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

9122 General Poster Session (Board #48D), Sat, 8:00 AM-12:00 PM
A prospective longitudinal study of cancer-related fatigue in patients undergoing
breast-conserving surgery and radiation with or without chemotherapy
for breast cancer. Presenting Author: Mylin Ann Torres, Department
of Radiation Oncology, Emory University, Atlanta, GA
Background: We prospectively evaluated risk factors for persistent cancerrelated
fatigue in women with breast cancer undergoing lumpectomy with
or without chemotherapy (CTX) prior to whole breast radiotherapy (XRT).
We assessed the potential role of inflammatory mediators, demographic
characteristics, and treatment history including CTX. Methods: Following
lumpectomy, 60 women received a definitive course of whole breast XRT
(50 Gy plus a 10 Gy boost). Prior to XRT, at week 6 of XRT, and 6 weeks
post XRT, subjects completed the Multidimensional Fatigue Inventory
(MFI) and underwent blood draws for inflammatory mediators (protein and
mRNA). Results: Independent multivariate analyses of clinical and demographic
factors revealed that CTX (p�.001) , given neoadjuvantly or
adjuvantly, and age �50 (p�.03) were significant predictors of higher
fatigue scores post XRT. Mean MFI scores in patients treated with CTX
(n�24) were 20 points higher than patients not treated with CTX (p�.001)
with a clinically meaningful difference in scores being 10 points on the
MFI. Gene ontology analysis of differentially expressed genes indicated
increased activation of genes involved in immune and inflammatory
responses in fatigued vs. non-fatigued patients (p�.001). Of the inflammatory
mediators, plasma IL-6 prior to XRT was the strongest predictor of post
XRT fatigue (p�.02). Moreover, plasma IL-6 concentrations prior to XRT
were significantly higher in patients who received CTX (mean 4.96 vs.
2.53, p�.01). Patients who received CTX also had significantly higher
levels of NF Kappa B DNA binding 6 weeks post XRT (p�.001), and
transcription factor binding analysis revealed a greater representation of
genes with the NF Kappa B DNA binding motif in fatigued vs. non-fatigued
patients (p �.05). Conclusions: Collectively, these data suggest an interaction
between CTX and XRT leading to inflammation and fatigue several
weeks post XRT. This relationship was independent of whether CTX was
given pre or post-operatively. Treatments targeting inflammation before
XRT may reduce fatigue post therapy, particularly in patients previously
treated with CTX.
9124 General Poster Session (Board #48F), Sat, 8:00 AM-12:00 PM
A national survey of support and information needs of Australian women
living with advanced breast cancer. Presenting Author: Linda R. Mileshkin,
Peter MacCallum Cancer Centre, Melbourne, Australia
Background: Improved treatments mean women with advanced breast
cancer (ABC) are living longer, sometimes for many years. As a result, these
women may experience chronic needs that are different from those with
early breast cancer. We aimed to assess the support and information needs
of women living with ABC. Methods: A national postal survey was sent to
2,345 women with ABC registered as members of the consumer organizations
BCNA and/or BreaCan. Women were asked about their disease,
treatment, experiences of care, and to complete the Supportive Care Needs
Survey. Results: The response rate was 34% (792 valid responses). Mean
age was 57 (range 25-99) with 21% living alone and 27% working. 18%
reported living with ABC for �7 years. 656 (85%) were having current
treatment: chemotherapy (43%), hormonal therapy (46%), bisphosphonates
(49%), and/or trastuzumab (Herceptin) (19%) respectively. 49% of
women reported having access to a Breast Care Nurse (BCN) since
diagnosis of ABC but only 3% cited a BCN or cancer nurse as their main
contact. The majority (76%) cited their medical oncologist as their main
contact, 8% cited their family doctor. Women wanted information about:
treatment options (84.2%), new treatments (79.2%), symptoms/side
effects (78.9%), clinical trials (60.8%), managing pain (57.2%) and
financial assistance (38%). Women � 65 had significantly higher levels of
unmet needs than those �65 for the 7 items below, including all items
from the sexual domain. Conclusions: Women with ABC have many unmet
needs with younger women particularly needing more support with sexual
needs and anxiety. Women are heavily reliant on their medical oncologist,
who may not be equipped or best placed to meet these needs. Models of
care need to be developed to address the unmet supportive care needs of
women living with ABC.
Moderate-high Moderate-high
Item
need < 65
need > 65 P value
Uncertainty about the future 50% 39% 0.009
Concerns about the worries of
those close to you
48% 35% 0.002
Worry that the results of
treatment are beyond your control
37% 27% 0.026
Changes in sexual relationships 28% 15% 0.001
Changes in sexual feelings 27% 15% 0.001
Being given information about
sexual relationships
21% 9% �0.0001
More choice about cancer specialists 17% 8% 0.002
Patient and Survivor Care
597s
9123 General Poster Session (Board #48E), Sat, 8:00 AM-12:00 PM
The relationship among age, anxiety, and depression in older adults with
cancer. Presenting Author: Talia Weiss, Memorial Sloan-Kettering Cancer
Center, New York, NY
Background: Depression and anxiety are common psychological sequelae of
cancer, resulting in decreased adherence to treatment regimens and longer
hospital stays. In men with prostate cancer, aging is associated with
reduced anxiety and increased depression. The overall goal of this study
was to examine the association among age, anxiety, and depression in a
cohort of older adults receiving chemotherapy (chemo). Methods: This is a
secondary analysis of a prospective longitudinal study investigating chemotherapy
toxicity in older adults with cancer. Eligibility included: age � 65,
diagnosis of cancer, and scheduled to receive a new chemo regimen.
Baseline data (pre-chemotherapy) included: age, sociodemographics, tumor
and treatment factors (including tumor type and stage), geriatric
assessment parameters (functional status, comorbidities, psychological
state, nutritional status, social support). Anxiety and depression were
measured by the Hospital Anxiety and Depression Scale (HADS). Univariate
and multiple regression analyses were conducted to test the relationship
between age, anxiety, and depression. Results: The average age of the 500
patients (56% females) was 73.1 (range 65-91, SD�6.18) with 5% Stage
I, 12% Stage II, 22% Stage III and 61% stage IV. Mean depression and
anxiety scores were: 3.6�3.17; 4.7�3.60. Clinically significant depression
was reported in 12.6% (n�62). Clinically significant anxiety was
reported in 20.9% (n�103). In univariate analyses, there was no association
between anxiety and age, or depression and age. In multivariable
analyses, older age (beta� -0.07, p � 0.05) was associated with decreased
anxiety, as well as lack of social support (p � 0.01) and increased number
of comorbidities (p � 0.01). In multivariable analysis, depression was
associated with lack of social support (p � 0.01), increased number of
comorbidities (p � 0.01), and advanced stage (p � 0.01). Conclusions:
This study supports previous research that anxiety decreases with age in
older adults with cancer. However, depression remained constant with
increasing age. Greater resources and attention to identifying and treating
the psychological sequelae of cancer in older adults are warranted.
9125 General Poster Session (Board #48G), Sat, 8:00 AM-12:00 PM
Efficacy and safety of balugrastim compared with pegfilgrastim in patients
with breast cancer who are receiving chemotherapy. Presenting Author:
Constantin D. Volovat, Centrul de Oncologie Medicala, Iasi, Romania
Background: Patients receiving cancer chemotherapy are at an increased
risk of neutropenia. Recombinant granulocyte colony stimulating factors
(G-CSFs) have been developed to stimulate proliferation and differentiation
of neutrophils. Pegfilgrastim is a pegylated recombinant G-CSF that allows
for once-per-cycle dosing. Balugrastim is a long-acting G-CSF composed of
a genetic fusion between recombinant human serum albumin and G-CSF.
The objective of this study was to compare the efficacy and safety of
balugrastim and pegfilgrastim in patients with histologically or cytologically
confirmed breast cancer who were scheduled to receive doxorubicin and
docetaxel. Methods: In this double-blind, randomized, active-comparator,
noninferiority trial, patients with �1.5x109 neutrophils/L, and �100x109 platelets/L were randomly assigned to subcutaneous injections of balugrastim
40 mg (n�153) or pegfilgrastim 6 mg (n�151) with stratifications for
weight, prior chemotherapy exposure, and global location. The primary
efficacy endpoint was the duration of severe neutropenia (days with an
absolute neutrophil count �0.5x109 cells/L) during the cycle 1 for the
population of patients who did not have major protocol violations. Results:
Mean duration of severe neutropenia in cycle 1 was 1.1 days in the
balugrastim group and 1.0 days in the pegfilgrastim group (95% CI for
difference between groups -0.13 to 0.37). Fifty-eight percent of patients in
the balugrastim group and 59% in the pegfilgrastim group had severe
neutropenia during cycle 1 (95% CI for difference between groups
-11.98% to 10.41%). Two and 4 patients, respectively, had febrile
neutropenia during cycle 1; no patients in either group had febrile
neutropenia during cycles 2-4. Twenty percent of patients in the balugrastim
group and 19% in the pegfilgrastim group had adverse events that the
investigator considered to be related to study medication. Six and 7
patients, respectively, had serious adverse events. Conclusions: The results
of this study support the noninferiority of balugrastim versus pegfilgrastim,
demonstrating that both compounds have comparable efficacy. There were
no unexpected safety events.
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