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

6020 Poster Discussion Session (Board #8), Tue, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
A critical evaluation of oncology clinical practice guidelines. Presenting
Author: Bradley Norman Reames, University of Michigan, Ann Arbor, MI
Background: Clinical Practice Guidelines (CPGs) play an essential role in
cancer care today, but there are significant concerns regarding their
content and reliability. In 2011, the Institute of Medicine (IOM) report
“Clinical Practice Guidelines We Can Trust” created standards for developing
trustworthy CPGs. Using these standards as a benchmark, we sought to
evaluate recent oncology guidelines. Methods: CPGs and consensus statements
addressing the screening, evaluation or management of the four
leading causes of cancer-related mortality in the US (non-small cell lung,
breast, prostate and colorectal cancers) published between January 2005
and December 2010 were identified using MEDLINE. A standardized
scoring system based on the eight standards set forth by the IOM was
devised, and the methodology, content and disclosure policies of CPGs
were critically evaluated by four independent reviewers. All CPGs were
given two scores; points were awarded out of a possible 8 major criteria and
20 sub-criteria. Results: We identified 168 CPGs for inclusion in the study;
45% were from US groups. None of the CPGs fully met all the IOM
standards. On average, CPGs only met 2.8 of 8 standards set forth by the
IOM (mean 2.8 points out of 8, SD 1.7; 8.3 out of 20, SD 4.3). Less than
half of CPGs were based on a systematic review. Only half of CPG panels
addressed conflicts of interest. Overall, the CPGs were most consistent with
IOM standards for transparency regarding the development process,
articulation of recommendations, and use of external review. Most did not
comply with standards for inclusion of patient and public involvement in
the development or review process, nor did they specify their process for
updating. CPGs from the US had higher overall scores than CPGs from
international groups. CPGs addressing non-small cell lung cancer had
higher overall scores (mean 3.9) than those for other cancers. Conclusions:
The vast majority of oncology CPGs fails to meet the IOM standards for
trustworthy guidelines. Notably, most CPGs are not based on systematic
reviews, lack full disclosure, and do not include all relevant stakeholders in
the guideline process. This highlights the need for improved CPG development
processes.
6022 Poster Discussion Session (Board #10), Tue, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
Trade-offs associated with axillary lymph node dissection: Implications of
the eligibility versus enrollment in ACOSOG Z0011. Presenting Author:
Monica Shalini Krishnan, Harvard Radiation Oncology Program, Boston,
MA
Background: Results from ACOSOG Z0011 suggest axillary lymph node
dissection (ALND) may not be necessary for patients following positive
sentinel lymph node biopsy (SLNB). Concerns have been raised regarding
generalizability of this trial, given the low-risk patient population. It is
uncertain whether a subgroup who would have been eligible for ACOSOG
Z0011 but were not adequately represented in the study may still benefit
from ALND. Methods: We constructed a decision analysis using a Monte
Carlo model to simulate axillary recurrence risk, lymphedema, and quality
of life of women aged 45, 55 and 75 y/o with Stage II cancers following
breast conserving surgery (BCS) with positive SLNB who were then treated
with ALND and whole-breast radiation (BRT) or BRT alone. Women were
divided into two risk groups based on the Memorial Sloan-Kettering Cancer
Center non-sentinel lymph node (NSLN) nomogram: those with risk of
residual nodal involvement of 30-60% (high risk); and those with risk less
than 30% (low risk, similar to the Z0011 patients). Probabilities and
utilities for health states were derived from prior studies. Results: BRT alone
resulted in improved quality-adjusted life expectancy (QALE) in the
low-risk group, while ALND with BRT resulted in improved QALE in the
high-risk group. Overall survival (OS) was similar at 5 years with both
treatment strategies in both groups but was superior with ALND at 20 years
in the high risk group (Table). Differences in outcomes decreased with
increasing age. In the low-risk group, sensitivity analysis showed BRT alone
is preferred unless the axillary recurrence risk with BRT is greater than
1.6% or the lymphedema risk with ALND is less than 10%. In the high-risk
group, ALND with BRT is the preferred strategy unless the axillary
recurrence risk with BRT is less than 2.3%. Conclusions: Patients who
would have been eligible for ACOSOG Z0011 but are at higher risk of having
residual nodal disease following BCS and positive SLNB may benefit from
ALND plus BRT rather than BRT alone.
Overall survival and QALE in 55 y/o women.
5 yr OS 20 yr OS QALE (yrs)
BRT ALND BRT ALND BRT ALND
Low risk (NSLN 0-30%) 88% 88% 47% 47% 15.53 15.46
High risk (NSLN 31-60%) 86% 86% 38% 42% 13.55 14.36
Health Services Research
6021 Poster Discussion Session (Board #9), Tue, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
Cancer patients’ trade-offs for efficacy, toxicity, and cost. Presenting
Author: Yu-Ning Wong, Fox Chase Cancer Center, Philadelphia, PA
Background: When making treatment decisions, cancer patients (pts) must
make trade-offs between efficacy, toxicity (tox) and cost. However, little is
known about how individual characteristics influence these decisions,
particularly as many face high out of pocket costs. Methods: We presented
cancer pts with hypothetical scenarios that asked them to choose between
2 treatments of varying levels of efficacy, tox and cost. Each scenario
included 9 choice pairs. Pts were given 2 of 3 scenarios described in the
Table. Tox was also varied. Demographics, cost concerns and numeracy
were assessed. Within each scenario, we used latent class methods to
distinguish pt groups with discrete preferences. We then used regressions
with group membership probabilities as covariates to identify associations.
Results: We enrolled 400 pts. Median age was 61 years (range 27-90). 63%
were female. 41% were college educated. 51% had an annual income
�$60K. 25% were enrolled at a community hospital. 98% were insured.
Within each of the 3 scenarios, we identified 3 pt classes with preferences
for survival or aversion to high cost or toxicity. Across each of the scenarios,
�6% of pts in the group averse to high cost chose the costlier treatment.
�92% of pts in the group that favored survival chose the highest efficacy
treatment. �65% of pts in the group with aversion to tox chose the lower
tox treatment. Within each of the scenarios, pts in the group with
preference for survival were more likely to have an income of �$60K
(p�.05) and greater numeracy skills (p�.05). In scenarios 2 and 3, pts
with concerns about treatment costs were more likely to be in the class that
was averse to high cost (p�.05 for both). Conclusions: Even in hypothetical
scenarios presented to insured pts, socioeconomic status was predictive of
treatment choice. Higher income pts may be more likely to focus on survival
when making decisions while those with greater cost concerns may be more
likely to avoid costly treatment, regardless of survival or tox. This raises the
possibility that health plans with greater cost-sharing may have the
unintended consequence of increasing disparities in care.
Efficacy Range of costs
1 DFS 86% vs 73% $500-$10,000 over 6 m
2 DFS 73% vs 67% $250- $6,000 over 6 m
3 2 yr survival 23% vs 15% $60 - $800 every 3 wk
6023 Poster Discussion Session (Board #11), Tue, 8:00 AM-12:00 PM and
11:30 AM-12:30 PM
The involvement of partners in breast cancer treatment decision making.
Presenting Author: Sarah T. Hawley, University of Michigan, Ann Arbor, MI
Background: Incorporating partners into treatment decision making is an
important element of patient-centered care, yet little is known about the
role of partners in the decision process. Methods: We surveyed 503 partners
of a population-based sample of breast cancer survivor 4 years after
diagnosis (RR� 76%, N�382).The outcome was partners’ reports of
decision regret. Independent variables included decision making process
measures (partners’ reports of sufficient treatment information receipt and
sufficient involvement in decision making), race/ethnicity, age, education
and income. Multivariable logistic regression was used to assess associations
between decision regret and race/ethnicity, controlling for other
variables. Results: 49% of partners were white, 14% African American,
15% more-acculturated Latino, and 18% less-acculturated Latino. One
quarter (26%) of partners reported that they received insufficient information
and one third (35%) desired more involvement in decision-making.
Compared to whites, less-acculturated Latino partners more often reported
that they received insufficient information (41% vs. 18%, p�0.05) and
desired more involvement in decision-making (49% vs. 14%, p�0.001).
Overall 30% of partners reported high decision regret. Multivariate analyses
showed factors associated with high decision regret were lessacculturated
Latinos, insufficient information receipt and desire for more
involvement (Table). Conclusions: Most partners of breast cancer survivors
reported low decision regret and positively appraised their involvement in
the decision process. Less acculturated Latinos reported more dissatisfaction
with the decision process. Findings suggest the need for culturally
appropriate treatment decision support interventions that include partners.
Factors associated with high decision regret
Race/ethnicity
White
African American
Latino–more acculturated
Latino–less acculturated
Sufficient information
Yes
No
Sufficient involvement
Yes
No
Controlled for age, education, and income.
387s
OR (95%CI)
N�382
1.00
1.34 (0.58-3.12)
1.82 (0.78-4.27)
2.43 (1.00-5.89)
1.00
2.33 (1.25-4.31)
1.00
1.91 (1.04-3.48)
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