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Annals of Oncology Conclusion: The combination of everolimus and capecitabine has a reasonable toxicity profile and may show significant activity in patients with advanced HCC pretreated with sorafenib. This combination therapy warrants further investigation as a possible second line treatment for selected patients with HCC. Disclosure: All authors have declared no conflicts of interest. 782TiP REVIEW OF THE MANAGEMENT OF ADVANCED GASTRIC CANCER; AN EXPERIENCE FROM A LOW RESOURCE SETTING K. Beecham 1 , V.D.N.K. Vanderpuye 1 , N.A. Adu-Aryee 2 1 Radiotherapy, Korlebu Teaching Hospital, Accra, GHANA, 2 Surgery, Korlebu Teaching Hospital, Accra, GHANA Purpose: Adjuvant treatment combines Epirubicin, Cisplatin and 5-FU (ECF). Replacement of 5FU and Cisplatin with Capecitabine (X) and Oxaliplatin (O) has shown an efficacy similar to ECF, with improved tolerability and safety. The outcome of management of advanced gastric cancer at the Oncology Unit was assessed, with emphasis on the use of Capecitabine alone or in combination. Patients & methods: 27 patients adenocarcinoma of the stomach between 2004 and 2008 were eligible. Time to disease progression (TTP) as well as tolerability of treatment was assessed retrospectively. Results: Median follow up was 12 months (1 to 60 months). No adjuvant treatment was given in 36%. 26% received concurrent chemoradiation with Capecitabine. 11.1% received palliative radiotherapy only. One patient did not complete radiotherapy due to side effects. 26.6% received Capecitabine alone and combined with Oxaliplatin in 11.1% Grade 3/4 diarrhoea was reported in 7.4%; neuropathy and neutropenia were seen in 3.7%. Median time to progression in patients who had adjuvant treatment was 6.4 months (2 to 13 months). Conclusion: There is a favorable tolerability of Capecitabine used alone or in combination with radiotherapy or other chemotherapy drugs. Disclosure: All authors have declared no conflicts of interest. Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds398 | ix257
abstracts genitourinary tumors, non-prostate 783O RANDOMIZED PHASE II STUDY OF FIRST-LINE EVEROLIMUS (EVE) + BEVACIZUMAB (BEV) VERSUS INTERFERON ALFA-2A (IFN) + BEV IN PATIENTS (PTS) WITH METASTATIC RENAL CELL CARCINOMA (MRCC): RECORD-2 A. Ravaud 1 , C. Barrios 2 , Ö. Anak 3 , D. Pelov 4 , A. Louveau 5 , B. Alekseev 6 , T. M-H 7 , S.S. Agarwala 8 , S. Yalcin 9 , B. Melichar 10 1 Medical Oncology, Bordeaux University, Bordeaux, FRANCE, 2 Department of Medicine, PUCRS School of Medicine, Porto Alegre, BRAZIL, 3 Oncology Global Development, Novartis Pharma AG, Basel, SWITZERLAND, 4 Oncology, Novartis Pharmaceuticals Corporation, Florham Park, NJ, UNITED STATES OF AMERICA, 5 Oncology, Novartis Pharma S.A.S., Paris, FRANCE, 6 Oncourological Department, Moscow Hertzen Oncology Institute, Moscow, RUSSIAN FEDERATION, 7 Oncology, OncoCare Cancer Centre, Singapore, SINGAPORE, 8 Cancer Center, St. Luke’s Hospital & Health Network, Bethlehem, PA, UNITED STATES OF AMERICA, 9 Medical Oncology, Hacettepe University Institute of Oncology, Ankara, TURKEY, 10 Department of Oncology, Palacky Univeristy Medical School and Teaching Hospital, Olomouc, CZECH REPUBLIC Background: Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progression-free survival (PFS) per central review based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). Results: In EVE + BEV (n = 182) and IFN + BEV (n = 183) arms, median age was 60/60 years, 76/72% of pts were men, MSKCC risk was favourable/intermediate/poor in 36/57/7% and 36/57/7% of pts, and 43/46% of pts had >2 organs involved, respectively. For EVE + BEV and IFN + BEV, median treatment duration was 8.5/8.3 months, respectively; 23/26% of pts discontinued due to AEs. In EVE + BEV and IFN + BEV arms, median PFS by central review was 9.3/10.0 months (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P =0.485), respectively; probability of subsequent phase III success was 5.1%. Results of central and local PFS analysis were consistent. Objective response rate was 27/28% in EVE + BEV and IFN + BEV arms, respectively. Median overall survival (OS) was not reached in the EVE + BEV arm and was 25.9 months (95% CI: 21.1, 30.2) in the IFN + BEV arm. Most frequent AEs (%) were stomatitis (63), proteinuria (49), diarrhoea (39), hypertension (38), and epistaxis (35) in EVE + BEV arm and decreased appetite (45), fatigue (41), proteinuria (37), and pyrexia (35) in IFN + BEV arm. Conclusions: In RECORD-2, PFS and tolerability were similar for first-line EVE + BEV and IFN + BEV. Final OS analysis will occur after 2-year follow-up. Disclosure: A. Ravaud: Alain Ravaud is a member of global, European, and/or French boards on urological tumors for Pfizer, Novartis, GlaxoSmithKline, Bayer-Schering, and Dendreon, and has received institutional grant support from Pfizer, Novartis, and Roche. Ö. Anak: Ozlem Anak is an employee of Novartis Pharma AG. D. Pelov: Diana Pelov is an employee of Novartis Pharmaceuticals Corporation. A. Louveau: Anne-Laure Louveau is an employee of Novartis Pharma S. A.S. T. M-H: Tay M-H is a speaker for an advisory board for Novartis Pharmaceuticals Corporation. B. Melichar: Bohuslav Melichar has received honoraria from Novartis and Roche and served on an advisory board for Roche. All other authors have declared no conflicts of interest. 784O CLINICAL ACTIVITY AND SAFETY OF ANTI-PROGRAMMED DEATH-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) IN PATIENTS (PTS) WITH PREVIOUSLY TREATED, METASTATIC RENAL CELL CARCINOMA (MRCC) D.F. McDermott 1 , C.G. Drake 2 , M. Sznol 3 , T.K. Choueiri 4 , J.D. Powderly 5 , D.C. Smith 6 , J.M. Wigginton 7 , G. Kollia 8 , A. Gupta 9 , M.B. Atkins 10 1 Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, UNITED STATES OF AMERICA, 2 Department of Urology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD, UNITED STATES OF AMERICA, 3 Section of Medicine Oncology, Yale Cancer Center, New Haven, CT, UNITED STATES OF AMERICA, 4 Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, UNITED STATES OF AMERICA, 5 Oncology, Carolina Bio-Oncology Institute, Huntersville, NC, UNITED STATES OF AMERICA, 6 Department of Internal Medicine, University of Michigan, Ann Arbor, MI, UNITED STATES OF AMERICA, 7 Discovery Medicine-clinical Oncology, Bristol-Myers Squibb, Princeton, NJ, UNITED STATES OF AMERICA, 8 Biostatistics and Data Management, Bristol-Myers Squibb, Princeton, NJ, UNITED STATES OF AMERICA, 9 Discovery Medicine, Immuno-oncology, Bristol-Myers Squibb, Princeton, NJ, UNITED STATES OF AMERICA, 10 Internal Medicine, Georgetown Lombardi Comprehensive Cancer Center, Washington DC, UNITED STATES OF AMERICA Purpose: BMS-936558 is a fully human monoclonal antibody that blocks the PD-1 co-inhibitory receptor expressed by activated T cells. In the initial portion of a phase 1 study, BMS-936558 showed promising activity in pts with various solid tumors, including mRCC. Accrual was expanded to better characterize antitumor, safety, and dose effects. Methods: Pts with RCC were treated with BMS-936558 IV q2wk at 10 mg/kg initially, followed by additional pts at 1 mg/kg. Pts received up to 12 cycles (4 doses/ cycle) of treatment or until unacceptable toxicity, confirmed progressive disease, or complete response (CR). Clinical activity was assessed by RECIST v1.0. Results: As of Feb 24, 2012, 34 mRCC pts had been treated at 1 mg/kg (n = 18) or 10 mg/kg (n = 16). ECOG performance status was 0 in 13 pts and 1 in 21 pts. The number of prior therapies was 1 (n = 10), 2 (n = 9), or ≥3 (n = 15), and included prior immunotherapy (n = 20) or antiangiogenic therapy (n = 25); 32/34 pts had prior nephrectomy. Sites of metastatic disease included lymph node (n = 28), liver (n = 9), lung (n = 30), and bone (n = 10). Median duration of therapy was 32 wks (range 4 − 97.3 wks). The incidence of grade 3 − 4 related adverse events was 18% and included hypophosphatemia (6%), elevated ALT (3%), and cough (3%); there were no drug-related deaths among mRCC pts. Clinical activity (response or prolonged stable disease) was observed at both doses (Table). Two pts had a persistent reduction in target lesion tumor burden in the presence of new lesions and were not categorized as responders. There were responses in all sites of disease. Conclusions: BMS-936558 is well tolerated and has durable clinical activity in pts with previously treated, mRCC. Additional long-term follow-up data will be reported. Dose (mg/kg) No. pts a ORR No. pts (%) [95% CI] 1 17 4 (24) [7 − 50] 10 16 5 (31) [11 − 59]* Annals of Oncology 23 (Supplement 9): ix258–ix293, 2012 doi:10.1093/annonc/mds399 Response duration (months) 17.5 + , 9.2 + , 9.2, 5.6+ 22.3 + , 21.7 + , 12.9, 12.0, 8.4 SD ≥24 wk No. pts (%) [95% CI] 4 (24) [7 − 50] 5 (31) [11 − 59] PFSR at 24 wk (%) [95% CI] 47 [23 − 71] 67 [43 − 91] a Response-evaluable pts dosed by 07/01/2011 *1 CR ORR = objective response rate ([{CR + PR} ÷ n] × 100); SD = stable disease; PFSR = progression-free survival rate. Disclosure: D.F. McDermott: Advisory Role: Bristol-Myers Squibb (myself, Ad board participation). C.G. Drake: Consultant or Advisory Role: Bristol-Myers Squibb, Dendreon Inc., and Amplimmune Inc. (myself, compensated). Stock Ownership: Amplimmune (myself). Other Renumerations: Patents Licensed, Bristol-Myers Squibb (myself). M. Sznol: Consultant or Advisory Role: Bristol-Myers Squibb (myself, compensated). Research Funding: Bristol-Myers Squibb (clinical trials funding, myself). T.K. Choueiri: Consultant or Advisory Role: GlaxoSmithKline, Aveo, Novartis and Pfizer (myself, compensated). Research Funding: Pfizer (myself). © European Society for Medical Oncology 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com
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Annals of Oncology www.annonc.oxfor
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subscriptions A subscription to Ann
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Annals of Oncology Official Journal
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The European Society for Medical On
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Audit Committee Chair: Fortunato Ci
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Familial cancer Judith Balmaña, Ba
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ESMO 2012 Congress Travel Grants 47
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Exhibitors The following companies
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ESMO Fellowships, 1989-2011 The Eur
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Ondrej Gojis, Czech Republic 2008-2
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abstracts hpv biology and implicati
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abstracts the characterization of l
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abstracts description of intra-tumo
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prevent cell death. It is anticipat
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22IN TARGETING THE HOST IN TNBC G.
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abstracts a paradigm shift in early
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abstracts how can medical oncologis
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feasibility), but by how high the c
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abstracts re-inventing the medical
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abstracts emerging diagnostic and t
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abstracts biologically based treatm
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abstracts molecular targets in mali
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abstracts melanoma therapy: from fr
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diagnosis and can also be used for
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analysis at 11 months median follow
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mouse model of Kras mutant NSCLC. I
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abstracts key topics in supportive
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ESMO-CSCO Joint Symposium: Building
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ESMO-EANM-ESR Joint Symposium: Imag
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ESMO-ESTRO Joint Symposium: Innovat
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ESMO-MASCC Joint Symposium: Integra
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ESO Society Symposium: Celebrating
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Results: TIMP-1 expression was incr
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will benefit from this targeted the
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cytomegalovirus (CMV). Analysis of
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functional consequences of Endoglin
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elationship between the ROR score,
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183P EPIDERMAL GROWTH FACTOR RECEPT
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Plasma adiponectin level on the pre
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Table: 198P PFS OS Median, mo HR Me
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204P EVALUATION OF PTEN AND PIK3CA
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Material and methods: We searched P
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Results: The median concentration o
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Table: 226P Methods: Pts were rando
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However, additional analysis sugges
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Conclusions: BW and serum Ctrough o
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261P BREAST CANCER SUBTYPES AND OUT
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90 mg/m2-cyclophophamide 600 mg/m2
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to 9 weeks after dosing. Trastuzuma
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Patients and methods: We reviewed d
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sector patients. The aim of this st
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Linear Logistic Model with Relaxed
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Results: The median CTC fold change
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312: Table: Chemotherapy uptake wit
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abstracts breast cancer, locally ad
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Results: 8 trials (2092 pts) with 1
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absolute difference of median value
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Novartis, Genentech, and sanofi-ave
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Results: Three RCTs with 1023 patie
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collected from all patients for det
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355P FIRST REPORT OF LONG-TERM RESP
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361P A RETROSPECTIVE ANALYSIS OF PL
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publications and aggregated in a me
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Thus the primary aim to target BCSC
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383 WHY DO WOMEN WITH BREAST CANCER
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Results: We evaluated 76 pts with M
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more than 6 cycles of capecitabine.
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406TiP PHASE II TRIAL OF PRIMARY SY
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abstracts CNS tumors 410O CONDITION
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Conclusions: Our data suggested tha
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Conclusions: As in other cancer typ
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432 GAMMA KNIFE RADIOSURGERY AS A M
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abstracts developmental therapeutic
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1PR), but no responses were seen in
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RO and Cd, as well as PD data for c
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and vulvar Ca), and 11 SDs were obs
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knowing HLA-A status double-blindly
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Acquired-resistance to EGFR inhibit
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474P PHASE 1 STUDY OF THE SELECTIVE
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TST is active in breast and gastric
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Treatment-induced shedding of circu
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Methods: Either co-cultures of peri
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501 PRECLINICAL DATA INVESTIGATING
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509TiP LUX-LUNG 8: A RANDOMIZED, OP
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(P = 0.64). Synchronous BBC was sig
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abstracts gastrointestinal tumors,
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Disclosure: M. Lee: I am an employe
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plus intravenous Bev(7.5mg/kg q 21d
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anti-EGFR treatment. The present st
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patients harboring a T/T genotype t
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551P ADJUVANT CHEMOTHERAPY (AC) USE
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experienced significantly more ≥
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functioning scales. Exploratory ana
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oxaliplatin (100 mg/m 2 )/raltitrex
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572P PANERB STUDY: WHICH CATEGORY O
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Results: 92/114 patients were preop
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585P CHANGES IN THE INTESTINAL ENVI
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592P PHASE II TRIAL OF COMBINED CHE
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minutes. In a previous study, 30-mi
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Disclosure: S. Oudard: Has acted as
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939P NEOADJUVANT SIPULEUCEL-T IN LO
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945 BONE TURNOVER MARKERS AND POTEN
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952 SEQUENTIAL ANDROGEN DEPRIVATION
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managed in a multidisciplinary (MD)
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or hypercalcemia at screening; prio
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meeting. The prevalence of LGSC is
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Table: 975PD Continued AMG 386 + pa
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physicians in the U.S. and Europe.
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989P PHASE II STUDY OF COMBINATION
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elated with stage, nodal involvemen
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1004P CASE CONTROL STUDY ON TWO DIF
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eight patients who had infertility
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abstracts head and neck cancer 1016
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same CT/RT; Arm B2: 3 cycles of ind
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induction chemotherapy in the treat
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patients. We have developed a rando
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morbidities that radiation would le
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Conclusions: Through adequate selec
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abstracts hematological malignancie
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anthracyclines in vitro. A favorabl
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than the standard target of ≥2.5
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Patients: From November 2002 to May
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lymphadenopathy and multiple cutane
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prospective non-interventional stud
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Funding: GSK Biologicals Disclosure
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survival rates of 13-25% (Prieto et
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high response rates and prolonged p
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GlaxoSmithKline, Merck Sharp & Dohm
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advisor for Merck Sharp & Dohme, an
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or cutaneous melanoma. A survival u
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systemic therapy or were intolerant
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abstracts neuroendocrine tumors and
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morbidity, with G3 tumors behaving
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pts. Poorly differentiated endocrin
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Adenocarcinoma was present in 25 pa
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Method: Endobronchial ultrasound gu
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widely used by single agent or plat
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disease after surgery were treated
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stage IIIA NSCLC, EML4-ALK fusion-p
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1200P CONCOMITANT CHEMORADIATION GI
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Patients and methods: The study was
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months (95% CI:13-25). The PFS and
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maintenance therapy had favourable
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abstracts non-small cell lung cance
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Ingelheim, GSK Biologicals (compens
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1234PD RANDOMIZED PHASE III TRIAL O
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GlaxoSmithKline (myself, compensate
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1243P IDENTIFICATION OF MICRORNA (M
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N-arm n=34 P-arm n=32 All n=66 Male
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1255P POPULATION BASED EVALUATION O
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1262P DISTINCT SPREAD OF EGFR MUTAT
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1268P VISUAL DISTURBANCES IN PATIEN
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MERCK SERONO: Advisor, speaker in s
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Conclusions: These data from SAiL a
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NSCLC diagnosis and time of BM diag
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1291P PHASE I/II DOSE-FINDING STUDY
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Network utilization of WBCGF in the
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1303P COST EFFECTIVENESS OF PEMETRE
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Results: The patients’ characteri
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EGFR mut at exons 18, 19, 21, and K
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Methods: EML4-ALK fusion was screen
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Results: The median survival time (
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enefit from sustained EGFR blockade
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epresented by 19 pts (32%) female,
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and at least one prior course of ch
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Methods: NSCLC patients with radiog
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1367TiP LONG-TERM ERLOTINIB THERAPY
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Austria, Czech Republic, Finland, G
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were every 6 weeks (wk) (S1), every
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Advantage enrollees (83% vs. 25%) [
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Results: Based on 10,000 simulation
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cancer tumors 12%, Germ cell tumor
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Material and methods: 50 lung cance
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1414TiP IMPLEMENTATION OF CANCER RE
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abstracts palliative care 1422O EFF
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Method and results: A total of 317
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1436P SURVEY ON MODELS OF INTEGRATI
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care unit (PCU) at the National Can
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Characteristic No. % Total 63 1 st
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hysterectomised-9.10% and cervix ca
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abstracts psycho-oncology 1462PD IN
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events, tumour response, and surviv
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abstracts sarcoma 1477O ADHESION TO
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1481PD A PHASE II STUDY OF DOVITINI
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1488P ORGANISATION OF SARCOMA PATIE
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Patients and methods: From August 2
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chemotherapy respectively. At a med
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of this group Those with relapsed d
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1515 PREDICTORS OF SURVIVAL IN ADOL
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abstracts small cell lung cancer an
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emaining receiving either CAV or to
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1533P EXPRESSION OF WILM⍰TUMOUR G
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more than 3 months after first line
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lower recurrence rate of NE. Pegfil
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egimens (HR = 2.5, p < 0.001). Phys
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1561P PREDICTIVE DIAGNOSTICS FOR RE
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Methods: A prospective multicentre
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Table: 1574P Pharmacokinetic parame
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Novartis and unrestricted research
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studies have shown that chemotherap
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(Grade 1) and moderate to severe (G
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declined to relatively lower level
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1609P PHYSICAL ACTIVITY (PA) AND PH
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patients were admitted to the oncol
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Dicarbamin 100 mg/day on day 5 befo
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Results: Anemia was detected in 83.
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important to carry out randomized s
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abstracts translational research 16
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expression. Then, we analyzed PB sa
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Table: 1657P TH BV + TH HR (95% CI)
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BRAF mutations. Circulating free DN
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1671P PHASE I CLINICAL TRIAL OF CAN
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1678P PREDICTIVE VALUE OF TWO PHENO
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theorized that the PI3K/AKT pathway
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Material and methods: 101 patients
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overexpressing and 232 had triple n
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author index author index A Aamdal
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author index Badran A. ix288 (874)
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author index Bösmüller H. ix209 (
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author index Chen A. ix319 (966O) C
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author index De Droogh E. ix452 (13
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author index Esposito G. ix209 (618
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author index Geiges G. ix306 (930P)
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author index Hartono S. ix70 (155P)
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author index Iwasaki H. ix542 (1694
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author index Kodaira M. ix90 (228P)
Page 567 and 568:
author index Lichtensztejn D. ix350
Page 569 and 570:
author index Martinez A. ix496 (153
Page 571 and 572:
author index Morishita N. ix432 (13
Page 573 and 574:
author index Okamoto N. ix432 (1320
Page 575 and 576:
author index Piau S. ix456 (1401P)
Page 577 and 578:
author index Rodríguez Rodríguez
Page 579 and 580:
author index Scoggins C.R. ix371 (1
Page 581 and 582:
author index Stern L. ix272 (823P)
Page 583 and 584:
author index Trypaki M. ix429 (1308
Page 585 and 586:
author index Whitmore J.B. ix310 (9
Page 587 and 588:
subject index subject index A AAV-H
Page 589 and 590:
subject index ix115 (316TiP), ix116
Page 591 and 592:
subject index diffuse large B-cell
Page 593 and 594:
subject index (1033P), ix340 (1036P
Page 595 and 596:
subject index medical information,
Page 597 and 598:
subject index (612P), ix214 (633),
Page 599 and 600:
subject index RCC, ix274 (830P) re-
Page 601 and 602:
subject index TR-FRET, ix84 (206P)
Page 603 and 604:
drug index drug index 1248P, 1250P,
Page 605 and 606:
translational research index transl
Page 607 and 608:
Page 609:
show all

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