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

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9057 General Poster Session (Board #40D), Sat, 8:00 AM-12:00 PM<br />

Widespread use <strong>of</strong> complementary and alternative medicine (CAM) among<br />

non-Hodgkin lymphoma (NHL) survivors. Presenting Author: Alexis D. Leal,<br />

Mayo Clinic, Rochester, MN<br />

Background: The incidence <strong>of</strong> CAM use among patients with cancer is<br />

higher when compared to the general population. However, there are few<br />

studies examining CAM use in NHL survivors, and limited data are available<br />

regarding beliefs in CAM. This study was conducted to examine the<br />

prevalence <strong>of</strong> CAM use in NHL, define CAM beliefs among NHL survivors,<br />

and explore differences between patients with indolent and aggressive<br />

lymphoma. Methods: Newly diagnosed lymphoma patients were prospectively<br />

enrolled within 9 months <strong>of</strong> diagnosis in the University <strong>of</strong> Iowa/Mayo<br />

Clinic SPORE Molecular Epidemiology Resource from 2002-2008. NHL<br />

patients who completed the 3-year post diagnosis questionnaire, which<br />

includes questions regarding CAM use and beliefs, were included in this<br />

study. Chi-squared tests and Wilcoxon rank-sum tests were used to assess<br />

the association <strong>of</strong> CAM use with prognostic and demographic factors.<br />

Results: 719 patients were included with a median age <strong>of</strong> 63 years (range<br />

22-92). 53% were male. Overall, 636 (89%) reported ever using CAM.<br />

78% <strong>of</strong> patients used vitamins and 54% alternative therapies (chiropractic<br />

(36%) and massage therapy (24%)). Among CAM users, 141 (22%)<br />

believe CAM can assist the body to heal, 123 (19%) believe CAM can<br />

relieve cancer symptoms, 115 (18%) believe CAM use gives a feeling <strong>of</strong><br />

control, 106 (17%) believe CAM can boost immunity, 24 (4%) believe<br />

CAM can cure cancer, and 35 (6%) believe CAM can prevent the spread <strong>of</strong><br />

cancer. Female gender was associated with increased overall CAM use<br />

(p�0.0001) as well as use <strong>of</strong> vitamins (p�0.0001), herbal supplements<br />

(p�0.006) and alternative therapy (p�0.0002) specifically for cancer.<br />

Older age was also associated with increased vitamin use (p�0.005) and<br />

decreased herbal supplements use (p�0.008). There was no significant<br />

difference in overall CAM use between those with follicular lymphoma<br />

grades I-II (n�195, 91%) and non-relapsed diffuse large B-cell lymphoma<br />

(n�151, 87%), although massage therapy was utilized more <strong>of</strong>ten by FL<br />

survivors (29% versus 18%, p�0.005). Conclusions: CAM modalities are<br />

used by the majority <strong>of</strong> NHL survivors (89%). The assessment <strong>of</strong> CAM use<br />

and education regarding potential harms is imperative for the NHL survivor.<br />

9059 General Poster Session (Board #40F), Sat, 8:00 AM-12:00 PM<br />

Prevention <strong>of</strong> palmoplantar erythrodysesthesia (PPE) with an antiperspirant<br />

in breast cancer patients treated with pegylated liposomal doxorubicin<br />

(PLD), a placebo-controlled, double blinded, phase lll trial (SAKK 92/08).<br />

Presenting Author: Thomas Ruhstaller, Swiss Group for <strong>Clinical</strong> Research,<br />

Berne, Switzerland<br />

Background: PPE, also known as hand-foot syndrome, is a distinctive<br />

adverse drug reaction <strong>of</strong> PLD treatment. PLD has been detected in elevated<br />

concentrations in eccrine sweat glands in palms and soles. We postulated<br />

that prophylactic administration <strong>of</strong> an antiperspirant (F511 cream) prior<br />

and during treatment with PLD could decrease the incidence <strong>of</strong> PPE.<br />

Methods: Patients (pts) with metastatic breast cancer treated with PLD<br />

monotherapy �10mg/m2 per week applied an antiperspirant to the left or<br />

right hand and foot and a corresponding placebo to the opposite site with<br />

double-blinding for the content <strong>of</strong> the cream applied to either side<br />

(intra-patient randomization). The creams were applied once daily during<br />

the first week, then three times per week. The primary endpoint was the rate<br />

<strong>of</strong> PPE grade (G) � 2 in the antiperspirant or placebo treated side. Pts were<br />

evaluable if they developed PPE G � 2 or had received cumulatively at least<br />

160mg/m2 PLD. Patient-reported extent <strong>of</strong> symptom burden was a secondary<br />

endpoint. Using McNemar’s matched pairs design 53 pts were needed<br />

to detect a difference <strong>of</strong> 20% between the sides with a significance level <strong>of</strong><br />

5% and power <strong>of</strong> 90%. Results: 52 <strong>of</strong> 90 pts from 11 Swiss centers<br />

included were evaluable. Median age was 64.5 years; median duration <strong>of</strong><br />

PLD treatment was 12 weeks. 30 pts developed PPE G � 2. In 3 pts PPE G<br />

� 2 occurred on the placebo side but not on the antiperspirant side<br />

(p�0.097; table). PPE G � 2 was borderline significantly more frequent in<br />

placebo foot than antiperspirant foot (p�0.048). Patient-reported extent <strong>of</strong><br />

symptom burden showed a trend in favor <strong>of</strong> the antiperspirant side for skin<br />

problems (peeling, blistering, bleeding) in the group <strong>of</strong> pts with PPE G � 2<br />

(p�0.051). Conclusions: In this double-blind trial with intra-patient randomization<br />

we observed a trend towards less PPE G � 2 with application <strong>of</strong> the<br />

antiperspirant cream F511 in pts treated with PLD as determined by the<br />

treating physician and reported by the pts.<br />

Antiperspirant side<br />

PPE grade > 2 toxicity<br />

No Yes Total<br />

Placebo side<br />

No 22 (42%) 0 (0%) 22 (42%)<br />

Yes 3 (6%) 27 (52%) 30 (58%)<br />

Total 25 (48%) 27 (52%) 52 (100%)<br />

Patient and Survivor Care<br />

581s<br />

9058 General Poster Session (Board #40E), Sat, 8:00 AM-12:00 PM<br />

Prospective survey study regarding the implementation <strong>of</strong> new communication<br />

skills curriculum for medical oncology trainees. Presenting Author:<br />

Nathan M. Shumway, San Antonio Military Medical Center, Ft. Sam<br />

Houston, TX<br />

Background: After a diagnosis <strong>of</strong> cancer, many patients suffer from anxiety<br />

and distress from uncertainty <strong>of</strong> symptoms, treatments, and prognosis.<br />

Clinicians must recognize opportunities to explore concerns. This study<br />

assesses oncology trainees’ views about communication with cancer<br />

patients before (PRE) and after (POST) a 12 month curriculum. Methods:<br />

Medical oncology fellows were surveyed PRE and POST a communication<br />

curriculum consisting <strong>of</strong> case studies and 6 core lectures which included<br />

fundamentals, breaking bad news, transitions to palliative care, advanced<br />

care planning, conducting family conferences, and discussing treatment<br />

options and informed consent. A 5 point Likert-scale was used to measure<br />

fellows’ attitudes and comfort regarding communication PRE and POST<br />

with questions grouped according to core topics. (�2 � trainee disagreement,<br />

3�neutral opinion, and � 4 indicated agreement). Results: PRE and<br />

POST surveys were completed by 11 and 8 trainees respectively. In PRE<br />

100% felt communication skills were important and 63% believed these<br />

skills could be taught. 82% felt there was not enough time during most<br />

visits to address emotion. This decreased to 27% in POST. 18% PRE<br />

agreed they were comfortable recognizing coping mechanisms versus<br />

100% POST. 45% felt comfortable eliciting values in PRE versus 87.5%<br />

POST. Only 1 fellow (9%) felt comfortable addressing futility in PRE versus<br />

25% in POST. The median grouped score for fundamentals increased from<br />

15 to 17 (p�0.016) and median grouped score for advance care plans and<br />

DNR increased from 11 to 13(p�0.026). Conclusions: There is a need to<br />

improve oncology communication skills. Our curriculum is just one approach.<br />

After intervention, the majority <strong>of</strong> fellows agreed there was enough<br />

time to address emotion and felt more comfortable recognizing coping<br />

mechanisms and eliciting values. Discussing futility remains difficult for<br />

our fellows. All fellows were more comfortable with fundamental communication<br />

skills and advance care plans after the curriculum. The extent the<br />

curriculum contributed to the change in survey results is unclear. Further<br />

research is needed to guide communication education <strong>of</strong> oncologists.<br />

9060 General Poster Session (Board #40G), Sat, 8:00 AM-12:00 PM<br />

Pharmacokinetics, pharmacodynamics, and tolerability <strong>of</strong> BCD-017, a<br />

novel pegylated filgrastim: Results <strong>of</strong> open-label controlled phase I study<br />

with dose escalation in healthy volunteers. Presenting Author: Kirill D.<br />

Nikitin, BIOCAD, Moscow, Russia<br />

Background: Pegfilgrastim (conjugate <strong>of</strong> filgrastim and 20 kDa PEG) is<br />

approved for treatment <strong>of</strong> chemotherapy-associated neutropenia. BCD-017<br />

is a covalent conjugate <strong>of</strong> filgrastim with 30 kDa PEG. Increased molecular<br />

weight <strong>of</strong> PEG molecule may provide additional benefits compared to<br />

pegfilgrastim. We have conducted this open-label phase I study to assess<br />

the PK, PD and tolerability <strong>of</strong> BCD-017. Methods: 24 healthy male<br />

volunteers signed the informed consent and were sequentially assigned to<br />

receive 1, 3 or 9 mg <strong>of</strong> BCD-017 or 5 mcg/kg/day <strong>of</strong> filgrastim for 7 days, 6<br />

volunteers per group. Outcome measures included absolute neutrophil<br />

count (ANC) and �D34� cell count, PK parameters and adverse events<br />

(AEs). Results: BCD-017 induced a fast and significant increase <strong>of</strong> ANC.<br />

Median maximum ANC (ANCmax) for BCD-017 1, 3, 9 mg and filgrastim<br />

was 18.68 (10.62-21.02), 25.92 (15.43-28.07), 32.22 (18.22-45.79),<br />

and 28.21 (21-31.95) �103 cells/mm3 , respectively; median time to<br />

ANCmax was 24 (12-24); 48 (24-72); 72 (48-72); and 132,5 (12-169) h,<br />

respectively; median increase in �D34� cells number 96 h post dose was<br />

4.7 (1.2-6.5), 6.5 (1.7-12.3), 40.9 (24.5-102), and 17.8 (3.3-35.2)<br />

times, respectively. Filgrastim serum concentration was analyzed using<br />

ELISA. Median Cmax for BCD-017 3 and 9 mg and filgrastim was 45<br />

(31-65), 446 (191-649), and 40 (20-54) ng/mL, respectively; median<br />

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<br />

was well tolerated. No dose-limiting AEs were observed. AEs included<br />

headache, back pain, myalgia, arthralgia, thrombocytopenia, hyperuricemia,<br />

alkaline phosphatase/LDH increased. All AEs were <strong>of</strong> grade 1-2.<br />

Compared to filgrastim, the best tolerability was observed in 3 mg group.<br />

Conclusions: BCD-017 is shown to be a potent stimulator <strong>of</strong> granulopoiesis.<br />

BCD-017 3 mg did not differ from filgrastim in terms <strong>of</strong> ANC increase and<br />

its safety was shown in healthy volunteers. Further phase II study <strong>of</strong><br />

BCD-017 for treatment and prophylaxis <strong>of</strong> neutropenia in patients receiving<br />

cytotoxic chemotherapy is necessary.<br />

Visit abstract.asco.org and search by abstract for the full list <strong>of</strong> abstract authors and their disclosure information.

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