Annual Meeting Proceedings Part 1 - American Society of Clinical ...

92s Cancer Prevention/Epidemiology
1525 Poster Discussion Session (Board #14), Sun, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
Cost-effectiveness of the 21-gene recurrence score assay in the setting of
multifactorial decision making for chemotherapy in early-stage breast
cancer. Presenting Author: Shelby D. Reed, Duke Clinical Research
Institute, Durham, NC
Background: The objective of this study was to incorporate evidence from
two recently-published studies to reevaluate the cost-effectiveness of the
21-gene Recurrence Score (RS) assay (Oncotype DX) in the context of
multifactorial decision making to guide the use of chemotherapy for
node-negative, estrogen receptor–positive breast cancer in the United
States from the societal and healthcare system perspectives. Methods: We
developed a decision-analytic model to first cross-classify hypothetical
patients by clinicopathologic characteristics according to the Adjuvant!
using risk groups and RS risk groups. We generated estimates of long-term
costs, survival, and quality-adjusted survival for the RS-guided and
non–RS-guided strategies using a probabilistic state transition model. In
addition to costs for the 21-gene assay, we assigned attributable costs for
chemotherapy, hormonal therapy, monitoring for disease recurrence, and
distant recurrence. For the societal perspective, we also considered
incremental patient time costs. Costs and survival were discounted at 3%
annually. Results: With the RS-guided strategy, 40.4% of patients were
expected to receive chemotherapy relative to 47.3% in the non–RS-guided
strategy. Targeted use of chemotherapy in the RS-guided strategy was
expected to increase survival by 0.19 years (95% CI, 0.09 to 0.32) and
0.16 QALYs (95% CI, 0.08 to 0.28). Lifetime direct medical costs were
expected to be $2692 (95% CI, 1546 to 3821) higher with the RS-guided
strategy. The incremental cost-effectiveness ratios (ICERs) were $14,059
per life-year saved (95% CI, $6840-$28,912) and $16,677 per QALY
(95% CI, $7613-$37,219). When incorporating lower indirect costs of
$950 per patient, the ICERs were $9095 per life-year saved (95% CI,
dominant-$23,397) and $10,788 per QALY (95% CI, $6840-$30,265).
In probabilistic sensitivity analysis, more than 99% of the ICERs were less
than $50,000 per life-year saved and per QALY. Conclusions: Our updated
cost-effectiveness estimates are supportive of the economic value of the
21-gene RS assay in the setting of node-negative, estrogen receptor–
positive breast cancer.
1527 Poster Discussion Session (Board #16), Sun, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
Associations between allergies and risk of hematologic malignancies:
Results from the Vitamins and Lifestyle (VITAL) cohort study. Presenting
Author: Mazyar Shadman, University of Washington, Seattle, WA
Background: Several case-control studies have suggested a reduced risk of
hematologic malignancies (HMs) for individuals with allergies, but results
have been inconsistent, and prospective cohort studies have not confirmed
this association. Herein, we used the large prospective VITAL study to
examine this association. Methods: 64,847 men and women, aged 50-76,
completed a baseline questionnaire in 2000-2002 and reported on their
current allergies and history of physician-diagnosed asthma. Individuals
with prior cancer other than non-melanoma skin cancer were excluded from
this analysis. Incident HMs were identified through December 2009 by
linkage to the SEER registry; those with a diagnosis of a non-HM during
follow-up were censored at the time of that diagnosis. Multivariable Cox
proportional hazards models were built with adjustment for sex, race/
ethnicity, education, smoking, self-rated health, physical activity, history
of anemia in the year before baseline, vegetable use and family history of
leukemia or lymphoma. Results: Our analysis included 64,839 participants,
among whom 681 (1.03%) incident HMs were found (MDS [69],
AML (41], myeloproliferative disorders [60], mature B-cell neoplasms
[262], chronic lymphocytic leukemia [107], plasma cell disorders [83],
Hodgkin lymphoma [23], T-cell/NK-cell neoplasms [22], and others [14]).
In multivariable analyses, a history of any allergy was associated with
increased risk of HM (HR�1.21; 95% CI 1.02-1.43, p�0.02). This
association was seen for current allergies to plants/grass/trees (HR 1.27
[1.06-1.52], p�0.001) but not for allergies to mold/dust, animals, insects,
food, or medications. We did not find an association between a history of
asthma and incident HMs (HR�0.95 [0.72-1.26]). Conclusions: Our study
indicates a moderately increased risk of HMs inindividuals with a history of
allergy, especially to plant, grass or trees. While no causality can be
inferred, this may suggest a possible carcinogenic role for chronic stimulation
of the immune system. However, further mechanistic investigations
focusing on the biochemical markers of immune system as well as on
possible gene effect modifiers are needed.
1526 Poster Discussion Session (Board #15), Sun, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
Racial disparities in treatment patterns and clinical outcomes in patients (pts)
with HER2� metastatic breast cancer (MBC). Presenting Author: Adam Brufsky,
University of Pittsburgh School of Medicine, Pittsburgh, PA
Background: Data examining prognosis and treatment outcomes for black pts
with HER2� MBC are limited. Methods: registHER is a large, observational
cohort of pts (N�1,001) with HER2� MBC diagnosed w/in 6 mos of enrollment
and followed until death, disenrollment, or 6/09 (median follow-up 27 mos).
Demographics, treatment patterns, and clinical outcomes were described for
black (n�126) and white pts (n�793). Progression Free Survival (PFS) and
Overall Survival (OS) were examined. Multivariate analyses adjusted for baseline
and treatment factors. Results: Black pts were more likely to be obese (BMI �
30), have diabetes, and a history of cardiovascular disease (CVD) than white pts
(Table). Black pts were less likely to have estrogen receptor (ER)/progesterone
receptor (PR)� disease and more likely to present with stage IV MBC. In
trastuzumab (T)-treated pts, incidence of cardiac safety events (grade �3) was
higher in black (13/119 [10.9%]) than white pts (59/746 [7.9%]). Unadjusted
median OS (mos) was significantly lower (blacks: 27.1, 95%CI 23.2-32.1;
whites: 37.3, 95%CI 34.6-41.1) and median PFS (mos) was lower (blacks: 7.0,
95%CI 5.7-9.7; whites: 10.2, 95%CI 9.3-11.2) in black than white pts. The
adjusted OS hazard ratio (HR) for black vs. white was 1.32 (95%CI 1.04, 1.69);
the adjusted PFS HR was 1.31 (95% CI 1.07, 1.61). Conclusions: These
population-based data show poorer prognostic factors and independently worse
clinical outcomes in black vs. white pts, and represent the largest database to
date with black pts with HER2� MBC. Further research is needed to explore the
basis for the differences noted in this hypothesis-generating analysis.
Demographic and clinical characteristics of black and white pts.
Black
White
Variable (%)
(n�126)
(n�793)
Age (y), median (min, max)
BMI (kg/m
50 (20,90) 54 (22,92)
2 )
-
-
30
50.8
32.4
ER/PR status
-
-
ER� or PR�
42.1
54.7
ER- and PR-
54.8
41.5
Unknown
3.2
3.8
Stage, initial diagnosis
-
-
IV
31.0
26.6
I-III, MBC 12 mos
50.8
61.0
Baseline CVD 30.2 15.8
Diabetes 13.5 6.5
T-based 1st-line regimens
(n�102)
(n�670)
C only
77.5
65.4
HT only
4.9
6.3
C and HT
11.8
20.6
T alone
5.9
7.8
Abbreviations: BMI, body mass index; C, chemotherapy; HT, hormone therapy.
1529 Poster Discussion Session (Board #18), Sun, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
Outcomes from an electronic medical record (EMR)-based standardized
tobacco assessment and cessation program in a NCI-designated comprehensive
cancer center. Presenting Author: Graham Walter Warren, Roswell Park
Cancer Institute, Buffalo, NY
Background: Tobacco assessment and cessation is advocated by ASCO and
national clinical oncology guidelines, but there is little information on large
scale clinically efficient models to assess tobacco use and provide
cessation in a structured evidence based manner. Automation through the
electronic medical record (EMR) could reduce subjective interpretation by
clinicians and assist in increasing data tracking accuracy to enhance
meaningful use initiatives. Methods: A standard set of evidence based
tobacco assessment questions were incorporated into an annotated fixedvariable
response system in the EMR delivered by nursing at initial consult
and at follow-up. A logic based EMR referral system was developed to
determine patient eligibility for mandatory automated referral to a dedicated
tobacco cessation service. An evidence based institutional clinical
cessation program was developed to provide cessation support to referred
patients. The evidence based screening and referral algorithms will be
presented. Results: Over 13 months, 677 patients were referred and 529
patients were successfully contacted to date for cessation support. In the
529 patients, 21 (3.9%) were inappropriate referrals (never smokers or
long term former smokers), 48 patients (9.1%) did not want to enroll, but
wanted to discuss cessation at a later date. Notably, only 18 patients
(3.4%) refused any intervention. In a total of 415 patients enrolled in the
cessation program, 104 patients (25.1%) were thinking about quitting
(contemplation), 134 patients (32.3%) were preparing to quit, 169
patients (40.7%) were quitting (action phase), and 8 patients (1.9%) have
relapsed. Tobacco assessments and automated referrals through the EMR
took a median of 4 minutes to complete. Conclusions: A large volume of
patients were screened and referred to a dedicated cessation program with
low patient refusal for intervention without impeding physician workflow.
These data suggest that this nursing driven EMR based assessment is a
highly efficient clinical model for tobacco assessment and cessation.
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