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

402s Health Services Research
6081 General Poster Session (Board #6F), Mon, 1:15 PM-5:15 PM
Physician age and surveillance intensity following curative-intent treatment
for breast cancer patients. Presenting Author: Steven F. Abboud,
Saint Louis University , St. Louis, MO
Background: Breast carcinoma is a large health care concern for patients,
physicians, and society. 2.5 million women have been treated for breast
cancer and are candidates for surveillance in the US. We have documented
dramatic variation in post-treatment surveillance strategies utilized by
ASCO experts caring for such patients. Since it is often asserted that
younger physicians order more tests than older physicians, we sought to
measure the effect of clinician age on post-treatment surveillance intensity
for breast cancer patients by analyzing a recent survey of ASCO members.
Methods: We surveyed the 3245 ASCO members who indicated that breast
cancer treatment was a major focus of their practice. 4 succinct clinical
vignettes describing generally healthy women with breast cancer of varying
prognoses and a menu of 12 surveillance modalities were offered. The
menu was chosen after a literature search indicated that no other
surveillance tests were commonly used. We analyzed data from one of the 4
idealized vignettes only (the patient with TNM IIA carcinoma) and stratified
responses by clinician age. Practice patterns were compared by years after
completion of training (0-10, 11-20, 21-30, 30-40, �40 years), a
surrogate measure of physician age. Statistical analysis employed ANOVA.
Results: There were 1012 responses; 915 were evaluable. Statistically
significant differences were observed across age strata for CBC, liver
function tests (LFTs), and serum CEA level only. For example, ASCO
clinicians in practice for 0-10 years after completion of training recommended
CBCs 1.3 � 1.4 (mean � SD) times in year 1. Those � 40 years
after completion of training recommended CBCs 2.4 � 1.3 times in year 1
(p�0.001). Conclusions: Younger physicians recommend statistically significantly
fewer CBCs, LFTs, and serum CEA levels during post-treatment
surveillance than older physicians. However, the magnitude of the difference
is clinically small for all 3 modalities and does not explain the known
overall variation in surveillance practice among clinically active experts.
6083 General Poster Session (Board #6H), Mon, 1:15 PM-5:15 PM
Chemotherapy in the oldest old: The feasibility of cytotoxic therapy in the
80� population. Presenting Author: Shelly Sud, Division of Medical
Oncology, The Ottawa Hospital Cancer Centre, Department of Medicine,
University of Ottawa, Ottawa, ON, Canada
Background: The incidence of most common malignancies increases with
age. As life expectancy improves globally, more elderly cancer patients will
be candidates for systemic therapy. There is little data investigating
chemotherapy (CT) in those over 80 – the “oldest old”. Our hypothesis is
that CT in the 80� population may be associated with significant toxicities
and is therefore not feasible for many patients. Methods: A retrospective
chart review was undertaken to report outcomes of patients �80 years old
who initiated CT for solid tumors at the Ottawa Hospital Cancer Center
between Nov. 2005 and Jan. 2010. Baseline data on patient demographics,
cancer type and CT were collected. Primary endpoints included: rates
of CT dose reduction, omission, delay and discontinuation due to toxicity,
hospitalization and blood transfusion rates. Results: CT was initiated on
212 occasions (32% lung, 31% GU, 24% GI, 13% other cancer). Median
age was 83 (range 80-92) and 60% of patients were male. Where data were
available, 60% had a good performance score (ECOG 0-1) and 63% were
current or ex-smokers. 82% had Charlson risk index scores of �5, 37% had
�6 baseline medications, 18% lived alone independently. At baseline,
11% were anemic, 12% had leukocytosis, and 45% had impaired renal
function (eGFR�60). Most patients had stage 4 disease (76%), were
treated with palliative intent (75%) and were receiving first line CT (77%).
Initial dose was adjusted in 34% of cases. Therapy was discontinued due to
toxicity in 30% of cases, and 53% of patients required dose reduction,
omission or delay. In 38% of cases, patients were hospitalized during their
course of therapy or within 30 days thereof. Blood transfusions were
required in 24%. Factors associated with risk of hospitalization included
baseline number of medications �6 (OR 1.96, 95% CI 1.1-3.5) and
baseline anemia (OR 2.55, 95% CI 1.07-6.05). Initial dose reduction at
cycle 1 did not significantly affect rates of hospitalization, transfusion or CT
discontinuation. Conclusions: CT in the 80� population is associated with a
significant risk of hospitalization, transfusion and discontinuation due to
toxicity, even when doses are adjusted from the outset. We plan to
prospectively validate these findings.
6082 General Poster Session (Board #6G), Mon, 1:15 PM-5:15 PM
Comparison of drug approval between health Canada (HC) and the U.S.
Food and Drug Administration (FDA). Presenting Author: Doreen Ezeife,
University of Calgary, Calgary, AB, Canada
Background: Differences in drug approval processes between countries can
impact patient access to new therapies. In Canada, patients can freely
access a new treatment after regulatory approval by Health Canada (HC)
followed by funding approval from the provincial government. The aims of
this study were to delineate the Canadian drug approval timeline and to
compare the time to drug approval between HC and the US FDA. Methods:
Cancer drugs approved by the FDA from 1989 to 2011 were reviewed. For
each drug, the following endpoints were determined: publication date of
phase I and pivotal phase III trial, date of FDA and HC approval, HC
submission date, and funding approval in Alberta (AB). Time intervals
between the aforementioned endpoints were calculated. Results: Of 55
FDA-approved drugs, 51 drugs are approved by HC with 40 of these drugs
funded in AB. HC approval occurs an average of 14.4 months post FDA
approval (95% CI -36.9 to 66.1, sign rank test p�0.0001). However, there
was no significant difference between the mean time from Phase I to FDA
approval (48.5 months; 95% CI 21.2 to 75.8) and Phase I to HC approval
(61.5 months; 95% CI 32.4 to 90.5). Most drugs (74%) were approved by
the FDA prior to publication of the phase III trial. There was a trend towards
faster drug approval from Phase III to FDA approval compared to HC
(-14.97 versus 0.1 months, p � 0.05). HC submission occurs before FDA
drug approval 77% of the time (mean 3.0 months prior; 95%CI: -59.1 to
43.4, p � 0.0206). HC approval occurs on average 17 months post HC
submission. AB funding approval occurs on average 22 months after HC
approval. The time interval from Phase I to AB funding approval was
significantly shorter for targeted compared to cytotoxic agents (mean time
58 vs. 120 months; p � 0.039). Conclusions: HC drug approval lags behind
FDA approval by about 14 months. Time from Phase III to drug approval
tends to be shorter for the FDA compared to HC. This is the first
documentation, to our knowledge, of the time required to bring a drug from
phase I trial to provincial funding approval.
6084 General Poster Session (Board #7A), Mon, 1:15 PM-5:15 PM
Does drug cost drive drug adherence? The designer drug phenomenon.
Presenting Author: Jalal Ebrahim, St. Michael’s Hospital, University of
Toronto, Toronto, ON, Canada
Background: Cancer patients (pts) are on many medications, both for
malignancy and supportive therapies. The cost of oral medications are
funded by either the pt, public, or private mechanisms. Low adherence
rates are observed in oral treatments, and non-adherence is the primary
cause of treatment failures. To our knowledge, cost-related adherence to
oral therapy in the context of malignancy has not been studied extensively
in the existing literature. We assessed the relationships between oral
medication costs and adherence rates. Methods: This cohort study enrolled
453 pts at 3 outpatient heme/onc clinics in the Greater Toronto Area. A
7-item survey was designed to assess pt demographics, self-reported
adherence to oral medication, type of drug coverage (private payer, public
payer, self payer) and patients’ perceived cost of oral drugs. Oral medications
were recorded and actual monthly costs were calculated. Descriptive
statistics were used to describe frequencies. Spearman Rank Order
Correlations and Chi-Square Analyses were used to examine relationships
between variables. Results: Of 453 pts, 50% had a private drug plan, 24%
paid out of pocket, 44% had government funding and 4% reported their
physician had arranged funding. 51% of pts had oral drug costs of �
$100/month. Self reported adherence to prescribed oral medications was
80%. As the cost of prescribed medications increased, so did self reported
adherence (r�0.144, p�0.002). There was also a significant relationship
between drug coverage and oral drug costs (c²�23.78, df�12, p�0.02).
Pts paying out of pocket were significantly less likely than all other pts to
have oral drug costs of �$500/month (11% vs 19%) Conclusions: As oral
drug costs increase, so does likelihood of adhering to prescribed regimen.
This implies that further pt education about the efficacy and importance of
medications may help with adherence, regardless of cost. It is possible that
pts are provided with more education regarding newer and more expensive
agents than they are regarding older and cheaper agents, regardless of
efficacy. Disparities observed in medication costs between those with
private drug plans vs. those without suggests financial restrictions may
affect prescription patterns in this group.
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