General Poster Session B (Board #A67), Fri, 12:00 PM - 1:30 PM and
`
`315
`5:30 PM - 7:00 PM
`3 tumor of the breast: A single centre experience. N. Ghosal, S. Tolan, R.
`pilot B. Magee, A. Stewart; The Christie Hospital, Manchester, United Kingdom
`swinaen
`ound: Phyllodes tumour (PT) is a rare fibroepithelial neoplasm with significant
`packareth local recurrence and distant spread. Local excision (LE) or mastectomy
`risk : treatment of choice butthe role of radiotherapy (RT) is unclear. Methods: The
`(MM) IS all patients with PT treated between 1983 and 2005 at The Christie,
`cha neste’, UK were reviewed. Clinico-pathological and treatment outcome data
`Mane recorded. Results: 39 patients (median age 49.5 yr) were treated for tumors
`ified histologically as benign (14), borderline (3), or malignant(22). Benign tumors
`commonerin youngerpatients (median age 39.6 yr v 55.9 yr for malignant,p =
`6) 20 patients were treated with LE, 19 with MX and 5 patients had axillary
`0,006" all were node negative. 11 patients (28%) received RT; indications included
`Seour size and close margins. Median follow up is 12.6 yr (range 1.3-26.0 yr).
`la9e yr relapse free survival (RFS) for benign and malignant tumors is 79% and 43%
`ie ctively (p=0.004) and 67% for the borderline group. LE (93%) was the treatment
`espe
`e for benign tumors. Adjuvant RT wasusedin 1 patient post-LE andin 4 patient
`of cholc
`r repeated excisions for recurrence: no further relapse occurred. The 10 yr RFS for
`BN nts treated with LE is 77%. 3 borderline tumors were treated as follows MX
`a X + RT and LE alone (required salvage MX for relapse}. 16 patients with
`por nant tumors had a MX (72%), with a 10 yr RFS of 56%. 44% received post-MX
`i erith little effect on relapse observed. All 6 patients with malignant histology
`B ated by LE relapsed. The median survival for patients with malignant tumors was
`ES yr. All 3 patients who died of distant disease had malignant tumors, however1
`Bont with allegedly benign histology died of metastatic. sarcomatoid carcinoma,
`ossibly representing malignant
`transformation. Conclusions: LE is satisfactory
`freatment for benign PT, but was associated with a 100% localfailure rate for
`malignant tumors. Multiple attempts to re-excise should be avoided 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 deemedathighrisk oflocalfailure.
`
`TREATMENT
`
`316
`
`General Poster Session B (Board #A68), Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`
`Breast cancer managementby nurses: Survey showing gapsin clinical knowledge. H. J.
`Burstein, P. Peterson CCMEP, E, Rudell CCMEP; Dana-Farber Cancer Institute,
`Boston, MA; Projects In Knowledge, Little Falls, NJ
`Background: Self-assessments, while subjective, may determine gaps in knowledge
`and competencethat 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 competenceofUSclinicians involved in
`breast cancer treatment, PIK surveyedits proprietary database ofclinicians who care
`for these patients. Methods: Online questionnaires were sentto clinicians who care
`for breast cancerpatients, including participants in PIK’s year-long CME curriculum in
`breast cancer management. Participants were asked to choose the response(highly,
`somewhat, or notat all competent) that best representedtheir knowledgeandskills
`on 12 topics related to breast cancer, including its diagnosis, epidemiology, genetics,
`pathophysiology, and treatment; the rationale for using, and the safety andefficacy of,
`endocrine/hormone and targeted therapies;
`the ability to distinguish among and
`manage theside 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/nursepractitioners. On each question, >80% ofthelatter 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 notat all competent in discussing the safety and efficacy of biologic and
`endocrine therapies, respectively; and 48% as notatall competentin distinguishing
`among and managing the side effects of chemotherapy and targeted agents.
`Conclusions: High percentages of nurses/nursepractitioners reported gapsin clinical
`knowledge and competenceontopics related to the diagnosis and treatmentof breast
`cancer patients, especially in the use of targeted therapies. Education addressing
`these gaps may lead to practice improvement amongtheseclinicians.
`
`317
`
`General Poster Session B (Board #A69), Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`318
`
`General Poster Session B (Board #A70}, Fri, 12:00 PM - 1:30 PM and
`5:30 PM - 7:00 PM
`
`Studies of bioavailability and food effects of MER-101 zoledronic acid tablets in postmeno-
`pausal women.
`7. W. Leonard, C. McHugh, K. Madigan, A. Walsh, J. Fox; Merrion
`Pharmaceuticals LLC, Wilmington, NC; Merrion Pharmaceuticals Ireland Ltd, Dublin,
`freland
`
`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-101 uses GIPET to achieve oncological doses with
`excellent GI 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 1mgIV infusion. Methods: MER-101--01, a single
`weekly dose, openlabel, 3-way crossover study in 13 osteoporotic wornen examined
`10mg and 20mg MER-101 tablets versus a img IV infusion. Absorption was
`determined via an LCMS urine assay ofaliquots 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
`MER-101 15mg and 20mgtablets versus the IV infusion. Absorption was determined
`using an LCMSassay 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, overnightfast,
`breakfast 30 minutes later. (b) MER-101 20mg, overnight fast, breakfast 30 minutes
`later. (c) MER-101 20mg, FDA standardized breakfast. {d) MER-101 20mg, bedtime,
`following a 4-hour fast.
`(e) ZA img IV infusion. Safety assessments included AE
`Monitoring, PE, hematology, urinalysis, and blood chemistry panels. Results: Bioavail-
`ability of MER-101 20mgtablet was equal to a Img ZAinfusion; the 10mg tablet was
`approximately half the 1mg ZA infusion. Administration of the 20mg tablet with food
`fesulted in a large reduction in bioavailability. MER-101 absorption improved with the
`highttime dosing regimen and with the morning dose/4-hour fasting regimen. Serum
`Profiles indicate retention of enteric tablets in the stornach longer than 30 minutes.
`qT €
`resultant food interaction from the shorter fasting time likely resulted in reduced
`‘Oavailability. Conclusions: The MER-101 20mg tablet dosed weekly for 4 weeks
`Provides a systemic dose equivalent to a 4mg zoledronic acid IV infusion. MER-101
`Potentially offers a substantial
`improvement over IV infusion in bisphosphonate
`Srapy for women with breast cancer.
`*
`
`Changesin clavicle structure assessed by radiogrametry may predictfracture risk in breast
`cancer (BC) women during adjuvant anastrozole (aANS). J. Wojtacki, K. W. Zielinski, 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 haslimited value in predicting BFR in BC pts taking
`aromataseinhibitors. Evidence exists that other than densitometric (“bone quantity”)
`features of bone (bone geometry, microstructure: “bone quality”) may contribute to
`changes in BFR. Theinfluence of aANS on radiogrametrical bone structure andits
`predictive value for BFR was studied. Methods: 48 BC women taking aANSas 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 andII. rib based on chest PA X-ray
`radiagrams 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 (S/C - “geometrical”
`parameter)
`increases significantly during ANS in both skeletal
`locations (clavicle
`p<0,001; II. rib p<0,01); in the control group only statistically insignificant raise in the
`S/C was seen; 2) increase in the contrast between cortical and spongiouspart of bone
`shadowin 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 II. rib was not significant: 4) there was no differencein
`the value of changes of parameterC in time for both analyzed locations and groups;
`5) pts with fractures during aANS (N=11) hadsignificantly higher increase in the S/C
`per month than those without fractures (p=0,0475) and controls (p<0,001); however,
`initial values of S/C did notdiffer significantly between above groups. Conclusions:1}
`ANSexerts osteopathic activity and induces quantitative changes in bone geometry,
`which mayrelate to increased BFR; 2) analysis ofvariations in values of the S/C during
`aANS seemsto be helpful in predicting BFR; its clinicalfeasibility forit will be assessed
`in the prospective study on more representative groupof pts.
`
`Grun. Exh. 1064
`PGRfor U.S. Patent No. 9,408,862
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`141
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`Grun. Exh. 1064
`PGR for U.S. Patent No. 9,408,862
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