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S32
A B S T R A C T S
There is limited information of the effectiveness of multi-
gene assays in older breast cancer patients.
Objectives:
To investigate the role of the 21-gene
Recurrence Score (RS) in guiding cost-effective treatment,
SEER and Genomic Health collaborated (npj Breast Cancer,
2016;2:16017) to evaluate BC-specific mortality (BCSM) by age
and RS results.
Methods:
Oncotype DX RS results were provided
electronically to SEER, per registry linkage methods. Eligible
pts were diagnosed (Jan 2004 - Dec 2011) with N0 HR+ BC, and
had no prior malignancy or multiple tumors. BCSM, defined
previously (
JNCI
. 2010;102:1584), was analyzed separately for
pts <70 and
70 y. Mortality estimates were compared using
a log-rank test.
Results:
Of 184,190 eligible pts, 70%/30% were <70 y/
70 y.
35,487 of 128,712 pts <70 y (28%) had RS results (median age 55
y; 29%/54% grade 1/2; 26%/54%
1 cm/
1-2 cm). 4,647 of 55,478
pts
70 y (8%) had RS results (median age 73 y; 25%/55% grade
1/2; 20%/48%
1 cm/
1-2 cm). Reported CT use and 5-y BCSM
are shown in Table 1. CT use was lower for pts
70 y (p<0.001).
Continuous RS result was associated with BCSM for pts both
<70 and
70 y (p<0.001). As expected, 5-y other-cause mortality
was higher in pts
70 y (11%) than in pts <70 y (4%), but was
not associated with RS results (p=0.92). 5-y BCSM was worse
for pts
70 y, particularly for those with RS
18 (p<0.001). For
pts
70 y with no RS assay (50,422 pts; 4% CT use), 5-y BCSM
was 5.4% (95% CI, 5.2%, 5.6%).
Conclusion:
This large population-based observational
study of N0 HR+ BC indicates that RS strongly predicts BCSM
in pts <70 and
70 y, and that unacceptably high BCSM persists
in US clinical practice for pts
70 y with an RS
18 (but not
RS <18). Further research and actions are urgently needed
to understand and address the factors behind this outcome
disparity.
Disclosure of interest:
S. Shak Shareholder of: Genomic
Health, Employee of: Genomic Health, V. Petkov: None
declared, D. Miller Shareholder of: Genomic Health, Employee
of: Genomic Health, N. Howlader: None declared, L. Penberthy:
None declared
Keywords:
Breast cancer, elderly, multi-gene assay, prognosis
O16
PRIMARY ENDPOINTS TO ASSESS TREATMENT EFFICACY
IN CLINICAL TRIALS CONDUCTED IN ELDERLY CANCER
PATIENTS
F. Etchepare
1,
*, C. Terret
2
, F. Bonnetain
3
, P. Soubeyran
4
,
L. Mourey
5
, D. Heitz
6
, E. Brain
7
, A. Bellenguez
8
, C. Bellera
9
,
S. Mathoulin-Pélissier
10
1
Inserm U1219 Research Centre, Epicene Team (Epidemiology
of Cancer and Environmental Exposure), Clinical Research and
Clinical Epidemiology Unit, French National Cancer Institute
(INCa) Integrated Cancer Research Site (SIRIC), Institut Bergonié,
Comprehensive Cancer Centre, Bordeaux,
2
Department of Medical
Oncology, Centre Léon Bérard, Regional Comprehensive Cancer
Centre, Claude-Bernard Lyon-1/ Université de Lyon, Lyon,
3
Unité
de Méthodologie et qualité de vie en oncologie, EA3181, CHU
Besançon, Besançon,
4
French National Cancer Institute (INCa),
Integrated Cancer Research Site (SIRIC), Department of Medical
Oncology, INSERM U1218, Institut Bergonié, Comprehensive Cancer
Centre, Université de Bordeaux, Bordeaux,
5
Service d’Oncologie
Médicale, Institut Claudius Regaud, IUCT-O, Toulouse,
6
Service
de Geriatrie, Hopitaux Universitaires de Strasbourg, Strasbourg,
7
Service d’Oncologie Médicale, Hôpital René Huguenin/ Institut
Curie, Saint-Cloud,
8
Inserm U1219 Research Centre, Epicene
Team (Epidemiology of Cancer and Environmental Exposure),
Clinical Research and Clinical Epidemiology Unit, Institut Bergonié,
Comprehensive Cancer Center,
9
Inserm U1219 Research Centre,
Epicene Team (Epidemiology of Cancer and Environmental
Exposure), Clinical Research and Clinical Epidemiology Unit,
Institut Bergonié, Comprehensive Cancer Centre,
10
Inserm
U1219 Research Center, Epicene Team (Epidemiology of Cancer
and Environmental Exposure), Clinical Research and Clinical
Epidemiology Unit, Institut Bergonié, Comprehensive Cancer
Centre/Université de Bordeaux, Bordeaux, France
Introduction:
For randomized controlled trials (RCT)
run in oncology, the validated and most objectively defined
evaluation criterion remains overall survival (OS - delay
between randomization and death), although endpoints such
as progression-free survival (PFS) or disease-free survival
(DFS) are more commonly used. Nowadays, the priority
given to living better, and ideally also longer, challenges the
relevance and accuracy of these tumor-specific endpoints to
assess the benefit/risk balance of new strategies, especially in
elderly patients.
Geriatric oncology experts and task forces led by the
International Society of Geriatric Oncology (SIOG) and
the European Organization for Research and Treatment
Cancer (EORTC) have acknowledged the heterogeneity of
primary endpoints used in RCT conducted in elderly cancer
patients. In France, DIALOG (Dialogue Intergroupe pour la
Table 1 (abstract O15)
RS <18
RS 18-30
RS
31
N
CT (% of N) 5-y BCSM (95% CI)
N
CT (% of N) 5-y BCSM (95% CI)
N
CT (% of N) 5-y BCSM (95% CI)
All pts
21760
7%
0.4 (0.3,0.5)
15152
35%
1.4 (1.1,1.7)
3222
70%
4.5 (3.5,5.8)
<70 y
19137
8%
0.3 (0.2,0.4)
13549
37%
1.2 (0.9,1.5)
2801
72%
3.7 (2.8,4.9)
70 y
2623
2%
1.2 (0.6,2.2)
1603
15%
2.8 (1.9,4.2)
421
53%
11.7 (7.1,18.9)