the prostate, lung, colorectal and ovarian cancer screening trial fifth annual african-american...
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The Prostate, Lung, The Prostate, Lung, Colorectal and Colorectal and Ovarian Cancer Ovarian Cancer Screening TrialScreening Trial
Fifth Annual Fifth Annual African-American African-American
Prostate Cancer Disparity Prostate Cancer Disparity SummitSummit
September 24, 2009September 24, 2009
Christine D. Berg, M.D.Christine D. Berg, M.D.Project Officer, PLCOProject Officer, PLCO
Chief, Early Detection Research Chief, Early Detection Research GroupGroup
Division of Cancer PreventionDivision of Cancer Prevention
PLCO Trial: Study PLCO Trial: Study DesignDesign Screening Centers: 10Screening Centers: 10
Participants: 154,935Participants: 154,935 Gender: 50:50Gender: 50:50 Age: 55-74 yearsAge: 55-74 years Recruitment: 1993-2001Recruitment: 1993-2001 Screening: 1993-2006Screening: 1993-2006
PProstate – Annual DRE x 4 and PSA x 6rostate – Annual DRE x 4 and PSA x 6 Follow-up for 14 years (T0 – T13)Follow-up for 14 years (T0 – T13)
Annual surveys: activeAnnual surveys: active Monitoring and QA: activeMonitoring and QA: active Mortality searches: active and NDI, passiveMortality searches: active and NDI, passive Annual interim analysisAnnual interim analysis
PLCO Screening CentersPLCO Screening Centers
PLCO: Selected PLCO: Selected CharacteristicsCharacteristics
0
5
10
15
20
25
30
35
55-59 60-64 65-69 70-74
Screening Control
RaceRace ScreeniScreeningng
ControControll
WhiteWhite 86.286.2 83.883.8
BlackBlack 4.54.5 4.34.3
HispaHispanicnic
2.12.1 2.12.1
AsianAsian 4.04.0 3.93.9
OtherOther 0.80.8 0.90.9
MissinMissingg
2.42.4 5.05.0
Prostate Cancer DetectedProstate Cancer Detectedby 10 years by 10 years
Clinical StageClinical Stage ScreeningScreening ControlControl
II 18 (0.5)18 (0.5) 15 (0.5)15 (0.5)
IIII 3297 (95.5)3297 (95.5) 2790 (93.8)2790 (93.8)
IIIIII 49 (1.4)49 (1.4) 56 (1.9)56 (1.9)
IVIV 73 (2.1)73 (2.1) 79 (2.7)79 (2.7)
UnknownUnknown 15 (0.4)15 (0.4) 34 (1.1)34 (1.1)
Comparison of Gleason Comparison of Gleason ScoresScores
Gleason scoreGleason score
on biopsyon biopsy ScreeningScreening
ControlControl
2 - 42 - 4 222 (6.4)222 (6.4) 137 (4.6)137 (4.6)
5 -65 -6 2047 2047 (59.3)(59.3)
1656 1656 (55.7)(55.7)
77 815 815 (23.6)(23.6)
779 779 (26.2)(26.2)
8 - 108 - 10 289 (8.4)289 (8.4) 341 341 (11.5)(11.5)
Unknown Unknown
79 (2.3)79 (2.3) 61 (2.1)61 (2.1)
Compliance and Compliance and ContaminationContamination
Screening before entry (screening/control)Screening before entry (screening/control) PSA test DRE PSA test DRE
Once: 34.6/34.3 32.8/31/9 Once: 34.6/34.3 32.8/31/9 Two or more: 9.4/9.8 22.2/22.0Two or more: 9.4/9.8 22.2/22.0
ComplianceCompliance PSA 85%; DRE 86%PSA 85%; DRE 86%
Testing in the control groupTesting in the control group PSA: 40% in first year to 52% in sixth yearPSA: 40% in first year to 52% in sixth year DRE: Range from 41 to 46%DRE: Range from 41 to 46%
Andriole GL et al. N Engl J Med 2009;360:1310-1319
Number of Diagnoses of All Prostate Cancers and Number of Prostate-Cancer Deaths
PLCO Trial ResultsPLCO Trial Results Annual screening with DRE and PSA Annual screening with DRE and PSA
results in more prostate cancer compared results in more prostate cancer compared to community screening practicesto community screening practices Seven years: 2820 versus 2322 Seven years: 2820 versus 2322 Ten years: 3452 versus 2974Ten years: 3452 versus 2974
Few Prostate cancer related deaths in Few Prostate cancer related deaths in either groupeither group 50 screening and 44 controls at 7 years50 screening and 44 controls at 7 years 92 screening and 82 control at 10 years92 screening and 82 control at 10 years
Continued follow-up to be doneContinued follow-up to be done
UCLACA-125, PSA Assays
Blood Collection Blood Collection ProtocolProtocol
BiorepositoryEtiology & Early Marker Studies
Serum
T0, T1, T2, T3, T4, T52 ml
S
Serum
T0 (2), T1, T2, T4, T52 ml X 2
SS
Plasma, Buffy Coat, RBC
T0, T32 ml X 4
PP B R
Serum
T02 ml
S
Plasma, Buffy Coat, RBC
T3, T4, T5 (2) 2 ml X 4
PP B R
Whole Blood
T3 (2)2 ml X 6
W WW
W
Samples Collected Per Patient
Serum 13 vials 26 ml
Plasma 12 vials 24 ml
Buffy Coat 6 vials 14 ml
RBC 3 vials 6 ml
Whole Blood 12 vials 24 ml
Total 46 vials 92 ml
Tubes Additive Size Specimens
Red/Gray Clot Activator 6 ml Serum
Red None 10 ml Serum
GreenSodiumHeparin
10 mlPlasma, Buffycoat & RBC
Royal Blue None 7 ml Zinc-free Serum
LavenderLiquidEDTA
10 mlPlasma, BuffyCoat &RBC
Yellow ACD-A 8.5 ml Whole Blood
Specimens Available by Cancer Specimens Available by Cancer Sites and Specimen TypesSites and Specimen Types
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
Prost
ate
Breas
t
Lung
Colore
ctal
Mel
anom
a
Bladder
Non-Hodgki
n's ly
mphom
a
Endomet
rium
Leuke
mia
Kidney
Pancr
eas
Ovarie
s(Ova
rian)
Multi
ple M
yelo
ma
Liver
Mouth
Stom
ach
Brain
Thyroid
Laryn
x
Esophag
us
Nu
mb
er o
f V
ials RBC
Buffy Coat*
Plasma
Serum
Whole Blood
75,476
34,043
17,20617,084
9,4908,837
6,7235,734
4,8294,489
1,7351,900
2,1382,289
3,5073,501
1,4341,242
1,1931,086
TMAs with PLCO TumorsTMAs with PLCO Tumors
Supports multiplehistologies per spot
PLCO Trial ConclusionsPLCO Trial Conclusions
PSA not a perfect testPSA not a perfect test Low mortality rates achieved at high rate of Low mortality rates achieved at high rate of
overdiagnosisoverdiagnosis Important to have better biologic Important to have better biologic
understanding of aggressive prostate cancer understanding of aggressive prostate cancer and means of differentiating from indolent and means of differentiating from indolent diseasedisease
PLCO biospecimen repository useful PLCO biospecimen repository useful genetic and somatic risk assessmentgenetic and somatic risk assessment development and validation of early markers of development and validation of early markers of
detectiondetection
With appreciationWith appreciation
PLCO Research ColleaguesPLCO Research Colleagues PLCO Site Coordinators and StaffPLCO Site Coordinators and Staff NCI ColleaguesNCI Colleagues The trial participants without whom The trial participants without whom
these studies would not have been these studies would not have been possiblepossible