azienda ulss 13 – mirano ve dipartimento di scienze mediche u.o.c. di oncologia & ematologia...
TRANSCRIPT
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Azienda ULSS 13 – Mirano VEAzienda ULSS 13 – Mirano VE
Dipartimento di Scienze MedicheDipartimento di Scienze MedicheU.O.C. di Oncologia & Ematologia OncologicaU.O.C. di Oncologia & Ematologia Oncologica
Ufficio di Epidemiologia & Sperimentazioni ClinicheUfficio di Epidemiologia & Sperimentazioni Cliniche
Giovanni L. PappagalloGiovanni L. Pappagallo([email protected])([email protected])
MULTIPLE TREATMENT CHOICES:MULTIPLE TREATMENT CHOICES:ARE THEY EQUALLYARE THEY EQUALLY(cost) EFFECTIVE?(cost) EFFECTIVE?
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YOUR TREATMENT CHOICE…YOUR TREATMENT CHOICE…
Statistical Significancevs
Clinical Significance
Registrative Studiesvs
Therapeutic Strategies
Controllingthe Cost of InnovativeCancer Therapeutics
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YOUR TREATMENT CHOICE…YOUR TREATMENT CHOICE…
Statistical Significancevs
Clinical Significance
Registrative Studiesvs
Therapeutic Strategies
Controllingthe Cost of InnovativeCancer Therapeutics
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A. Stone & K. Carroll, ASCO 2008
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A. Stone & K. Carroll, ASCO 2008
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P<0.05P<0.05
• Early terminationEarly termination
• OverpoweringOverpowering
• Inadequate Inadequate control groupcontrol group
• Inadequate (?) Inadequate (?) primary endpointprimary endpoint
• Subgroup analysisSubgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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RL Schilsky, ASCO 2005
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RL Schilsky, ASCO 2005
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J Slutsman, ASCO 2005
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J Slutsman, ASCO 2005
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HR 0.54(95%CL 0.43-0.67)
target Δ ofHERA trial:RRR 23%
Trastuzumabbetter
Controlbetter
J Slutsman, ASCO 2005
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HR 0.62(95%CL
0.41-0.95)
target Δ ofCALGB 9633:RRR 33%
CarboTaxolbetter
Controlbetter
J Slutsman, ASCO 2005
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P<0.05P<0.05
• Early terminationEarly termination
• OverpoweringOverpowering
• Inadequate Inadequate control groupcontrol group
• Inadequate (?) Inadequate (?) primary endpointprimary endpoint
• Subgroup analysisSubgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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Target Δ: HR erlotinib:placebo = 0.75 (2 months OS improvement)Analysis after 381 events (450 patients; α 5%, power 80%)
Analysis after 486 events (569 patients)
Actual difference:0.33 months (10 days)
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Analysis after ??? events (1125 patients)
Actual difference: 1.2 months
Target Δ: HR cetuximab:placebo = 0.80 (2.5 months OS improvement)Analysis after 845 events (1100 patients; α 5%, power 90%)
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P<0.05P<0.05
• Early terminationEarly termination
• OverpoweringOverpowering
• Inadequate Inadequate control groupcontrol group
• Inadequate (?) Inadequate (?) primary endpointprimary endpoint
• Subgroup analysisSubgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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“Standard” therapy?
Equipoise?
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“Standard” therapy?
Equipoise?
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“Standard” therapy?
New “standard”?
Equipoise?
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S.D. Averbuch, ASCO 2008
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P<0.05P<0.05
• Early terminationEarly termination
• OverpoweringOverpowering
• Inadequate Inadequate control groupcontrol group
• Inadequate (?) Inadequate (?) primary endpointprimary endpoint
• Subgroup analysisSubgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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F. Pignatti, ESMO 2008
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S T
Prentice, Statist Med 1989;8:431.
Effect of Effect of
treatment on treatment on
surrogatesurrogate
Effect of Effect of
surrogate on true surrogate on true
endpointendpoint
VALIDATION OF SURROGATE ENDPOINTS:VALIDATION OF SURROGATE ENDPOINTS:
“FULL CAPTURE OF EFFECT”“FULL CAPTURE OF EFFECT”
Effect of treatment on true endpointEffect of treatment on true endpoint
must be fully captured by surrogatemust be fully captured by surrogate
Trt
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S T
Prentice, Statist Med 1989;8:431.
Effect of Effect of
treatment on treatment on
surrogatesurrogate
Effect of Effect of
surrogate on true surrogate on true
endpointendpoint
VALIDATION OF SURROGATE ENDPOINTS:VALIDATION OF SURROGATE ENDPOINTS:
“FULL CAPTURE OF EFFECT”“FULL CAPTURE OF EFFECT”
Effect of treatment on true endpointEffect of treatment on true endpoint
must be fully captured by surrogatemust be fully captured by surrogate
Trt
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P<0.05
• Early termination
• Overpowering
• Inadequate control group
• Inadequate (?) primary endpoint
• Subgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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AO Sartor
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A. Gennari, 2008
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S.L. George
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F. Cappuzzo, WCLC 2009
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P<0.05P<0.05
• Early terminationEarly termination
• OverpoweringOverpowering
• Inadequate Inadequate control groupcontrol group
• Inadequate (?) Inadequate (?) primary endpointprimary endpoint
• Subgroup analysisSubgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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P<0.05P<0.05
• Early terminationEarly termination
• OverpoweringOverpowering
• Inadequate Inadequate control groupcontrol group
• Inadequate (?) Inadequate (?) primary endpointprimary endpoint
• Subgroup analysisSubgroup analysis
P≥0.05P≥0.05
• UnderpoweringUnderpowering
• Inadequate (?) Inadequate (?) patient selectionpatient selection
Poor ClinicalPoor ClinicalSignificanceSignificance
whenwhen
Possible ClinicalPossible ClinicalSignificanceSignificancealso whenalso when
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E. Winer, St. Gallen 2009
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Competing causes of mortality
Hanrahan et al. J Clin Oncol 2007; 25: 4952-60
Probability
10 1500.0
0.1
0.2
0.3
0.4
5Time from diagnosis (years)
Breast-cancer deathsOther deaths
Age ≥50 years and ER+
ER+, oestrogen receptor-positive
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E. Winer, St. Gallen 2009
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YOUR TREATMENT CHOICE…YOUR TREATMENT CHOICE…
Statistical Significancevs
Clinical Significance
Registrative Studiesvs
Therapeutic Strategies
Controllingthe Cost of InnovativeCancer Therapeutics
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C. Belani, ASCO 2009 F. Cappuzzo, WCLC 2009Only 19% of placebo pts received Pemetrexed at any time
Only 16% of placebo pts received Erlotinib at any time
MAINTENANCE THERAPY IN ADVANCED NSCLC: MAINTENANCE THERAPY IN ADVANCED NSCLC: PROOF OF PRINCIPLEPROOF OF PRINCIPLE
OR READY-TO-USE STRATEGY?OR READY-TO-USE STRATEGY?
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(one of)The Best 1st Line The Best 2nd Line
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YOUR TREATMENT CHOICE…YOUR TREATMENT CHOICE…
Statistical Significancevs
Clinical Significance
Registrative Studiesvs
Therapeutic Strategies
Controllingthe Cost of InnovativeCancer Therapeutics
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YOUR TREATMENT CHOICE…YOUR TREATMENT CHOICE…
Statistical Significancevs
Clinical Significance
Registrative Studiesvs
Therapeutic Strategies
Controllingthe Cost of InnovativeCancer Therapeutics
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YOUR TREATMENT CHOICE…YOUR TREATMENT CHOICE…
Statistical Significancevs
Clinical Significance
Registrative Studiesvs
Therapeutic Strategies
Controllingthe Cost of InnovativeCancer Therapeutics
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Thank You for Your Attention!Thank You for Your Attention!