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ACRO 2015
1
Drew Moghanaki, MD, MPHHunter Holmes McGuire Veterans Affairs Hospital
Virginia Commonwealth UniversityRichmond, Virginia
High Risk Prostate Cancer
Disclosures
I am employed by the healthcare system that brought you this
2PIVOT, NEJM 2011
What’s So Controversial?
• Nihilism about the value of radiotherapy for high risk– ADT alone?
• Justifying toxicity of tri-modality treatment– Surgery, Radiotherapy, and ADT
• Publications by data scientists– Misinforming urologists– Confusing patients– Irritating radiation oncologists
3
4ADT Alone?
Lancet, 2009
HR: 0·44 (0·30–0·66, p<0·0001)
1996-200278% = T3
23% = SV+40% = PSA>20
Max PSA <70
Lancet, 2011
1995-200583% = T34% = T4
18% = GS 8-1063% = PSA >20
Max PSA <70
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Challenges for Urologists
• Difficult to “get it all”
• MRI may help– Outperforms Partin Tables– Unintended consequence
• False reassurance • More aggressiveness NVB sparing• Higher positive margin
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Gupta et al, Urol Oncol 2014Borofsky et al, Urol 2013Brown et al, Urol oncol 2009
Non-Believers
• Failure after Prostatectomy– Urologists preferred to observe– Some considered ADT, at time of symptoms– Gradually, salvage RT was considered
• Data showed OS with salvage RT– Fast PSA doublers (Trock, 2008)– Slow PSA doublers (Cotter, 2011)
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RADIOTHERAPY
Helping Improve Urologists’ Outcomes in High Risk Patients for
Decades10
Gambling with High Risk
11Karlin et al, J Urol 2014
ASTRO/AUA Guideline
Clinical Principle: Physicians should “offer” adjuvant radiotherapy to patients with adverse pathologic findings [SV, EPE, +Margin]
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Still believes he will live longer
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15 year: Urinary Function
Resnick, NEJM 2013
15 year: Sexual Function
Resnick, NEJM 2013
15 year: Bowel Function
Resnick, NEJM 2013
Data Scientists and Big Data
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Low Risk Interm Risk High Risk
Scandinavian RegistrySooriakumaan et al, BMJ 2014
}
The survival of CURED patients should be equal, irrespective of treatment.
IF BASELINE HEALTH WAS SIMILAR AT BASELINE
OBVIOUSLY, THEY ARE NOT
Slide by Julian Rosenman, MD, PhD
}
Rad
ioth
erap
ySu
rger
yScandinavian Registry
n >30,000
Years
Surv
ival
0 —
60 —70 —80 —90 —
100 —
|14
|10.5
|7
|3.5
|0
Cured radiation patientsCured surgery patients
Why such a difference? What is
missing?
Slide by Julian Rosenman, MD, PhD
Survival of Cured Patients
The Absurd
21Nat Rev Urology 2013
Hope and the ASCENDE Trial
276 = High Risk
12 months LHRH+
46 Gy EBRT
32 Gy EBRT vs 115 Gy I-125
7y DFS Nadir + 0.2 38% 82%Nadir + 2 71% 86%
22ASCO GU, 2015ABS, 2015ESTRO, 2015
Take Home Points
• Sharp instruments often miss tumor– Leave behind toxicity
• Routine tri-modality therapy should be avoided– No need to bother with surgery
• Don’t get fooled by data scientists– QOL, Shared Decision, Multi-Disciplinary
Clinics23
Dr. Ehdaie may want you to believe
• He knows how to interpret the data– Yes, he does.
• Surgery helps pts live longer.– Yes, for high risk in PIVOT– (Halsted once challenged radiotherapy)
• He’ll concede we need a RCT– SPCG 15 (open, est. completion 2027)– VA High Risk Study (concept) 24
What Dr. Ehdaie may forget to mention
Gatekeeper effect…
He may be less familiar with this
(Since Zelefsky helps keeps things honest at MSKCC)
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