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

588s Patient and Survivor Care
9085 General Poster Session (Board #43H), Sat, 8:00 AM-12:00 PM
A randomized trial to determine if vitamin B6 can prevent hand and foot
syndrome in cancer patients treated with capecitabine chemotherapy.
Presenting Author: Tareq Braik, John H. Stroger Jr. Hospital of Cook
County, Chicago, IL
Background: Capecitabine is an oral fluoropyrimidine that is used to treat
various malignancies. Hand and Foot Syndrome (HFS) is a dose limiting
toxicity of capecitabine and can limit the use of this agent in some patients.
Some investigators have observed that pyridoxine (vitamin B6) can ameliorate
HFS caused by capecitabine. We designed a prospective trial to
determine if pyridoxine can prevent HFS in patients receiving capecitabine.
Methods: In our double-blind, placebo controlled trial, we randomly
assigned eligible patients treated with capecitabine to receive either daily
pyridoxine 100 mg or placebo along with their capecitabine-containing
chemotherapy regimen. Patients were observed during the first four cycles
of capecitabine treatment. The primary end point was the incidence and
grade of HFS that occurred in both arms. Results: Between 2008 and
2011, 77 patients were randomly assigned to receive either pyridoxine
(n�38) or placebo (n�39). Both arms were matched in baseline characteristics.
The median age was 53.5 years. The ethnic composition of the study
population was African American 53%, Caucasian 22%, Hispanic 18%,
and Asian 7%. The daily doses of capecitabine were: 2000 mg/m2 (69
pts), 1650 mg/m2 (5 pts), 1400 mg/m2 (2 pts) and 1000 mg/m2 (1 pt).
Dosages of capecitabine were equally matched between the two arms of the
study. HFS occurred after a median of 2 chemotherapy cycles in both
groups. HFS developed in 10/38 (26%) patients in the pyridoxine group
and in 8/39 (20%) patients in the placebo group (p�0.547). Therefore, the
risk of HFS was 6 percentage points higher in pyridoxine group (95% CI for
difference: -13 percentage points to �25 percentage points). Given our
study results, we can be confident of excluding a true benefit from
pyridoxine larger than 13 percentage points. No difference in HFS grades
was observed. Conclusions: Prophylactic pyridoxine (vitamin B6), given
concomitantly with capecitabine-containing chemotherapy, was not effective
for the prevention of HFS.
Grades HFS I HFS II HFS III No HFS
Pyridoxine 4 (11%) 2 (5%) 4 (11%) 28 (73%)
Placebo 2 (5%) 3 (8%) 3 (8%) 31 (79%)
9087 General Poster Session (Board #44B), Sat, 8:00 AM-12:00 PM
Usefulness of medical oncologists’ estimates of survival time in people with
advanced cancer. Presenting Author: Belinda E. Kiely, NHMRC Clinical
Trials Centre, University of Sydney, Sydney, Australia
Background: We sought to determine the calibration, precision, prognostic
significance and suitability of estimated survival time (EST) as a basis for
estimating and explaining prognosis in advanced cancer. Methods: Medical
oncologists recorded their EST as the “median survival of a group of
identical patients” in patients with advanced cancer and a life expectancy
�3 months recruited to a randomized trial of sertraline (Lancet Oncol
2007; 8: 603). Calibration, precision and suitability were defined by the
proportions of patients whose observed survival times (OST) were bounded
by simple multiples of their EST (based on our previous studies), i.e. 50%
expected to live longer (or shorter) than their EST; 30% expected to live
from 0.75 to 1.33 times their EST (arbitrary criterion for precision); 50%
expected to live from half to double their EST (range for typical scenario);
10% expected to live �3 times their EST (best case scenario), or �¼ of
their EST (worst case scenario). Results: Characteristics of the 114 patients
were: median age 63 years, Karnofsky performance status (KPS) �70 in
25%, and a median of 8.5 months since diagnosis of advanced cancer.
Primary cancer sites included breast (18%), colorectal (16%), lung (15%),
prostate (12%) and ovary (10%). Median survival was 10.6 months after a
median follow-up of 14 months and 68 deaths. EST were well-calibrated:
54% of patients lived longer than their EST and 46% lived shorter than
their EST. EST were imprecise (21% within 0.75 to 1.33 times OST) but
equally likely to be over-optimistic (34% �1.33 x OST) or over-pessimistic
(39% �0.75 x OST). 6% of patients lived �¼ of their EST; 62% lived from
half to double their EST and 9% lived �3 times their EST. Independently
significant predictors of OST in a multivariable Cox model included EST
(HR�0.92, p�0.004), dry mouth (HR�5.07, p�0.0001), alkaline phosphatase
�101U/L (HR�2.80, p�0.0002), KPS �70 (HR�2.30,
p�0.007), prostate primary (HR�0.23, p�0.002), and steroid use
(HR�2.35, p�0.02). Conclusions: Medicaloncologists’ EST were wellcalibrated,
imprecise, independently associated with OST, and useful for
estimating and explaining best case, worse case, and typical scenarios for
survival time in patients with advanced cancer.
9086 General Poster Session (Board #44A), Sat, 8:00 AM-12:00 PM
In-hospital and long-term outcomes in patients with malignancy undergoing
percutaneous endoscopic gastrostomy (PEG). Presenting Author: Emily
Keung, Department of Surgery, Brigham and Women’s Hospital, Boston,
MA
Background: PEG is widely performed in cancer patients as a means of
providing nutrition or palliation. Although considered safe, PEG-associated
outcomes in these patients remain poorly described. We examined the
safety and benefits of PEG placement in this patient population. Methods: A
five year retrospective review of all patients with malignancy (excluding
head/neck, thoracic) who underwent attempted PEG at our institution was
performed. Results: PEG was placed in 187 of 189 patients; 64 with
hematologic malignancy (H-M), 125 non-hematologic malignancy (NH-M).
Median age at time of PEG was 60.8 years. Indication was nutritional
support (100%) in H-M, enteral access (59.2%) and management of
obstructive symptoms (38.4%) in NH-M. A minority were able to return
home (27.5%), discontinue parenteral nutrition (22%), advance diet for
nutrition (24.6%) or comfort (17.1%) with the rest remaining NPO. Overall
rates of PEG-related major (aspiration, tube dislodgement/leakage, bleeding,
visceral injury, respiratory failure after procedure, cardiac arrest) and
minor (superficial infection, ileus) complications were 21.4% and 11.3%,
respectively, with higher rates in H-M (34.4% and 20.3% vs 14.4% and
6.4%). All cause in-hospital mortality was high: 31.3% H-M, 13.6%
NH-M. Median time from PEG placement to death was 54 days. Leading
cause of death differed by malignancy: respiratory failure and sepsis in H-M
(31% and 21%), primary malignancy in NH-M (75%). Overall one year
mortality was 56%. Code status was changed in 21% of patients after PEG
(“Full Code” to “Do Not Resuscitate/Do No Intubate” or “Comfort Measures
Only”). Multivariate/subgroup analyses will be presented at time of meeting.
Conclusions: PEG placement in this study population was associated
with significant procedure-related complications and failed to achieve TPN
independence or advancement of diet. Nearly 25% of patients declined
aggressive resuscitation strategies after undergoing surgery for PEG. Thus,
higher burden of counseling is needed to carefully weigh the risk and
benefit of PEG placement in these patients. Further studies are needed to
elucidate the factors affecting the decision process and patient selection.
9088 General Poster Session (Board #44C), Sat, 8:00 AM-12:00 PM
Risk of rash with nilotinib: A systematic review of the literature and
meta-analysis. Presenting Author: Aaron Mark Drucker, University of
Toronto, Toronto, ON, Canada
Background: Nilotinib is indicated for the treatment of chronic myelogenous
leukemia (CML). The reported incidence and risk of rash from this
medication vary widely and have been inconsistently reported in published
trials. Therefore we conducted a systematic review and meta-analysis of the
literature to determine the incidence and risk of developing rash. Methods:
Relevant studies were identified from the PubMed database (1998-2012),
abstracts presented at ASCO and ASH Conferences (2004-2011) and Web
of Science database (1998-2012). Eligible studies were limited to prospective
Phase II-III clinical trials in which patients received nilotinib at doses
of either 300 mg or 400 mg twice daily. Incidence, relative risk (RR), and
95% confidence intervals (CI) were calculated using random-effects or
fixed-effects models based on heterogeneity of included studies. Results:
Data from a total of 3,186 patients receiving nilotinib in 16 clinical trials
were available for analysis. The overall incidence of all-grade and highgrade
(grade �3) rash were 33.1% (95% CI: 27.7-39.1) and 2.6% (95%
CI: 2.1-3.4), respectively. Incidence of all-grade rash for patients with
CML, gastrointestinal stromal tumor (GIST) and systemic mastocytosis
were 33.2% (95% CI: 27.2-39.9), 25.7% (95% CI: 14.0-42.5) and
25.0% (95% CI: 15.7-37.4), respectively. Nilotinib was associated with
increased risk of all-grade rash (RR�2.891, 95% CI: 2.079-4.020;
P�0.001) when compared to patients treated with imatinib. Risk of
high-grade rash was increased compared to imatinib (RR�1.823, 95% CI:
0.670-4.957), but this was not statistically significant (P�0.24).
Conclusions: Patients with hematologic malignancies and GIST who are
treated with nilotinib are at significant risk for developing a rash. Further
studies for characterization, prevention and treatment of this untoward
toxicity are needed in order to maintain patients’ quality of life and
minimize the need for dose modification, which may impact clinical
outcome.
Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.