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

572s Patient and Survivor Care
9020 Poster Discussion Session (Board #4), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
Patient-reported cognitive impairments among women with breast cancer
randomly assigned to hormonal therapy (HT) alone versus chemotherapy
followed by hormonal therapy (C�HT): Results from the Trial Assigning
Individualized Options for Treatment (TAILORx). Presenting Author: Lynne
I. Wagner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern
University, Chicago, IL
Background: Cognitive impairment is a complication of chemotherapy.
Perceived cognitive impairments (PCI) were prospectively assessed among
TAILORx participants randomized to HT alone versus chemotherapy followed
by HT (C�HT). Methods: TAILORx participants with an OncoType DX
Recurrence Score 11-25 were randomly assigned to HT or C�HT. PCI,
fatigue, endocrine symptoms and health-related quality of life (HRQL) were
assessed at baseline, 3, 6, 12, 24, and 36 months, using the Functional
Assessment of Cancer Therapy (FACT) in 455 patients enrolled after
1/15/10. PCI change scores � 4.5 from baseline were defined a priori as
clinically meaningful. Linear regression (LR) was used to model PCI scores
on baseline PCI, treatment and other factors. Results: PCI scores were
significantly worse at 3, 6, and 12 months compared to baseline for both
groups (Table). The decline was greater for C�HT than HT at 3 months, but
scores were similar at 12 months. Tests of an interaction between
menopausal status and treatment were non-significant. PCI correlated with
fatigue (r � 0.57-0.64) but not FACT Emotional well-being (EWB; r �
0.28-0.38); controlling for EWB did not account for differences in PCI
change scores between treatment arms. Conclusions: Our study is the first
to examine PCI among breast cancer patients randomized to receive C�HT
vs. HT alone. C�HT was associated with greater declines in PCI at 3
months, but at 12 months PCI was similar in the C�HT and HT groups. PCI
was associated with fatigue but not EWB. Pre- and post-menopausal groups
demonstrated the same pattern of change. Since this study did not include
a control group of patients not treated with HT, further study is required to
determine if and to what extent HT contributes to PCI.
Mean change in PCI score from baseline.
3 months 6 months 12 months
Change
scores Difference
(LR) P value Change
scores Difference
(LR) P value Change
scores Difference
(LR) P value
HT -2.78 -3.61 � 0.001 -3.27 -2.28 � 0.05 -4.67 1.20 n.s.
C�HT -6.40 -5.66 -6.08
9022 Poster Discussion Session (Board #6), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
Subjective cognitive complaints one year after ceasing adjuvant endocrine
therapy for early-stage breast cancer: Findings from the Breast International
Group (BIG) 1-98 trial. Presenting Author: Kelly-Anne Phillips, Peter
MacCallum Cancer Centre, Melbourne, Australia
Background: We have previously reported that, in the BIG 1-98 trial,
objective cognitive function improved in postmenopausal women one year
after cessation of adjuvant endocrine therapy for breast cancer. Here we
evaluate changes in subjective cognitive function (SCF). Methods: One
hundred postmenopausal women, randomized to receive five years of
adjuvant tamoxifen, letrozole, or sequences of both, completed selfreported
measures on SCF, psychological distress, fatigue and quality of
life during the fifth year of trial treatment (year 5) and one year after
treatment completion (year 6). Changes between years 5 and 6 were
evaluated using the Wilcoxon signed-rank test. SCF and its correlates were
explored. Results: Mean age of participants was 63.9 years [SD�7.1 years].
SCF and the other patient-reported outcomes did not change significantly
after cessation of endocrine therapy with the exception of improvement in
hot flushes (p�0.0005). No difference in changes was found between
women who were taking tamoxifen or letrozole at year 5. SCF was the only
psychosocial outcome with a substantial correlation between year 5 and 6
(Spearman’s R�0.80). Correlations between SCF and the other patientreported
outcomes were generally low. Conclusions: Although objective
cognitive function improved after cessation of adjuvant endocrine therapy
in the BIG 1-98 trial, improvement in SCF was not evident. The underlying
reason for the clear disconnect between objective and subjective cognitive
function seen in this and most other studies, is a crucial issue. It should be
a research priority in order to effectively tackle the concerns of women
about their cognition during and after breast cancer treatment.
9021 Poster Discussion Session (Board #5), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
Cognitive function and fatigue in colorectal cancer (CRC) patients: A
prospective longitudinal controlled study. Presenting Author: Janette L.
Vardy, Sydney Cancer Centre, University of Sydney, Sydney, Australia
Background: A subset of cancer patients has cognitive impairment and
fatigue after chemotherapy (CTh). We evaluated these symptoms and
potential mechanisms in CRC patients and healthy controls (HC). Methods:
Cognitive function was evaluated in CRC patients and HC at baseline
(pre-CTh), 6 and 12 months. Group 1A (Stage II/III) received CTh and Gr
1B (Stage I/II) no CTh. Gr 2 had limited metastatic CRC. All subjects
completed cognitive assessment and questionnaires for fatigue, QOL,
anxiety/depression, and perceived cognitive function. Blood tests evaluated:
10 cytokines, clotting factors, sex hormones, CEA, CBC and apolipoprotein
genotyping as potential causal factors. Primary endpoints: cognitive
function and fatigue (Gr. 1A & 1B) at 12 months. Associations between
results and demographic and disease-related factors were sought. Results:
359 CRC patients (173 Gr 1A, 116 Gr 1B, 70 Gr. 2) and 72 HC were
assessed. Median age 58 (23-75 years); 58% male. Cognitive impairment:
baseline Gr 1A 34% vs 1B 32.5% (p�.9), Gr 1 33% vs HC 10%
(p�0.001); 12 months Gr 1A 21% vs 1B 16% (p�0.43), Gr 1 19% vs HC
2% (p�0.001). Cognitive domains most affected: verbal & visual memory,
processing speed. Men had greater impairment than women (p�0.009).
Cognitive decline from 0-12 months: Gr 1A 30%, Gr 1B 19%, Gr 2 24%,
and HC 16%. Perceived cognitive impairment at 12 months: Gr 1A 19% vs
1B 7% (p�.04), Gr 1 14% vs HC 0% (p�.009). Fatigue was greatest in Gr
1A (70%) at 6 months; at 12 months Gr. 1A 46% vs 1B 31% (p�0.056),
Gr 2 60%, HC 36%. Cytokines were elevated in CRC patients compared to
HC. No association was found with cognitive function and: fatigue, QOL,
anxiety/depression, cytokines, sex hormones, clotting factors, CEA or apoE
genotype. Objective cognitive function was associated with perceived
cognitive function at baseline only. Fatigue at baseline was associated with
hemoglobin and at 12 months with neutrophil count. Conclusions: Compared
to HC, CRC patients had more cognitive impairment at baseline, 6
and 12 months; but impairment was not significantly different between
those who did and did not receive CTh. The mechanisms of cognitive
impairment remain unknown. Fatigue improved with time.
9023 Poster Discussion Session (Board #7), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
Methylphenidate (MP) and nursing telephone intervention (NTI) for cancerrelated
fatigue (CRF) in advanced cancer patients: A double-blind randomized
phase II trial. Presenting Author: Eduardo Bruera, University of Texas
M. D. Anderson Cancer Center, Houston, TX
Background: CRF is the most common and distressing symptom in advanced
cancer patients. Preliminary studies support MP and NTI for CRF
(Bruera et al. JCO 2006). The primary objective of our study was to
determine the effect of MP as compared to placebo (P). A secondary
objective was to investigate the role of NTI as compared to control
telephone intervention (CTI). Methods: Advanced cancer patients with
fatigue �4/10 on the Edmonton Symptom Assessment Scale (ESAS),
normal cognition, no evidence of major depression and hemoglobin �8
were eligible. Patients were randomized to 4 groups in a 2x2 factorial
design (MP�NTI, P�NTI, MP�CTI and P�CTI). Primary endpoint was
Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale
scores between day 15 and baseline. The dose and duration of methylphenidate
was 5 mg every two hours, as needed, up to 20 mg/day. We tested the
median difference in FACIT-F subscale scores between the groups using
the Kruskal Wallis test and Wilcoxon signed rank test. Longitudinal
regression analysis was conducted with a mixed model. Results: Total
accrual was 197. Mean (SD) age was 58 (12), female 67% (N�148), white
72% (N�136), gastrointestinal cancers were the most common 22%
(N�41). Baseline FACIT-F subscores were similar among the 4 groups. The
median FACIT-F subscores showed significant improvement between Day
15 and baseline for all four groups except for P�CTI (Table): MP�NTI
(4.5, P�0.004), P�NTI (8, P�0.001), MP�CTI (7, P�0.001), and
P�CTI (5, P�0.06), with no statistically significant difference between MP
and P (6 vs. 6, P�0.89). Longitudinal regression analysis showed a time
effect (P�0.001) and group differences for NTI vs. CTI with FACIT-F
(P�0.13) and ESAS (P�0.03). Grade 3 toxicities were similar between the
MP and P arms (34/93 vs. 24/97, P�0.09). Conclusions: MP was not
effective as compared to P for CRF in advanced cancer patients. NTI may
be effective and should be further studied.
FACIT-F at baseline, day 8 and day 15 group.
Median (interquartile range)
Group Baseline Day 8 Day 15
MP�NTI 21 (12) 31 (14) 25 (16)
P�NTI 20 (13) 32 (14) 28 (13)
MP�CTI 20 (14) 27 (14) 27 (14)
P�CTI 22 (14) 31 (18) 28 (23)
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