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Annals of Oncology in Johnson & Johnson, have served as an abiraterone consultant/advisory board member, and have received consulting fees/grants/travel support fees from Janssen Research & Development, All other authors have declared no conflicts of interest. 895O THE IMPACT OF ABIRATERONE ACETATE (AA) THERAPY ON PATIENT-REPORTED PAIN AND FUNCTIONAL STATUS IN CHEMOTHERAPY-NAIVE PATIENTS WITH PROGRESSIVE, METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) E. Basch 1 , C.J. Ryan 2 , T. Kheoh 3 , K. Fizazi 4 , C.J. Logothetis 5 , D.E. Rathkopf 6 , M.R. Smith 7 , P.N. Mainwaring 8 ,Y.Hao 9 ,T.Griffin 10 ,S.Li 11 , M. Meyers 12 , A. Molina 10 , C. Cleeland 13 1 Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, UNITED STATES OF AMERICA, 2 Department of Medicine (Hematology/ Oncology), UCSF, San Francisco, CA, UNITED STATES OF AMERICA, 3 Biostatistics, Janssen Research & Development, Los Angeles, CA, UNITED STATES OF AMERICA, 4 Cancer Medicine, Institut Gustave Roussy, Villejuif, FRANCE, 5 Department of Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX, UNITED STATES OF AMERICA, 6 Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, UNITED STATES OF AMERICA, 7 Department of Genitourinary Medical Oncology, Massachusetts General Hospital. Boston, MA, UNITED STATES OF AMERICA, 8 Medical Oncology, Hematology & Oncology Clinics of Australia, Brisbane, AUSTRALIA, 9 Outcome Research, Janssen Global Services, Raritan, NJ, UNITED STATES OF AMERICA, 10 Oncology, Janssen Research & Development, Los Angeles, CA, UNITED STATES OF AMERICA, 11 Biostatistics, Janssen Research & Development, Spring House, PA, UNITED STATES OF AMERICA, 12 Oncology, Janssen Research & Development, Raritan, NJ, UNITED STATES OF AMERICA, 13 Symptom Research, MD Anderson Cancer Center, Houston, TX, UNITED STATES OF AMERICA Background: AA is a potent, selective androgen biosynthesis inhibitor. The impact of AA on pain and functional status was prospectively evaluated as part of a large phase 3 trial in asymptomatic/mildly symptomatic, progressive, chemotherapy-naïve mCRPC. Material and methods: COU-AA-302 is an international, randomized, double-blind study of AA (1 g daily) + prednisone (P; 5 mg twice daily) versus placebo (PL) + P in chemo-naïve mCRPC patients (pts) with prior medical/surgical castration and anti-androgen therapy. Pain and functional status were assessed at baseline and throughout study treatment using the BPI-SF and FACT-P questionnaires, respectively. For each measure, clinically significant progression/degradation was evaluated using prespecified definitions. Results: 546 pts were randomized to AA + P and 542 to PL + P, with median treatment durations of 13.8 and 8.3 months, respectively. Baseline scores were similar between arms; at baseline, mean worst pain intensity score was 1.2 and mean pain interference score was 0.7 in each arm. AA + P significantly delayed average pain intensity progression, pain interference progression, and degradation in FACT-P total score and most subscales, except the social/family well-being subscale where there was no difference (Table). A post hoc sensitivity analysis using a more stringent definition of worst pain intensity progression (ie, a 2 point worsening at 2 consecutive study visits), showed a significant advantage of AA + P over PL + P at the 25th percentile (median was not reached for this analysis). Conclusions: In asymptomatic/minimally symptomatic mCRPC, AA + P delayed functional decline and progression of pain compared to PL + P alone. The extent of these benefits, coupled with improvements in other efficacy end points [Ryan et al ASCO 2012], suggests that AA is a suitable therapy option in this setting. Table: 895O Disclosure: T. Kheoh is an employee of Janssen R&D and holds stock options of Johnson & Johnson.K. Fizazi has the following conflicts of interest to disclose: Honoraria: Janssen Consultancy: Janssen, Cougar Biotechnology Speaker/Advisory Board Participation: Janssen, C.J. Logothetis has received consultancy fees and travel support from Ortho Biotech and research support from Johnson & Johnson, M.R. Smith has served as an advisor to Cougar Biotechnology and Johnson & Johnson and has received research funding from Cougar Biotechnology and Johnson & Johnson. Y. Hao is an employee of Janssen Global Services and holds stock options of Johnson & Johnson. T. Griffin is an employee of Janssen R&D and holds stock options of Johnson & Johnson. S. Li is an employee of Janssen R&D and holds stock options of Johnson & Johnson. M. Meyers is an employee of Janssen R&D and holds stock options of Johnson & Johnson. A. Molina is an employee of Janssen R&D and holds stock options of Johnson & Johnson. All other authors have declared no conflicts of interest. 896O IMPACT OF ENZALUTAMIDE, AN ANDROGEN RECEPTOR SIGNALING INHIBITOR, ON TIME TO FIRST SKELETAL RELATED EVENT (SRE) AND PAIN IN THE PHASE 3 AFFIRM STUDY K. Fizazi 1 , H.I. Scher 2 , F. Saad 3 , C.N. Sternberg 4 , K. Miller 5 , P. Mulders 6 , K. Chi 7 , E. Basch 8 , M. Hirmand 9 , J.S. de Bono 10 1 Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Orsay, France, Villejuif, FRANCE, 2 Genitourinary Oncology Service, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center, New York, NY, USA, New York, NY, UNITED STATES OF AMERICA, 3 Department of Surgery, University of Montreal Hospital Center, Montreal, QC, CANADA, 4 Depatment of Medical Oncology, San Camillo Forlanini Hospital, Rome, ITALY, 5 CC 8: Chirurgische Medizin, Klinik für Urologie, Charité - Universitätsmedizin Berlin, Berlin, GERMANY, 6 Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, NETHERLANDS, 7 Department of Experimental Therapeutics, British Columbia Cancer Agency, Vancouver, BC, CANADA, 8 Departmentgenitourinary Cancer, Memorial Sloan Kettering Cancer Center, New York, NY, UNITED STATES OF AMERICA, 9 Department of Clinical Development, Medivation, Inc., San Francisco, CA, UNITED STATES OF AMERICA, 10 Division of Clinical Studies, The Institute of Cancer Research, Sutton, UNITED KINGDOM Background: Enzalutamide-proposed INN (ENZA, MDV3100) inhibits androgen binding to AR, AR nuclear translocation, and AR association with DNA. The AFFIRM trial (NCT00974311) demonstrated that ENZA increased survival by 4.8 mo (P
and week 13 BPI-SF Q3 scores), 28% ENZA and 39% placebo pts (P = 0.0018) had pain progression assessed by pt diaries (increase over baseline in mean pain score). Median time to pain progression (confirmed increase in FACT-P score of “I have pain”) was not yet reached vs 13.8 mo for ENZA and placebo (P = 0.0004, HR 0.56). There was a mean reduction in pain severity (average of 4 severity items of the BPI-SF) of 0.65 favoring ENZA (P
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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 subtyping soft tissue sar
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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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number of biomarkers have been trie
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Table: 248O 249PD PROTEOMIC PREDICT
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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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Patients and methods: Chemotherapy-
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612P ARE PATIENTS WITH RESECTABLE R
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Conclusions: AMPK and ACC activatio
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of surgical monotherapy in patients
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Table: 632 633 AFLIBERCEPT/FOLFIRI
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factors play the determining role i
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Abstract withdrawn in exceptional c
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were respectively 10.6 vs 8.5 vs 3.
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Results: 20 gastrointestinal cancer
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abstracts gastrointestinal tumors,
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Day 8. A second identical course wa
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proven in stage I GC. The aim of th
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Conclusions: Longer OS to FOLFOX wa
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692P PRELIMINARY SAFETY DATA FROM A
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subgroup. Taking into consideration
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Results: Three years of adjuvant im
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considered sufficient to give an 80
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721P FIRST-LINE TREATMENT WITH FOLF
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after Gem-based therapy. The additi
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Page 247 and 248: validate the revised AJCC 7th stagi
Page 249 and 250: Results: Among 862 MM we identified
Page 251 and 252: Results: Frequently reported advers
Page 253 and 254: gastric cancer patients with CNS me
Page 255 and 256: discriminate the prognosis of HCC p
Page 257 and 258: prospective, non-interventional stu
Page 259 and 260: abstracts genitourinary tumors, non
Page 261 and 262: 787O EXTERNAL VALIDATION OF THE ASS
Page 263 and 264: patient preference for P over S, an
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Page 267 and 268: Hb, PS and LM. Median PFS for patie
Page 269 and 270: may have led to reduced dose and sh
Page 271 and 272: Results: 1,622 patients were identi
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Page 275 and 276: Patients and methods: This is a sin
Page 277 and 278: treatment at week 4, and week 12 by
Page 279 and 280: effective in second or further line
Page 281 and 282: Conclusions: In pts with RCC treate
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Page 287 and 288: efused HDCT. Of 23 patients, 20 com
Page 289 and 290: we identified 49 and 220 patients w
Page 291 and 292: 879 TREATMENT OF PATIENTS WITH META
Page 293 and 294: Median overall survival (OS) was 26
Page 295: abstracts Genitourinary tumors, pro
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Page 301 and 302: atio HR 0.39; CI 0.18, 0.83, p = 0.
Page 303 and 304: We observed tumor responses and pro
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Page 309 and 310: Disclosure: S. Oudard: Has acted as
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Page 313 and 314: 945 BONE TURNOVER MARKERS AND POTEN
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Page 317 and 318: managed in a multidisciplinary (MD)
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Page 321 and 322: meeting. The prevalence of LGSC is
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Page 329 and 330: elated with stage, nodal involvemen
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Page 333 and 334: eight patients who had infertility
Page 335 and 336: abstracts head and neck cancer 1016
Page 337 and 338: same CT/RT; Arm B2: 3 cycles of ind
Page 339 and 340: induction chemotherapy in the treat
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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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1076P RITUXIMAB PLUS SUBCUTANEOUS C
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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
Page 541 and 542:
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)
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author index Lichtensztejn D. ix350
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author index Martinez A. ix496 (153
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author index Morishita N. ix432 (13
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author index Okamoto N. ix432 (1320
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author index Piau S. ix456 (1401P)
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author index Rodríguez Rodríguez
Page 579 and 580:
author index Scoggins C.R. ix371 (1
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author index Stern L. ix272 (823P)
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author index Trypaki M. ix429 (1308
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author index Whitmore J.B. ix310 (9
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subject index subject index A AAV-H
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subject index ix115 (316TiP), ix116
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subject index diffuse large B-cell
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subject index (1033P), ix340 (1036P
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subject index medical information,
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subject index (612P), ix214 (633),
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subject index RCC, ix274 (830P) re-
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subject index TR-FRET, ix84 (206P)
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drug index drug index 1248P, 1250P,
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translational research index transl
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