Download the ESMO 2012 Abstract Book - Oxford Journals
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Results: 1,622 patients were identified. 1,079 received first-line SUN, 284 SOR, 168<br />
TEM, 40 PAZ, 26 EVE, and 25 BEV. With a median follow-up of 13 months, <strong>the</strong><br />
mean healthcare cost PPPM was:<br />
Cost PPPM<br />
1st-line Agent<br />
Total Inpatient O<strong>the</strong>r outpatient mRCC drugs<br />
TEM $15,900 $6,480 $4,959 $3,532<br />
BEV $15,429 $6,529 $3,795 $4,021<br />
EVE $14,519 $3,585 $6,007 $4,063<br />
SUN $14,084 $6,208 $3,834 $2,965<br />
PAZ $12,461 $5,049 $3,895 $2,766<br />
SOR $12,266 $4,759 $3,662 $3,938<br />
Inpatient costs accounted for <strong>the</strong> largest share of total cost. O<strong>the</strong>r outpatient services<br />
and mRCC drug costs were <strong>the</strong> next largest cost drivers. ER and office visits and<br />
o<strong>the</strong>r Rx each averaged less than $500 PPPM. OOP cost averaged $453 PPPM, but<br />
ranged from $380 for EVE to $2,045 for BEV.<br />
Conclusions: Different first-line targeted agents appear to be associated with<br />
different total costs of care in mRCC. Patient characteristics, incidence and severity of<br />
adverse events, rates and duration of response, and choice of subsequent <strong>the</strong>rapies<br />
may all play a role. Fur<strong>the</strong>r characterization of such underlying factors may help<br />
optimize patient care and reduce cost.<br />
Disclosure: Y. Su: Employment or Leadership Role: Bristol-Myers Squibb<br />
(employment, myself, compensated). Stock Ownership: Bristol-Myers Squibb<br />
(myself). P. Landsman-Blumberg: Stock Ownership: Merck & Co., Inc. (myself).<br />
C. Poehlein: Employment or Leadership Role: Bristol-Myers Squibb (employment,<br />
myself, compensated). Stock Ownership: Bristol-Myers Squibb (myself). I. Waxman:<br />
Employment or Leadership Role: Bristol-Myers Squibb (employment, myself,<br />
compensated). Stock Ownership: Bristol-Myers Squibb (myself). All o<strong>the</strong>r authors<br />
have declared no conflicts of interest.<br />
817P SORAFENIB IN PATIENTS WITH RENAL CELL CARCINOMA<br />
AND BRAIN, BONE OR LUNG METASTASES: SUBANALYSIS<br />
OF THE NON-INTERVENTIONAL PREDICT STUDY<br />
J. Mardiak 1 ,J.Ma 2 , E. Korbenfeld 3 , M. Zemanova 4 , N. Leonhartsberger 5 ,<br />
K. Stauch 6 , A. Boeckenhoff 7 ,J.Yu 8 , B. Escudier 9 , D. Jäger 10<br />
1 Department of Medical Oncology, National Cancer Institute, Bratislava, SLOVAK<br />
REPUBLIC, 2 Cancer Institute and Hospital, Chinese Academy of Medical<br />
Sciences, Beijing, CHINA, 3 Oncology, Hospital Británico de Buenos Aires,<br />
Buenos Aires, ARGENTINA, 4 First Faculty of Medicine, Charles University,<br />
Prague, CZECH REPUBLIC, 5 Department of Urology, Medical University<br />
Innsbruck, Innsbruck, AUSTRIA, 6 Global Non-interventional Studies, Bayer<br />
HealthCare, Leverkusen, GERMANY, 7 Global Development – Global Clinical<br />
Development, Bayer HealthCare, Wuppertal, GERMANY, 8 Global Medical Affairs,<br />
Bayer HealthCare, Montville, NJ, UNITED STATES OF AMERICA, 9 Department of<br />
Immuno<strong>the</strong>rapy, Institut Gustave Roussy, Villejuif, FRANCE, 10 National Center for<br />
Tumor Diseases, University Medical Center Heidelberg, Heidelberg, GERMANY<br />
Background: Clinical trials in advanced renal cell carcinoma (RCC) tend to exclude<br />
patients (pts) with brain metastases (mets). We report safety and efficacy outcomes<br />
from a subanalysis of PREDICT (NCT 00895674), a large, non-interventional study<br />
of sorafenib in pts with advanced RCC, according to sites of mets.<br />
Methods: Pts were eligible based on a diagnosis of advanced RCC and a decision by<br />
<strong>the</strong> investigator to prescribe sorafenib under compliance of <strong>the</strong> local product label.<br />
Physician assessments of efficacy and tolerability were collected for up to 12 months.<br />
Results: Of <strong>the</strong> efficacy population (n = 2311), 1079 pts (47%) had mets in >1 organ.<br />
Sites included bone (n = 635), brain (n = 113), lung (n = 1639); 750 pts had mets only<br />
in <strong>the</strong> lung (‘lung only’). Baseline characteristics across disease-site subsets were: 69–<br />
Table: 817P<br />
74% male; 73–82% aged 1 site (6.2 months). Median DOT was longest in pts<br />
with lung only mets (9.1 months); in <strong>the</strong> o<strong>the</strong>r subsets it was numerically similar to<br />
overall median DOT (brain, 7.0 months; bone, 6.4 months; lung, 7.5 months).<br />
Sorafenib was generally well tolerated (Table). Serious adverse event rates were<br />
numerically higher in pts with brain mets vs <strong>the</strong> o<strong>the</strong>r subsets, but no<br />
cerebrovascular events were reported.<br />
Conclusions: In pts with RCC treated in clinical practice, sorafenib DOT was >6<br />
months regardless of number or location of metastases, and sorafenib was generally<br />
well tolerated regardless of disease site. Number (%) patients with AEs (safety<br />
population).<br />
Disclosure: J. Mardiak: Jozef Mardiak has received Research Grants from Novartis<br />
and has received honoraria from Pfizer and Pierre Fabre. J. Ma: Jianhui Ma has<br />
received Research Grants from Bayer. M. Zemanova: Milada Zemanova has<br />
received consulting and lecture fees from Glaxo Smith Kline and Roche. N.<br />
Leonhartsberger: Nicolai Leonhartsberger has received honoraria from Bayer,<br />
Pfizer and Roche. K. Stauch: Kathrin Stauch is an employee of Bayer HealthCare<br />
and owns stock in Bayer Pharma AG. A. Boeckenhoff: Annette Boeckenhoff is an<br />
employee of Bayer HealthCare and owns stock in Bayer Pharma AG. J. Yu: Jian<br />
Yu is an employee of Bayer HealthCare. B. Escudier: Bernard Escudier has served<br />
in an advisory role for Pfizer, Novartis, Roche, GSK, Bayer and Aveo, and has<br />
received honoraria from Pfizer, Novartis, Roche, GSK, Bayer and Aveo. D. Jäger:<br />
Dirk Jäger has received honoraria from Bayer, Amgen, Pfizer, Novartis, Roche,<br />
Fresenius Kabi and Hoffmann-La Roche. All o<strong>the</strong>r authors have declared no<br />
conflicts of interest.<br />
818P PROGRESSION FREE SURVIVAL (PFS) AND OVERALL<br />
SURVIVAL (OS) IN PATIENTS RECEIVING 3 TARGETED<br />
THERAPIES (TTS) FOR METASTATIC RENAL-CELL<br />
CARCINOMA (MRCC)<br />
R. Iacovelli 1 , M. Santoni 2 , G. Di Lorenzo 3 , L. Cerbone 4 , M. Aglietta 5 , C. Masini 6 ,<br />
M.O. Giganti 7 , C. Messina 8 , C.N. Sternberg 9 , G. Procopio 10<br />
1 Department of Radiology, Oncology and Human Pathology, Sapienza University<br />
of Rome, Rome, ITALY, 2 Medical Oncology, Università Politecnica delle Marche,<br />
Ancona, ITALY, 3 Department of Oncology, Cattedra di Oncologia Medica,<br />
Università degli Studi Federico II, Napoli, ITALY, 4 Medical Oncology, San Camillo<br />
and Forlanini Hospital, Rome, ITALY, 5 Div Oncologia ed Ematologia, Fondazione<br />
Piemontese per la Ricerca sul Cancro Onlus, Candiolo, ITALY, 6 Dept. of<br />
Hematology/Oncology, Ospedale Policlinico-Modena, Modena, ITALY, 7 Medical<br />
Oncology, Niguarda Cà Grande Hospital, Milan, ITALY, 8 Medical Oncology,<br />
Ospedali Riuniti di Bergamo, Bergamo, ITALY, 9 Medical Oncology, San Camillo<br />
Forlanini Hospital, Rome, ITALY, 10 Medical Oncology, Fondazione IRCCS –<br />
Istituto Nazionale dei Tumori, Milano, ITALY<br />
Background: In recent years, TTs have improved <strong>the</strong> prognosis of mRCC patients<br />
(pts). Despite a not negligible number of pts received 3 TTs in clinical practice, no<br />
TTs have been evaluated as 3 rd line. Aim of this study is to investigate <strong>the</strong> clinical<br />
outcome in pts who received 3 TTs.<br />
Patients and methods: Pts with clear-cell mRCC who received 3 TTs were included.<br />
A questionnaire was sent to main Italian centers involved in <strong>the</strong> treatment of mRCC.<br />
Demographic data, history of RCC, type and length of first, second and third line<br />
were collected; MSKCC risk class was calculated before starting <strong>the</strong> 1 st and 3 rd lines,<br />
Heng class before <strong>the</strong> 3 rd line. Sequences of class and specific TTs were evaluated:<br />
TKIàTKIàmTOR and TKIàmTORàTKI or sunitinib (SU)-sorafenib(SO)- everolimus<br />
(EV) and SU-EV-SO. Median PFS, OS and Time to Strategy Failure (TTSF: from<br />
start of 1 st to end of 3 rd line) were estimated with <strong>the</strong> Kaplan-Meyer method with<br />
Event<br />
Metastases subsets<br />
Brain (n = 121) Bone (n = 673) Lung, all (n = 1723) Lung, only (n = 779) Overall (n = 2599)<br />
Any AE 77 (63.6) 401 (59.6) 1011 (58.7) 406 (52.1) 1479 (56.9)<br />
Any drug-related AE 58 (47.9) 316 (47.0) 861 (50.0) 366 (47.0) 1240 (47.7)<br />
Any SAE 39 (32.2) 156 (23.2) 297 (17.2) 90 (11.6) 477 (18.4)<br />
Any drug-related SAE 12 (9.9) 42 (6.2) 89 (5.2) 30 (3.9) 140 (5.4)<br />
Most frequent any grade drug-related AEs*<br />
Hand–foot skin reaction 20 (16.5) 106 (15.8) 366 (21.2) 188 (24.1) 520 (20.0)<br />
Diarrhea 19 (15.7) 111 (16.5) 306 (17.8) 114 (14.6) 443 (17.1)<br />
Rash †<br />
Annals of Oncology<br />
8 (6.6) 58 (8.6) 155 (9.0) 65 (8.3) 220 (8.5)<br />
Alopecia 5 (4.1) 36 (5.4) 96 (5.6) 44 (5.7) 145 (5.6)<br />
Decreased appetite 7 (5.8) 24 (3.6) 44 (2.6) 12 (1.5) 76 (2.9)<br />
ix270 | <strong>Abstract</strong>s Volume 23 | Supplement 9 | September <strong>2012</strong>