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A trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) and the Australasian Gastro-Intestinal Trials Group (AGITG). - PowerPoint PPT Presentation
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A trial of the
National Cancer Institute of Canada Clinical Trials Group
(NCIC CTG)
and the
Australasian Gastro-Intestinal Trials Group(AGITG)
Randomized Phase III Trial of Randomized Phase III Trial of Cetuximab + Best Supportive Care Cetuximab + Best Supportive Care (BSC) versus BSC Alone in Patients (BSC) versus BSC Alone in Patients
with Pre-treated with Pre-treated Metastatic EGFR-Positive Colorectal Metastatic EGFR-Positive Colorectal
Cancer Cancer (NCIC CTG CO.17)(NCIC CTG CO.17)
NCIC CTG CO.17 Abstract Authors
NCIC CTGNCIC CTG• Derek Jonker, M.D.Derek Jonker, M.D.
• Chris O’Callaghan, D.V.M. Chris O’Callaghan, D.V.M. Ph.D. Ph.D.
• Dongsheng Tu, Ph.D.Dongsheng Tu, Ph.D.
• Scott Berry, M.D.Scott Berry, M.D.
• Sheryl Koski, M.D.Sheryl Koski, M.D.
• Marianne Krahn, M.D.Marianne Krahn, M.D.
• Malcolm Moore, M.D.Malcolm Moore, M.D.
AGITGAGITG
• Christos Karapetis, M.D.Christos Karapetis, M.D.
• Niall Tebbutt, M.D.Niall Tebbutt, M.D.
• Guy van Hazel, M.B.B.SGuy van Hazel, M.B.B.S
• R. John Simes, M.D.R. John Simes, M.D.
• John Zalcberg, M.D., John Zalcberg, M.D., Ph.DPh.D
Disclosures
AuthorAuthor EmploymenEmploymentt
Consultant /Consultant /AdvisorAdvisor
Stock Stock OwnerOwner
HonorariaHonoraria
N. TebbuttN. Tebbutt Merck/Merck/AmgenAmgen
Merck/AmgenMerck/Amgen
J. ZalcbergJ. Zalcberg AmgenAmgen
D. JonkerD. Jonker No Conflicts of InterestNo Conflicts of Interest
C. KarapetisC. Karapetis No Conflicts of InterestNo Conflicts of Interest
M. MooreM. Moore No Conflicts of InterestNo Conflicts of Interest
S. BerryS. Berry No Conflicts of InterestNo Conflicts of Interest
S. KoskiS. Koski No Conflicts of InterestNo Conflicts of Interest
M. KrahnM. Krahn No Conflicts of InterestNo Conflicts of Interest
J. SimesJ. Simes No Conflicts of InterestNo Conflicts of Interest
D. TuD. Tu No Conflicts of InterestNo Conflicts of Interest
G. Van HazelG. Van Hazel No Conflicts of InterestNo Conflicts of Interest
C. C. O’CallaghanO’Callaghan
No Conflicts of InterestNo Conflicts of Interest
Study supported by Bristol-Myers-Squibb Company and ImClone Systems Inc.Study supported by Bristol-Myers-Squibb Company and ImClone Systems Inc.
Cetuximab: Multiple Mechanisms of Action
• IgG1 monoclonal IgG1 monoclonal antibodyantibody
• Binds to EGFR and Binds to EGFR and competitively inhibits competitively inhibits ligand binding (e.g. EGF)ligand binding (e.g. EGF)
• Blocks receptor Blocks receptor dimerization, tyrosine dimerization, tyrosine kinase phosphorylation, kinase phosphorylation, and signal transductionand signal transduction
• IgG1-induced Antibody-IgG1-induced Antibody-Dependent Cell Dependent Cell
CytotoxicityCytotoxicity (ADCC) (ADCC)Harari P. Harari P. Clin Cancer ResClin Cancer Res. . 2004;10:428.2004;10:428.
CetuximabEGFR
IgG1 MAb ADCC
IgG1 IgG1 (cetuximab)(cetuximab)
Lysis of antibody-coated cell
MAXIMIZE ANTI-TUMOUR ACTIVITY
EGFR MEDIATED EGFR MEDIATED Anti-tumour Anti-tumour
ActivityActivity
IgG1 MEDIATED IgG1 MEDIATED ADCCADCC
Fan Z, et al. Fan Z, et al. Cancer ResCancer Res.1993;53:4322-8 .1993;53:4322-8
Cetuximab: IgG1-Induced Antibody-Dependent Cell Cytotoxicity
(ADCC)
Cetuximab: Phase II Clinical Data
StudyStudy TreatmentTreatment NN EfficacyEfficacy
ORRORR TTPTTP
Irinotecan FailureIrinotecan FailureCunningham D. Cunningham D. N Eng J N Eng J MedMed 2004 2004(EMR 007 / BOND)(EMR 007 / BOND)
CetuximabCetuximab 111111 10.8%10.8% 1.5 mo1.5 mo
Cetuximab + Cetuximab +
IrinotecanIrinotecan
218218 22.9%22.9% 4.1 mo4.1 mo
Saltz L.Saltz L.J Clin Oncol J Clin Oncol 2004 2004 (IMC 0141)(IMC 0141)
CetuximabCetuximab 5757 8.8%8.8% 1.4 mo1.4 mo
Irinotecan, Oxaliplatin, Fluoropyrimidine FailureIrinotecan, Oxaliplatin, Fluoropyrimidine Failure
Lenz H-J.Lenz H-J.J Clin OncolJ Clin Oncol 2006 2006 (IMC 0144)(IMC 0144)
CetuximabCetuximab 346346 12.4%12.4% 1.4 mo1.4 mo
NCIC CTG CO.17: Randomized Phase III Trial in mCRC
EGFR EGFR testing testing
by IHCby IHC
* Cetuximab 400 mg/m* Cetuximab 400 mg/m2 2 IV week 1 then 250 mg/m IV week 1 then 250 mg/m22 IV weekly IV weekly
Disease Disease Progression Progression
oror
Unacceptable Unacceptable ToxicityToxicity
Stratification:Stratification:• CentreCentre• ECOG PS (0 or 1 ECOG PS (0 or 1 vs.vs. 2) 2)
RREEGGIISSTTEERR
RRAANNDDOOMMI I ZZEE
1:11:1
Cetuximab* + BSC
BSC alone
Failed or intolerant to all recommended therapiesFailed or intolerant to all recommended therapies
NCIC CTG CO.17: EGFR IHC testing – Dako pharmDxTM
• Graded by area of highest intensity 0 to 3+Graded by area of highest intensity 0 to 3+
• Considered EGFR detectable (positive) if any stained cellsConsidered EGFR detectable (positive) if any stained cells
mouse anti-EGFR primary Abmouse anti-EGFR primary Ab
goat anti-mouse secondary Ab labeled goat anti-mouse secondary Ab labeled with with horesradish peroxidasehoresradish peroxidase
EGFREGFR
DAB (colour)DAB (colour)
NCIC CTG CO.17: Study Endpoints*
• Primary: Overall Survival Primary: Overall Survival
• SecondarySecondary– Progression Free SurvivalProgression Free Survival
– Objective Response Rate (RECIST criteria)Objective Response Rate (RECIST criteria)
– Safety Safety
– Quality of Life (to be reported later in Quality of Life (to be reported later in 2007)2007)
* All primary and secondary analyses ITT (except * All primary and secondary analyses ITT (except safety)safety)
NCIC CTG CO.17: Key Eligibility Criteria
• Inclusion CriteriaInclusion Criteria
– Histologically proven EGFR detectable (by IHC) mCRCHistologically proven EGFR detectable (by IHC) mCRC
– ECOG performance status 0, 1 or 2ECOG performance status 0, 1 or 2
– Prior anti-TS therapyPrior anti-TS therapy
– Prior irinotecan or oxaliplatin therapyPrior irinotecan or oxaliplatin therapy
• Failed for metastastic disease orFailed for metastastic disease or
• Relapsed within 6 months orRelapsed within 6 months or
• Documented as unsuitable for therapyDocumented as unsuitable for therapy
• Exclusion CriteriaExclusion Criteria
– Prior therapy with an EGFR inhibitor Prior therapy with an EGFR inhibitor
NCIC CTG CO.17: Statistical Considerations
• Survival Analysis / Sample SizeSurvival Analysis / Sample Size– Two-sided alpha of 5%Two-sided alpha of 5%
– 90% power to detect:90% power to detect:
• 9.6% difference in 1-year survival 9.6% difference in 1-year survival
• hazard ratio [HR] of 0.74 hazard ratio [HR] of 0.74
• assuming a 14.1% 1-year survival for the BSC assuming a 14.1% 1-year survival for the BSC groupgroup
– 445 deaths needed445 deaths needed
• The analysis was conducted after 572 The analysis was conducted after 572 subjects were randomized and 456 deaths subjects were randomized and 456 deaths were recordedwere recorded
NCIC CTG CO.17: Subject DispositionRegisteredRegisteredN = 1243*N = 1243*
RandomizedRandomizedN = 572N = 572
CetuximabCetuximabN = 287N = 287
BSCBSCN = 285N = 285
On TreatmentOn TreatmentN = 17N = 17
On TreatmentOn TreatmentN = 0N = 0
Off TreatmentOff TreatmentN = 271N = 271
Off TreatmentOff TreatmentN = 274N = 274
EGFR detectable; N = 981 (79%)EGFR detectable; N = 981 (79%)
* Patients were allowed to be enrolled at the time of previous chemotherapy * Patients were allowed to be enrolled at the time of previous chemotherapy
Clinical Cut OffClinical Cut Off
• Deaths (N = 12)Deaths (N = 12)• PD (N = 205)PD (N = 205)• Symptomatic progression (N = 27)Symptomatic progression (N = 27)• Drug toxicity (N = 9)Drug toxicity (N = 9)• Subject request (N = 10)Subject request (N = 10)
TreatedTreatedN = 288N = 288
TreatedTreatedN = 274N = 274
No CetuximabNo Cetuximab N = 4N = 4
Withdrew ConsentWithdrew Consent N = 6N = 6N = 5N = 5
NCIC CTG CO.17: Demographic Characteristics
All Randomized PatientsAll Randomized Patients Cetuximab + BSC Cetuximab + BSC
N = 287 (%)N = 287 (%)
BSC BSC
N = 285 (%)N = 285 (%)
GENDERGENDER MaleMale 64.864.8 63.963.9
FemaleFemale35.235.2 36.136.1
AGE (years)AGE (years) MedianMedian 6363 6464
RangeRange 28.6 - 88.128.6 - 88.1 28.7 - 85.928.7 - 85.9
<65 years<65 years 61.761.7 55.455.4
>> 65 years 65 years 38.338.3 44.644.6
ECOG ECOG Performance Performance
StatusStatus
00 25.125.1 22.522.5
11 51.651.6 54.054.0
22 23.323.3 23.523.5
NCIC CTG CO.17: Prior Chemotherapies
Number of Prior Number of Prior Chemotherapy Chemotherapy RegimensRegimens
Cetuximab + Cetuximab + BSCBSC
N = 287 (%)N = 287 (%)
BSCBSC
N = 285 (%)N = 285 (%)
1 - 21 - 2 17.417.4 18.918.9
3 - 43 - 4 68.268.2 63.263.2
≥≥ 55 14.414.4 17.917.9
Type of RegimenType of Regimen
Prior TS InhibitorPrior TS Inhibitor 100.0100.0 100.0100.0
Prior Irinotecan Prior Irinotecan RegimenRegimen
96.596.5 95.895.8
Prior Oxaliplatin Prior Oxaliplatin RegimenRegimen
97.997.9 97.597.5
NCIC CTG CO.17: Overall Survival
Cetuximab + BSCCetuximab + BSC BSCBSC
NN 287287 285285
Median Survival Median Survival (Months) (Months) (95% CI)(95% CI)
6.1 6.1 (5.4, 6.7) (5.4, 6.7)
4.6 4.6 (4.2, 4.9) (4.2, 4.9)
6 Month Survival Rate 6 Month Survival Rate
(95% CI)(95% CI)0.50 0.50
(0.45, 0.56) (0.45, 0.56)0.33 0.33 (0.28, 0.39) (0.28, 0.39)
12 Month Survival Rate 12 Month Survival Rate
(95% CI)(95% CI)0.21 0.21
(0.16, 0.27)(0.16, 0.27)0.16 0.16 (0.11, 0.21) (0.11, 0.21)
Hazard Ratio*Hazard Ratio* 0.770.77
95% CI95% CI (0.64, 0.92) (0.64, 0.92)
Log-Rank*Log-Rank* p-value = p-value = 0.0046 0.0046
* Stratified by ECOG PS (0-1 versus 2) at randomization* Stratified by ECOG PS (0-1 versus 2) at randomization
CETUXIMAB + BSCCENSORED
BSCCENSORED
SUBJECTS AT RISK
CET+BSC 287 217 136 78 37 14 4 0 0 0
BSC 285 197 85 44 26 12 8 2 1 0
Pro
po
rtio
n A
live
Pro
po
rtio
n A
live
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
MONTHS
0 3 6 9 12 15 18 21 24 27
NCIC CTG CO.17: Overall Survival
HR 0.77HR 0.77 (95% CI =0.64 – 0.92) (95% CI =0.64 – 0.92)
Stratified log rankStratified log rank p-value = 0.0046 p-value = 0.0046
Study armStudy arm MS MS (months)(months)
95% CI95% CI
Cetuximab + Cetuximab + BSCBSC
6.16.1 5.4 – 6.75.4 – 6.7
BSC aloneBSC alone 4.64.6 4.2 – 4.94.2 – 4.9
NCIC CTG CO.17: Survival Result by Subgroups
SubsetSubset Hazard Ratio and 95% CI Hazard Ratio and 95% CI
Median SurvivalMedian Survival
CetuxCetux BSCBSC
0.77 (0.64 – 0.92)0.77 (0.64 – 0.92) 6.1 mo6.1 mo 4.6 mo4.6 mo
0.72 (0.58 – 0.89)0.72 (0.58 – 0.89) 7.1 mo7.1 mo 5.0 mo5.0 mo
0.89 (0.62 – 1.27)0.89 (0.62 – 1.27) 3.4 mo3.4 mo 3.0 mo3.0 mo
0.77 (0.61 – 0.98)0.77 (0.61 – 0.98) 6.1 mo6.1 mo 4.6 mo4.6 mo
0.75 (0.56 – 1.00)0.75 (0.56 – 1.00) 5.9 mo5.9 mo 4.5 mo4.5 mo
0.69 (0.50 – 0.94)0.69 (0.50 – 0.94) 5.5 mo5.5 mo 4.2 mo4.2 mo
0.80 (0.63 – 1.01)0.80 (0.63 – 1.01) 6.5 mo6.5 mo 4.8 mo4.8 mo
All randomizedAll randomized
ECOG 0-1ECOG 0-1
ECOG 2ECOG 2
Age <65Age <65
Age Age ≤≤6565
FemaleFemale
MaleMale
Favours BSCFavours BSC
0.40.4 0.60.6 0.80.8
Favours CetuximabFavours Cetuximab
1.21.2 1.41.4 1.61.6
NCIC CTG CO.17: Progression Free Survival
Cetuximab + Cetuximab + BSCBSC BSCBSC
NN 287287 285285
2 Month PF Survival Rate2 Month PF Survival Rate
(95% CI)(95% CI)0.45 0.45
(0.40, 0.51) (0.40, 0.51)
0.39 0.39 (0.33, 0.45) (0.33, 0.45)
4 Month PF Survival Rate 4 Month PF Survival Rate
(95% CI)(95% CI)0.28 0.28 (0.23, 0.33) (0.23, 0.33)
0.13 0.13 (0.09, 0.18) (0.09, 0.18)
6 Month PF Survival Rate6 Month PF Survival Rate (95% CI) (95% CI)
0.15 0.15 (0.10, 0.19) (0.10, 0.19)
0.03 0.03 (0.01, 0.06) (0.01, 0.06)
Hazard Ratio*Hazard Ratio* 0.680.68
95% CI95% CI (0.57, 0.80) (0.57, 0.80)
Log-Rank*Log-Rank* p-value < 0.0001 p-value < 0.0001
* Stratified by ECOG PS (0-1 versus 2) at randomization* Stratified by ECOG PS (0-1 versus 2) at randomization
NCIC CTG CO.17: Progression Free Survival
CETUXIMAB + BSCCETUXIMAB + BSCCENSOREDCENSORED
BSCBSCCENSOREDCENSORED
Pro
po
rtio
n P
rog
ress
ion
-Fre
eP
rop
ort
ion
Pro
gre
ssio
n-F
ree
0.00.0
0.10.1
0.20.2
0.30.3
0.40.4
0.50.5
0.60.6
0.70.7
0.80.8
0.90.9
1.01.0
MONTHSMONTHS
00 33 66 99 1212 1515
HR 0.68HR 0.68 (95% CI =0.57 – 0.80) (95% CI =0.57 – 0.80)
Stratified log rankStratified log rank p-value < 0.0001 p-value < 0.0001
Study armStudy arm Med PFS Med PFS (months)(months)
95% CI95% CI
Cetuximab + BSCCetuximab + BSC 1.91.9 1.8 – 1.8 – 2.12.1
BSC aloneBSC alone 1.81.8 1.8 – 1.8 – 1.91.9
NCIC CTG CO.17: Overall Best ResponseCetuximab + BSC Cetuximab + BSC
N = 287 (%)N = 287 (%)
BSCBSC
N = 285 (%)N = 285 (%)
Partial Response Partial Response 19 (6.6)*19 (6.6)* 0 0
Stable DiseaseStable Disease 84 (29.3)*84 (29.3)* 29 (10.2)*29 (10.2)*
Progressive DiseaseProgressive Disease 133 (46.3)133 (46.3) 155 (54.4)155 (54.4)
Inevaluable for Response Inevaluable for Response 35 (12.2)35 (12.2) 98 (34.4)98 (34.4)
Unknown Unknown 16 (5.6)16 (5.6) 3 ( 1.1)3 ( 1.1)
Objective Response Rate Objective Response Rate (ORR)(ORR) (95% CI) (95% CI)
6.6%*6.6%*
(4.0, 10.2)(4.0, 10.2)
0%0%
Disease Control RateDisease Control Rate 35.9%35.9% 10.2%10.2%
* 4 Cetuximab patients with PR and 6 with SD, and 2 BSC patients with SD were * 4 Cetuximab patients with PR and 6 with SD, and 2 BSC patients with SD were still active atstill active at data cut-off and not included (censored) in data above for “best” responsedata cut-off and not included (censored) in data above for “best” response
Difference in ORRDifference in ORR
(95% CI)(95% CI)
6.6%6.6%
(4.0, 10.2)(4.0, 10.2)
CMHCMH p-value < p-value < 0.0001 0.0001
NCIC CTG CO17: Unplanned Anti-Cancer Therapy*
Cetuximab + Cetuximab + BSCBSC
N = 287 (%)N = 287 (%)
BSCBSC
N = 285 (%)N = 285 (%)
Patients with any anti-Patients with any anti-cancer treatment cancer treatment beforebefore progression progression
4 (1.4)4 (1.4) 45 (15.4)45 (15.4)
RadiotherapyRadiotherapy 2 (0.7)2 (0.7) 24 (8.4)24 (8.4)
ChemotherapyChemotherapy 1 (0.3)1 (0.3) 20 (7.0)20 (7.0)
Hormonal therapyHormonal therapy 0 (0.0)0 (0.0) 4 (1.4)4 (1.4)
ImmunotherapyImmunotherapy 0 (0.0)0 (0.0) 4 (1.4)4 (1.4)
OtherOther 1 (0.3)1 (0.3) 9 (3.2)9 (3.2)
* Not allowed per protocol* Not allowed per protocol
NCIC CTG CO.17: Specific Therapies Before Progression*
Number of PatientsNumber of Patients
Cetuximab + Cetuximab + BSCBSC BSCBSC
TS InhibitorsTS Inhibitors 11 88
Mitomycin-CMitomycin-C 00 44
OxaliplatinOxaliplatin 00 11
IrinotecanIrinotecan 11 77
CetuximabCetuximab 00 66
VEGF InhibitorsVEGF Inhibitors 00 33
* Not allowed per protocol* Not allowed per protocol
NCIC CTG CO17: Therapy Post-Progression
Cetuximab + Cetuximab + BSCBSC
N = 287 (%) N = 287 (%)
BSCBSC
N = 285 (%)N = 285 (%)
Patients with any anti-Patients with any anti-cancer treatmentcancer treatment afterafter progressionprogression
79 (27.5)79 (27.5) 66 (23.2)66 (23.2)
RadiotherapyRadiotherapy 52 (18.1)52 (18.1) 41 (14.4)41 (14.4)
ChemotherapyChemotherapy 36 (12.5)36 (12.5) 38 (13.3)38 (13.3)
Hormonal therapyHormonal therapy 6 (2.1)6 (2.1) 9 (3.2)9 (3.2)
ImmunotherapyImmunotherapy 5 (1.7) 5 (1.7) 11 (3.9)11 (3.9)
OtherOther 13 (4.5)13 (4.5) 13 (4.6)13 (4.6)
NCIC CTG CO.17: Specific Post-Progression Anti-Cancer
TherapiesNumber of PatientsNumber of Patients
Cetuximab + Cetuximab + BSCBSC BSCBSC
TS InhibitorsTS Inhibitors 2424 2020
IrinotecanIrinotecan 1111 1313
Mitomycin-CMitomycin-C 12 12 88
CetuximabCetuximab 11 1616
Oxaliplatin Oxaliplatin 99 55
VEGF InhibitorsVEGF Inhibitors 1010 66
NCIC CTG CO.17: Grade 3 / 4 Adverse Events
Grade 3 / 4 AE Grade 3 / 4 AE
> 10%> 10%
Cetuximab + Cetuximab + BSC BSC N = 288 N = 288
(%)(%)
BSCBSC
N = 274 (%)N = 274 (%)P ValueP Value
Any Grade 3 / 4 AEAny Grade 3 / 4 AE 226 (78.5)226 (78.5) 162 (59.1) 162 (59.1) <0.000<0.00011
FatigueFatigue 95 (33.0)95 (33.0) 71(25.9)71(25.9)
DyspneaDyspnea 47 (16.3)47 (16.3) 34 (12.4)34 (12.4)
Abdominal PainAbdominal Pain 38 (13.2) 38 (13.2) 43 (15.7)43 (15.7)
Pain-OtherPain-Other 43 (14.9) 43 (14.9) 20 (7.3)20 (7.3) 0.0050.005
Infection w/o Infection w/o NeutropeniaNeutropenia 37 (12.8)37 (12.8) 15 (5.5)15 (5.5) 0.0030.003
Rash / Rash / DesquamationDesquamation 34 (11.8) 34 (11.8) 1 (0.4)1 (0.4) <0.000<0.000
11
* Hypomagnesemia as a laboratory toxicity was not correlated to clinical symptoms/ AEs* Hypomagnesemia as a laboratory toxicity was not correlated to clinical symptoms/ AEs
Other Grade 3 / 4 ToxicityOther Grade 3 / 4 Toxicity
Hypomagnesemia*Hypomagnesemia* 15 (5.8)15 (5.8) 00 <0.0001<0.0001
Hypersensitivity Hypersensitivity Reaction Reaction 13 (4.5)13 (4.5) 00 <0.0001<0.0001
Grade 0 Grade 1 Grade 2+
Su
rviv
al
Pro
bab
ilit
y
0
20
40
60
80
100
Survival (months)0 6 12 18
NCIC CTG CO17: OS by Worst Grade of Rash
GradeGrade nnMedian Median SurvivaSurviva
ll
00 3232 2.6 mo2.6 mo
11 111155
4.8 mo4.8 mo
2+2+ 131366
8.4 mo8.4 moPro
port
ion
Aliv
ePro
port
ion
Aliv
e
MonthsMonths- Landmark-type analysis excluding all patients dying within 28 days - Landmark-type analysis excluding all patients dying within 28 days of entryof entry- 90% experienced rash by 29 days, Median time to rash = 10 days- 90% experienced rash by 29 days, Median time to rash = 10 days
GradeGrade HRHR 95%CI95%CI p-valuep-value
2+ 2+ vsvs 0 0 0.330.33 (0.22, (0.22, 0.50)0.50)
<0.0001<0.0001
1 1 vsvs 0 0 0.610.61 (0.40, (0.40, 0.93)0.93)
0.0210.021
2+ 2+ vsvs 1 1 0.540.54 (0.41, (0.41, 0.72)0.72)
<0.0001<0.0001
NCIC CTG CO.17: Conclusions
• Cetuximab significantly prolonged OS compared to Cetuximab significantly prolonged OS compared to BSC in patients in which all other therapy had failedBSC in patients in which all other therapy had failed
• This is the first time single-agent biologic targeted This is the first time single-agent biologic targeted therapy has shown a survival benefit in colorectal therapy has shown a survival benefit in colorectal cancercancer
• PFS and RR were also significantly improved with PFS and RR were also significantly improved with cetuximab over BSCcetuximab over BSC
• The safety profile of cetuximab monotherapy is The safety profile of cetuximab monotherapy is acceptable and consistent with the reported incidence acceptable and consistent with the reported incidence from previous mono-therapy studiesfrom previous mono-therapy studies
• The results of this study add to the large body of The results of this study add to the large body of evidence suggesting benefit for cetuximab in evidence suggesting benefit for cetuximab in metastatic colorectal cancermetastatic colorectal cancer
Acknowledgements
• NCIC CTG and AGITG Investigators and NCIC CTG and AGITG Investigators and Central Office StaffCentral Office Staff
• BMS / ImCloneBMS / ImClone
• Study Nurses, Coordinators, MonitorsStudy Nurses, Coordinators, Monitors
• Patients and their FamiliesPatients and their Families
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