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

392s Health Services Research
6040 General Poster Session (Board #1C), Mon, 1:15 PM-5:15 PM
Utilization of accelerated partial breast irradiation for ductal carcinoma in
situ, 2002-2007: Report from the National Cancer Data Base. Presenting
Author: Tomasz Czechura, North Shore University HealthSystem, Evanston,
IL
Background: The use of accelerated partial breast irradiation using brachytherapy
(APBI-b) for patients with invasive cancer is increasing but data for
ductal carcinoma in situ (DCIS) cases are limited. The American Society of
Radiation Oncology (ASTRO) guidelines suggest that APBI-b should be
used only on a �cautionary� or �on trial� basis for women with DCIS. The
purpose of this study was to examine utilization trends and correlates of
APBI-b use for patients with DCIS. Methods: A total of 70,043 postlumpectomy
patients from the National Cancer Database diagnosed with DCIS
between 2002 and 2007 were studied. Chi-square tests and logistic
regression models were used to determine trends and factors related to
APBI-b use. Results: The use of APBI-b increased from 0.7% in 2002 to
10.0% in 2007 (p�0.001). Independent predictors APBI-b use were age,
race, insurance status, comorbidity index, facility type, and facility location.
Older patients were more likely to use APBI-b; relative to patients
30-39 years old, the OR for patients 80-89 years old was 5.9 (95% CI:
3.7-9.6). APBI-b use was higher in whites (4.9%), compared to blacks
(4.4%), Hispanics (2.8%), and Asian pacific islanders (1.5%; p�0.001).
Compared to noninsured, Medicare (OR�2.1, 95% CI: 1.3-3.3) and
managed care patients (OR�2.0, 95% CI: 1.3-3.2) were more likely to
undergo APBI-b. 2.3% of community cancer programs, 5.7% of comprehensive
community programs and 4.1% of academic/research programs
utilized APBI-b for treating DCIS (p�0.001). The use of APBI-b varied
significantly by facility location; the West and South regions of the country
were more likely to use APBI-b (OR�14, 95% CI: 10.1-19.6) than the
Northeast region. 91% of the APBI-b patients fit the ASTRO �cautionary�
guideline and 9% of patients fit the ASTRO �on trial� guidelines. In 2002,
4% of ABPI-b patients fit the �on trial� guidelines which increased to 8.6%
in 2007 (p�0.001). Conclusions: The use of APBI-b for DCIS increased
from 2002-2007. APBI-b use varies by socioeconomic and facility factors
with age being the most significant factor. Future studies are needed to
determine the indications for APBI-b in patients with DCIS.
6042 General Poster Session (Board #1E), Mon, 1:15 PM-5:15 PM
Prospective evaluation of perceived barriers to medication adherence by
patients on oral antineoplastics. Presenting Author: Benyam Muluneh,
University of North Carolina Hospitals and Clinics Department of Pharmacy,
Chapel Hill, NC
Background: Appropriate use of oral antineoplastics (OA), especially those
with a food-effect, is a challenge for patients and clinicians. Patient
adherence is essential to optimize outcomes, minimize toxicity, minimize
bias in clinical trials, and reduce health care costs. As the use of OA grows,
due to the narrow therapeutic margin, it is critical to understand the
barriers to patient adherence. The purpose of this study was to analyze
cancer patients’ use of OAs and identify opportunities to improve patient
adherence. Methods: We developed and tested a 30-question survey to
address frequency and reasons for reducing/skipping doses; sources of
information for OA use; perceived importance of food-drug effects, and
ease of understanding directions on vial label. Surveys, consisting of Likert
scale and multiple choice questions, were distributed to adult cancer
patients on OAs at the UNC Cancer Hospital clinics. Results: Seventy-seven
patients taking OAs with CML, RCC, breast cancer, and GI tumors
completed the survey with a response rate of 97%. This was a welleducated
population with 71% having completed some college; 54%
female and 58% older than 50 years. Forty-three percent of patients taking
drugs with a significant food-drug effect (sorafenib, pazopanib, lapatinib,
imatinib, nilotinib, and capecitabine) did not think about the last time they
ate before taking their OA and 23% did not know that their OA had a
food-drug effect. In addition, 21% of patients indicated they intentionally
skipped/cut back on their OAs and 38% of those did not inform their
physician. Although 97% reported no difficulty reading instructions on
drug vial, nearly 20% had some difficulty understanding the directions.
Conclusions: There are three main barriers associated with appropriate use
of OAs: confusion or misunderstanding about the timing of drug with food;
reducing/stopping drug without informing MD; and difficulty understanding
directions on the drug vial label. A multipronged integrated approach
involving the pharmacist, physician and nurse is needed to optimize
communication of directions for optimal OA use.
6041 General Poster Session (Board #1D), Mon, 1:15 PM-5:15 PM
Conflict of interest disclosure in off-label oncology clinical trials. Presenting
Author: Blair Billings Irwin, Duke University Medical Center, Durham,
NC
Background: Off-label prescribing of anti-cancer targeted therapies is
increasingly prevalent. Post-regulatory evidence and reporting requirements
for reimbursement for off-label oncologic indications are less
stringent than the threshold for United States Food and Drug Administration
registration. What are the prevalence, reliability, and predictors of
conflict of interest (COI) and funding disclosure statements in published
reports of studies of cancer targeted therapies conducted in the postregulatory
setting? Methods: As a part of a federally-funded systematic
review, manuscripts were included in the analysis if they were used to
support one of 19 indications for cancer targeted therapies that were
off-label but reimbursable according to authoritative compendia in 2006 or
before. Studies were categorized according to trial design, trial results,
average impact factor of journals, and the presence of COI and funding
disclosure statements. Results: Sixty-nine studies were included in the
systematic review. Prevalence of COI and funding disclosures was low, at
33% and 58%, respectively; time trends showed some improvement
between 2002 to 2007, but only 60% of studies had disclosures by 2007.
Predictors of COI disclosure were publication in high impact factor journals
(p�0.001), large study sample size (p�0.001), enrollment exclusively in
the US (p�0.04), and study of the targeted therapy in combination with
other agents as opposed to the study drug alone (p�0.03). Studies with
multiple sites were more likely to include a funding disclosure statement
(p�0.01). Conclusions: There is need for more consistent disclosure of
potential sources of bias in COI and funding statements in studies of
off-label indications for anti-cancer targeted therapies.
6043 General Poster Session (Board #1F), Mon, 1:15 PM-5:15 PM
Bias in reporting of endpoints of efficacy and toxicity in randomized clinical
trials (RCTs) for women with breast cancer (BC). Presenting Author:
Francisco Emilio Vera Badillo, Princess Margaret Hospital, Toronto, ON,
Canada
Background: Phase III RCTs are designed to assess clinically important
differences in endpoints that reflect benefit to patients. Accurate and
unbiased reporting is essential to guide rational therapy. Here we evaluate
the quality of reporting of the primary endpoint (PE) and of toxicity in RCTs
for BC. Methods: PUBMED was searched from 1995-2011 to identify RCTs
for BC. Scales for assessing bias in reporting of the PE and of toxicity were
developed. For the PE, scales assessed whether the concluding statement
of the abstract (CSAbs) was (a) based on the PE, (b) described appropriately
a statistically positive or negative result for the PE, or (c) was based on
secondary endpoints. Bias and completeness of reporting of toxicity was
assessed using a hierarchy scale of whether reporting occurred in the
CSAbs, elsewhere in the abstract, in the discussion of the article or only in
the results. Association of bias with Journal Impact Factor (JIF); changes in
the PE compared to protocol information in clinicaltrials.gov and funding
source was also evaluated. Results: 164 trials were evaluated; 33% showed
bias in reporting of the PE. The PE was more likely to be reported in the
CSAbs if statistically significant [OR 5.2, 95% CI 1.9-14.3, p�0.001]. A
statistically negative PE was not reported in the CSAbs in 27% of trials. Of
the 30 trials where protocol information was available in clinicaltrials.gov,
there were non-significant associations for the PE to show a positive result
if had been changed, and for greater bias in reporting the PE if it was
unchanged. 67% of studies showed bias in reporting of toxicity. Only 14%
mentioned toxicity in CSAbs. When the PE was positive, bias in reporting of
toxicity was more common [OR 2.0, 95% CI 1.0-3.9, p�0.04]. There was
no apparent association between bias in reporting of either the PE or
toxicity and JIF or funding source, but a non-significant association
between change in the PE and industry funding. Conclusions: Bias in
reporting of the PE is common especially for studies with a negative PE.
Reporting of toxicity is poor especially for studies with a positive PE.
Changing of the PE appears to be a strategy to increase the likelihood of
observing a statistically significant result.
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