking or writing engagements,
public presenations:
Servier, Merck Serono, Amgen, Roche, Lilly, Bayer, Novartiis, Takeda, Beigene
Direct research support to the responsible project lead:
Servier, Roche, Genentech, Bayer, Janssen, Merck Serono, Medimmune
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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
CURRENTS CONCEPTS IN RECTAL CANCER
DIAGNOSIS 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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ESMO PRECEPTORSHIP PROGRAM 6
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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7
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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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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15
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 Breugom on
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 AFTER
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 from 60 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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20
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. Stage DFS HRP value
OS HRP value
AbsoluteGain in OS
G3NeuroTox
MOSAIC1 2246 FULV2 FOLFOX4 II/III 0.800.003
0.840.046
4,2% at 6 ystage III
12%
NSABP-C072 2407 FULV Roswell
FLOX II/III 0.800.0034
0.820.002
2,7 at 5 yStage III
8,2%
XELOXA3 1886 FULVMayo
CAPEOX III 0.800.0038
0.830.04
6 % at 7 y 11%
AIO044 1233 FU mFOLFOX6
II/III 0.790.030
0.96NS
0.7 at 3 y 9%
NSABP R045 1284 FU/Cape
+ 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
THE ROLE OF ADJUVANT CHEMOTHERAPY IN LOCALISED RECTAL CANCER: WHAT IS THE EVIDENCE WE HAVE?
THE ADORE TRIAL
BOLUS 5FU-LVMayo Clinic Schedule
FOLFOX
Rectal Cancer patients who
completed preoperativeLong course
chemoradiationand Surgery with
free marginsypT3-4N0
oranyTN1-2
1:1 Randomization
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Hong YS et al. Lancet Oncol 2014
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 by
8% 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
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25
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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RECTAL CANCER: ESMO CLINICAL PRACTICE GUIDELINES ANNALS OF ONCOLOGY 2013
Intermediate
(bad)Advanced
(ugly)
Early
(good)
cT1-2; cT3a
T3 (b) if mid or high
N0 (or cN1 if high)
MRF –ve; EMVI –ve
cT2 very low,
cT3 mrf –ve (unless
cT3a(b) and mid or
high rectum,
N1-2, EMVI +ve,
limited cT4aN0
cT3 MRF +ve
cT4a,b
Lateral node +ve
Surgery (TME alone)
25Gy in 5F
or
CRT Followed by TME
CRT
Followed by surgery
(25Gy in 5F
Elderly or severe co-
morbidity)
Glimelius B et al. Ann Oncol 2013; 24(Suppl 6):vi81-vi88
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George TG , et al. Curr Colorectal Cancer Rep 2015; 11:275-280
DOWNSTAGING AFTER NEOADJUVANT
TREATMENT : NEOADJUVANT RECTAL SCORE
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NEOADJUVANT RECTAL SCORE
A 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 2017; 16:
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NEOADJUVANT CT PLUS CT-RT VERSUS CT-RT FOLLOWED BY
SURGERY AND ADJUVANT CT IN MRI DEFINED HIGH RISK RECTAL
CANCER: THE PHASE II RADOMIZED VALENCIAN EXPERIENCE
Fernández-Martos et al. Ann Oncol 2015; 26: 1722-1728
Concurrent CRT withCAPOX
CAPOX x 4
MRI defined Locally advanced
Rectal Cancer patientsN=108
1:1 Randomization
S AdjuvantCAPOX
Concurrent CRT withCAPOX
S
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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
30
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 TRIAL
PI: Prof. C. van de Velde
CRT withCAPECITABINEWeek 1-6
5x5 RTWeek 1
MRI defined Locally advanced
Rectal Cancer patientsN=920
1:1 Randomization
SURGERYWeek12
AdjuvantCT OPTIONAL
Neoadjuvant XELOX x6Week 3-16
SURGERYWeek 24-28
DFS at 3 years improved by 10% from 50 to 60%
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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
MULTIDISCIPLINARY TEAM FOR COLORECTAL CANCERBIOMEDICAL RESEARCH INSTITUTE INCLIVA
UNIVERSITY HOSPITAL VALENCIA
MRI: Salvador Campos
Pathology: Samuel Navarro, Carolina Martínez
Surgery: Alejandro Espí, Estephanie García-Botello,
Vicente Plá, David Moro, José Martín Arévalo.
Radiation Oncology: Esther Jordá
Medical Oncology: Susana Roselló, Desam Roda,
Noelia Tarazona, Tania Fleitas, Marisol Huerta, Isabel
Chirivella (Family Cancer Unit), Andrés Cervantes
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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