`
`TREATMENT
`
`315
`
`General Poster Session B (Board #A67), Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`5 tumor of the breast: A single centre experience. N, Ghosai _S. Toian, H.
`B, Magee, A. Stewart; The Christie Hospital, Manchester, United Kingdom
`ound: Phyllodes tumour (PT) is a rare fibroepithelial neoplasm with significant
`Backgrboth local recurrence and distant spread. Local excision (LE) or mastectomy
`ri5 of treatment of choice but the role of radiotherapy (RT) is unclear. Methods: The
`(MXl'Sof all patients with PT treated between 1983 and 2005 at The Christie,
`chafishester, UK were reviewed. Clinico—pathological and treatment outcome data
`Mano ecorded. Results: 39 patients (median age 49.5 yr) were treated for tumors
`w re'fged histologically as benign (14), borderline (3), or malignant (22). Benign tumors
`claSSIcommoner in younger patients (median age 39.6 yr v 55.9 yr for malignant, p =
`War?) 20 patients were treated with LE, 19 with MX and 5 patients had axillary
`0'00 '
`- all were node negative. 11 patients (28%) received RT; indications included
`surgetu'mour size and close margins. Median follow up is 12.6 yr (range 1.3—26.0 yr).
`large10 yr relapse free survival (RFS) for benign and malignant tumors is 79% and 43%
`The ectively (p=0.004) and 67% for the borderline group. LE (93%) was the treatment
`resFaoice for benign tumors. Adjuvant RT was used in 1 patient post-LE and in 1 patient
`ofc repeated excisions for recurrence: no further relapse occurred. The 10 yr RFS for
`afterms treated with LE is 77%. 3 borderline tumors were treated as follows MX
`Pa“: Mx + RT and LE alone (required salvage MX for relapse). 16 patients with
`aw“ pant tumors had a MX (72%), with a 10 yr RFS of 56%. 44% received post-MX
`mTa gyith little effect on relapse observed. All 6 patients with malignant histology
`R gated by LE relapsed. The median survival for patients with malignant tumors was
`“% y, A“ 3 patients who died of distant disease had malignant tumors, however 1
`agent with allegedly benign histology died of metastatic-sarcomatoid carcinoma,
`ossibly representing malignant
`transformation.
`.Conclusions: LE is satisfactory
`treatment for benign PT, but was associated‘wnh a 100% local failure rate for
`malignant tumors. Multiple attempts to re—exc:se should be. av0ided and MX per-
`formed instead. MX provided superior local control of malignant PT. RT did not
`significantly impact local control; however numbers treated were small. it should be
`considered for malignant tumors deemed at high risk of local failure.
`
`316
`
`General Poster Session B (Board #A68), Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`_H. i
`Breast cancer management by nurses: Survey showing gaps in clinical knowledge.
`_B_L_1rstein, P. Peterson CCMEP, E. Rude/l CCMEP; Dana-Farber Cancer institute,
`Boston, MA; Projects In Knowledge, Little Falls, NJ
`Background: Self-assessments, while subjective, may determine gaps in knowledge
`and competence that affect performance. Projects In Knowledge (PIK), an approved
`provider of continuing medical and nursing education, implements programs in breast
`cancer. To gauge the current knowledge and competence of US clinicians involved in
`breast cancer treatment, PIK surveyed its proprietary database of clinicians who care
`for these patients. Methods: Online questionnaires were sent to clinicians who care
`for breast cancer patients, including participants in PlK‘s year-long CME curriculum in
`breast cancer management. Participants were asked to choose the response (highly,
`somewhat, or not at all competent) that best represented their knowledge and skills
`on 12 topics related to breast cancer, including its diagnosis, epidemiology, genetics,
`pathophysiology, and treatment; the rationale for using, and the safety and efficacy of,
`endocrine/hormone and targeted therapies;
`the ability to distinguish among and
`manage the side effects of these agents; and the relationship between drug class and
`survival relative to patient and tumor characteristics. Results: Of 303 responses, 151
`were from nurses/nurse practitioners. On each question, >80% of the latter reported
`being less than highly competent. Most described themselves as highly (9%) or
`somewhat (57.3%) competent on breast cancer epidemiology and as highly (18%) or
`somewhat (62%) competent on demographic factors related to treatment. In contrast,
`65% and 46% described themselves as not at all competent in discussing the
`rationale for using targeted biologic and endocrine therapies, respectively; 63% and
`57% as not at all competent in discussing the safety and efficacy of biologic and
`endocrine therapies, respectively; and 48% as not at all competent in distinguishing
`among and managing the side effects of chemotherapy and targeted agents.
`Conclusions: High percentages of nurses/nurse practitioners reported gaps in clinical
`knowledge and competence on topics related to the diagnosis and treatment of breast
`cancer patients. especially in the use of targeted therapies. Education addressing
`these gaps may lead to practice improvement among these clinicians.
`
`317
`
`General Poster Session B (Board #A69), Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`Studies of bioavailability and food effects of MEB-101 zoledronic acid tablets in postmeno-
`pausal women.
`T. W. Leonard, C. McHugh, K. Madigan, A. Walsh, J. Fox; Merrion
`Pharmaceuticals LLC, Wilmington, NC; Merrion Pharmaceuticals ire/and Ltd, Dublin,
`ire/and
`
`Background: MER-101 is an alternate administration route for zoledronic acid (ZA) iv
`infusion. The weekly enteric— coated tablet delivers systemic ZA doses equivalent to
`monthly 4mg infusions. MER-iOl uses GIPET to achieve oncological doses with
`excellent Gl tolerability. The objectives of MER-101—01 and MER-101—02 were to
`examine the bioavailability and food effects on absorption of different strengths and
`regimens of MER-101 versus ZA 1mg iv infusion. Methods: MER—101—01, a single
`weekly dose, open label, 3—way crossover study in 13 osteoporotic women examined
`10mg and 20mg MER-101 tablets versus a 1mg IV infusion. Absorption was
`determined via an LCMS urine assay of aliquots for 48 hours post-dose. Dosing was
`after an overnight fast, which continued 4-hours post-dose. MER-101—02, a single—
`dose, open label, 5-way crossover study in 30 postmenopausal women examined
`MEFl-101 15mg and 20mg tablets versus the IV infusion. Absorption was determined
`using an LCMS assay of serum collected pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 5, 7, 10,
`14. 24, and 36 hours post-dose. Treatment arms: (a) MER- 101 15mg, overnight fast,
`breakfast 30 minutes later. (b) MEFl—101 20mg, overnight fast, breakfast 30 minutes
`Pier. (0) MER—101 20mg, FDA standardized breakfast. (01) MER—101 20mg, bedtime,
`following a 4—hour fast.
`(e) ZA 1mg lV infusion. Safety assessments included AE
`monitoring, PE, hematology, urinalysis, and blood chemistry panels. Results: Bioavail—
`ability of MER-101 20mg tablet was equal to a 1mg ZA infusion; the 10mg tablet was
`al3l>roximately half the 1mg ZA infusion. Administration of the 20mg tablet with food
`rGllsulted in a large reduction in bioavailability. MER-101 absorption improved with the
`nIghttime dosing regimen and with the morning dose/4~hour fasting regimen. Serum
`profiles indicate retention of enteric tablets in the stomach longer than 30 minutes.
`The resultant food interaction from the shorter fasting time likely resulted in reduced
`bioavailability. ConCIusions: The MER-101 20mg tablet dosed weekly for 4 weeks
`PFOVides a systemic dose equivalent to a 4mg zoledronic acid iv infusion. MER—iOl
`Potentially offers a substantial
`improvement over IV infusion in bisphosphonate
`therapy for women with breast cancer.
`\
`
`318
`
`General Poster Session B (Board #A70), Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`Changes in clavicle structure assessed by radiogrametry may predict fracture risk in breast
`cancerlBC) women during adjuvant anastrozole (aANS). J. Woltacki K. W. Zieiinski, W J.
`Kruszewski, A. Labuc; Medical University of Gdansk, Gdansk, Poland; Medical
`University, Lodz, Poland
`
`in postmenopausal BC
`Background: aANS increases bone fractures risk (BFR)
`women. Bone mineral density has limited value in predicting BFR in BC pts taking
`aromatase inhibitors. Evidence exists that other than densitometric ("bone quantity”)
`features of bone (bone geometry, microstructure; "bone quality”) may contribute to
`changes in BFR. The influence of aANS on radiogrametrical bone structure and its
`predictive value for BFR was studied. Methods: 48 BC women taking aANS as primary
`endocrine therapy and 37 non-randomly matched pts (no further endocrine therapy
`following adjuvant chemo/radiotherapy) were studied. Bone structure was assessed
`using the radiogrametrical digital analysis of clavicle and Il. rib based on chest PA X-ray
`radiograms taken before and min. after 6 mths of treatment/ observation (median: 16,
`range: 6—45/ 17, range: 6—43, respectively) and then digitally processed using image
`analyzer. Results: 1) the linear spongious/cortical width ratio lS/C — "geometrical"
`parameter)
`increases significantly during ANS in both skeletal
`locations (clavicle
`p<0,001; ||. rib p<0,01); in the control group only statistically insignificant raise in the
`8/0 was seen; 2) increase in the contrast between cortical and spongious part of bone
`shadow in clavicle and ii. rib (C — "densitometric" parameter) was observed in both
`groups; difference did not reach significance; 3) ANS induced significantly higher
`increase in the S/C in clavicle than observed in the control group (p<0,001); the
`difference for data taken from ll. rib was not significant; 4) there was no difference in
`the value of changes of parameter C in time for both analyzed locations and groups;
`5) pts with fractures during aANS (N=11) had significantly higher increase in the S/C
`per month than those without fractures (p=0.0475) and controls (p<0,001); however,
`initial values of SiC did not differ significantly between above groups. Conclusions: 1)
`ANS exerts osteopathic activity and induces quantitative changes in bone geometry,
`which may relate to increased BFR; 2) analysis of variations in values of the S/C during
`aANS seems to be helpful in predicting BFR; its clinical feasibility for it will be assessed
`in the prospective study on more representative group of pts.
`
`
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`Grun. Exh. 1064
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`141
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`PGR for U.S. Patent No. 9,408,862
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`Grun. Exh. 1064
`PGR for U.S. Patent No. 9,408,862
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