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

398s Health Services Research
6065 General Poster Session (Board #4F), Mon, 1:15 PM-5:15 PM
Prevalence and characteristics of patients with stage IV solid tumors who
receive no anticancer therapy. Presenting Author: Alexander C. Small,
Division of Hematology and Medical Oncology, The Tisch Cancer Institute,
Mount Sinai School of Medicine, New York, NY
Background: Clinicians caring for patients with cancer are well aware that a
subset of patients who present with metastatic solid tumors never receive
anticancer therapy for reasons including poor functional status, comorbidities,
and patient preference. The prevalence and characteristics of this population
have not previously been described. Methods: The National Cancer Database
was queried for patients diagnosed with metastatic (stage IV) solid tumors
including breast, cervix, colon, kidney, small-cell and non-small cell lung
[NSCLC and SCLC], prostate, rectum and uterus. Patients who received
neither radiation therapy nor systemic therapy were identified. Other factors
such as age, race, income, insurance status, and diagnosis year were assessed.
In an exploratory analysis, log-binomial regression was used to estimate
prevalence ratios (PR) for the proportion of untreated stage IV to treated stage
IV cancer cases according to these factors. Results: From 2000-2008,
773,233 patients with stage IV cancer were identified of whom 159,284
(21%) received no anticancer therapy (Table). Patients with NSCLC accounted
for 55% of untreated patients. Across all cancer types, older age (PR range
1.37-1.49, all p�0.001), black race (PR range 1.05-1.32, all p�0.001),
lack of medical insurance (PR range 1.47-2.46, all p�0.001), and lower
income (except uterus) (PR range 0.91-0.98 for every $10,000 income, all
p�0.001) were associated with increased prevalence of not receiving treatment.
Conclusions: Approximately 20% of patients who present with stage IV
solid tumors never receive anticancer therapy. These findings have potential
implications with regards to healthcare policy and access to care.
Prevalence of patients with metastatic cancer who receive no anticancer
therapy (2000-2008).
Cancer Type
Untreated
stage IV
Total
stage IV % untreated
Cancer-specific
% of total
untreated cases
Kidney 12,079 47,417 25.5% 7.6%
NSCLC 87,400 353,748 24.7% 54.9%
Uterus 297 1,217 24.4% 0.2%
SCLC 21,085 99,206 21.3% 13.2%
Rectum 4,305 26,140 16.5% 2.7%
Colon 18,816 119,748 15.7% 11.8%
Cervix 1,407 9,535 14.8% 0.9%
Breast 7,313 57,148 12.8% 4.6%
Prostate 6,582 59,074 11.1% 4.1%
Total 159,284 773,233 20.6% 100.0%
6067 General Poster Session (Board #4H), Mon, 1:15 PM-5:15 PM
The use of the word “cure” in oncology. Presenting Author: Kenneth David
Miller, Sinai Hospital of Baltimore, Baltimore, MD
Background: Use of the word “cure” in cancer care reflects a balance of
physician and patient optimism, realism, medico-legal concerns, and even
superstition. The purpose of this study was to survey a group of clinicians
regarding the frequency and determinants of using the word “cure” in their
practice. Methods: In 2011, 180 oncology clinicians at the Dana-Farber
Cancer Institute were invited to complete a survey regarding the word
“cure” in cancer care. Participants completed a 19 question survey
regarding how commonly their patients are cured, how often they use the
word cure, in what circumstances they would tell a patient that they are
cured, the timing of telling a patient that they are cured, and hesitancy in
using the word cure. Three patient case scenarios were presented to elicit
participants’ views regarding whether patients were cured and whether they
need continued follow-up. Results: The 117 participants who provided
answers to the cure questions (65% of the original 180 invitees), were
evenly divided between males and females,73% were medical doctors, and
56% had 10 or more years of experience since their training. Eighty-one
percent of respondents were hesitant to tell a patient that they are cured
and 63% would never tell a patient that they are cured. Only 7% feel that
greater than 75% of their patients are, or will be, cured. This varied
significantly by subspecialty (p�0.001). The participating clinicians reported
that only 34% (sd: 30%) of patients ask if they are cured. In
considering 20-year survivors of seminoma, large cell lymphoma, and
estrogen positive breast cancer, 81%, 73%, and 47% of clinicians,
respectively, believed that the patients were cured and 33%, 38%, and
52% recommended annual oncology follow-up of the patients. Twentythree
percent of clinicians believed that patients should never be discharged
from the cancer center. Conclusions: Oncologists report that
patients are hesitant to ask whether they are cured, and the clinicians are
hesitant to tell, although this varied by cancer subspecialty. Annual
oncology follow-up was frequently endorsed, even after 20 years in
remission.
6066 General Poster Session (Board #4G), Mon, 1:15 PM-5:15 PM
Utility of positron emission tomography (PET) scans on the management of
cancers of unknown primary. Presenting Author: Hao Chen, British Columbia
Cancer Agency, Vancouver, BC, Canada
Background: PET scans can be potentially useful in the diagnostic and
staging workup of certain cancers. Although frequently ordered, its precise
role in the investigation and management of cancers of unknown primary
(CUP) remains poorly defined. Our main study aims were to 1) compare the
utility of PET vs. CT scans in determining the primary site, lymph node
status, and metastases for patients with CUP, and 2) describe the overall
survival of patients for whom the primary site was determined by PET vs.
those who were not. Methods: Patients diagnosed with CUP in British
Columbia, Canada from 2006 to 2009, evaluated at 1 of 5 regional cancer
centers in the province, and underwent a PET scan were reviewed. We
measured concordance rates between PET and CT scans and constructed
regression models to characterize the effect of PET scans on treatment and
survival. Results: A total of 175 patients were included: median age was 60
years and 76% were men. PET scans were most commonly performed for
the following indications: locating primary (45%); staging (42%); and
others (13%). Among those in whom CT did not detect the primary site,
PET revealed the location of the primary in 9% of cases. CTs and PETs were
concordant in demonstrating nodal status and metastases in 91% and 95%
of patients, respectively. PET scans were able to show additional nodal
involvement and uncover metastatic disease in 9% and 5%, respectively,
when compared to CT scans. Identification of the site of primary cancer by
PET did not substantially modify subsequent therapy (p�0.37) and it also
failed to significantly improve the median overall survival (10.1 vs. 7.3
months, p�0.57) when compared to those in whom the location of the
primary was unconfirmed. Conclusions: In this retrospective cohort of CUP
patients, CT and PET scans appear to provide a similar level of diagnostic
and staging information. For a small proportion of CUP patients, PETs were
superior in clarifying the primary site, nodal status, and metastases, but
these did not alter therapy or increase overall survival. Based on these
findings and considering the cost implications of intensive imaging studies,
the diagnostic value of PET scans over CT scans appears limited to a small
subset of patients with CUP.
6068 General Poster Session (Board #5A), Mon, 1:15 PM-5:15 PM
Sown the seeds: An analysis of published trials in clinical oncology.
Presenting Author: Natalie M. Spradlin, Vanderbilt University Medical
Center, Nashville, TN
Background: Competition in the pharmaceutical marketplace has resulted
in “seeding trials” which appear to serve little scientific purpose other than
to gain a financial hold in the marketplace. Hallmarks of “seeding” clinical
trials [Kessler, et al N Eng J Med 1994] include trial design that does not
support stated research goals, industry sponsorship without novel findings
or poor scientific rationale, and drugs introduced into an already crowded
therapeutic class, i.e. “me too” drugs. We evaluated clinical trials published
in high impact oncology journals to ascertain the prevalence of trials
bearing the characteristics of a seeding trial. Methods: We conducted a
PubMed search using “clinical trial”, “oncology”, published 2/2005 –
2/2010, in Ann Oncol, J Clin Oncol, Lancet, Lancet Oncol, ortheN Engl J
Med. All phase I/II, II and III studies were included. Phase I, hematology,
radiation oncology, and pediatric studies were excluded. Data collected
included disease site, phase, funding source, journal, and whether the trial
fit criteria for “seeding” as previously defined. Results: 1781 articles have
been evaluated to date. 528 met criteria for analysis. 130 were considered
seed studies. Seed studies per journal were Ann Oncol 26 of 128, J Clin
Oncol 88 of 340, Lancet 8of22,Lancet Oncol 5 of 16, and N Engl J Med 3
of 22. Studies published per disease site and percent seed studies were
melanoma 19 and 31.6%, breast 106 and 30.2%, GI 126 and 20.6%,
lung 101 and 29.7%, GU 65 and 24.6%, gynecology 40 and 30%, head
and neck 24 and 12.5%, CNS 24 and 12.5%, sarcoma 11 and 18.2%, and
advanced cancer 12 with zero seeds. Overall phase totals were phase I/II
16, phase II 272, and phase III 240. Seed studies per phase were phase II
28.7%, phase III 21.7% and zero for phase I/II. 210 studies were solely
industry sponsored, and of these, 37.1% were seed studies. Funding was
not listed for 73 studies. Conclusions: The integrity of clinical trials is
challenged in the race to claim major market share. Our analysis of clinical
trials published in high impact oncology journals found seeding trials
account for 24.6% of publications. 37.1% of industry sponsored trials are
seed studies. Seed studies are more common among the major disease
sites or sites for which targeted therapies exist.
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