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

9057 General Poster Session (Board #40D), Sat, 8:00 AM-12:00 PM
Widespread use of complementary and alternative medicine (CAM) among
non-Hodgkin lymphoma (NHL) survivors. Presenting Author: Alexis D. Leal,
Mayo Clinic, Rochester, MN
Background: The incidence of CAM use among patients with cancer is
higher when compared to the general population. However, there are few
studies examining CAM use in NHL survivors, and limited data are available
regarding beliefs in CAM. This study was conducted to examine the
prevalence of CAM use in NHL, define CAM beliefs among NHL survivors,
and explore differences between patients with indolent and aggressive
lymphoma. Methods: Newly diagnosed lymphoma patients were prospectively
enrolled within 9 months of diagnosis in the University of Iowa/Mayo
Clinic SPORE Molecular Epidemiology Resource from 2002-2008. NHL
patients who completed the 3-year post diagnosis questionnaire, which
includes questions regarding CAM use and beliefs, were included in this
study. Chi-squared tests and Wilcoxon rank-sum tests were used to assess
the association of CAM use with prognostic and demographic factors.
Results: 719 patients were included with a median age of 63 years (range
22-92). 53% were male. Overall, 636 (89%) reported ever using CAM.
78% of patients used vitamins and 54% alternative therapies (chiropractic
(36%) and massage therapy (24%)). Among CAM users, 141 (22%)
believe CAM can assist the body to heal, 123 (19%) believe CAM can
relieve cancer symptoms, 115 (18%) believe CAM use gives a feeling of
control, 106 (17%) believe CAM can boost immunity, 24 (4%) believe
CAM can cure cancer, and 35 (6%) believe CAM can prevent the spread of
cancer. Female gender was associated with increased overall CAM use
(p�0.0001) as well as use of vitamins (p�0.0001), herbal supplements
(p�0.006) and alternative therapy (p�0.0002) specifically for cancer.
Older age was also associated with increased vitamin use (p�0.005) and
decreased herbal supplements use (p�0.008). There was no significant
difference in overall CAM use between those with follicular lymphoma
grades I-II (n�195, 91%) and non-relapsed diffuse large B-cell lymphoma
(n�151, 87%), although massage therapy was utilized more often by FL
survivors (29% versus 18%, p�0.005). Conclusions: CAM modalities are
used by the majority of NHL survivors (89%). The assessment of CAM use
and education regarding potential harms is imperative for the NHL survivor.
9059 General Poster Session (Board #40F), Sat, 8:00 AM-12:00 PM
Prevention of palmoplantar erythrodysesthesia (PPE) with an antiperspirant
in breast cancer patients treated with pegylated liposomal doxorubicin
(PLD), a placebo-controlled, double blinded, phase lll trial (SAKK 92/08).
Presenting Author: Thomas Ruhstaller, Swiss Group for Clinical Research,
Berne, Switzerland
Background: PPE, also known as hand-foot syndrome, is a distinctive
adverse drug reaction of PLD treatment. PLD has been detected in elevated
concentrations in eccrine sweat glands in palms and soles. We postulated
that prophylactic administration of an antiperspirant (F511 cream) prior
and during treatment with PLD could decrease the incidence of PPE.
Methods: Patients (pts) with metastatic breast cancer treated with PLD
monotherapy �10mg/m2 per week applied an antiperspirant to the left or
right hand and foot and a corresponding placebo to the opposite site with
double-blinding for the content of the cream applied to either side
(intra-patient randomization). The creams were applied once daily during
the first week, then three times per week. The primary endpoint was the rate
of PPE grade (G) � 2 in the antiperspirant or placebo treated side. Pts were
evaluable if they developed PPE G � 2 or had received cumulatively at least
160mg/m2 PLD. Patient-reported extent of symptom burden was a secondary
endpoint. Using McNemar’s matched pairs design 53 pts were needed
to detect a difference of 20% between the sides with a significance level of
5% and power of 90%. Results: 52 of 90 pts from 11 Swiss centers
included were evaluable. Median age was 64.5 years; median duration of
PLD treatment was 12 weeks. 30 pts developed PPE G � 2. In 3 pts PPE G
� 2 occurred on the placebo side but not on the antiperspirant side
(p�0.097; table). PPE G � 2 was borderline significantly more frequent in
placebo foot than antiperspirant foot (p�0.048). Patient-reported extent of
symptom burden showed a trend in favor of the antiperspirant side for skin
problems (peeling, blistering, bleeding) in the group of pts with PPE G � 2
(p�0.051). Conclusions: In this double-blind trial with intra-patient randomization
we observed a trend towards less PPE G � 2 with application of the
antiperspirant cream F511 in pts treated with PLD as determined by the
treating physician and reported by the pts.
Antiperspirant side
PPE grade > 2 toxicity
No Yes Total
Placebo side
No 22 (42%) 0 (0%) 22 (42%)
Yes 3 (6%) 27 (52%) 30 (58%)
Total 25 (48%) 27 (52%) 52 (100%)
Patient and Survivor Care
581s
9058 General Poster Session (Board #40E), Sat, 8:00 AM-12:00 PM
Prospective survey study regarding the implementation of new communication
skills curriculum for medical oncology trainees. Presenting Author:
Nathan M. Shumway, San Antonio Military Medical Center, Ft. Sam
Houston, TX
Background: After a diagnosis of cancer, many patients suffer from anxiety
and distress from uncertainty of symptoms, treatments, and prognosis.
Clinicians must recognize opportunities to explore concerns. This study
assesses oncology trainees’ views about communication with cancer
patients before (PRE) and after (POST) a 12 month curriculum. Methods:
Medical oncology fellows were surveyed PRE and POST a communication
curriculum consisting of case studies and 6 core lectures which included
fundamentals, breaking bad news, transitions to palliative care, advanced
care planning, conducting family conferences, and discussing treatment
options and informed consent. A 5 point Likert-scale was used to measure
fellows’ attitudes and comfort regarding communication PRE and POST
with questions grouped according to core topics. (�2 � trainee disagreement,
3�neutral opinion, and � 4 indicated agreement). Results: PRE and
POST surveys were completed by 11 and 8 trainees respectively. In PRE
100% felt communication skills were important and 63% believed these
skills could be taught. 82% felt there was not enough time during most
visits to address emotion. This decreased to 27% in POST. 18% PRE
agreed they were comfortable recognizing coping mechanisms versus
100% POST. 45% felt comfortable eliciting values in PRE versus 87.5%
POST. Only 1 fellow (9%) felt comfortable addressing futility in PRE versus
25% in POST. The median grouped score for fundamentals increased from
15 to 17 (p�0.016) and median grouped score for advance care plans and
DNR increased from 11 to 13(p�0.026). Conclusions: There is a need to
improve oncology communication skills. Our curriculum is just one approach.
After intervention, the majority of fellows agreed there was enough
time to address emotion and felt more comfortable recognizing coping
mechanisms and eliciting values. Discussing futility remains difficult for
our fellows. All fellows were more comfortable with fundamental communication
skills and advance care plans after the curriculum. The extent the
curriculum contributed to the change in survey results is unclear. Further
research is needed to guide communication education of oncologists.
9060 General Poster Session (Board #40G), Sat, 8:00 AM-12:00 PM
Pharmacokinetics, pharmacodynamics, and tolerability of BCD-017, a
novel pegylated filgrastim: Results of open-label controlled phase I study
with dose escalation in healthy volunteers. Presenting Author: Kirill D.
Nikitin, BIOCAD, Moscow, Russia
Background: Pegfilgrastim (conjugate of filgrastim and 20 kDa PEG) is
approved for treatment of chemotherapy-associated neutropenia. BCD-017
is a covalent conjugate of filgrastim with 30 kDa PEG. Increased molecular
weight of PEG molecule may provide additional benefits compared to
pegfilgrastim. We have conducted this open-label phase I study to assess
the PK, PD and tolerability of BCD-017. Methods: 24 healthy male
volunteers signed the informed consent and were sequentially assigned to
receive 1, 3 or 9 mg of BCD-017 or 5 mcg/kg/day of filgrastim for 7 days, 6
volunteers per group. Outcome measures included absolute neutrophil
count (ANC) and �D34� cell count, PK parameters and adverse events
(AEs). Results: BCD-017 induced a fast and significant increase of ANC.
Median maximum ANC (ANCmax) for BCD-017 1, 3, 9 mg and filgrastim
was 18.68 (10.62-21.02), 25.92 (15.43-28.07), 32.22 (18.22-45.79),
and 28.21 (21-31.95) �103 cells/mm3 , respectively; median time to
ANCmax was 24 (12-24); 48 (24-72); 72 (48-72); and 132,5 (12-169) h,
respectively; median increase in �D34� cells number 96 h post dose was
4.7 (1.2-6.5), 6.5 (1.7-12.3), 40.9 (24.5-102), and 17.8 (3.3-35.2)
times, respectively. Filgrastim serum concentration was analyzed using
ELISA. Median Cmax for BCD-017 3 and 9 mg and filgrastim was 45
(31-65), 446 (191-649), and 40 (20-54) ng/mL, respectively; median
Tmax was 48 (24-72), 36 (24-48), and 8 (6-8) h respectively; median T1/2 was 65 (51-70), 46 (41-57), and 6.7 (6.2-7.6) h, respectively. BCD-017
was well tolerated. No dose-limiting AEs were observed. AEs included
headache, back pain, myalgia, arthralgia, thrombocytopenia, hyperuricemia,
alkaline phosphatase/LDH increased. All AEs were of grade 1-2.
Compared to filgrastim, the best tolerability was observed in 3 mg group.
Conclusions: BCD-017 is shown to be a potent stimulator of granulopoiesis.
BCD-017 3 mg did not differ from filgrastim in terms of ANC increase and
its safety was shown in healthy volunteers. Further phase II study of
BCD-017 for treatment and prophylaxis of neutropenia in patients receiving
cytotoxic chemotherapy is necessary.
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