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

580s Patient and Survivor Care
9053 General Poster Session (Board #39H), Sat, 8:00 AM-12:00 PM
3D index calculated from duration and severity of neutropenia and a degree
of fever as prognostic factors predicting mortality of chemotherapy-induced
febrile neutropenia in hematologic malignancies. Presenting Author: Ryosuke
Shirasaki, Department of Hematology/Oncology, Teikyo University
School of Medicine, Tokyo, Japan
Background: Risk stratification of patients with febrile neutropenia (FN) is
important to select the suitable therapeutic option. Although the MASCC
scoring system is used as a reliable risk-discriminator, the objective
evaluation of “burden of illness” has been difficult to be pointed-out. The
latest IDSA Guidelines on FN proposes a set of risk factors based on the
expert’s recommendations. The present study demonstrates usefulness of
newly proposed 3D-index on predicting mortality of chemotherapy-induced
FN in hematologic malignancies (HM). Methods: Patients with HM admitted
to our hospital between Jan 2008 and Dec 2011 were enrolled, and
data from 282 FN episodes in 129 FN patients including 20 infectionassociated
deaths were retrospectively analyzed to determine useful
prognostic factors on the mortality of FN. Correlation between mortality and
59 characteristics including 3D-index were examined by univariate analysis
and receiver operating characteristic curve analysis. 3D-index is a
duration and severity of neutropenia and degree of fever. Total duration of
days during neutropenia was not calculate at the time of risk evaluation.
3D-indexes after three and five days from the start of FN were also
analyzed. Results: 32 out of 59 characteristics were significantly correlated
with mortality by univariate analysis. Among them, 3D-index and 3Dindexes
after three and five days were demonstrated as more useful factors
(3D-index, p�0.0015; 3D-index after three days, p�0.0030; 3D-index
after five days, p�0.0044). And 3D-index after three days over 4000
indicates patients’ mortality above 20%, index 2600-4000 15-20% ,
index 900-2600 10-15%, and index below 900 below 10%, respectively.
Conclusions: 3D-indexes after three days were suggested as useful predictors
for infection-related mortality during FN. It was suggested that FN
patients were categorized into four risk groups according to the value.
9055 General Poster Session (Board #40B), Sat, 8:00 AM-12:00 PM
Comparison of three different radiation fractionation schedules in the
palliation of painful bone metastasis. Presenting Author: Monica Malik,
Nizam’s Institute of Medical Sciences, Hyderabad, India
Background: The purpose of this study was to compare the efficacy of a
single fraction versus two multifractionated regimens in the palliation of
painful bone metastases. Methods: Patients with painful bone metastases
were randomized into three groups. Group I received a dose of 8 Gy in a
single fraction, Group II received 20 Gy in five fractions and Group III
patients received 30 Gy in 10 fractions. Pain score, ECOG performance
status and analgesic requirement were recorded at baseline and at 1, 4, 8
and 12 weeks following treatment. Pain score was recorded on a 5-point
verbal rating scale from 0 (no pain) to 4 (extremely severe pain). Overall
response was defined as decrease in pain score by at least one point.
Complete response was defined as achieving a pain score of zero at any
point during follow-up. Duration of overall response was defined as the time
from initial response till return of pain to its baseline value. Results: 45
patients were included with 15 in each group. Median age was 55 years
(range 29-78 years). 17(37.7%) had metastasis in pelvic bones; 17(37.7%)
in the spine while the remainder in the appendicular bones. Overall
response rates in Groups I, II and III at week 1 were 60%, 53.3% and 60%
respectively (p�0.71). At 1 month, overall response rates were 71.4%,
73.3% and 73.3% (p�0.84) and at 3 months; 78.5%, 80% and 80%
respectively (p�0.86). The rate of complete response in all the three
groups was 20%. Improvement in performance status in Groups I, II and III
was seen in 60%, 66% and 80% respectively (p�0.69). Analgesic usage
decreased in 86%, 87% and 80% patients in groups I, II and III
respectively (p�0.66). Out of the nine complete responders, two sustained
the response for less than four weeks, four patients up to eight weeks and
remaining three till the end of follow-up. There was no statistically
significant difference in between the three arms among all the variables
compared. Conclusions: All three groups showed equal efficacy in pain
palliation, analgesic requirement, improvement in performance status and
duration of response. In patients with very advanced disease and short life
expectancy, where the treatment goal is to decrease pain, 8 Gy in single
fraction is a convenient and cost effective schedule.
9054 General Poster Session (Board #40A), Sat, 8:00 AM-12:00 PM
A positron emission tomography (PET) study to assess the degree of
neurokinin-1 (NK1) receptor occupancy in the human brain after single
doses of netupitant to healthy male subjects. Presenting Author: Giorgia
Rossi, Helsinn Healthcare SA, Lugano, Switzerland
Background: Netupitant (NETU) is a highly selective neurokinin 1 (NK1) receptor antagonist for the prevention of nausea and vomiting associated
with emetogenic chemotherapy. In this study, PET imaging with the NK1 receptor-binding–selective tracer 11C-GR205171 was used to determine
the levels and the duration of central NK1 receptor occupancy (RO)
achieved by therapeutic doses of NETU. Methods: This was a single dose,
randomized, open-label, PET study investigating the degree of NK1 RO in
human brain after single oral doses of NETU (100, 300 or 450 mg) in 6
healthy male subjects. PET scans and blood samples for NETU determination
were obtained up to 96 hrs post dose. The Patlak model was used to
define the net uptake rate of 11C-GR205171 in the brain regions of interest
while the percent of NK1 RO was calculated as the relative difference
between the uptake rate at baseline and post-treatment administration.
Results: NETU plasma concentrations over the 100 mg to 450 mg dose
range were comparable with those obtained in previous single dose studies.
ANK1RO of 90% or higher was achieved with all tested single oral doses in
the majority of the outlined brain regions 6 hrs after dosing (corresponding
to netupitant Cmax). All doses had a long duration of blockade of NK1 receptors with the 300 mg dose showing moderate (62%) to high (94%)
NK1 RO for all investigated brain regions at 96 hrs post dose. The
relationship between NETU concentration and NK1 RO, assessed using a
sigmoid Emax model, indicated that in the striatum, the reference brain
area with the highest NK1 receptor expression, a concentration of 225 �g/L
of NETU corresponded to an NK1 RO of 90%. This data suggests that a
single oral dose between 100 and 300 mg NETU would be needed to reach
90% NK1 RO levels in human brain. Conclusions: PET results demonstrate
that NETU is a potent agent targeting NK1 receptors with a high degree of
occupancy for a long duration. NETU, given as single doses of 100 to 450
mg was well tolerated.
9056 General Poster Session (Board #40C), Sat, 8:00 AM-12:00 PM
Pulmonary symptoms and their importance to patients with non-small cell
lung cancer undergoing second- and third-line chemotherapy. Presenting
Author: Susan Magasi, Northwestern University Feinberg School of Medicine,
Chicago, IL
Background: As new cancer therapies are developed, it is important to
evaluate their efficacy based not only on survival outcomes but also
meaningful patient benefit in terms of symptoms and concerns that are
important to patients. The purpose of this study of patients undergoing
2nd /3rd line chemotherapy for non-small cell lung cancer (NSCLC) was to
characterize pulmonary symptoms and the importance patients place on
these symptoms, as a part of assessing the content validity of the
Pulmonary Symptom Index (PSI) of the Functional Assessment of Cancer
Therapy – Lung (FACT-L). Methods: We conducted semi-structured thematic
interviews with 20 stage III/IV NSCLC patients undergoing 2nd or 3rd line treatment. Interviews included open elicitation of NSCLC symptoms
and their functional impact, and participant ratings of the relative importance
of pulmonary symptoms. Results: Mean age was 62 years (range
30-79); 80% had non-squamous histology, and 30% had co-morbid COPD.
While participants described a range of symptom experiences and severity,
a core set of pulmonary symptoms emerged - shortness of breath (reported
by 16/20, 13/20 rated as very important), cough (reported by 14/20, 10/20
rated as very important), and chest tightness (reported by 15/20, 9/20
rated as very important); these matched key symptoms in the PSI.
Symptom importance ratings were influenced by the functional impact they
had upon patient ability to perform valued roles and responsibilities.
Patients described diverse coping strategies including breaking down
activities into manageable tasks, priority setting, physical assistance,
emotional support, and health promoting changes in diet and exercise.
Ninety percent (18/20) of participants reported tiredness or fatigue; most
said it was “very important.” A quarter (5/20) of the participants reported
having no pulmonary symptoms. Conclusions: These results in NSCLC
patients undergoing 2nd /3rd line treatment support the importance, relevance,
and impact of core pulmonary symptoms included in the PSI and
offer initial evidence that its content may constitute a key element of
patient benefit in evaluating the efficacy of new cancer therapies.
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