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

9016 Clinical Science Symposium, Tue, 9:45 AM-11:15 AM
Patterns of antidepressant use in cancer patients (pts): An analysis from
SOAPP (ECOG E2Z02: Symptom Outcomes and Practice Patterns). Presenting
Author: Judith Manola, Dana-Farber Cancer Institute, Boston, MA
Background: Antidepressant (AD) use is common in outpatient oncology,
but the pattern and determinants of prescribing for commonly used AD are
unknown. Methods: 3106 pts with cancer of the breast, prostate, colon/
rectum, or lung were enrolled from multiple sites in a study of symptoms.
Five depression case-finding methods were explored : 3 based on MDASI
items reported by patients (1) sadness/ depression��4, (2) distress��4,
(3) interference with mood��7 or enjoyment��7; 2 based on clinician’s
report (4) presence of psychological distress, (5) depression being listed as
one of top 3 symptoms. AD use (excluding tricyclic antidepressants and
psychostimulants) was examined by depression status. Logistic regression
models were used to examine the effect of demographic and clinical
characteristics on AD use. Results: Rates of depressive symptoms varied by
casefinding method (1�29%, 2�28%, 3�14%, 4�24%, 5�11%); 47%
(1457) pts were defined as having depressive symptoms by at least one
method. AD were prescribed in 25% of depressed pts compared to 14% of
non-depressed pts. After adjusting for other covariates, factors associated
with greater use of AD included depression (OR�1.7, P�0.01), family
history of depression (OR�2.2, P�0.01), female sex (OR�1.8, P�0.01),
younger age (OR�1.2, P�0.04), non-Hispanic White race (OR�2.0,
P�0.01), prior chemo/immune/ hormonal treatment (OR�1.5, P�0.01),
more concurrent medication use (OR�3.3, P�0.01), anxiolytics use
(OR�2.0, P�0.01), sedative use (OR�2.1, P�0.01), receiving counseling
(OR�1.6, P�0.04), patient’s perception of poor QOL (OR�1.3,
P�0.02), duration of current treatment �1 year (OR�1.6, P�0.01), and
being enrolled by a CCOP (OR�1.8, P�0.01). These significant associations
remained regardless of the case-finding method used for depression,
with only slight changes in the magnitude of ORs. Conclusions: Depressive
symptoms are common in outpatients with cancer. One-fourth of solid
tumor pts with depressive symptoms are taking an AD. Antidepressant
prescribing varies by type of institution, race/ethnicity, age, concomitant
medication exposure and several other clinical factors.
9018 Poster Discussion Session (Board #2), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
SWOG S0715: Randomized placebo-controlled trial of acetyl-L-carnitine
for the prevention of taxane-induced neuropathy during adjuvant breast
cancer therapy. Presenting Author: Dawn L. Hershman, Columbia University
Medical Center, New York, NY
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a
common, disabling side effect of taxanes that leads to suboptimal
treatment and diminished quality of life. Acetyl-L-Carnitine (ALC) is a
natural compound involved in tubulin acetylation and neuronal protection.
Pre-clinical and phase II studies suggest ALC may be effective for the
prevention and treatment of CIPN. Methods: A randomized, double-blind,
multi-center, phase III trial comparing ALC (1000 mg TID) vs placebo for
24 wks in women with stage I-III breast cancer undergoing adjuvant taxane
therapy was conducted. The primary objective was to determine if ALC
prevents CIPN as measured by the 11-item neurotoxicity (NTX) component
of the FACT-Taxane scale (low score � worse NTX) at 12 wks. Secondary
objectives included change at 24 wks, change in the Trial Outcome Index
(TOI), fatigue (FACIT Fatigue) and NTX grade. Patients were stratified by
planned treatment, and age (�60, �60). Results: 409 patients were
evaluable (208 ALC, 201 placebo). No imbalances were observed by age,
ethnicity, race, planned taxane treatment, performance status, or stage.
The mean FACT-NTX score was 5.2 points lower at 12 wks on ALC and 4.5
points lower on placebo. In a linear regression adjusting for baseline score,
planned treatment and age, wk 12 scores were 0.9 points lower on ALC
than placebo (95% CI: -2.2 to 0.4, p�.17). At 24 wks, the mean observed
FACT-NTX score was lower for ALC (5.3 vs. 3.6). In the multivariate model,
wk 24 scores were 1.8 points lower on ALC (95% CI: -3.2 to -0.4, p�.01),
representing more self-reported NTX. Grade 3/4 NTX was more frequent in
the ALC arm (p�.04). Also at 24 wks, 38% on ALC had �5 point decrease
score compared to 28% on placebo (OR�1.57, p�.05), and FACT-TOI
scores were 3.5 points lower on ALC (95% CI: -6.5 to -0.4, p�.03). No
differences between arms were observed for the FACIT-Fatigue scale or for
other toxicities. Conclusions: There is no evidence that ALC has a positive
impact on CIPN at 12 wks. However, ALC increases CIPN by 24 wks.
Correlative studies are ongoing to explain this unexpected finding. Patients
should be discouraged from using ALC and other supplements without
proven efficacy.
Patient and Survivor Care
571s
9017 Poster Discussion Session (Board #1), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
A prospective study to evaluate the efficacy and safety of oral acetyl-Lcarnitine
(ALC) in treatment of chemotherapy-induced peripheral neuropathy
(CPIN). Presenting Author: Yuanjue Sun, Sixth Affiliated Hospital of
Shanghai Jiaotong University, Shanghai, China
Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a
major side effect of many commonly used chemotherapeutic. This side
effect of chemotherapy can be debilitating and effective treatment for CIPN
remains elusive. Previous studies demonstrated that Acetyl-L-Carnitine
(ALC) is effective in attenuating CIPN, controlled study is needed to
substantiate ALC’s effect in treatment of CIPN. Methods: This study was
designed to evaluate the efficacy and safety of Acetyl-L-Carnitine (ALC)
Hydrochloride Enteric-coated Tablet (oral administration) in the treatment
of CIPN. It was a prospective, randomized, double-blinded, placebocontrolled
and paralleled clinical study (registration No. 2007L03540). Of
239 subjects enrolled in the study (NCI grade 2 or above), 118 subjects
received 3g/day ALC orally for 8 weeks and 121 received placebo. Primary
endpoint was set as improvement of peripheral neuropathy at least 1 grade
and assessment was made in week 4, 8 and 12 after enrollment. Results: In
full analyses set (FAS) and per-proposal set (PPS), the peripheral sensory
neuropathy was significantly ameliorated in ALC group with 50.5% and
51.6% patients meeting the primary endpoint at week 8 and 12 respectively
while only 24.1% and 23.1% of patients in the placebo group at week
8 and 12 respectively (p�0.001 in both sets). Secondary endpoint such as
nerve electrophysiological test and Physical Condition Score (Karnofsky
performance status, KPS) were also significantly improved in patients with
ALC treatment (in FAS, P�0.0463 and P�0.022; in PPS, P�0.0076and
P�0.0064, respectively). Cancer-related fatigue was significantly alleviated
after ALC treatment in PPS (P�0.0135). Safety: 236 subjects were
included in safety assessment and 41 patients experienced 62 adverse
events during the course of study. There was no significant difference in
AE/SAE incidence between the two groups (P�0.3903). Conclusions: Oral
administration of ALC is effective in attenuating CIPN as well as in
reducing cancer-related fatigue and improving physical conditions in
cancer patients. The treatment of oral ALC is safe and well tolerated.
9019 Poster Discussion Session (Board #3), Mon, 1:15 PM-5:15 PM and
4:45 PM-5:45 PM
Low-level laser therapy for chemotherapy-induced peripheral neuropathy.
Presenting Author: John Muzi Lee, Legacy Health Systems, Portland, OR
Background: Chemotherapy induced peripheral neuropathy (CIPN) is a
common and serious side effect from chemotherapy agents. Low-level laser
light therapy (LLLT) devices were approved in 2002 for pain management.
Studies suggest a local release of serotonin, increased mitochondrial ATP
production, or anti-inflammatory effects as a mechanism of action. We then
questioned whether LLLT would show efficacy in mitigating symptoms
caused by CIPN. Methods: In a single center prospective randomized trial,
participants were randomized to receive either treatment with LLLT twice a
week for 8 weeks or placebo LLLT twice a week for 4 weeks followed by
actual treatment twice a week for 4 weeks. FACT/GOG-NTX, Brief Pain
Inventory (BPI -Severity and Interference), SF-36 Quality of Life (Physical
and Mental Score), monofilament and function testing (buttoning, coin use
and walking) were conducted prior to initiation of therapy, during, at
completion, and 2 months after treatment. 20 participants, 16 women and
4 men (average age 58 and 63 respectively), were enrolled between
October 2009 and June 2010. 10 patients were randomized to each group.
Average time from end of chemotherapy to enrollment was 32.6 months
(range 2 - 120 mo). All patients had neuropathic involvement of the feet.
14 patients had additional involvement of the hands. Results: Compared to
baseline, patients receiving any amount of active treatment showed
significant improvement at 8 weeks in NTX, BPI, function testing, and
SF36 Mental score. Those receiving 4 weeks of placebo treatment showed
improvement in only BPI, NTX and SF36 Mental score. At 2-month follow
up, all 20 patients showed a significant improvement in walking and SF 36
mental score, suggesting 4 weeks of active treatment improved function.
No significant difference in monofilament testing was observed throughout
the study in either group. Direct comparison between 4 or 8 weeks of
treatment vs. placebo showed a statistically significant difference in
walking function at 2-months. All patients tolerated therapy well without
side effects. Conclusions: Low-level laser light therapy improved functional
test over placebo and may be a viable option for non-medical management
of CIPN. Further study of LLLT in CIPN is warranted.
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