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

568s Patient and Survivor Care
9004 Oral Abstract Session, Mon, 8:00 AM-11:00 AM
A video decision support tool for CPR in advanced cancer: A randomized
controlled trial. Presenting Author: Angelo E. Volandes, Massachusetts
General Hospital, Boston, MA
Background: End-of-life decision-making is important to patients, including
whether or not to attempt cardiopulmonary resuscitation (CPR). Doctors
often rely solely on verbal descriptions to communicate information
regarding CPR. Video decision support tools have the potential to improve
patients’ understanding of CPR by providing visual images of what this
intervention entails. The objective of this study was to examine the effect of
a CPR video among patients with advanced cancer on their preferences and
knowledge of CPR. Methods: A randomized controlled trial of 150 subjects
with diverse advanced cancers (� 1-year prognosis) recruited from 4
cancer centers in the United States. Subjects were randomized to either a
verbal narrative describing CPR, or to a video with verbal narrative. The
video depicts CPR and reviews the success rate in advanced cancer. Study
endpoints were subjects’ CPR preferences, knowledge of CPR (knowledge
scores ranged from 0-4, higher score indicating more knowledge), and
perceived value of the video. Chi-square tests were used to compare the
distributions of categorical outcomes and two-sample t-tests were used to
compare the means between the two groups. Results: A total of 150
subjects were randomized to a verbal narrative (n�80) or video with verbal
narrative (n�70). Mean age was 62, 49% were women, 47% White, 34%
Black, and 47% had lung or colon cancer. Among subjects receiving the
verbal narrative, 38 (47.5%) preferred to have CPR attempted; 41 (51.2%)
chose not to have CPR; and 1 (1.3%) was uncertain. In the video group, 14
(20%) preferred to have CPR attempted; 55 (78.6%) chose not to have
CPR; and 1 (1.4%) was uncertain (P�0.001). The mean knowledge score
was higher in the video group than in the verbal group (3.3 vs. 2.6
respectively; P�0.001). Of the subjects who viewed the video, 94.1%
stated they were comfortable watching the video, 97.1% found the video
helpful, and 100% would recommend the video. Conclusions: Compared to
subjects who only heard a verbal description, subjects with advanced
cancer who viewed a CPR video were more likely to prefer not having CPR,
and were more knowledgeable about CPR. The majority of subjects found
the video helpful, comfortable to view, and would recommend it to others.
9006 Oral Abstract Session, Mon, 8:00 AM-11:00 AM
Long-term protective effects of the angiotensin receptor blocker telmisartan
on epirubicin-induced inflammation, oxidative stress, and myocardial
dysfunction. Presenting Author: Giovanni Mantovani, Department of Internal
Medical Sciences, Service of Medical Oncology, University of Cagliari,
Cagliari, Italy
Background: Chronic inflammation, oxidative stress and renin-angiotensin
system (RAS) play a significant role in chemotherapy-induced cardiotoxicity
(CTX). Telmisartan (TEL), an antagonist of the angiotensin II type-1
receptor, reduces anthracycline (ANT)-induced CTX. Methods: A phase II
placebo (PLA)-controlled randomized trial was carried out to assess the role
of TEL in the prevention of cardiac subclinical damage induced by
epirubicin (EPI). Forty-nine patients (mean age � SD, 53.0�8 years),
cardiovascular disease-free with cancer at different sites and eligible for
EPI-based treatment, were randomized to one of two arms: TEL n�25; PLA
n�24. A conventional echocardiography equipped with Tissue Doppler
imaging, strain and strain rate (SR) was performed, and serum levels of
proinflammatory cytokines, IL-6 and TNF-�, and oxidative stress parameters,
reactive oxygen species (ROS) and glutathione peroxidase were
assessed. All assessments were carried out at baseline, after every 100
mg/m2 EPI dose and at 6, 12 and 18-month follow-up (FU). Results: A
significant reduction in the SR peak in both arms was observed at t2 (cumulative dose of 200 mg/m2 EPI) in comparison to t0. Conversely, at t3, t4 (300, 400 mg/m2 EPI), 6, 12 and 18-month FU, the SR increased
reaching the normal range only in TEL arm, while in PLA arm SR remained
significantly lower as compared to t0. The differences between SR changes
in PLA and TEL arms were significant from 300 mg/m2 EPI (t3)upto18 month-FU. IL-6 increased significantly in PLA arm at t2 compared to t0, but
remained unchanged in the TEL arm. ROS levels also increased significantly
at t2 vs. baseline in PLA arm, while remained unchanged in TEL arm.
The mean change in ROS and IL-6 at t2 was significantly different between
the two arms. At 3, 6, 12 and 18 month-FU, ROS and IL-6 decreased in
comparison to t2 in PLA arm, while remained low in TEL arm. Conclusions:
Our results suggest that TEL is able to reverse acute EPI-induced
myocardial dysfunction and maintain a normal systolic function up to 18
month-FU. These effects are likely due to two different mechanisms, RAS
blockade and prevention of chronic inflammation/oxidative stress.
9005 Oral Abstract Session, Mon, 8:00 AM-11:00 AM
ZOOM: A prospective, randomized trial of zoledronic acid (ZOL;q4wkvsq
12 wk) for long-term treatment in patients with bone-metastatic breast
cancer (BC) after 1 yr of standard ZOL treatment. Presenting Author: Dino
Amadori, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori,
Meldola, Italy
Background: ZOL (4 mg q 4 wk) is an established therapy for reducing the
risk of debilitating skeletal-related events (SREs) in patients (pts) with
bone metastases (mets) from BC. As BC treatments continue to improve pt
survival, long-term SRE-reduction is increasingly important, and evaluation
of modified ZOL dosing to retain efficacy with reduced adverse events (AEs)
is warranted. Methods: ZOOM, a phase III prospective, randomized,
open-label, multicenter study, assessed the safety and efficacy of quarterly
(4 mg q 12 wk; Arm 1) vs monthly (4 mg q 4 wk; Arm 2) ZOL for ~1 yr in pts
with BC who have � 1 bone met, and have received ~1 yr of prior ZOL
treatment (9 to 12 doses over � 15 months; last dose � 3 months prior).
The primary endpoint was skeletal morbidity rate (SMR; number of
SREs/pt/yr). Sample size to detect non-inferiority with 80% power (1-sided
a � 0.025) was 420 pts. Secondary endpoints included time to first SRE,
bone pain, bone marker (N-telopeptide of type I collagen; NTX) levels, and
safety. Results: 425 pts were enrolled (209 in Arm 1; 216 in Arm 2); arms
were well balanced for pt and disease characteristics, and anticancer
therapies. SMR was similar between arms: 0.26 (95% confidence interval
[CI] � 0.15, 0.37) in Arm 1 vs 0.22 (95% CI � 0.14, 0.29) in Arm 2;
between-arms difference � 0.04 (upper limit of 1-tailed 97.5% CI �
0.17). Despite the proximity of 0.17 to the adjusted non-inferiority margin
(0.19), the non-inferiority of Arm 1 vs 2 remains statistically significant.
Safety analyses showed that ZOL was well tolerated. Renal AEs were
reported in similar proportions of pts in both arms; 7 cases of osteonecrosis
of the jaw were reported (1.65% overall; 4 cases in Arm 1 vs 3 in Arm 2).
Conclusions: ZOOM is the first randomized trial to compare ZOL q 12 wk vs
ZOLq4wkinBCptsafter 1 yr of standard ZOL therapy. SMR was similar
between arms. Limitations in study design suggest the need to confirm
non-inferiority of ZOL q 12 wk in other ongoing phase III trials.
9007 Oral Abstract Session, Mon, 8:00 AM-11:00 AM
Post diagnosis weight gain and the role of exercise in breast cancer
survivors. Presenting Author: Tara Beth Sanft, Yale University, New Haven,
CT
Background: Obesity is linked to poor breast cancer (Br Ca) outcomes
including higher risk of recurrence and death. No study has examined if
post-diagnosis weight (wt) gain modifies the effect of exercise interventions
on body composition. We examined wt change from diagnosis (diag) to
enrollment (enroll) into a 6-mo randomized trial of exercise v. usual care to
explore if post-diagnosis wt gain modified the effect of exercise on body wt,
body fat, lean body mass (LBM) and bone mineral density (BMD) in breast
cancer survivors. Methods: 75 inactive Br Ca survivors were recruited and
randomized to exercise (n � 37) or usual care (UC) (n � 38). At baseline,
women completed a questionnaire assessing self-report wt at diag and at
the time of enroll into the study (~3 yr). The exercise group participated in
150 min/wk of supervised exercise. The UC group maintained their
physical activity level. Body composition was assessed at enroll and 6-mo
via dual-energy X-ray absorptiometry (DXA) by one radiologist blinded to
intervention group. Results: Wt and DXA data were available for 68 / 75
participants. On average, women gained 3.3�8.2 kg from diag to enroll,
with 53% gaining wt (mean � 8.9 � 6.8 kg) and 47% maintaining or losing
wt (mean change � -2.9 �3.9 kg). The majority of wt gain occurred among
women who were non-obese at diag (BMI � 30), with 60% of non-obese
women gaining wt (mean � 8.0 � 6.8 kg) compared with 38% of obese
women gaining wt (mean � 12.2 � 6.4 kg). Those randomized to exercise
lost body fat including women who gained wt since diag (mean % fat loss
for exercisers (-0.92 � 0.31) vs. UC (0.36 �0.30), p � .0063) and women
who did not gain wt since diag (mean % fat loss for exercisers (-0.65 �
0.39) vs. UC (0.45�0.47), p � .08) even after adjusting for obesity status
at diag. Similar improvements in LBM and BMD were observed with
exercise in women who did or did not gain wt since diag. Conclusions: Wt
gain in Br Ca survivors is common, the majority of weight gain in this study
occurred among women who were not obese at diag. Exercise led to body fat
loss and other favorable body composition changes among both non-obese
and obese women. Exercise and other wt management programs should be
offered to all Br Ca survivors regardless of BMI at diagnosis as a strategy
towards prevention of wt gain.
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