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

582s Patient and Survivor Care
9061 General Poster Session (Board #40H), Sat, 8:00 AM-12:00 PM
Randomized double-blind evaluation of dronabinol for the prevention of
chemotherapy-induced nausea. Presenting Author: Steven M. Grunberg,
Fletcher Allen Health Care, Burlington, VT
Background: Although great progress has been made in the control of
chemotherapy-induced vomiting (CIV), prevention of chemotherapyinduced
nausea (CIN) has been less successful. Preliminary data suggests
that some families of lesser used antiemetic agents, such as the cannabinoids,
may have greater efficacy against nausea than against vomiting.
Methods: Adult solid tumor patients (pts) receiving cyclophosphamide
� 1500 mg/m2 (C) and/or doxorubicin � 40 mg/m2 (A) were eligible. Pts
could have received prior mildly emetogenic chemotherapy (EC). Pts were
not eligible who were receiving other moderately or highly EC, were
receiving cranial, abdominal or pelvic radiotherapy, had CIV/CIN with
previous chemotherapy, had other causes for nausea/vomiting besides
chemotherapy, or were scheduled to receive other antiemetics. Pts with
habitual cannabinoid use were not eligible. All pts received palonosetron
0.25 mg (PALO) and dexamethasone 10 mg (DXM) IV before chemotherapy.
Patients were randomized double-blind to receive dronabinol 5 mg
(D) or matching placebo (P) 3 times a day for 5 days. Nausea, vomiting and
toxicity data was collected daily for 5 days. Results: 62 pts were entered on
study – female/male 61/1, White/Black/Hispanic/Other 45/14/2/1, median
age (range) 58 (29-76). No significant difference was noted in CIVdependent
endpoints (including No Vomiting, Complete Response, or
Complete Protection) or in rescue medication use. However pts receiving D
had a shorter duration of nausea – Mean number of days of nausea (D vs P)
1.86 days vs 3.10 days (p�0.027) – and a trend toward greater frequency
of No Nausea (D vs P) 37% vs 17% (p�0.143). Common toxicities
included fatigue (D/P 17/11), headache (D/P 16/16), dizziness (D/P 14/7),
constipation (D/P 14/11), and diarrhea (D/P 13/6) No pt discontinued
therapy due to mood changes. Conclusions: Low-dose D decreased the
duration of CIN and increased the frequency of No Nausea in pts receiving
C and/or A. Agents to prevent CIV (such as PALO and DXM) and to prevent
CIN (such as D) have complementary activity and result in improved overall
control when used together.
9063 General Poster Session (Board #41B), Sat, 8:00 AM-12:00 PM
Decision-making preferences of advanced cancer Hispanic patients from the
United States and Latin America. Presenting Author: Henrique Afonseca
Parsons, University of Texas M. D. Anderson Cancer Center, Houston, TX
Background: To determine whether preferences in frequency of passive decision
making differ between Hispanic patients from Latin America (HLA) and
Hispanic-American (HA) patients. Methods: We conducted a survey of advanced
cancer Hispanic patients referred to outpatient palliative care clinics in the U.S,
Chile, Argentina, and Guatemala. Information on demographic variables, PS,and-
Marin Acculturation Assessment Tool (only U.S. patients) was collected.
Decision-making preference was evaluated by the decision-making assessment
tool. Results: A total of 387 patients with advanced cancer were surveyed: 91
(24%) in the US, 100 (26%) in Chile, 94 (25%) in Guatemala, and 99 (26%) in
Argentina. Median age was 59 years, and 61% were female. HLA preferred
passive decision-making strategies significantly more frequently with regard to
involvement of the family (24% versus 10%, p�0.009) or the physician (35%
versus 26%, p�0.001), even after controlling for age and education (OR 3.8,
p�0.001 for physician and 2.4, p�0.03 for family) (Table 1). 76/91 HA
(83.5%), and 242/293 HLA (82%) preferred family involvement in decisionmaking
(p�NS). No differences were found in decision-making preferences
between low- and highly acculturated U.S. Hispanics. Conclusions: HA prefer
more active decision-making as compared to HLA. Among HA, acculturation did
not seem to play a role in decision-making preference determination. Our
findings in this study confirm the importance of family participation in decision
making in both HA and HLA. However, HA patients were much less likely to want
family members or physicians to make decisions on their behalf.
Distribution of decision-making preferences according to the dyadic independent
relationships between patient and family.
USA
(N�90)
Latin America
(N�296)
n (%) n (%) p
Passive 9 (10%) 69 (24%) �0.001
Shared 45 (50%) 144 (49%)
Active 32 (36%) 64 (22%)
Didn’t know/preferred not to answer 4 (4%) 17 (6%)
Distribution of decision-making preferences according to the triadic simultaneous
relationships between patient, physician, and family.
USA
(N�91)
Latin America
(N�293)
n (%) n (%)
p
Passive 13 (14%) 69 (23.5%) �0.001
Shared 31 (34%) 151 (51.5%)
Active 47 (52%) 73 (25%)
9062 General Poster Session (Board #41A), Sat, 8:00 AM-12:00 PM
The effect of melatonin on appetite and other symptoms in patients with
advanced cancer and cachexia: A double-blind placebo-controlled trial.
Presenting Author: Egidio Del Fabbro, University of Texas M. D. Anderson
Cancer Center, Houston, TX
Background: Patients with advanced cancer experience anorexia and weight
loss which impairs their quality of life. Prior studies suggest melatonin, a
frequently used integrative medicine may attenuate weight loss, anorexia,
fatigue, and depression. These studies were limited by a lack of blinding
and absence of placebo controls. The primary objective of this study was to
compare melatonin to placebo for appetite in patients with cachexia.
Methods: A randomized, double-blind, 28 day trial of melatonin 20mg vs.
placebo in patients with advanced lung or gastrointestinal cancer, appetite
scores �3 ona0to10scale (10 � worst appetite) and a history of weight
loss � 5% within 6 months. Patients unable to maintain oral intake, thyroid
or adrenal dysfunction, or with a karnofsky �40 were excluded from the
study. The assessments included weight, symptom severity by Edmonton
Symptom Assessment Scale (ESAS) and quality of life by the Functional
Assessment of Anorexia/Cachexia Therapy (FAACT).Differences between
groups from baseline to day 28 were analyzed using one-sided two sample t
tests (appetite, pain and well-being) or Wilcoxon two-sample tests for the
other variables. Interim analysis at half point had a Lan-DeMets monitoring
boundary with an O’Brien-Fleming stopping rule. The decision boundaries
for the interim test was to accept the null hypothesis of no treatment
difference (futility) if the test statistic Z � 0.39 (p � 0.348). Results: After
interim analysis of 48 patients, the study was closed by the Data Safety
Monitoring Board for futility. There were no significant differences between
groups in appetite (p�0.78), weight (p� 0.17), FAACT score (p�0.95),
insomnia (p�0.62) or other symptoms measured by the ESAS from
baseline to day 28.No significant toxicities were observed. Conclusions: In
cachectic patients with advanced cancer, 20mg oral Melatonin at night
does not improve appetite, weight or quality of life compared to placebo.
9064 General Poster Session (Board #41C), Sat, 8:00 AM-12:00 PM
The use of olanzapine versus metoclopramide for the treatment of breakthrough
chemotherapy-induced nausea and vomiting (CINV) in patients
receiving highly emetogenic chemotherapy. Presenting Author: Rudolph M.
Navari, Indiana University School of Medicine South Bend, South Bend, IN
Background: Olanzapine (OLN) has been shown to be a safe and effective
agent for the prevention of CINV. OLN may also be an effective rescue
medication for patients who develop breakthrough CINV despite having
received guideline directed CINV prophylaxis. Methods: A double blind,
randomized phase III trial was performed for the treatment of breakthrough
CINV in chemotherapy naïve patients receiving highly emetogenic chemotherapy
(HEC) (cisplatin, �70 mg/m2 , or doxorubicin, �50 mg/m2 and
cyclophosphamide, � 600mg/m2 ) comparing OLN to Metoclopramide
(METO). Patients who developed breakthrough emesis or nausea despite
prophylactic dexamethasone (12 mg IV), palonosetron (0.25 mg IV), and
fosaprepitant (150 mg IV) pre chemotherapy and dexamethasone (8 mg
p.o. daily, days 2-4) post chemotherapy were randomized to receive OLN,
10 mg orally daily for three days or METO, 10 mg orally TID for three days.
Patients were monitored for emesis and nausea for the 72 hours after taking
OLN or METO. Eighty patients (median age 56 yrs, range 38-79; 43
females; ECOG PS 0,1) consented to the protocol and all were evaluable.
Results: During the 72 hour observation period, 30 of 42 (71%) patients
receiving OLN had no emesis compared to 12 of 38 (32%) patients with no
emesis for patients receiving METO (p�0.01). Patients without nausea (0,
scale 0-10, M.D. Anderson Symptom Inventory) during the 72 hour
observation period was: OLN: 67% (28 of 42); METO 24% (9 of 38)
(p�0.01). There were no Grade 3 or 4 toxicities. Conclusions: OLN was
significantly better than METO in the control of breakthrough emesis and
nausea in patients receiving HEC.
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