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

9138 General Poster Session (Board #50D), Sat, 8:00 AM-12:00 PM
Prospective cohort study of chemotherapy-induced alopecia with or without
scalp cooling. Presenting Author: Julie Lemieux, URESP, Centre de
Recherche FRSQ du CHA Universitaire de Québec, Quebec City, QC,
Canada
Background: Scalp cooling can prevent chemotherapy-induced alopecia.
Success varies according to the type of chemotherapy. A controversy exists
regarding the use of scalp cooling because of the lack of efficacy data with
modern chemotherapy regimen and safety data. We present a prospective
cohort study design to measure alopecia. Methods: The prospective study
was conducted at the Centre des Maladies du Sein Deschênes-Fabia (CMS)
in Quebec City (where scalp cooling is offered routinely and 85% of women
use it) and at the Centre Hospitalier Universitaire de Montreal (CHUM), in
Montreal (where scalp cooling is not available). Women were eligible if they
were going to receive neoadjuvant or adjuvant chemotherapy for breast
cancer. The study involved completion of questionnaires (on degree of
alopecia, hair type, hair care, use of head accessories, tolerance to scalp
cooling and questions related to sick leave from work) and having pictures
taken at baseline, cycle 3 and at the last cycle of chemotherapy. For the last
43 patients, the EORTC QLQ-C30/BR23 and an adaptation for Hairdex
were added. Results: A total of 136 patients were recruited (110 at CMS
over 2 years and 26 at the CHUM over a 9-month period). Preliminary
efficacy results are shown in the Table (data on quality of life have not yet
been analyzed). Hair preservation was defined as a SUCCESS for hair loss
(since the beginning of chemotherapy) characterized as “not at all”, “a
little” or “moderate” and “FAILURE” when characterized as “a lot” or “all”
or “hair shaved”. Overall, in the scalp cooling group, 34% were considered
a “success” using hairdresser evaluation and 49% using patient evaluation;
for the non scalp-cooling group, these rates were 9% and 4%
respectively. Conclusions: Scalp cooling appears to be efficacious for
preventing chemotherapy-induced alopecia in this exploratory cohort study.
Success of scalp cooling as assessed at last cycle of chemotherapy.
CMS
CHUM
(n�99 evaluable)
(n�23 evaluable)
Hairdresser evaluation
AC 7 (32%) 1 (25%)
TC 14 (45%) 0 (0%)
FEC-D 6 (20%) 0 (0%)
Other 7 (44%) 1 (9%)
Total 34 (34%) 2 (9%)
Patient evaluation N(%) N(%)
AC 8 (36%) 0
TC 19 (61%) 0
FEC-D 12 (40%) 0
Other 9 (56%) 1 (9%)
Total 48 (49%) 1 (4%)
9140 General Poster Session (Board #50F), Sat, 8:00 AM-12:00 PM
Validation of the chemotherapy-induced neuropathy assessment scale.
Presenting Author: Sheeba K. Thomas, University of Texas M. D. Anderson
Cancer Center, Houston, TX
Background: Many of the assessment tools used to assess peripheral
neuropathy in clinical trials focus on painful neuropathy. However, some
chemotherapy agents cause both painful and non-painful peripheral
neuropathy. The Chemotherapy-Induced Neuropathy Assessment Scale
(CINAS) was designed to evaluate the multi-dimensional nature of chemotherapy-induced
neuropathy, including non-painful sensory and motor
deficits. This study evaluated the psychometric properties of the CINAS in
patients with multiple myeloma (MM) receiving induction chemotherapy
and/or autologous hematopoietic stem cell transplantation. Methods: We
collected demographic and clinical data and administered 2 items measuring
pain and numbness/tingling at its worst (0-10 scale), and the CINAS. A
total CINAS score was computed by summing all 11 CINAS items. For
reliability and validity analyses, we used the highest total CINAS score for
each patient. Validity was assessed by factor analysis and by correlating
CINAS subscales with the pain and numbness/tingling items. Cronbach
alpha reliability coefficients were computed. To test sensitivity, we compared
change in total CINAS score during induction from baseline to last
total CINAS score in a subset of patients (N�20) receiving bortezomib or
thalidomide. We hypothesized that such patients would develop neuropathy.
Results: Ninety patients were enrolled. Participants were primarily
white (90%) and male (63%). Factor analysis revealed 3 underlying
constructs for the CINAS - sensory, motor functioning, and allodynia -
explaining 74% of the common variance. Cronbach alphas were 0.84,
0.85, and 0.83 for the sensory, motor functioning, and allodynia subscales,
respectively, while subscale correlations with the numbness/
tingling item were 0.74, 0.56, and 0.52, respectively. Pain was only
modestly correlated with these subscales (0.21, 0.36, 0.29). Total CINAS
scores of patients receiving bortezomib or thalidomide induction worsened
significantly (from 3.4 to 11.9, effect size�0.55, p�.02). Conclusions:
The CINAS demonstrated validity, reliability and sensitivity in patients with
MM during and after chemotherapy and can be used to assess the
multidimensional aspects of chemotherapy-induced neuropathy.
Patient and Survivor Care
601s
9139 General Poster Session (Board #50E), Sat, 8:00 AM-12:00 PM
Advance care planning (ACP) among hematopoietic cell transplant (HCT)
patients and bereaved caregivers. Presenting Author: Elizabeth T. Loggers,
Fred Hutchinson Cancer Research Center, Seattle, WA
Background: HCT remains a high risk, potentially curative treatment
typically offered to young, otherwise healthy patients with hematologic
malignancies. Given this, patients and caregivers may not have considered
end-of-life ACP. This study investigated the effect of pre-transplant ACP in
surviving patients or bereaved caregivers. Methods: A retrospective, mixedmethods,
audio-taped telephone survey adapted from validated instruments
was conducted by a trained interviewer with English-speaking HCT
survivors (n�18) and bereaved caregivers (n�11), 6-12 months post-HCT.
Subjects were identified via HCT databases at two high-volume, tertiary
centers between 2001-2003. Analysis included percentages from quantitative
sections and qualitative transcripts coding by 2 investigators, with
differences resolved by consensus. Results: HCT survivors [median age 47
years (range 33-67); 50% college-educated; all white] were interviewed a
median of 13 months after HCT for acute leukemia (7), lymphoma (5), or
other (6). Twelve (67%) had discussed mortality risk pre-HCT with the
medical team; of these, 83% felt hope was increased or unchanged (I/U)
and 100% felt clinician commitment to transplant was I/U by the
conversation. Regardless of whether mortality was discussed, 50% had
living wills and �75% had a formal proxy, yet 67% didn’t discuss mortality
with family members pre-HCT. “Ignorance is bliss” was expressed by 6
survivors while 2 survivors regretted not discussing mortality risk. Bereaved
caregivers [73% spouses; all W] were interviewed a median of 10 months
after their loved one’s death, which occurred a median of 31 days (range
13-152) post-HCT. 100% were the patient’s proxy. Nine (82%) had
discussed mortality risk pre-HCT with the medical team; of these, 78% felt
hope was I/U, 100% felt clinician commitment to transplant was I/U, and
78% discussed EOL preferences with the patient pre-HCT, with 67%
feeling ACP reduced burden. Four expressed appreciation for “the straight
story.” Conclusions: Discussions of potential mortality with patients and
caregivers before HCT did not affect hope, and supported confidence in
medical teams.
9141 General Poster Session (Board #50G), Sat, 8:00 AM-12:00 PM
Physical and functional well-being in women with breast cancer taking
gabapentin for hot flashes. Presenting Author: Kavita Dayal Chandwani,
University of Rochester Medical Center, Rochester, NY
Background: Hot flashes reduce quality of life (QOL) in women with breast
cancer. In a randomized, double-blind, placebo-controlled trial of gabapentin
for hot flashes, 900 mg of the drug was found to reduce hot flashes in
women with breast cancer; however, their QOL of has not been studied. We
conducted secondary analyses to study two domains of QOL: physical
(PWB) and functional well-being (FWB) in women in this trial. Methods: A
nationwide sample of women with breast cancer and hot flashes � 2/day
was studied at baseline (T1), 4 weeks (T2), and 8 weeks (T3) of treatment
with gabapentin 300mg/day (G300) and 900mg/day (G900) in divided
doses, and a matching placebo (PL). PWB and FWB were assessed via
subscales of the Functional Assessment of Cancer Therapy-Breast. Linear
mixed model analyses of PWB and FWB were conducted, adjusted for
demographic and treatment variables. Results: The mean age of women
(N�384) was 54.9 years � 8.07 (range: 31-81, 72% �50 years); 76%
were married; 71% had more than high school education; 95% were
Caucasian and 3% African-American; 10% were undergoing chemotherapy,
and 9% radiotherapy (RT). PWB showed significant time effect
(p�.0001) and interaction of time and treatment (p�.0001). There was an
improvement in PWB in the G300 by T2 with no change at T3, while the
improvement in PL and G900 was more modest at T2 and continued at T3
(PL - T1 20.7, T2 21.2, T3 21.6; G300 - T1 20.9, T2 22.2, T3 22.2; and
G900 - T1 21.2, T2 21.5, T3 21.7). FWB also showed a significant time
effect (p�.001) and interaction of time and treatment (p�.002). FWB in
G300 improved by T2, with no additional improvement at T3; it was
unchanged in G900 at T2 with a slight reduction at T3; PL showed a
modest improvement at T2 followed by a modest worsening at T3 (PL - T1
17.8, T2 18.1, T3 17.9; G300 - T1 17.9, T2 18.6, T3 18.6; G900 - T1
18.6, T2 18.6, T3 18.5). Conclusions: As reported previously, G900 is
effective in reducing hot flashes. In this analysis, however, PWB and FWB
showed different patterns of change over time between the two gabapentin
and placebo groups with G900 showing minimal effects on PWB and FWB.
Future trials to further study the changes in physical and functional
well-being of women with breast cancer taking gabapentin for hot flashes
are needed.
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