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

594s Patient and Survivor Care
9110 General Poster Session (Board #46H), Sat, 8:00 AM-12:00 PM
Efficacy and safety of half-dose pegfilgrastim in cancer patients receiving
cytotoxic chemotherapy. Presenting Author: Ryan C. Ramaekers, Saint
Francis Cancer Treatment Center, Grand Island, NE
Background: Pegfilgrastim reduces neutropenia risk in patients (pts) on
cytotoxic chemotherapy. A single 6 mg dose per chemotherapy cycle
commonly causes bone pain and leukocytosis. While half-dose pegfilgrastim
has been shown to be safe and effective in breast cancer pts, there is no
data on half-dose pegfilgrastim in general oncology pts. Methods: We
evaluated the efficacy and safety of half-dose pegfilgrastim in general
oncology pts on cytotoxic chemotherapy at St Francis Cancer Center. Pts
who received at least one dose of 6 mg pegfilgrastim and developed
NCI-CTCAE grade 2 or more bone pain and/or leukocytosis (WBC�10,000/
ml) were given 3 mg dose pegfilgrastim on their following chemotherapy
cycles. Pt demographics, type/number of chemotherapy regimens, efficacy,
side effects and complications were evaluated. McNemar’s test, logistic
regression analysis and ANOVA were used for statistical analysis. Results:
Twenty-six pts (3 males, 23 females, all Caucasian) with median age 55
(range 34-86) received a total of eighty-three 3 mg doses of pegfilgrastim.
Cancers treated were breast (N�16), colorectal (N�7), head and neck
(N�1), non-Hodgkin lymphoma (N�1) and non-small cell lung cancer
(N�1). Chemotherapy received was anthracycline (N�9), taxane (N�7),
5-FU/oxaliplatin (N�7), 5-FU/cisplatin (N�1), gemcitabine/oxaliplatin
(N�1), pemetrexed/carboplatin (N�1). No neutropenia or chemotherapy
dose modifications occurred on half-dose pegfilgrastim. In the 26 pts we
report, bone pain occurred in 23 pts at 6 mg and 14 pts at 3 mg dose.
Leukocytosis occurred in 23 pts at 6 mg and only 2 pts at 3 mg dose
(McNemar’s test, P�0.01). While older age and full-dose pegfilgrastim
were predictive of bone pain, more than one line of chemotherapy and
half-dose pegfilgrastim were predictive of lack of leukocytosis (logistic
regression analysis/ANOVA, P�0.01). Conclusions: Half-dose pegfilgrastim
in general oncology pts receiving cytotoxic chemotherapy seems to be safe
and effective with less bone pain and leukocytosis without resultant
neutropenia or need for chemo modification. Larger prospective studies of
half-dose pegfilgrastim in this setting are needed to further understand the
feasibility of this approach.
9112 General Poster Session (Board #47B), Sat, 8:00 AM-12:00 PM
Determinants of fatigue improvement in outpatient oncology according to
baseline categories of fatigue severity. Presenting Author: Michael Fisch,
University of Texas M. D. Anderson Cancer Center, Houston, TX
Background: Understanding the determinants of fatigue response may help
distinguish between different fatigue phenotypes and inform trial designs.
Methods: Patients with invasive cancer of the breast, prostate, colon/
rectum, or lung were enrolled from multiple sites. At baseline and 4-5
weeks later patients rated their symptoms on a 0-10 numerical rating scale.
A 2-point change was considered clinically significant for fatigue change.
Logistic regression models and ordinal logistic regression models were used
to examine the effects of demographic and clinical factors on fatigue
change. Separate models were constructed for fatigue deterioration in
patients with mild fatigue at baseline and lack of improvement for those
with severe fatigue at baseline or any significant change for those with
moderate baseline fatigue. Results: 3,106 pts were enrolled at baseline and
3,032 were analyzable for fatigue change. At baseline, 23% had no
fatigue, 35% mild, 25% moderate, and 17% severe. Improvement varied
by baseline fatigue score with response in 54% with severe fatigue, 31%
with moderate, and 9% with mild. Overall, 13 different parameters were
significant in these 3 models of fatigue change, but no single parameter
was common to all 3 categories of fatigue. Exposure to anxiolytics and
duration of current treatment were significant in models of mild and severe
fatigue; antidepressant exposure was significant for mild and moderate
fatigue, and baseline fatigue level was a significant parameter in moderate
and severe fatigue. In colorectal and lung cancer patients, gender was not
significant for fatigue change in patients with mild or moderate fatigue, but
gender was the strongest predictor fatigue improvement in patients with
severe fatigue with men most likely to significantly improve (OR�2.49,
95% CI 1.15-5.41, p�0.021). Conclusions: Clinically significant improvement
in fatigue varies between 9% and 54%. Predictors of fatigue change
vary depending on categories of baseline fatigue severity. Gender is the
strongest predictor for fatigue improvement among lung and colorectal
outpatients with severe baseline fatigue. Future trial designs should
account for gender and baseline fatigue severity.
9111 General Poster Session (Board #47A), Sat, 8:00 AM-12:00 PM
Continued suppression of bone turnover following a single dose of zoledronic
acid: Time to re-think dosing intervals in the management of bone
metastases? Presenting Author: Christine E. Simmons, St. Michael’s
Hospital, University of Toronto, Toronto, ON, Canada
Background: The management of patients (pts) with bone metastases has
changed significantly over the past decade, with the advent of newer, more
potent anti-osteoclastic agents. However, the dosing interval in which these
agents are given has not changed; pts are still dosed at a frequency of
monthly or q3weekly injections. It is not known if this is the optimal dosing
frequency or due to convention. The purpose of this study was to determine
the duration of suppression of bone turnover by Zoledronic Acid (ZA) in a
population of bisphosphonate naive metastatic breast cancer (MBC) pts.
Methods: This prospective single arm phase II study enrolled 26 pts with
MBC to bone who had not received bisphosphonates in the metastatic
setting. A single dose of ZA was given at week 0, and biomarkers of bone
turnover (serum CTX) were collected every 2 weeks subsequently. Pain
scores and quality of life data were collected every 4 weeks. Pts remained
on study if their biomarkers remained suppressed, but came off study as
soon as escape from suppression was noted, (defined as a rise � 50% of
baseline value). Results: At 12 weeks, 73% (95% CI 56%-90%) of pts had
continued suppression of bone turnover demonstrated by serum CTX. The
pts that escaped suppression did so at a median of 8 weeks after first
infusion of ZA (range 8-10 weeks). The magnitude of suppression (proportion
decrease from baseline) of serum CTX at week 4 was significantly
greater in those who had continued suppression compared to those who
escaped suppression before 12 weeks (75% vs 58%, p � 0.02). The
absolute baseline value of CTX was significantly lower in pts who maintained
suppression (507 vs. 745 ng/L, p � 0.04). Quality of life scores and
pain medication use did not change appreciably during this period.
Conclusions: This study suggests that ZA may not need to be given at
conventional intervals in the majority of pts, and may safely be withheld
without increased risk to morbidity or decline in quality of life over a 12
week period. Baseline CTX and the magnitude of suppression of bone
turnover at 4 weeks may predict for the optimal dosing frequency.
Confirmation in a randomized trial is needed.
9113 General Poster Session (Board #47C), Sat, 8:00 AM-12:00 PM
Pain, sleep disturbance, and fatigue symptom cluster in patients suffering
from chronic chemotherapy-induced neuropathic pain (CINP). Presenting
Author: Jennifer S. Gewandter, University of Rochester Medical Center,
Rochester, NY
Background: Various symptom cluster combinations of pain, fatigue, sleep
disturbance (SD), and depression have been identified in cancer patients.
The presence of symptom clusters has not been assessed in patients with
persistent CINP. This exploratory analysis aimed to determine which
symptoms statistically clustered with pain in cancer survivors with CINP.
Methods: The University of Rochester Cancer Center Community Clinical
Oncology Program recruited 461 patients with CINP � 4 (on a 0-10 scale)
who had completed chemotherapy (median 7 months ago) for a pain
intervention trial. At baseline, groups of highly associated symptoms that
included pain were identified empirically using factor and cluster analyses
of the 11 symptoms in the University of Rochester Symptom Inventory plus
the Hospital Anxiety and Depression Scale (HADS) scores. To investigate if
associated symptoms track together over time, multiple linear regression
(MLR) analysis was performed using changes in symptom severity between
baseline and week 6, controlling for gender, age, education, race, and
marital status. Results: Subjects were 88% white and 71% female, and on
average 61 years old. Mean (standard deviation) baseline pain, fatigue, and
SD were 5.7 (2.8), 5.0 (2.7), and 4.2 (3.1), respectively; 26% of subjects
had borderline or abnormal HADS scores. Factor analysis identified 3
factors that accounted for 88% of the variance. One factor included pain,
fatigue, SD, but not HADS, and accounted for 37% of the variance.
Variable clustering also identified pain, SD, and fatigue as 1 symptom
cluster. Changes in severity of SD and fatigue (p � 0.0001), but not HADS,
were associated with changes in pain (adjusted R2 � 0.168) in MLR
analysis. Conclusions: Pain, fatigue, and SD were identified as a symptom
cluster by factor and cluster analyses, and were found to track together over
time by MLR. Since these data suggest that pain is associated with sleep
quality and fatigue in patients with persistent CINP, targeting one of these
symptoms may lead to reductions in the others. Future research should
investigate interventions that target pain, fatigue, and SD concurrently in
cancer survivors suffering from CINP.
Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.