24.12.2012 Views

Download the ESMO 2012 Abstract Book - Oxford Journals

Download the ESMO 2012 Abstract Book - Oxford Journals

Download the ESMO 2012 Abstract Book - Oxford Journals

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

798PD OPEN-LABEL PHASE II TRIAL OF FIRST-LINE EVEROLIMUS<br />

MONOTHERAPY IN PATIENTS WITH ADVANCED PAPILLARY<br />

RENAL CELL CARCINOMA: RAPTOR INTERIM ANALYSIS<br />

B. Escudier 1 , S. Bracarda 2 , J.P. Maroto 3 , C. Szczylik 4 , P. Nathan 5 , S. Negrier 6 ,<br />

K. Slimane 7 , C. May 8 , C. Porta 9 , V. Grünwald 10<br />

1 Oncology, Institut Gustave Roussy, Villejuif, FRANCE, 2 Medical Oncology,<br />

Ospedale San Donato, Arezzo, ITALY, 3 Medical Oncology, Hospital de la Santa<br />

Creu i Sant Pau, Barcelona, SPAIN, 4 Clinical Oncology, Wojskowy Instytut<br />

Medyczny, Warsaw, POLAND, 5 Cancer Services, Mount Vernon Cancer Centre,<br />

Northwood, UNITED KINGDOM, 6 Oncology, Centre Leon Berard, Lyon,<br />

FRANCE, 7 Oncology, Novartis Pharmaceuticals, Rueil-Malmaison, FRANCE,<br />

8 Oncology, Novartis Pharma GmbH, Nuremberg, GERMANY, 9 Medical<br />

Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, ITALY,<br />

10 Clinic for Hematology, Hemostasis, Oncology, and Stem Cell Transplantation,<br />

Hannover Medical School, Hannover, GERMANY<br />

Background: Treatment options for patients with papillary renal cell carcinoma<br />

(RCC) are limited. Everolimus, a mammalian target of rapamycin (mTOR) inhibitor,<br />

has demonstrated efficacy in clear cell metastatic RCC; mTOR signaling is also<br />

dysregulated in papillary RCC. The ongoing RAPTOR (RAD001 in Advanced<br />

Papillary Tumor Program in Europe; ClinicalTrials.gov, NCT00688753) trial is<br />

evaluating everolimus mono<strong>the</strong>rapy in treatment-naive patients with advanced<br />

papillary RCC. Here, we present <strong>the</strong> results of a preliminary analysis.<br />

Patients and methods: RAPTOR is an open-label, single-arm, multicentre phase II<br />

trial. Adult patients with advanced type I or type II papillary RCC and ECOG<br />

performance status of 0 or 1 were enrolled. Prior systemic <strong>the</strong>rapy for RCC was not<br />

permitted. Patients received oral everolimus 10 mg once daily until disease<br />

progression or unacceptable toxicity. The primary end point is proportion of patients<br />

progression free at 6 months.<br />

Results: At data cut-off (April 11, <strong>2012</strong>), 71 of 92 (77%) enrolled patients were<br />

eligible for analysis according to central pathology review (confirmed papillary renal<br />

cancer); 16 of <strong>the</strong> 92 patients were still on treatment. Most patients were men (73%)<br />

and most were

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!