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

9089 General Poster Session (Board #44D), Sat, 8:00 AM-12:00 PM
The chemotherapy-induced peripheral neuropathy (CIPN) outcome measure
standardization (CI-PeriNomS) study: From consensus to validity and
reliability in CIPN assessment. Presenting Author: Guido Cavaletti, University
of Milan-Bicocca, Monza, Italy
Background: Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a
debilitating and dose limiting complication of cancer treatment. However,
the impact of CIPN has never been studied in a clinimetric manner, in its
impact on quality of life. This study was performed to select appropriate
outcome measures and to establish, for the first time with a clinimetric
approach, their validity and reproducibility. Methods: After literature review
and a consensus meeting, face/content validity were obtained for the
following scales: the National Cancer Institute Common-Toxicity-Criteria
(NCI-CTC), the Total Neuropathy Score (TNSc), the modified INCAT
sensory sumscore (mISS), the European Organization for Research and
Treatment of Cancer (EORTC) QLQ-C30 and CIPN20 quality of life
measures. 281 patients with stable CIPN were examined through an EU/US
collaboration involving 20 oncology/neurology centers. For each scale the
inter- and intra-rater agreement was evaluated by means of weighted
K-Cohen coefficients and 95% confidence intervals, when analyzing
qualitative ordinal scales and by means of Spearman’s rank correlation
coefficient and t-test when analyzing quantitative ordinal scales. The
adopted weights for the estimate of K-Cohen coefficients were the Fleiss-
Cohen weights. For validity purposes, the Kruskal-Wallis equality-ofpopulations
rank test was performed relating the mISS and TNSc to the
NCI-CTC grades. Results: Proper, although slightly different, inter-/intraobserver
scores (i.e. r � 0.7) were obtained for the TNSc, mISS, and
NCI-CTC sensory/motor subscales. Test-retest values were also high for the
EORTC QLQ-C30 and for the recently developed and never formally tested
CIPN20. Acceptable validity scores were obtained through correlation
between the the mISS and TNSc to the NCI-CTC scores (p values ranging
from 0.04 to � 0.001). Conclusions: Proper validity and reliability scores
were demonstrated for the set of selected outcome measures in CIPN.
These results will allow to base new trials on a solid methodological
background, although future studies are warranted to investigate the
responsiveness issues.
9091 General Poster Session (Board #44F), Sat, 8:00 AM-12:00 PM
Gender difference in vulnerability and geriatric syndromes among elderly
cancer survivors. Presenting Author: Lin Fan, University of Rochester
Medical Center, Rochester, NY
Background: Few studies have evaluated the gender difference of vulnerability
and geriatric syndromes (GS) among cancer survivors. Methods: Using
2003 Medicare Current Beneficiary Survey, we applied multivariable
logistic regression to evaluate the association of gender with vulnerability
and GS among cancer survivors. Vulnerability is measured by Vulnerable
Elders Survey-13 (VES-13), which is calculated from age, self-rated health
status, difficulty with physical activities and functional activities. Vulnerability
is defined by a VES-13 score of 3 or higher. 8 common geriatric
syndromes were assessed: sight trouble, hearing trouble, nutrition problem,
incontinence, falls, depression, memory loss and osteoporosis. Cancer
survivors are defined as patients with cancer diagnosed more than one year
ago. Results: Among the 1,883 cancer survivors, 749 (40.0%) were male;
1,134 (60.0%) were female. Female survivors had a higher prevalence of
vulnerability (47.8% vs 35.7%), and GS (65.5% vs 44.6%) than male
survivors. Mean GS number was 1.19 for female survivors, while 0.77 for
male survivors (p�0.001). More specifically, female survivors had significantly
higher prevalence of sight trouble (7.73% vs 5.0%), incontinence
(14.3% vs 7.1%), falls (28.9% vs 22.1%), depression (13.8% vs 7.7%)
and osteoporosis (38.2% vs 6.7%). After adjusting for confounders, female
survivors were more likely to be vulnerable (adjusted OR (AOR): 1.62; CI:
1.21-2.17; p�0.001); have a geriatric syndrome (AOR: 2.39; CI: 1.91-
3.00; p�0.001); have sight trouble (AOR: 1.70; CI: 1.00-2.87; p�0.049);
have incontinence (AOR: 2.48; CI: 1.67-3.69; p�0.001); have depression
(AOR: 1.87; CI: 1.29-2.71; p�0.001); and have osteoporosis (AOR: 8.48;
CI: 6.07-11.84; p�0.001). Conclusions: Female cancer survivors experience
a higher prevalence of vulnerability and overall geriatric syndromes.
Patient and Survivor Care
589s
9090 General Poster Session (Board #44E), Sat, 8:00 AM-12:00 PM
Incidence, characteristics, and associations of oxaliplatin-induced peripheral
neuropathy in colorectal cancer patients: Results of a prospective,
multicenter, international study. Presenting Author: Andreas Argyriou,
Department of Neurology, “Saint Andrew’s” State General Hospital of
Patras, Patras, Greece
Background: We sought to trace the incidence and severity of oxaliplatininduced
peripheral neuropathy (OXLIPN) and to determine its clinical
pattern. Among other associations, we also specifically aimed at testing
whether the degree of acute neuropathy is clinically related to the
development and severity of chronic OXLIPN. Methods: 170 patients (mean
age 64y), scheduled to be treated with either FOLFOX or XELOX for
metastatic colorectal cancer were studied. Patients were prospectively
monitored at baseline and followed-up during chemotherapy in four
European sites. The motor/neurosensory NCI-CTCv3 criteria and the
clinical version of the Total Neuropathy Score were applied to clinically
grade the severity of OXLIPN. Nerve conduction studies were also longitudinally
performed. Results: Evidence of acute OXLIPN was disclosed in
146/170 patients (85.9%). The vast majority of patients manifested
cold-induced perioral (95.2%) or pharyngolaryngeal dysesthesias (91.8%).
Other uncommon symptoms, such as jaw spasm were also present. Severe
acute OXLIPN, requiring prolongation of OXL infusion from 2 to 4-6 hours
was evident in 32/146 patients (21.9%). Overall, 123/170 patients
(72.4%) experienced chronic OXLIPN. Severities were grade I: 39 (22.9%);
grade II: 52 (30.6%); grade III: 33 patients (19.4%). Worst severities were
related to cumulative oxaliplatin dose (r:0.269;p�0.001). Follow-up
assessments revealed significant decrease in all sensory action potentials
examined. The severity of the acute OXLIPN was significantly correlated
with both the development (r:0.450;p�0.001) and degree of the chronic
form (r:0.703;p�0.001). Conclusions: Most patients treated with oxaliplatin-based
chemotherapy would manifest OXLIPN, mainly of moderate
degree. The severity of the acute syndrome appears to clinically correlate
with the degree of the chronic form of OXLIPN. Our data suggest that acute
phenomena, related to axonal hyperexcitability, could contribute to the
development of peripheral neuropathy; thus it could be advisable to test
agents against acute OXLIPN in order to verify their effects on the chronic
form.
9092 General Poster Session (Board #44G), Sat, 8:00 AM-12:00 PM
Risk of skin rash with the proteasome inhibitor bortezomib: Updated
systematic review and meta-analysis. Presenting Author: Emily Christine
Case, Columbia University, College of Physicians and Surgeons, New York,
NY
Background: Rash is a common, adverse event to the novel proteasome
inhibitor bortezomib (Velcade). Indicated for the treatment of multiple
myeloma and mantle cell lymphoma, bortezomib is the first proteasome
inhibitor approved by regulatory agencies. Because the incidence of
bortezomib-induced skin rash varies widely in published manuscripts, we
performed a systematic literature review and meta-analysis to determine
the incidence and overall risk. Methods: We searched PubMed and Web of
Science databases and abstracts presented at the American Society of
Clinical Oncology and The American Society of Hematology annual meetings
(1998 to July 2011) to identify relevant clinical studies. Eligible
studies included prospective clinical phase II and phase III trials, with data
on the incidence of rash in patients taking 1.3mg/m2 , 1.5mg/m2 ,or1.6
mg/m2 of bortezomib intravenously either weekly or twice weekly. The
incidence of rash and relative risk (RR) were calculated using randomeffects
or fixed-effects model, depending on the heterogeneity of included
studies. Results: A total of 2,616 patients with various hematologic and
solid malignancies from 35 clinical trials were included for analysis.
Among patients receiving twice weekly bortezomib, the summary incidence
of all-grade and high-grade rash were 18.8 % (95% CI: 14.9% to 23.5%)
and 3.6 % (95% CI: 2.3% to 5.7%), respectively. We found no significant
increase in all grade rash incidence with higher doses of bortezomib: 19.3
% (95% CI: 15% to 24.5%) and 20.8% (95% CI: 11.6% to 34.4%) for
doses of 1.3 mg/m2 and 1.5 mg/m2 , respectively. In addition, bortezomib
was associated with an increased risk in both all grade (RR: 19.70, 95% CI:
8.73 to 44.44, p�0.001) and high-grade rash (RR: 5.35, 95% CI: 2.16 to
13.29, p�0.001), compared to controls. Weekly bortezomib is associated
with lower risk of rash compared to twice weekly dosing (incidence 3.9%
versus 18.8%, p�0.001). Conclusions: Bortezomib is associated with a
significant risk of developing rash with a higher risk among patients
receiving twice weekly dosage. Management of rash to bortezomib is
critical to prevent a negative effect on quality of life and dose modifications,
both of which affect clinical outcome.
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