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Annals of Oncology neutropenia in patients with cancer. These consisted of two large multicentre observational studies plus three small single-centre studies conducted across 12 European countries. All studies were conducted in Europe and reflected real-life clinical use of biosimilar G-CSF. Patients receiving biosimilar G-CSF for interventional treatment were excluded from this analysis. Results: Data from 1302 patients treated with biosimilar G-CSF were available for analysis. The most frequent types of cancer were breast cancer (n = 541; 42%), lung cancer (n = 212; 16%) and lymphoma/leukaemia (n = 201; 15%). Thirty-six percent of patients had a febrile neutropenia risk of >20% while 39.6% had a risk of 10 − 20% based on chemotherapy regimen. A further 12.1% of patients received biosimilar G-CSF despite a febrile neutropenia risk of
1561P PREDICTIVE DIAGNOSTICS FOR RESPONSE TO THERAPY OF CHEMOTHERAPY ASSOCIATED ANEMIA WITH DARBEPOETIN ALFA +/- INTRAVENOUS IRON IN CANCER PATIENTS: PFAD-3 A MULTICENTRE COHORT STUDY IN OUTPATIENTS H..T. Steinmetz 1 , K. Kuhr 2 , M. Hellmich 2 , M. Heinz 1 , M. Neise 3 , J. Mittermüller 4 , H.W. Tessen 5 , M. Reiser 6 , K. Severin 1 and S. Schmitz 1 1 Hematology and Oncology, Outpatient Clinic, Cologne, GERMANY, 2 University, Institut für Medizinische Statistik, Informatik und Epidemiologie, Cologne, GERMANY, 3 Hematology and Oncology, Outpatient Clinic, Krefeld, GERMANY, 4 Hematology and Oncology, Outpatient Clinic, Germering, GERMANY, 5 Hematology and Oncology, Outpatient Clinic, Goslar, GERMANY, 6 Hematology and Oncology, PIOH - Outpatient Clinic, Cologne, GERMANY Introduction: Seven randomized studies have demonstrated a benefit of combining erythropoiesis stimulating agents (ESA) with intravenous iron (iv Fe) in the treatment of chemotherapy-associated anemia in cancer patients (pts). Because, so far there is no proven recommendation for the best pretherapeutic diagnostics to select optimal therapy (ESA, iron or both), we conducted a multicenter cohort study. Methods: Cancer pts were included and eligible for response if they had a symptomatic anemia (hemoglobin (Hb) < 11g/dl), received a chemotherapy, gave written informed consent, and had a pretherapeutic diagnostics of anemia: Ferritin (F), transferrin saturation (TSAT), endogenous erythropoietin (eEPO) and soluble transferrin-receptor (sTFR) on day 1 and 14. All pts were treated with Darbepoetin alfa (DA, 500 µg, q3w) with or without iv Fe-III-hydroxyd-saccharose (200mg in 250ml NaCl 0.9% q3w). The use of iv Fe based on the recommendations of the NCCN guidelines at the discretion of the oncologists. Pts with an absolute iron deficiency (F m < 30ng/ml, f < 15ng/ml) were excluded. Results: Between 03/07 - 08/10 in 9 outpatient clinics 331 pts received DA on day 0. Mean age was 66.3 years, 58% were women. 202 pts (61%) received at least one dose iv Fe additionally to DA on day 0. Baseline Hb was 9.53g/dl (SD 0.78) and increased in average 1.23g/dl (SD 1.34) and 1.53 g/dl (SD 1.49) til weeks 6 and 9, respectively. Transfusion rate in weeks 3-9 was 15.1%. Associations of relevant criteria with response are shown in the table. Conclusion: The results confirm the increase of Hb within the first 3 weeks as strong predictor for response to DA in week 6. Pts with Hb-increase ≥ 0.6 g/dl have a 6-fold higher chance of being responders than those without. Ferritin is a stronger predictor for response to iv Fe than TSAT. Supported by Amgen, Munich, Germany. Disclosure: H..T. Steinmetz: Member of advisory boards for Amgen, Janssen, Medice, Novartis, Roche, Vifor. Investigator in studies for Amgen, Janssen, Novartis, Roche, Vifor., M. Neise: Investigator in studies with Amgen, J. Mittermüller: Investigator in studies with Amgen, H.W. Tessen: Investigator in studies with Amgen, M. Reiser: Investigator in studies with Amgen, K. Severin: Ivestigator in studies with Amgen, Roche, Vifor, S. Schmitz: Investigator in studies with Amgen, Novartis, Roche, Vifor. All other authors have declared no conflicts of interest. 1562P A PROSPECTIVE DATA AUDIT OF THE MANAGEMENT OF CHEMOTHERAPY-INDUCED ANEMIA WITH DARBEPOETIN ALFA – THE APRIORI STUDY P. Boguradzki 1 , K. Boér 2 , A. Cipková 3 , E. Wojciechowska-Lampka 4 , M. Schützová 5 , J. Ocvirk 6 and E. Tóth 7 1 Hematology, Warsaw Medical University, Warsaw, POLAND, 2 Oncology Department, Szent János Kórház és Észak-budai Egyesített Kórházak, Budapest, HUNGARY, 3 Radiotherapy and Oncology, East Slovakian Cancer Institute, Košice, SLOVAK REPUBLIC, 4 Department of Lymphoma, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute, Warsaw, POLAND, 5 Hemato-oncologic Department, Faculty Hospital, Plzen-Lochotín, CZECH REPUBLIC, 6 Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, SLOVENIA, 7 Amgen Slovakia s.r.o., Piešt´any, SLOVAK REPUBLIC Background: Darbepoetin alfa (DA, Aranesp®) is an erythropoesis-stimulating agent (ESA) used to treat chemotherapy (CT) induced anaemia (CIA). In 2008 EORTC Table: 1561P guidelines changed to recommend starting ESA treatment at haemoglobin (Hb) 9 - 11 g/dL and stopping ESA if Hb was > 13 g/dL. In February 2008, the SmPC for DA was revised to recommend treatment start at Hb ≤ 10 g/dL and Hb be maintained in the 10 - 12 g/dL range. APRIORI was a prospective, noninterventional, observational, longitudinal, multicentre study collecting data from patients (pts) in Central and Eastern Europe with CIA receiving DA and CT. The aims were to evaluate the compliance with international guidelines and EU label for use of DA in treating CIA, to assess effectiveness of DA, and describe DA dosing characteristics. Methods: This study collected clinical data of cancer pts over 4 consecutive years (11/2006 – 12/2010), at 120 centers in Poland, Czech Republic, Slovakia, Slovenia, Hungary, and Russia. Pts were enrolled before the label change (BLC) as well as after the label change (ALC). The data were collected at enrolment and at follow-up visits during CT until the first follow-up visit after the end of CT. Results: Out of 6408 pts enrolled (mean (sd) age of 59.9 (±12.57) years, 44.4% male), 929/1648 (56.4%) pts enrolled BLC had Hb in the target 9 - 11 g/dL range, while 4284/4760 (90.0%) pts enrolled ALC had Hb in the target range of ≤ 10 g/dL. Total 666 (40.4%) pts had Hb < 9 g/dL and 53 (3.2%) pts had Hb > 11 g/dL BLC, while 476 (10.0%) pts had Hb > 10 g/dL ALC. BLC, 38 (35.8%) pts had any DA dosing withheld while exceeding the 13 g/dL Hb concentration limit, at any time during the study and ALC, 55 (7.8%) pts had the doses reduced while exceeding the 12 g/dL Hb concentration limit, at any time during the study. DA effectively increased Hb concentrations; mean Hb after achieving the target anaemia Hb level BLC 11.94 g/dL vs. 11.29 g/dL ALC. Only 4.9% of pts required RBC transfusion after 5 weeks of DA initiation. Out of 9 ADRs no serious and no fatal ADRs was reported during the study. Mortality was 4.9% (305 pts). Conclusion: Based on these data, the patients are being treated in accordance with the current European SmPC for darbepoetin alfa. This study was sponsored by Amgen GmbH CEE Headquarters. Disclosure: P. Boguradzki: Corporate-sponsored research - Amgen APRIORI, K. Boér: Corporate sponsored study - APRIORI study Amgen, A. Cipková: Corporatesponsored research - Amgen APRIORI, E. Wojciechowska-Lampka: Corporate-sponsored research - Amgen -APRIORI, M. Schützová: Corporatesponsored research - Amgen; member of advisory board - Amgen, J. Ocvirk: Corporate-sponsored research - Amgen APRIORI, E. Tóth: Amgen contract worker. 1563P THE USE OF BIOSIMILARS IN THE MANAGEMENT OF CHEMOTHERAPY-INDUCED ANAEMIA (CIA) IN SOLID TUMOURS, LYMPHOMA AND MYELOMA: THE ORHEO STUDY M. Michallet 1 , P. Soubeyran 2 , H. Albrand 3 and E. Luporsi 4 1 Service d’Hématologie, Pavillon Marcel Bérard 1g, Centre Hospitalier Lyon Sud, Lyon-Pierre Bénite, FRANCE, 2 Department of Medical Oncology, Institut Bergonié and Université Bordeaux Segalen, Bordeaux, FRANCE, 3 Medical Director, Laboratoire HOSPIRA France, Meudon La Forêt, FRANCE, 4 Medical Oncology, Centre Alexis Vautrin, Vandœuvre-lès-Nancy, FRANCE The approval of epoetin biosimilars in the European Union requires extensive scientific evaluation and stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar epoetins for the treatment of CIA in the clinical setting. Patients >18 years with CIA (haemoglobin [Hb] 5 mg/l : FI ≤ 2 *** Odds ratio, confidence intervall, and number of pts with … Annals of Oncology … DA therapy conform with protocol, treatment response and predictive factors evaluable ix504 | Abstracts Volume 23 | Supplement 9 | September 2012
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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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735P RADIOGRAPHIC PARAMETERS IN PRE
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validate the revised AJCC 7th stagi
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Results: Among 862 MM we identified
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Results: Frequently reported advers
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gastric cancer patients with CNS me
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discriminate the prognosis of HCC p
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prospective, non-interventional stu
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abstracts genitourinary tumors, non
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787O EXTERNAL VALIDATION OF THE ASS
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patient preference for P over S, an
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798PD OPEN-LABEL PHASE II TRIAL OF
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Hb, PS and LM. Median PFS for patie
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may have led to reduced dose and sh
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Results: 1,622 patients were identi
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RCC) was designed to address an unm
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Patients and methods: This is a sin
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treatment at week 4, and week 12 by
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effective in second or further line
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Conclusions: In pts with RCC treate
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using Drug inCode ® pharmacogeneti
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Table: 857P standard, but is not av
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efused HDCT. Of 23 patients, 20 com
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we identified 49 and 220 patients w
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879 TREATMENT OF PATIENTS WITH META
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Median overall survival (OS) was 26
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abstracts Genitourinary tumors, pro
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and week 13 BPI-SF Q3 scores), 28%
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Working Group (PCWG)-2 guidelines r
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atio HR 0.39; CI 0.18, 0.83, p = 0.
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We observed tumor responses and pro
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Here we report emerging data from t
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928P LHRH AGONIST-INDUCED SUPPRESSI
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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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evaluated by the screening instrume
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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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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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Page 455 and 456: Results: Based on 10,000 simulation
Page 457 and 458: cancer tumors 12%, Germ cell tumor
Page 459 and 460: Material and methods: 50 lung cance
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Page 463 and 464: abstracts palliative care 1422O EFF
Page 465 and 466: Method and results: A total of 317
Page 467 and 468: 1436P SURVEY ON MODELS OF INTEGRATI
Page 469 and 470: care unit (PCU) at the National Can
Page 471 and 472: Characteristic No. % Total 63 1 st
Page 473 and 474: hysterectomised-9.10% and cervix ca
Page 475 and 476: abstracts psycho-oncology 1462PD IN
Page 477 and 478: events, tumour response, and surviv
Page 479 and 480: abstracts sarcoma 1477O ADHESION TO
Page 481 and 482: 1481PD A PHASE II STUDY OF DOVITINI
Page 483 and 484: 1488P ORGANISATION OF SARCOMA PATIE
Page 485 and 486: Patients and methods: From August 2
Page 487 and 488: chemotherapy respectively. At a med
Page 489 and 490: of this group Those with relapsed d
Page 491 and 492: 1515 PREDICTORS OF SURVIVAL IN ADOL
Page 493 and 494: abstracts small cell lung cancer an
Page 495 and 496: emaining receiving either CAV or to
Page 497 and 498: 1533P EXPRESSION OF WILM⍰TUMOUR G
Page 499 and 500: more than 3 months after first line
Page 501 and 502: lower recurrence rate of NE. Pegfil
Page 503: egimens (HR = 2.5, p < 0.001). Phys
Page 507 and 508: Methods: A prospective multicentre
Page 509 and 510: Table: 1574P Pharmacokinetic parame
Page 511 and 512: Novartis and unrestricted research
Page 513 and 514: studies have shown that chemotherap
Page 515 and 516: (Grade 1) and moderate to severe (G
Page 517 and 518: declined to relatively lower level
Page 519 and 520: 1609P PHYSICAL ACTIVITY (PA) AND PH
Page 521 and 522: patients were admitted to the oncol
Page 523 and 524: Dicarbamin 100 mg/day on day 5 befo
Page 525 and 526: Results: Anemia was detected in 83.
Page 527 and 528: important to carry out randomized s
Page 529 and 530: abstracts translational research 16
Page 531 and 532: expression. Then, we analyzed PB sa
Page 533 and 534: Table: 1657P TH BV + TH HR (95% CI)
Page 535 and 536: BRAF mutations. Circulating free DN
Page 537 and 538: 1671P PHASE I CLINICAL TRIAL OF CAN
Page 539 and 540: 1678P PREDICTIVE VALUE OF TWO PHENO
Page 541 and 542: theorized that the PI3K/AKT pathway
Page 543 and 544: Material and methods: 101 patients
Page 545 and 546: overexpressing and 232 had triple n
Page 547 and 548: author index author index A Aamdal
Page 549 and 550: author index Badran A. ix288 (874)
Page 551 and 552: author index Bösmüller H. ix209 (
Page 553 and 554: 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)
Page 563 and 564:
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
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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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