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

586s Patient and Survivor Care
9077 General Poster Session (Board #42H), Sat, 8:00 AM-12:00 PM
Efficacy and safety of rolapitant, a novel NK-1 receptor antagonist, for the
prevention of chemotherapy-induced nausea and vomiting in subjects
receiving highly emetogenic chemotherapy. Presenting Author: Luis Enrique
Fein, Centro Oncologico de Rosario, Rosario, Argentina
Background: Management of chemotherapy-induced nausea and vomiting
(CINV) improves quality of life and increases the likelihood that patients
will continue to receive appropriate treatment. The objective of this dose
finding study was to evaluate rolapitant for the prevention of CINV in
subjects receiving highly emetogenic chemotherapy (HEC). Methods: A
phase II, double blind study in which 454 subjects receiving HEC
(�70mg/m2 cisplatin-based chemotherapy) were randomized in equal
fashion prior to chemotherapy to receive ondansetron � dexamethasone �
either placebo or 10, 25, 100 or 200mg of rolapitant. Subjects recorded
episodes of emesis, severity of nausea, and use of rescue medication(s)
daily within a subject diary from Days 1 through 6 of Cycle 1. Results: The
rolapitant 200mg group had significantly greater complete response rates
(no emesis and no use of rescue medication) in the overall (0 to 120 hours),
acute (0 to �24 hours) and delayed (�24 to 120 hours) phases compared
to the placebo group (62.5% vs. 46.7%, p�0.032; 87.6% vs. 66.7%,
p�0.001 and 63.6% vs. 48.9%, p�0.045, respectively). Moreover, the
200mg group had significantly greater rates of no emesis and no significant
nausea in the overall, acute, and delayed phases and achieved statistically
significant better QoL scores (FLIE questionnaire) compared to the placebo
group. Rates for no emesis and no significant nausea for the 200mg dose
group in Cycles 2 to 6 continued to demonstrate superior treatment effect
vs. placebo. Treatment-related adverse events were mild and included
constipation, headache, fatigue and dizziness. Overall, serious adverse
events (SAEs) occurred with similar incidences across all treatment groups
(9% - 14%). Most common SAEs were febrile neutropenia, neutropenia,
vomiting, dehydration, nausea and pneumonia and were considered related
to chemotherapy or underlying cancer and not to rolapitant. Conclusions:
Administration of rolapitant 200mg with ondansetron and dexamethasone
is safe and effective at preventing CINV in subjects receiving HEC.
9079 General Poster Session (Board #43B), Sat, 8:00 AM-12:00 PM
Development of a geriatric vulnerability score (GVS) in elderly advanced
ovarian cancer (AOC) patients (pts) treated in first line: A prospective
GINECO trial. Presenting Author: Gilles Freyer, Oncologie Médicale, Centre
Hospitalier Lyon-Sud, Lyon, France
Background: Two previous prospective GINECO studies in elderly patients
have underlined the prognostic value of geriatric covariates (Co) on overall
survival (OS) (Freyer G., et al. Ann Oncol. 2005 and Tredan O, et al Ann
Oncol 2007). Methods: This open prospective trial was designed to confirm
the impact of geriatric Co including psycho-geriatric Co on OS of elderly pts
(�70) with stage III-IV AOC treated in first line with 6 courses of
carboplatin AUC5/3weeks. Geriatric Co were tested for their impact on OS
in uni- and multivariate analyses. The best fitting proportional hazard
model (GVS) was developed with the inclusion of major (MaC) and minor Co
(miC). Results: From 08/2007 to 01/2010, 111 pts were included in 21
centres. A majority of pts displayed characteristics of vulnerability: age
(median:78, range: 70-93, �80:41%), PS�2: 43%, �3 major comorbidities:
27%, �4 comedications: 69%, ADL score�6: 55%, IADL score�25:
75%, HADS�15:37%. A total of 74% of pts, however, completed planned
chemotherapy. Gr3-4 haematological toxicity was observed in 50% of pts
(thrombocytopenia [27%], anaemia [19%], and neutropenia [30%]) and
gr3-4 non-haematological toxicity was fatigue (16%), anorexia (13%) and
infection (10%). Median OS was 16.2 months (95%CI[14-21]). MaC were:
albuminemia�35g/L; ADL score �6; IADL score �25 and miC:
lymphopenia�1G/L; HADS£14. The survival score�exp(0.320*Number
[MaC] �0.354*Number[miC]) was validated upon a bootstrap analysis.
Using a cutoff of 3, the simplified GVS score � Number[MaC] �
Number[miC] discriminated two groups with significantly different OS
:11.5 vs 21.7 months; HR�2.94; p�10-4 , but also treatment completion
rates: 65.4% vs 82.1%; OR�0.41; p�0.04; severe adverse events (SAE):
52.7% vs 28.6%; OR�2.8; p�0.009 and unplanned hospital admissions:
52.8% vs 30.3% OR�2.6; p�0.02. Conclusions: The GVS identified a
group of pts at high risk of severe toxicity, early treatment stopping,
unplanned hospitalization and poor outcome. GVS provides a useful tool to
identify vulnerable pts in future elderly AOC trials.
9078 General Poster Session (Board #43A), Sat, 8:00 AM-12:00 PM
Effect of aprepitant on adherence to high-dose cisplatin-based chemotherapy.
Presenting Author: Serge Makarenko, British Columbia Cancer
Agency, Vancouver, BC, Canada
Background: Treatment of locally advanced head and neck cancers (HNC)
and gastroesophageal cancers (GEC) frequently consists of high-dose
cisplatin, which is highly emetogenic. Our aims were to 1) explore the
impact of aprepitant for improving adherence to cisplatin-based chemotherapy
in HNC and GEC, 2) examine its effect on reducing chemotherapyinduced
nausea and vomiting (CINV) and 3) determine if use of aprepitant
changed after introduction of insurance coverage for this drug. Methods:
Patients diagnosed with HNC or GEC in British Columbia, Canada from Jan
2008 and June 2011 and prescribed high-dose cisplatin were reviewed.
Using regression models that adjusted for confounders, we evaluated the
relationship between aprepitant use and treatment and outcome characteristics,
such as number of chemotherapy cycles, prevalence of CINV, and
recurrence and survival. Results: A total of 333 patients were identified:
162 HNC and 171 GEC patients of whom 80% were men, 44% were aged
�/�60 years, 35% were smokers, and 42% were alcohol users. Aprepitant
was prescribed in 49%, nausea and vomiting occurred in 64 and 24%,
respectively, and completion of all planned cisplatin was 52%. Younger
patients (55 vs 41%, p�0.01) and those with less tumor burden (64 vs
38%, p�0.01) were more likely to be given aprepitant. Individuals who
received aprepitant were significantly less likely to experience CINV
(p�0.01). Use of aprepitant differed between HNC and GEC patients
(p�0.01); however, its use did not increase when insurance coverage of
this agent was introduced (p�0.16). In multivariate analyses, aprepitant
use was significantly associated with adherence to all planned cisplatin
treatments (OR 2.33, 95% CI 1.27-4.25, p�0.01). In Cox regression,
completion of all cisplatin cycles was significantly correlated with a lower
risk of recurrence (HR 0.56, 95%CI 0.32-0.97 p�0.04) and a trend
towards decreased death (HR 0.56, 95%CI 0.31-1.10, p�0.10).
Conclusions: Aprepitant was associated with a reduction in CINV in both
HNC and GEC patients and correlated with better adherence to high-dose
cisplatin-based chemotherapy. Individuals who completed all planned
cisplatin had improved outcomes, specifically a lower risk of recurrence
from HNC and GEC.
9080 General Poster Session (Board #43C), Sat, 8:00 AM-12:00 PM
Correlations between depression according DSM-IV-TR (DSM) criteria,
three validated scales, oncologist assessment, and clinical psychiatric
interview in elderly advanced ovarian cancer (AOC) patients (pts): A
GINECO study. Presenting Author: Marilène Filbet, Hospices Civils de Lyon
Lyon, France
Background: Depression is a major outcome in cancer pts. Clinicians
typically rely on their clinical impression of depression rather than pts
self-reports. Our aim was to explore the association between patientreported
depression, oncologist assessment (OA) and a clinical psychiatric
interview (CPI) in elderly AOC pts. Methods: This analysis was a secondary
endpoint of theElderly Women AOC trial, designed to assess the impact of
geriatric covariates, notably depression, on survival in pts over 70 receiving
6 courses of carboplatin. Depression was assessed using the Geriatric
Depression Scale-30 (GDS; cut off score of 10/30), the Hospital Anxiety
Depression Scale (HADS; cut off score of 15/42), the distress thermometer
(DT; cut off score of 4/10) and OA (yes/no). CPI was conducted by
psychologists within 10 days after inclusion. The interview guide for CPI
(yes/no) was constructed and adapted from three validated scale: GDS,
Hamilton Depression Rating Scale Hamilton (HDRS), Montgomery Asberg
Depression Rating Scale (MADRS) and the DSM criteria. DSM was
considered as the gold standard. Results: Out of 111 pts, 100 (90.1 %)
completed all the assessment (OA, GDS, HADS, DT, CPI). Patients
characteristics were: mean age 78, performance status �2: 48 (55%).
Thirty six pts (36%) were identified as depressed by the CPI versus 17
(17%) by OA, 32 (32%) by the GDS, 36 (36%) by the HADS, 58 (58%) by
the DT and 16 (16%) according to DSM. We found a significant correlation
between DSM and GDS (r�0.58; p�0.001), DSM and CPI (r�0.53;
p�0.001). We did not find any significant correlation between DSM and OA
(r�-0.05;p�0.733), DSM and DT (r�-0.07;p�0.583), and between DSM
and HADS (r�0.127;p�0.258). Identification according to OA (yes/no)
resulted in 87% false negatives and 18% false positives rates. The best
sensitivity and specificity as a screening tool was found for GDS, 94% and
80% respectively. Conclusions: The use of validated tools such as GDS and
a collaboration between psychologists and oncologists are warranted to
better identify emotional disorders in elderly women with AOC.
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