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Annals of Oncology 1584P HOME-BASED ZOLEDRONIC ACID (ZOL) INFUSION THERAPY IN PATIENTS WITH SOLID TUMOURS: COMPLIANCE AND PATIENT-NURSE SATISFACTION T. Lebret 1 , J. Mouysset 2 , A. Lortholary 3 , C. El Kouri 3 , L. Bastit 4 , M. Ktiouet 5 , K. Slimane 5 , X. Muracciole 6 and S. Guérif 7 1 Urology, Hôpital Foch, Suresnes, FRANCE, 2 Oncology, Polyclinique Parc Rambot-Provençale, Aix en Provence, FRANCE, 3 Medical Oncology, Catherine de Sienne Institute, Nantes, FRANCE, 4 Radiothérapie, Centre de Radiothérapie, Evreux, FRANCE, 5 Oncology, Novartis Pharmaceuticals, Rueil-Malmaison, FRANCE, 6 Service de Radiotherapie, CHU La Timone APHM Marseille, Marseille, FRANCE, 7 Radiothérapie, CHU Poitiers, Poitiers, FRANCE Objective: To explore patient and nurse satisfaction, compliance with practice guidelines, technical feasibility, and safety of home infusion of the bisphosphonate ZOL. Methods: This was a prospective longitudinal 1-year survey of home ZOL therapy in patients with bone metastases secondary to a solid malignancy. Randomly selected physicians prescribed home ZOL therapy (4 mg Zometa®, 15-min IV infusion, every 3-4 weeks). Three questionnaires were administered at 3 time points: physician questionnaire, nurse satisfaction and feasibility questionnaire, and patient satisfaction questionnaire. The main end-points were patient and nurse satisfaction with home ZOL therapy. Results: Of the 154 physicians who agreed to participate, 87 (56.5%) enrolled 818 patients for whom 788 case report forms were received of which 763 met inclusion criteria. Overall, 343 nurses (97.5% community) took part. Patient characteristics were: median age 68 yrs (30-95); male-female ratio 40/60; primary cancer: breast 55.2%, prostate 28.4%, lung 7.2%, other 9.4%; ECOG-PS 0 or 1: 78.6%. Overall, 90.9% of nurses were either highly satisfied or satisfied with how home ZOL therapy was run; 96.7% found the infusion either very easy or easy to perform; 97.5% felt that home therapy promoted a good relationship with patients, and 73% were either highly satisfied or satisfied with their hospital contacts. Among patients, 95.3% were either very satisfied or satisfied with home ZOL therapy. Causes for satisfaction were quality of the nurse-patient relationship (57.6%) in addition to expected reasons (e.g. less time travelling/waiting (68.8%), less disruption to daily routine (36.6%)). ZOL therapy was well tolerated (discontinuation due to adverse events 6.1%; osteonecrosis of the jaw 0.6%, fractures 0.2%). Practitioner compliance with recommendations was 73% for dental hygiene checks at inclusion and 48-56% thereafter, 66% for pre-infusion patient hydration, and often undocumented for calcium/vitamin D supplementation. Conclusions: There was a very high level of both patient and nurse satisfaction with home ZOL therapy. However, improved compliance with practice guidelines should be encouraged. Disclosure: T. Lebret: Consulting fees : Amgen, Novartis Advisory board : Amgen, Novartis Honorarium study Novartis, J. Mouysset: Honorarium study Novartis, A. Lortholary: Honorarium study Novartis, C. El Kouri: Honorarium study Novartis, L. Bastit: Honorarium study NovartisM. Ktiouet: Novartis EmployeeK. Slimane: Novartis Employee, X. Muracciole: Advisory board Novartis Consulting fees Novartis, S. Guérif: Consulting fees Novartis. 1585P A PROSPECTIVE MONO-INSTITUTIONAL STUDY ON THE IMPACT OF A SYSTEMATIC PREVENTION PROGRAM ON THE INCIDENCE AND OUTCOME OF OSTEONECROSIS OF THE JAW (ONJ) IN PATIENTS (PTS) TREATED WITH BISPHOSPHONATES (B) FOR BONE METASTASES N.M. La Verde, A. Bramati, S. Piva, M.C. Dazzani, S. Girelli, A. Moretti, D. Mihali, M. Dimaiuta, A. Pinto and G. Farina Oncology, A.O. Fatebenefratelli e Oftalmico, Milan, ITALY Background: B are commonly used to treat bone metastases in cancer pts, who have a higher risk of developing ONJ. The elective involvement of the jaw can have an anatomic rationale, since this region has a thin mucosa and microbiological contamination. The jaw is exposed to dental microtraumatisms and infections, so reparation mechanisms are essential. B inhibits bone turnover and since the increased demand for bone repair isn’t satisfied, the bone is exposed to osteonecrosis. To reduce this risk we have developed a specific prevention program focused primarily on reducing its incidence and, wherever it develops, the need for demolitive surgery with permanent sequelae. Patients and methods: All consecutive pts with bone lesions, that were eligible for treatment with B (either zoledronic or pamidronic acid) were prospectively evaluated. Before starting B, each patient was referred to an specialized odontoiatric team that performed: 1. dental examination; 2. orthopantomography; 3. professional dental hygiene. If the oral conditions weren’t satisfactory (i.e., tooth decay, dental plaque, broken teeth), the dentist completed the necessary intervention before starting B. Results: From April 2007 to April 2012 we collected data of 254 pts, 243 of which were treated with zoledronic acid and 9 with pamidronic acid. The median age was 74 years old (range 37-95), 92 male and 162 female. All pts had bone involvement: 74 pts had breast cancer, 39 lung cancer, 36 prostate cancer, 33 multiple myeloma and 72 others. On average the pts received 9.7 cycles (range 1-48). No case of ONJ was recorded. Conclusions: Our study demonstrates that ONJ can be effectively prevented with a serious program that involves a multidisciplinary team. The odontoiatric basal evaluation is necessary to identify pts with oral pathologies or inadequate oral hygiene who must undergo preventive dental treatment. When reparative phaenomena are compromised by B, the healthy oral environment prevents infections and subsequent morbidity. In our opinion, this type of preventive program should be mandatory for all pts starting B. Disclosure: All authors have declared no conflicts of interest. 1586P QOL AND SURVIVAL SURVEY OF CANCER CACHEXIA IN ADVANCED NSCLC PATIENTS - JNUQ-LC STUDY, TORG0912 S. Atagi 1 , F. Imamura 2 , A. Yokoyama 3 , K. Minato 4 , T. Harada 5 , N. Katakami 6 , T. Yokoyama 7 , Y. Ohashi 8 , K. Watanabe 9 and K. Eguchi 10 1 Department of Thoracic Oncology, Kinki-chuo Chest Medical Center, Osaka, JAPAN, 2 Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, JAPAN, 3 Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, JAPAN, 4 Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta, JAPAN, 5 Center for Respiratory Disease, Hokkaido Social Insurance Hospital, Sapporo, JAPAN, 6 Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, JAPAN, 7 Department of Respiratory Medicine, Kyorin University Hospital, Tokyo, JAPAN, 8 Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, JAPAN, 9 Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, Yokohama, JAPAN, 10 Internal Medicine, Division of Medical Oncology, Teikyo University School of Medicine, Tokyo, JAPAN Background: Cancer cachexia, mainly characterized by muscle atrophy and subsequent cancer induced weight loss (CIWL), is attributed to about a third of cancer deaths. Despite worsening prognoses with the symptoms, clinical factors involved and the effect of CIWL to the overall status remain unexplained. We planned a prospective cohort study, Japan Nutrition and QOL survey in patients with advanced NSCLC study to investigate changes in CIWL in relation to grip, QOL, and clinical parameters to understand their effects on prognosis. Method: Untreated stage IV NSCLC patients with ECOG PS of 0-2 were registered. Their body weight (BW), grip, QOL, Karnofsky Performance Scale, biochemical assay, and survival were recorded every four weeks for one year from the start of cancer treatments. Patients were classified by BW loss ≥ 5% and cachexia diagnosis by BW loss, fatigue, anorexia, and abnormal assay results. Estimated survival curves were drawn by Kaplan-Meier method, and Log-rank test was applied. To evaluate the effect of cancer cachexia attribution to QOL, we performed principal component analysis, factor analysis, and analysis on time course data using generalized estimating equation (GEE). Results: Out of 466 patients registered, 406 were evaluable and analyzed. Patient characteristics were: median age: 67 (33-87) years, male/female ratio: 280/126, median BW: 56.5kg, PS 0: 39.2%, and PS 1: 51.5%. The patients with BW loss of ≥ 5% (n = 219) reported more early deaths than those without (n = 166, p < 0.0001). Patients with cachexia (n = 169) reported more early deaths than those without (n = 216, p < 0.0001). All correlations between principal component scores estimated from the variables considered the signs of cancer cachexia (cancer cachexia attributions: more weight on anorexia, fatigue, BW and grip) and each factor scores of QOL domains estimated from QOL factor analyses were significant (p < 0.01). From the time course data analyses using GEE, cancer cachexia attributions of each visit are shown as useful variables for all QOL domains (p < 0.01). Conclusion: Cancer cachexia decreased QOL and possibly affected prognoses. Cachexia preventions and treatments based on the further elucidation of its pathology are needed. Disclosure: All authors have declared no conflicts of interest. 1587P SARCOPENIA AFFECTS TREATMENT TOXICITY IN METASTATIC COLORECTAL CANCER PATIENTS: RESULTS OF A PROSPECTIVE MULTICENTER STUDY M. Barret 1 , C. Dalban 2 , J. Taieb 3 , D. Malka 4 , T. Mansourbakht 5 ,E.Latko 6 and S. Antoun 7 1 Gastroenterology, Hopital Européen Georges Pompidou, Paris, FRANCE, 2 Department of Biostatistics and Epidemiology (ea4184), Centre Georges François Leclerc, Dijon, FRANCE, 3 Gastroenterology and Digestive Oncology, Hopital Européen Georges Pompidou, Paris, FRANCE, 4 Oncology, Institut Gustave Roussy, Villejuif, FRANCE, 5 Gastroenterology, Hopital de la Pitié Salpetriere, Paris, FRANCE, 6 Nutricia Advanced Nutrition, Danone, St Ouen, FRANCE, 7 Emergency Department, Institut Gustave Roussy, Villejuif, FRANCE Background: Malnutrition reduces tolerance to treatment, quality of life, and survival in numerous cancers, including metastatic colorectal cancer (mCRC). Previous Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds416 | ix511
studies have shown that chemotherapy toxicity may be linked to low muscle tissue (sarcopenia). Our study evaluated the effect of sarcopenia on chemotherapy toxicity among mCRC patients. Methods: In this prospective, cross-sectional, multicenter study, demographic, oncological, and nutritional data were collected in all consecutive mCRC patients in three hospitals. Computed tomography (CT) images were analyzed using Slice-O-Matic software V4.3 (Tomovision) to evaluate cross-sectional areas (cm 2 ) of muscle tissue (MT), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT). The 3 rd lumbar vertebra (L3) was chosen as a reference, since L3 and whole-body measurements are linearly related. Indexed on height, MT, VAT and SAT (cm 2 /m 2 ), were described, after stratification on sex. Sarcopenia was defined as MT 90% for all assessments during treatment. CTCAE consistently resulted in ix512 | 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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abstracts a paradigm shift in early
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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 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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ESMO-CSCO Joint Symposium: Building
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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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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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Page 531 and 532: expression. Then, we analyzed PB sa
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Page 535 and 536: BRAF mutations. Circulating free DN
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Page 541 and 542: theorized that the PI3K/AKT pathway
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Page 549 and 550: author index Badran A. ix288 (874)
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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)
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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)
Page 577 and 578:
author index Rodríguez Rodríguez
Page 579 and 580:
author index Scoggins C.R. ix371 (1
Page 581 and 582:
author index Stern L. ix272 (823P)
Page 583 and 584:
author index Trypaki M. ix429 (1308
Page 585 and 586:
author index Whitmore J.B. ix310 (9
Page 587 and 588:
subject index subject index A AAV-H
Page 589 and 590:
subject index ix115 (316TiP), ix116
Page 591 and 592:
subject index diffuse large B-cell
Page 593 and 594:
subject index (1033P), ix340 (1036P
Page 595 and 596:
subject index medical information,
Page 597 and 598:
subject index (612P), ix214 (633),
Page 599 and 600:
subject index RCC, ix274 (830P) re-
Page 601 and 602:
subject index TR-FRET, ix84 (206P)
Page 603 and 604:
drug index drug index 1248P, 1250P,
Page 605 and 606:
translational research index transl
Page 607 and 608:
Page 609:
show all

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