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Download the ESMO 2012 Abstract Book - Oxford Journals

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abstracts<br />

sarcoma<br />

1477O ADHESION TO CLINICAL PRACTICES GUIDELINES (CPG’S)<br />

AND ROLE ON SURVIVAL FOR SOFT TISSUE SARCOMA<br />

PATIENTS. ANALYSIS OF A POPULATION BASED COHORT<br />

FROM RHONE-ALPES REGION<br />

O. Derbel 1 , C. Cropet 2 , P. Meeus 3 , F-N. Gilly 4 ,G.Vaz 5 , P. Thiesse 6 , D. Cellier 7 ,<br />

D. Vince-Ranchere 8 , J-Y. Blay 9 , I. Ray-Coquard 9<br />

1 Department of Medical Oncology, Centre Léon Bérard, Lyon, FRANCE,<br />

2 Biostatistic Department, Centre Léon Bérard, Lyon, FRANCE, 3 Department of<br />

Surgery, Centre Léon Bérard, Lyon, FRANCE, 4 Department of Digestive Surgery,<br />

University Hospital Lyon Sud, Lyon, FRANCE, 5 Department of Surgery, Hopital<br />

Edouard Herriot, Lyon, FRANCE, 6 Department of Imaging, Centre Léon Bérard,<br />

Lyon, FRANCE, 7 Merck Serono, Lyon, FRANCE, 8 Department of Pathology,<br />

Centre Léon Bérard, Lyon, FRANCE, 9 University of Lyon, Department of Medical<br />

Oncology, Centre Léon Bérard, Lyon, FRANCE<br />

Sarcoma treatment has been suggested to be improved by <strong>the</strong> management in a<br />

multidisplinary expert team and adhesion to CPG’s (ann oncol 04). To confirm <strong>the</strong><br />

strong relation between medical practices and survival, an exhaustive analysis of <strong>the</strong><br />

outcome of <strong>the</strong> sarcoma patients population was performed in <strong>the</strong> Rhône–Alpes<br />

region.<br />

Patients and methods: From March 2005 to February 2007, 634 patients > 18<br />

years old, diagnosed with localized sarcoma in Rhone-Alpes were included (Soft<br />

tissue sarcoma (STS): n = 472; GIST: n = 129; bone primary site: n = 33).<br />

Adhesion to national CPG’s was analysed for all patients. Prognostic impact of<br />

conformity to CPG’s on overall survival (OS) and progression free survival (PFS)<br />

was analyzed for STS patients, in in a univariate analysis and a Cox model<br />

regression.<br />

Results: Institutional records of 472 patients with localized STS sarcoma were<br />

reviewed., The sex ratio (male/female) was 1.1 and varied with <strong>the</strong> type of sarcoma.<br />

The median age was 60 years (range from 18 to 92).The most frequent histological<br />

subtypes were liposarcoma (N= 133, 28%), unclassified sarcoma (N= 98, 20.7%), and<br />

leiomyosarcoma (N= 70, 14.8%). Conformity to CPGs for patients with localized<br />

sarcoma was 40, 62, 87, 94 and 82% for global conformity, initial surgery, radiation<br />

<strong>the</strong>rapy, chemo<strong>the</strong>rapy and follow-up, respectively. In multivariate analysis,<br />

conformity of surgery to CPG’s was an independent prognostic factor of PFS in<br />

patients with STS, along with age at diagnosis, grade and histological subtype (HR:<br />

0.5, 95%CI: 0.36-0.67) (p < 0.0001). Conformity of surgery (HR: 2.6), Age (HR: 1.07)<br />

and grade (HR: 0.06) are independents factors for overall survival in multivariate<br />

analysis for patients with liposarcomas.<br />

Conclusion: Conformity to CPG’s improves progression free survival for sarcoma<br />

patients. Conformity of surgical procedure to CPG’s is a major independent factor<br />

predicting PFS for STS patients and OS for patients with liposarcomas.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

Annals of Oncology 23 (Supplement 9): ix478–ix491, <strong>2012</strong><br />

doi:10.1093/annonc/mds414<br />

1478O CLINICAL BENEFIT WITH REGORAFENIB ACROSS<br />

SUBGROUPS AND POST-PROGRESSION IN PATIENTS WITH<br />

ADVANCED GASTROINTESTINAL STROMAL TUMOR (GIST)<br />

AFTER PROGRESSION ON IMATINIB (IM) AND SUNITINIB<br />

(SU): PHASE 3 GRID TRIAL UPDATE<br />

P.G. Casali 1 , P. Reichardt 2 , Y. Kang 3 , J. Blay 4 , P. Rutkowski 5 , H. Gelderblom 6 ,<br />

P. Hohenberger 7 , M. Leahy 8 , M. von Mehren 9 , H. Joensuu 10 , G. Badalamenti 11 ,<br />

M. Blackstein 12 , A. Le Cesne 13 , P. Schöffski 14 , R. Maki 15 ,J.Xu 16 , T. Nishida 17 ,<br />

I. Kuss 18 , D. Laurent 18 , G.D. Demetri 19<br />

1 Struttura Semplice Trattamento Medico dei Sarcomi dell’Adulto, Istituto<br />

Nazionale Tumori, Milano, ITALY, 2 Hematology, Oncology and Palliative, HELIOS<br />

Klinikum Bad Saarow, Bad Saarow, GERMANY, 3 Dept. of Oncology and<br />

Hematology, Asan Medical Center, Seoul, KOREA, 4 Medical Oncology, Centre<br />

Léon Bérard, Lyon Cedex, FRANCE, 5 Centrum Onkologii-, Instytut im. Marii<br />

Sklodowskiej – Curie, Warszawa, POLAND, 6 Medical Oncology, Leiden<br />

University Medical Center, Leiden, NETHERLANDS, 7 Dept. of Surgery,<br />

UniversitaetsMedizin Mannheim, Mannheim, GERMANY, 8 The Christie Hospital<br />

NHS Foundation Trust, Manchester, UNITED KINGDOM, 9 Fox Chase Cancer<br />

Center, Philadelphia, PA, UNITED STAES OF AMERICA, 10 Dept. of Oncology,<br />

Helsinki University Central Hospital, Helsinki, FINLAND, 11 U.O. di Oncologia<br />

Medica, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo,<br />

ITALY, 12 Mount Sinai Hospital, Toronto, CANADA, 13 Institut Gustave Roussy,<br />

Villejuif, FRANCE, 14 Universitaire Ziekenhuis Gasthuisberg, Leuven, BELGIUM,<br />

15 Departments of Medicine and Pediatrics, Mount Sinai School of Medicine,<br />

New York, NY, UNITED STATES OF AMERICA, 16 307 Hospital of PLA, Beijing,<br />

CHINA, 17 Osaka Police Hospital, Osaka, JAPAN, 18 Global Clinical Development<br />

Oncology 2, Bayer HealthCare Pharmaceuticals, Berlin, GERMANY, 19 Ludwig<br />

Center at Dana-Farber/Harvard Cancer Center and Sarcoma Center,<br />

Dana-Farber Cancer Institute, Boston, MA, UNITED STATES OF AMERICA<br />

Background: Regorafenib (REG) <strong>the</strong>rapy significantly improved progression-free<br />

survival (PFS) in patients (pts) with GIST after failure of both IM and SU (J Clin<br />

Oncol <strong>2012</strong>; 30: suppl; abstr LBA10008). Results of subgroup and post-progression<br />

analyses are presented here.<br />

Methods: Pts were randomized (2:1) to receive best supportive care plus ei<strong>the</strong>r REG<br />

160 mg or placebo (PL) po once daily (3 wks on/1 wk off). The primary endpoint<br />

was PFS. Upon progression in ei<strong>the</strong>r arm, unblinding could occur. Pts on PL were<br />

eligible for crossover to open-label (OL) REG and progressive pts on REG were<br />

allowed to continue REG upon local physician’s choice.<br />

Results: GRID screened 234 pts and randomized 199 (REG: 133, PL: 66), well<br />

balanced for baseline characteristics. The PFS primary endpoint (according to<br />

RECIST) was met both per central review (median PFS 4.8 mo for REG vs. 0.9 mo<br />

for PL), and by investigator assessment (median PFS 7.4 mo for REG vs. 1.7 mo for<br />

PL). Exploratory sensitivity analyses demonstrate similar positive impact on PFS<br />

across pre-specified subgroups by number of prior systemic <strong>the</strong>rapy, geographical<br />

region, age, baseline ECOG score, duration of prior treatment with imatinib, or KIT/<br />

PDGFRA mutation. Median overall survival has not been reached in ei<strong>the</strong>r arm.<br />

Taking <strong>the</strong> double-blind and OL periods toge<strong>the</strong>r, 188 pts received REG.<br />

© European Society for Medical Oncology <strong>2012</strong>. Published by <strong>Oxford</strong> University Press on behalf of <strong>the</strong> European Society for Medical Oncology.<br />

All rights reserved. For permissions, please email: journals.permissions@oup.com

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