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Annals of Oncology Table: 1620 Survival results according to glutamine supplementation (GLT) and wieght loss (WL) GLT- and KK+ GLT- and KK- GLT+ and KK+ GLT+ and KK- P-value Median OS Months) (95%CI) 15.7 (11.8-19.6) 21,7 (12.1-31.3) 13.5 (9.8-17.2) Not reached yet
Dicarbamin 100 mg/day on day 5 before chemotherapy administration. Treatment with Dicarbamin continued for all treatment period. 34 patients of control group (202 cycles of chemotherapy) were not giver any prophylaxis of neutropenia. Neutropenia was evaluated with Common Toxicity Criteria, Version 3.0. Results: Median age was 48 (29 – 55). Grade 4 neutropenia was reported in 6 (14.2%) patients treated with Dicarbamin and in 11 (32.3%) patients treated without Dicarbamin. The beneficial effect of Dicarbamin was also demonstrated by a quick recovery of granulocytes levels than in controls. In 15 (35.7%) patients treated with Dicarbamin granulocytes levels were normal all period of chemotherapy. The dose intensity of chemotherapy was more in group with Dicarbamin prophylaxis. The toxicity of Dicarbamin was not observed. Conclusions: Dicarbamin is an active agent for prophylaxis of neutropenia without specific toxicity. Disclosure: All authors have declared no conflicts of interest. 1624 NEXT AND VENICE: DESIGN OF TWO MULTICENTRE, PHASE IV, PROSPECTIVE, LONGITUDINAL STUDIES EVALUATING THE SAFETY PROFILE OF A BIOSIMILAR FILGRASTIM IN PATIENTS TREATED WITH CYTOTOXIC CHEMOTHERAPY S. Fruehauf 1 , C. Berthou 2 , S. Lepretre 3 , L. Cals 4 , F. Maloisel 5 and D. Kamioner 6 1 Haemato/Onkologie, Paracelsus Klinik Center for Tumor Diagnostics and Therapy, Osnabrück, GERMANY, 2 Département d’Clinique Hématologie, Hôpital Morvan, Brest, FRANCE, 3 Département D’Hématologie, 3Centre Henri Becquerel, Rouen, FRANCE, 4 Department of Medical Oncology, CHRU de Besançon, Besançon, FRANCE, 5 Department of Hematology and Oncology, Clinique Saint Anne, Strasbourg, FRANCE, 6 Oncologue Médical et Hématologue, Hôpital Privé de l’Ouest Parisien, Trappes, FRANCE Introduction: Nivestim is a European Union (EU)-licensed biosimilar filgrastim used in the treatment of chemotherapy-induced neutropenia and febrile neutropenia. Nivestim has similar pharmacokinetic and pharmacodynamic properties to its reference compound Neupogen®, and has demonstrated equivalent safety and efficacy in clinical trials. However, the safety of biosimilars in general is closely scrutinised. We present designs for two observational phase IV studies that will examine the safety profile of prophylactic and curative Nivestim in patients treated with cytotoxic chemotherapy in real-world clinical-practice. Method: NEXT (Tolérance de Nivestim chez les patients traités par une chimiothérapie anticancéreuse cytotoXique en praTique courante) and VENICE (VErträglichkeit von NIvestim unter zytotoxischer Chemotherapie in der Behandlung malinger Erkrankungen) are multicentre, prospective, longitudinal, observational studies that aim to monitor 2000 adult and 700 adult and paediatric patients respectively 12 months. The primary objective of the studies is to assess the safety of Nivestim in patients undergoing cytotoxic chemotherapy for malignancy through the evaluation of adverse events in all organ system classes, as required by EU pharmacovigilance guidelines. Secondary objectives include obtaining data on efficacy outcomes, lab values, patterns of use of Nivestim, dose intensity, indications for treatment, patient characteristics, physician knowledge of filgrastim prescribing, and the reasons for choosing Nivestim. VENICE will also include data on levels of CD34+ cells to assess predictive value as a marker of response. Data will be gathered over 3 patient visits: 1) inclusion visit, 2) first follow-up after first course of Nivestim, and 3) second follow-up after completion of chemotherapy. Results: Accrual figures as of 1 May 2012 are 630 (NEXT) and 136 (VENICE). Completion dates are June 2013 and June 2014 respectively. Conclusion: Data from NEXT and VENICE will provide additional information on the long-term safety and efficacy of Nivestim in patients receiving cytotoxic chemotherapy in clinical practice. Disclosure: S. Fruehauf: Receiving support from Hospira for the conduct of the VENICE study, C. Berthou: Receives support from Hospira for the conduct of the NEXT study, S. Lepretre: Receives support from Hospira for the conduct of the NEXT study, L. Cals: Received support from Hospira for the conduct of the NEXT study, F. Maloisel: Receive support from Hospira for the conduct of the NEXT study, D. Kamioner: Receives support from Hospira for the conduct of the NEXT study. 1625 NEUTROPENIA IN LUNG CANCER PATIENTS TREATED WITH CHEMOTHERAPY IN A ROUTINE CLINICAL PRACTICE – AN INSTITUTIONAL EXPERIENCE N.T. Hitij 1 , K. Mohorcic 1 , A. Sadikov 2 and T. Cufer 1 1 Department of Medical Oncology, University Clinic Golnik, Golnik, SLOVENIA, 2 Department of Artificial Intelligence, Faculty of Computer and Information Science Ljubljana, Ljubljana, SLOVENIA Background: Febrile neutropenia (FN) is a serious complication of chemotherapy (ChT). Lung cancer patients are fragile with much comorbidity mostly receiving intermediate FN (iFN) risk ChT schemas and primary prophylaxis with granulocyte colony-stimulating factors (ppG-CSF) should be used in a majority of pts according to recommendations. A routine use of ppG-CSF in clinical practice seems to be variable. Therefore, we conducted a retrospective analysis of lung cancer pts treated with ChT in a routine clinical practice at University Clinic Golnik (2009-2011), estimating the rate and severity of neutropenia, the rate of FN and treatment strategies. Patients and methods: A typical collective of 190 pts with advanced lung cancer (SCLC 29% and NSCLC 71%) treated with ChT alone were included. Most pts received platinum based ChT (cisplatin 64.7%, carboplatin 20.0%), only 15.3% received other ChT schemas. For most of the pts it was first line ChT (86.8%). Majority of the pts received 6 cycles of ChT (46.3%), 53.7% of pts received 2-6 cycles. Only one patient received ppG-CSF. Results: Neutropenia at any time during ChT was recorded in 100/190 (52.6%) of pts, in 60/190 (31.6%) of pts it was grade 3 or 4. FN was recorded in 16/190 (8.4%) of pts. Mostly, neutropenia developed after the first three cycles of ChT (76.0%). One patient died due to FN. There was no correlation between occurrence of neutropenia and cisplatin- vs. carboplatin- based ChT, nor the line of ChT. Secondary prophylactic G-CSF was used in 14/190 (7.4%) of pts, 8 of them received G-CSF after the episode of FN, and 6 of them due to higher grade neutropenia without FN. All pts with FN received standard antibiotic treatment, while secondary prophylaxis with G-CSF has not been initiated in 8 pts due to the dose reduction in following cycles and death in one case. No patient suffered from recurrent FN episode. Conclusion: Despite a negligible use of ppG-CSF in our collective of pts a very low rate of FN (8.4%) was observed. Due to retrospective nature of the analysis we certainly might have missed some cases of FN, less likely there were some major complications due to missed FN. Based on this retrospective analysis we cannot neglect the use of ppG-CSF in lung cancer patients receiving iFN risk ChT, though, the actual proportion of patients needing ppG-CSF is questionable. Disclosure: All authors have declared no conflicts of interest. 1626 CHLORHEXIDINE FOR THE PREVENTION OF BLOODSTREAM INFECTION (BSI) ASSOCIATED WITH PERMANENTLY IMPLANTABLE VENOUS PORTS (PORT-A) IN SOLID CANCER PATIENTS: A PROSPECTIVE COHORT STUDY H. Kao 1 , I. Chen 1 , S. Chang 2 , M. Hong 2 , S. Chien 3 ,F.Hu 4 , C. Hsu 5 and K. Yeh 6 1 Department of Oncology, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, TAIWAN, 2 Department of Nursing, National Taiwan University Hospital, Taipei, TAIWAN, 3 Center for Infection Control, National Taiwan University Hospital, Taipei, TAIWAN, 4 Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, TAIWAN, 5 Department of Oncology, National Taiwan University Hospital, Taipei, TAIWAN, 6 Oncology Dept., National Taiwan University Hospital, Taipei, TAIWAN Background: Chlorhexidine can prevent surgical wound infection and BSI related to central venous catheters, but its effects on preventing BSI associated with Port-A use in cancer patients remain obscure. Methods: Solid cancer patients who were implanted with a Port-A since Dec 2010 at our department for systemic anti-cancer therapies were prospectively followed for the occurrence of Port-A-associated BSI (PABSI), defined as BSI without other identifiable infection foci. All patients used chlorhexidine for Port-A topical care. The time to first PABSI in this cohort was compared with a previous cohort for whom iodine was used as topical anti-septic. Risk factors of PABSI were analyzed by Cox proportional hazards model. Results: The baseline characteristics of the two cohorts were similar (table). The PABSI incidence was 0.740 and 1.051 per 1000 catheter-day for the chlorhexidine and the iodine cohorts, respectively. The use of chlorhexidine can significantly delay the time to first Gram-positive-cocci (GPC) PABSI (hazard ratio (HR) 0.41, 95% CI 0.20-0.84, p = 0.015). Other Independent predictors of increased GPC PABSI occurrence included previous chemotherapy (HR = 13.65, 95% CI = 4.12-45.26), total parental nutrition (HR =5.17, 95% CI = 2.51-10.63), chronic steroid use (HR = 7.02, 95% CI = 2.60-18.90), and postoperative antibiotics (HR = 2.06, 95% CI = 1.02-4.14). Chlorhexidine had no significant effects on preventing Gram-negative bacilli or fungal PABSI. Conclusion: The use of chlorhexidine as topical anti-septic may help prevent GPC-related PABSI in cancer patients.(supported by grants NTUH 100-S1805) Iodine chlorhexidine p value Enrollment Oct 2009-Aug 2010 Dec 2010-Nov 2011 N 396 487 M/F 202/194 242/245 0.697 median age 57.7 59.1 0.121 Cancer type 0.892 GI 169 209 Lung 115 129 Breast 46 71 H&N cancer + NPC 20 26 Others 46 52 N of stage IV 324 (0.82) 376 (0.77) 0.136 Total catheter-day 81752 99977 Disclosure: All authors have declared no conflicts of interest. Annals of Oncology ix522 | 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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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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Page 531 and 532: expression. Then, we analyzed PB sa
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Page 541 and 542: theorized that the PI3K/AKT pathway
Page 543 and 544: Material and methods: 101 patients
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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
Page 555 and 556: author index De Droogh E. ix452 (13
Page 557 and 558: author index Esposito G. ix209 (618
Page 559 and 560: author index Geiges G. ix306 (930P)
Page 561 and 562: author index Hartono S. ix70 (155P)
Page 563 and 564: author index Iwasaki H. ix542 (1694
Page 565 and 566: author index Kodaira M. ix90 (228P)
Page 567 and 568: author index Lichtensztejn D. ix350
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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
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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