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

584s Patient and Survivor Care
9069 General Poster Session (Board #41H), Sat, 8:00 AM-12:00 PM
Attrition rates, reasons, and predictive factors in supportive/palliative
oncology clinical trials at a comprehensive cancer center. Presenting
Author: Isabella Claudia Glitza, University of Texas M. D. Anderson Cancer
Center, Houston, TX
Background: Attrition is common among supportive/palliative oncology
clinical trials. Few studies have documented the reasons and predictors for
dropout. We aimed to determine the rate, reasons and factors associated
with attrition both before reaching the primary endpoint (PE) and the end of
study (EOS). Methods: We conducted a review of all prospective interventional
supportive/palliative oncology trials by our department between
1999-2010. Patient and study characteristics and attrition data were
extracted. We determined factors associated with attrition using multivariate
logistic regression analysis. Results: 15 blinded randomized trials and 3
single arm trials were included. 16 of 18 studies did not reach accrual
target. Baseline demographics for the 1214 patients were: median age 60
(range 23-93 years), female 56%, Caucasians 69%, ECOG performance
status �3 41%, gastrointestinal malignancies (23%), median fatigue
7/10, appetite 5/10 and pain 4/10. Attrition rate was 26% (N�311) for PE
and 44% (N�535) for EOS. Common reasons for EOS dropout were patient
preference (N�93, 17%), symptom burden (N�87, 16%), death (N�45,
8%) and hospital admission (N�43, 8%), and were similar for PE
dropouts. No predictors were identified for PE attrition. The Table shows
poor performance status, anorexia and dyspnea are associated with EOS
attrition in multivariate analysis. Conclusions: We found that attrition rate
was high amongsupportive/palliative oncology clinical trials, and was
associated with poor function and high baseline symptom burden. These
findings have implications for future study designs including eligibility
criteria and sample size calculation.
Factors associated with EOS attrition in multivariate analysis.
Characteristics Odds ratio (95% confidence interval) p value
ECOG performance status �0.001
0 0.35 (0.11-1.16) 0.09
1 0.26 (0.12-0.58) �0.001
2 0.34 (0.16-0.72) 0.01
3 0.56 (0.26-1.2) 0.14
4 1.0 Ref
Median ESAS (interquartile range)
Appetite (per point) 1.08 (1.01-1.14) 0.02
Dyspnea (per point) 1.1 (1.03-1.18) �0.001
9071 General Poster Session (Board #42B), Sat, 8:00 AM-12:00 PM
Biomarkers of amenorrhea and ovarian function in breast cancer survivors.
Presenting Author: Kathryn Jean Ruddy, Dana-Farber Cancer Institute,
Boston, MA
Background: Ovarian function after treatment of early breast cancer may
affect fertility, menopausal symptoms, endocrine therapy decision-making,
and subsequent health and psychosocial concerns among young survivors.
We aim to improve understanding of ovarian reserve in women with a history
of breast cancer by comparing anti-mullerian hormone (AMH), estradiol
(E2), and follicle-stimulating hormone (FSH) levels in survivors with and
without amenorrhea, a surrogate for ovarian dysfunction and menopause.
Methods: As part of an ongoing prospective multi-center cohort study,
women diagnosed with breast cancer at age �41 have blood and surveys
collected one year after diagnosis. Women who reported that they were
receiving ovarian suppression or had undergone hysterectomy or bilateral
oophorectomy/ovarian ablation were excluded. Amenorrhea was defined as
�6 months between blood draw and last menstrual period. AMH, E2, and
FSH levels were compared between those with and without amenorrhea
using a Wilcoxon rank sum test with 2-sided p-values. Results: The first 199
eligible women with blood and survey data at one year were included in this
analysis. Median age was 37 years (range 22-40). Seventy-two(36%) had
received chemotherapy alone, 75 (38%) had received chemotherapy
followed by tamoxifen (TAM), 25 (13%) had received TAM alone, and 10
(5%) reported TAM use but did not respond to chemotherapy items. Median
AMH and E2 were lower and FSH was higher in women with amenorrhea,
and these differences remained significant when those on and off TAM were
analyzed separately (Table). Conclusions: AMH, E2, and FSH all are
promising biomarkers for amenorrhea and residual ovarian function in
young breast cancer survivors. Future research will evaluate whether AMH,
E2, and FSH at baseline and early in the survivorship period predict ovarian
function later.
N
Median
AMH
AMH
p value
Median
E2
E2
p value
Median
FSH
FSH
p value
Total patients 199 0.06 85.0 7.91
No amenorrhea 134 0.22 �0.0001 111.5 �0.0001 5.94 �0.0001
Amenorrhea 65 0.01* 25.0 31.48
No TAM 0.001 0.02 0.001
No amenorrhea 66 0.09 81.5 5.61
Amenorrhea 23 0.01* 30.0 47.09
TAM �0.0001 0.001 �0.0001
No amenorrhea 68 0.48 183.0 6.18
Amenorrhea 42 0.01* 16.5 29.04
* Values reported to be �0.02 were analyzed as 0.01
9070 General Poster Session (Board #42A), Sat, 8:00 AM-12:00 PM
Humoral and cellular immune response after influenza vaccination in
patients with postcancer fatigue and patients with chronic fatigue syndrome.
Presenting Author: Hetty Prinsen, Department of Medical Oncology,
Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Background: Postcancer fatigue (PCF) is a frequently occurring problem,
impairing quality of life. Patients with chronic fatigue syndrome (CFS) also
suffer from severe fatigue symptoms. We hypothesized that in fatigued
patients (PCF and CFS) alterations in immune response could explain
fatigue symptoms. Therefore, we examined whether the humoral and/or
cellular immune response after influenza vaccination differed between
fatigued patients and non-fatigued individuals and between PCF and CFS
patients. Methods: PCF (n�15) and CFS patients (n�22) were vaccinated
against influenza. Age and gender matched non-fatigued cancer survivors
(n�12) and healthy controls (n�23) were included for comparison.
Antibody responses were measured at baseline and at day 21 by a
hemagglutination inhibition test. T cell responses were measured at
baseline and at day 7 by a lymphocyte proliferation and activation assay.
Results: Both patient groups developed seroprotection rates comparable to
the accompanying control groups. Functional T cell reactivity was observed
in all groups. Proliferation at baseline was significantly lower in fatigued
patients compared to non-fatigued individuals. A significant increase in
proliferation from baseline to day 7 was observed in fatigued patients, but
not in controls. At day 7, proliferation was not significantly different
between fatigued patients and non-fatigued individuals. CD4�CD127-
FoxP3� expression was significantly higher in PCF patients compared to
non-fatigued cancer survivors. Conclusions: We observed a lower T cell
proliferation at baseline in fatigued patients compared to non-fatigued
individuals, suggesting a difference in the baseline state of the immune
system between fatigued patients and non-fatigued individuals. Furthermore,
the difference in CD4�CD127-FoxP3� expression between PCF and
CFS patients suggests subtle differences in immune state between these
two fatigued patient groups. However, since humoral and cellular immune
responses after vaccination did not differ significantly between fatigued
patients and non-fatigued individuals, vaccination of fatigued patients
(PCF and CFS) can be effective.
9072 General Poster Session (Board #42C), Sat, 8:00 AM-12:00 PM
A randomized, double blind, placebo-controlled crossover trial of a sustained
release methylphenidate in cancer-related fatigue. Presenting
Author: Carmelita P. Escalante, University of Texas M. D. Anderson Cancer
Center, Houston, TX
Background: Cancer-related fatigue (CRF) is common and distressing. This
study assessed the efficacy of OROS methylphenidate 18 mg daily (OM) vs.
placebo (P) for CRF reduction. Other objectives were to compare the effects
of OM vs. P on other symptoms, cognitive function, work yield, patient (pt)
perceptions and preferences, and an exploratory analysis of cytokines.
Methods: Initially, pts were randomly assigned (1:1) to receive OM-P or
P-OM for 4 weeks (wks). Pts were crossed to the other treatment after 2
wks. Assessments were done at baseline, 2 and 4 wks. Continuous and
categorical variables were assessed using Wilcoxon signed rank tests and
McNemar tests, respectively. The primary efficacy end point was the
change of “fatigue worst” on the Brief Fatigue Inventory (BFI) at the end of
each 2 wk period. Results: 42 female breast cancer pts were enrolled (3
ineligible, 6 unevaluable); 33 pts were studied. The mean age was 58
(range, 32-79), 30% had metastasis, 82% were receiving chemotherapy
(ctx), 9% hormonal therapy (ht), and 9% both ctx and ht. 94% were ECOG
�1 and 52% were employed. 45% were on pain medicines and none on
antidepressants. The mean baseline BFI was 5.7 (range 4.1-8.6). Fatigue
worst did not differ between OM and P (p� 0.54) or in other symptoms.
There was significance in WAIS-III Digit Symbol between OM and P
(p�0.01), and Hopkins Verbal Learning Test with BFI interfere and BFI
active (p�0.04, p�0.03, respectively). Hours (hrs) missed due to health
(p�0.03) and hrs worked (p�0.04) differed in OM vs. P. At study end, pts
were asked if OM improved CRF and if they wanted to stay on OM. 64% felt
improved. Of these, 58% wanted to continue. There were no serious
adverse events due to OM. There were differences in serum IL6 (p�0.03),
IL10 (p�0.0004), and TNF� (p�0.02) among OM and P. Conclusions: Low
dose OM did not show improvement in CRF on fatigue worst of BFI. Pts
taking OM had better cognition and less work absences. Pts tolerated OM
well and a majority felt better and wanted to continue OM. Future studies
examining higher doses or longer treatment duration with OM, pt preferences
and impact on productivity are necessary. Changes in serum cytokine
levels should be further explored.
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