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

394s Health Services Research
6048 General Poster Session (Board #2D), Mon, 1:15 PM-5:15 PM
Electronic prompt to improve outpatient code status documentation for
advanced lung cancer. Presenting Author: Jennifer S. Temel, Massachusetts
General Hospital Cancer Center, Boston, MA
Background: Rates of documentation of end-of-life care preferences in the
medical record remain low, even among patients with incurable malignancies.
The goal of this study was to assess the impact of electronic prompts
to encourage oncology clinicians to document code status in the outpatient
electronic health record (EHR) of patients with advanced lung cancers.
Methods: We conducted two clinician focus groups (n�15) at an affiliated
academic medical center to determine the appropriate content and timing
of the electronic reminders. Based on the focus groups, we developed
email reminders that were timed to the start of each new chemotherapy
regimen. Between 6/09 and 1/11, 102 eligible patients with advanced
lung cancer were approached, and 100 (98%) agreed to participate in the
prospective study. Email reminders were sent to oncology clinicians at the
patient’s next outpatient visit and with each new chemotherapy regimen.
Using a pre-post design, we compared study participants to a retrospective
cohort of 100 consecutive historical controls who began chemotherapy for
advanced lung cancer at least one year prior to the start of this study. The
primary outcome measure was the documentation of code status in the
EHR. Results: Study participants were similar to historical controls, with no
significant differences in age, gender, performance status, histology or
initial cancer therapy received. At one year follow-up, 33/98 (34%) of
participants had a code status documented in the outpatient EHR compared
with 12/83 (15%) of historical controls, p�0.003. Mean time to
code status documentation was significantly shorter in study participants
(8.6 months [95% CI 7.6-9.5]) compared with controls (10.5 months
[95% CI 9.8-11.3]), p�0.004. Conclusions: Email prompts triggered by
changes in chemotherapy improved the rate and timing of code status
documentation in the EHR.
6050 General Poster Session (Board #2F), Mon, 1:15 PM-5:15 PM
How do social factors explain outcomes in non-small cell lung cancer
among Hispanics/Latinos in California? Presenting Author: Manali I. Patel,
Stanford University Medical Center, Palo Alto, CA
Background: Hispanics in the United States have a lower age-adjusted
incidence and mortality rate from non-small cell lung cancer compared
with non-Hispanic whites. Previous studies have demonstrated the influence
of nativity on survival among Hispanic patients but no studies have
evaluated the interplay of nativity, clinical factors, social factors, and
neighborhood factors on survival among Hispanic patients with non-small
cell lung cancer. Methods: All Hispanic patients with non-small cell lung
cancer between the years of 1988-2008 were identified in the California
Cancer Registry (CCR). Kaplan Meier curves depict survival by nativity
status among Hispanics with non-small cell lung cancer. Cox proportional
hazard models estimate the hazard of mortality by race with adjustment for
individual covariates (age, gender, marital status), clinical factors (histologic
grade, surgery, radiation, and chemotherapy), and social and neighborhood
factors (neighborhood and ethnic enclave status). Results: A total of
4,062 Hispanic patients with non small cell lung cancer were included.
Overall, there was a 7% decreased risk of disease-specific mortality for
foreign-born patients as compared with US-born patients (HR 0.93,
p�0.08, 95% CI 0.87-1.00) although not-statistically significant. Adjustment
for individual patient factors and clinical factors conferred a statistically
significant 16% decreased risk of disease-specific mortality compared
with US-born patients (HR 0.84, p�0.0001, 95% CI 0.78-0.91). Adjustment
for socioeconomic status and neighborhood socioeconomic and
ethnic enclave status did not explain the differences in survival (HR 0.84, p
�0.001, 95% CI 0.78-0.91). Conclusions: Overall, foreign-born Hispanics
with non-small cell lung cancer have a decreased risk of disease-specific
mortality compared with US-born Hispanics with non-small cell lung
cancer but social factors do not explain this survival advantage. Further
investigation is needed to understand the drivers of the survival advantage
outcomes in foreign-born populations.
6049 General Poster Session (Board #2E), Mon, 1:15 PM-5:15 PM
Positron emission tomography/computed tomography (PET/CT) for the
diagnosis of recurrent cancer (PETREC): A multicenter, prospective cohort
study. Presenting Author: John J. You, McMaster University, Hamilton, ON,
Canada
Background: The clinical utility of PET/CT in patients with suspected cancer
recurrence remains unclear. The aim of this multi-center, prospective,
comparative effectiveness study is to assess the impact of PET/CT on
clinical management of patients with suspected cancer recurrence. Methods:
Patients were eligible if cancer recurrence (non-small cell lung, breast,
head and neck, ovarian, esophageal, Hodgkin’s or non-Hodgkin’s lymphoma)
was clinically suspected, and if conventional imaging (e.g. X-ray,
ultrasound, CT, or MRI) was non-diagnostic. As a pre-requisite to PET/CT
booking, clinicians were asked at enrolment to indicate their planned
management if PET/CT were not available. Patients then underwent
18FDG-PET/CT. Clinicians were then asked to indicate their management
plan based on PET/CT findings. Patients were followed up once at 3
months. The primary outcome was change in planned management after
PET/CT and was assessed independently and in duplicate by external
outcome adjudicators using all available source documents. Results: 101
patients (mean age 64 y, 45% male, median 1.3 y since last treatment)
were enrolled from 4 centers in Ontario, Canada between April 2009 and
June 2011. Distribution of tumor types was: non-small cell lung (55%),
breast (19%), ovarian (10%), esophageal (6%), lymphoma (6%), head and
neck (4%). 8 patients did not complete the study (non-adherence to
protocol, 2; death, 5; disease progression prior to PET/CT, 1), of whom 2
did not receive PET/CT. PET/CT changed planned management in 52
(53%) patients (Table). At 3 months, planned management was carried out
in 46/52 (88%) patients. Conclusions: In patients with suspected cancer
recurrence, PET/CT changes planned management from non-treatment to
treatment for approximately 1 in every 3 patients (“number needed to
scan” � 3) and contributes importantly to clinical management.
Impact on planned management
PET/CT for suspected
cancer recurrence (N�99)
No change 47 (47)
Major change*
Minor change
38 (38)
Clinical/imaging follow-up to biopsy 9 (9)
Imaging to clinical follow-up 2 (2)
Biopsy to clinical/imaging follow-up
Data are n (%). * No treatment to treatment.
3 (3)
6051 General Poster Session (Board #2G), Mon, 1:15 PM-5:15 PM
Improving the impact of clinical research: A systematic analysis of kidney
cancer trials. Presenting Author: Bradford Richard Hirsch, Duke Cancer
Institute, Durham, NC
Background: Clinical trials are essential to advancing cancer care, but the
means to evaluate and improve the portfolio have been lacking. This study
analyzes the renal cell carcinoma (RCC) trial portfolio using the database for
the Aggregate Analysis of ClinicalTrials.gov. As RCC is an area of promise, what
insights can an evaluation of the portfolio provide? Methods: 40,970 clinical
studies registered with ClinicalTrials.gov between October 2007 and September
2010 were aggregated by specialty using MeSH terms and submitted
conditions. 8,942 oncology trials were identified and categorized by cancer
type. 108 trials opening in October 2007 or later were identified as evaluating
treatments for RCC. Descriptive statistics were used to characterize trial
design, study agent(s), accrual and sponsorship. Results: 52 trials (48%)
assessed agents already recommended as 1st or 2nd-line treatments in the
National Comprehensive Cancer Network (NCCN) RCC Guidelines at the time
of study initiation and 19 (18%) studied other FDA-approved treatments. 37
trials (34%) included a novel (non-FDA approved) agent or vaccine. Total
anticipated or actual accrual was 12,753, with 50% accrued/accruing to trials
of only NCCN agents, 34% to novel agents and 16% to other FDA-approved
agents. Industry was identified as a sponsor or collaborator in 48% of trials
assessing only NCCN agents, 73% of novel agent trials and 53% of other
FDA-approved agent trials. As shown in the table, a minority of trials were
randomized, blinded or late-phase (Phase III or IV), regardless of approval
status of study agent. Conclusions: The majority of new studies and accrual in
RCC assess questions of treatment sequence and setting for established
therapies, many of which lack rigorous design. Across the portfolio, studies are
predominantly industry sponsored. Optimizing clinical research includes
increasing studies of novel therapeutics and improving the comparative
effectiveness research portfolio by increasing utilization of pragmatic designs,
registries and late-phase programs.
Trials Randomized Blinded Phase III or IV
Agent
n % n % n % n %
NCCN-recommended 52 48% 17 33% 3 6% 7 13%
Other FDA-approved 19 18% 3 16% 0 0% 1 5%
Novel 37 34% 9 24% 3 8% 4 11%
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