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

596s Patient and Survivor Care
9118 General Poster Session (Board #47H), Sat, 8:00 AM-12:00 PM
Disease-driven symptoms and response to chemotherapy in treatmentnaive
patients with advanced non-small cell lung cancer (NSCLC). Presenting
Author: Desiree Jones, University of Texas M. D. Anderson Cancer
Center, Houston, TX
Background: The disease-driven symptoms of treatment-naïve patients with
advanced NSCLC have not been the primary focus of previous studies. One
reason for this gap in the literature is that randomized trials typically lack
an opportunity to capture the symptom profiles of patients who are truly
treatment-naïve. To address this need, this study sought to: (i) characterize
the symptom profile of treatment-naïve patients with advanced NSCLC, and
(ii) describe patients’ response to chemotherapy. Methods: The study
sampleconsisted of43 treatment-naïve patients (no prior treatment by
surgery, radiation, or chemotherapy) with a primary diagnosis of advanced
NSCLC from the MD Anderson Cancer Center, and was derived from a larger
study (Cleeland et al. J Clin Oncol 29:2859-65, 2011). Patients’ symptoms
were assessed pre-chemotherapy, and then prospectively at 6, 12,
and 18 weeks from initiation of chemotherapy using the MD Anderson
Symptom Inventory Lung Cancer module. Results: The top symptoms
reported by patients, in order of severity, were shortness of breath, fatigue,
distress, sadness, drowsiness, and pain. Chemotherapy did not significantly
improve shortness of breath, drowsiness, pain, disturbed sleep, lack
of appetite, coughing, and constipation in this sample of patients, and was
associated with a significant increase in levels of fatigue and numbness
(mean difference in fatigue at 12 weeks from baseline � 2.8; 95% CI,
0.5–2.9; p � .01; and in numbness from baseline � 1.1; 95% CI,
0.2–2.0; p � .02). Conclusions: This study characterizes the disease-driven
symptoms of truly treatment-naïve patients with advanced NSCLC. Knowledge
of these symptoms is of intrinsic value in the clinical management of
advanced NSCLC as it provides the critical reference point against which
symptom palliation must be measured. Patients’ lack of symptomatic
improvement from chemotherapy in this study suggests that this sub-set of
patients may have had rapidly progressing disease and that chemotherapy
may have prevented symptoms levels from worsening. Consistent with
literature, transient but significant increase in both fatigue and numbness
are chemotherapy-related toxicities.
9120 General Poster Session (Board #48B), Sat, 8:00 AM-12:00 PM
Final results of a large collaborative, hospital-based quality improvement
study aimed at the implementation of interventions for the psychosocial
care of adult cancer patients (HUCARE project). Presenting Author:
Rodolfo Passalacqua, Istituti Ospitalieri di Cremona, Cremona, Italy
Background: Incorporating psychosocial research into practice is challenging.
Aim of this study is to assess the feasibility and effectiveness in real life
of interventions which have been tested in RCTs and have demonstrated to
improve pts psychosocial conditions Methods: This is an implementation
study of five EBM interventions conducted in 28 centers. We adopted the
model of Pronovost (BMJ 2008), which includes context analysis to
identify local barriers; introduction of the interventions, and evaluation of
how many pts receive the recommended interventions. Primary EPs: degree
of implementation detected in a blinded fashion by external personnel.
Interventions included: 1) EBM communication courses for doctors and
nurses; 2) use of a question prompt list (QPL) for all pts; 3) creation of the
Point of Information and Support (PIS) in the ward (J Clin Oncol
27:1794-99,2009); 4) identification of a referring nurse (RN) for informing
and educating pts; 5) screening of distress and social needs. Results: In
December 2008, 28 eligible centers applied to participate. 27 are
evaluable and 1 is too early. 156 oncologists and 401 nurses attended the
3 days training course. A QPL was subjected to cross-cultural adaptation,
yielding the first validated Italian QPL (BMC Health Serv Res 2010). 24
centers (89%) have successfully implemented the intervention; 3 centers
failed for various reasons: internal conflicts of the staff, poor motivation,
etc. Main results for each intervention are shown in the table. Conclusions:
A successful implementation of EBM measure was obtained in the vast
majority of oncology centers and yields to significant changes in the
delivery of psychosocial care. Project funded by the Italian Ministry of
Health and Lombardia Region.
EBM training
courses
(No. of
attendee, oncologists
plus nurses)
Referring
nurse (RN)
(% of pts
withaRN)
PIS
(No. of
centers
with a PIS)
Use of
the QPL
(% of pts
who receive
the QPL)
Psychosocial
evalutaion
(% of screened
patients)
Pre-implementation 0/598 0% 5 0% 0%
Post-implementation 557/598 (93%) 86% 22 73% 83%
9119 General Poster Session (Board #48A), Sat, 8:00 AM-12:00 PM
Evaluation of a non-peptidic mimic of host defense proteins, PMX30063,
in an animal model of oral mucositis. Presenting Author: Richard W Scott,
PolyMedix, Inc., Radnor, PA
Background: Oral ulcerative mucositis (OM) is a common, painful, doselimiting
toxicity of cancer therapy. The care for OM is largely palliative and
there is an urgent need for new and effective therapies. Host defense
proteins (HDPs) are amphiphilic components of the innate immune system
that serve as a primary response to infection. Exclusive of their direct
antimicrobial activity, HDPs have been shown to possess immune modulatory
and anti-inflammatory activities. We are developing non-peptidic
mimics of HDPs, capturing the structural and biological properties of HDPs
within a framework of smaller fully synthetic oligomers. The lead compound,
PMX30063, is in Phase 2 clinical trials for iv treatment of systemic
staphylococcal infections. Recently, we observed that HDP mimics attenuate
anti-inflammatory pathways and reasoned that these activities could be
leveraged into a mucositis intervention. Methods: In an acute radiation
hamster model, PMX30063 was applied as a topical rinse, 3 times daily at
1, 3 or 10 mg/ml over a 28 day treatment regimen ( n � 10), following a
single radiation dose to the buccal cheek pouch (40 Gy). In a fractionated
radiation model, radiation (7.5 Gy/dose) was administered on days 0, 1, 2,
3, 6, 7, 8 and 9, targeting the left buccal pouch mucosa. PMX30063 was
given topically 3 times daily at 3 mg/ml over a 35 day regimen beginning on
day0(n�10). OM was scored using an established blinded method.
Results: In the acute model, PMX30063 reduced the number of animal
days with ulceration from 43% in vehicle-treated hamsters to � 5% in all 3
PMX30063 dose groups (�2 test; p�0.001). In the fractionated model,
PMX30063 significantly reduced the daily mucositis scores prior to peak
mucositis and throughout the remaining course of treatment (Mann-
Whitney Rank-sum analysis; p�0.001). PMX30063 reduced the number
of animal days with ulceration from 55% in vehicle-treated hamsters to
3.3% (�2 test; p�0.001). The time courses of efficacy argue that direct
antimicrobial action is not the primary driver of efficacy. Conclusions: The
safe and highly efficacious activity of PMX30063 in animals supports its
further development as a topical therapeutic to prevent OM in cancer
patients.
9121 General Poster Session (Board #48C), Sat, 8:00 AM-12:00 PM
Clinical ethics consultation in oncology. Presenting Author: Andrew G.
Shuman, Memorial Sloan-Kettering Cancer Center, New York, NY
Background: There is limited empirical research exploring the nature of
clinical ethical consultations within the oncology population. Our objective
is to review, describe and compare clinical ethics consultations at two
NCI-designated comprehensive cancer centers, in order to identify opportunities
for systems improvement in clinical care. Methods: This case series is
derived from prospectively-maintained clinical ethics consultation databases
at each institution. All adult oncology patients receiving ethics
consultation from 2007 through 2011 were included as eligible cases.
Both qualitative and quantitative analyses were undertaken. Demographic
and clinical information were obtained from the databases for all patients,
and verified via chart abstraction. Additional variables studied included the
reason for and context of the ethical consultation, the patient’s code status
before and after consultation, and involvement of palliative care or other
adjuvant services. Opportunities for systems-level improvements and/or
educational initiatives were identified. Results: A total of 207 eligible cases
were identified. The most common primary issues leading to ethics
consultation were code status and advance directives (25%), surrogate
decision-making (17%), and medical futility (13%). Communication lapses
were identified in 41%, and interpersonal conflict arose in 51%. Prior to
ethics consultation, 26% of patients were DNR; 60% were DNR after
ethics consultation. Palliative care consultation occurred in 41% of cases.
Opportunities for systems improvement and professional education related
to goals of care at the end of life, the role of palliative care involvement, and
improved communication. Conclusions: Ethics consultations among cancer
patients reflect the realities inherent to their clinical management. Appropriately
addressing advance directives within the context of overall goals of
care is crucial. Thoughtful consideration of communication barriers,
sources of interpersonal conflict, symptom control, and end-of-life care are
paramount to optimal management strategies in this patient population.
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