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Annual Meeting Proceedings Part 1 - American Society of Clinical ...

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308s Genitourinary Cancer<br />

4626 General Poster Session (Board #8A), Sun, 8:00 AM-12:00 PM<br />

Impact <strong>of</strong> maximum standardized uptake value (SUVmax) evaluated by<br />

18-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography<br />

(FDG PET/CT) on survival for patients with advanced renal cell<br />

carcinoma. Presenting Author: Noboru Nakaigawa, Department <strong>of</strong> Urology,<br />

Yokohama City University Graduate School <strong>of</strong> Medicine, Yokohama, Japan<br />

Background: In this era <strong>of</strong> molecular targeting therapy when various<br />

systematic treatments can be selected, prognostic biomarkers are required<br />

for the purpose <strong>of</strong> risk-directed therapy selection. Numerous reports <strong>of</strong><br />

various malignancies have revealed that 18-Fluoro-2-deoxy-D-glucose<br />

( 18F-FDG) accumulation, as evaluated by positron emission tomography,<br />

can be used to predict the prognosis <strong>of</strong> patients. The purpose <strong>of</strong> this study<br />

was to evaluate the impact <strong>of</strong> the maximum standardized uptake value<br />

(SUVmax) from 18-fluoro-2-deoxy-D-glucose positron emission tomography/<br />

computed tomography (FDG PET/CT) on survival for patients with advanced<br />

renal cell carcinoma (RCC). Methods: A total <strong>of</strong> 67 patients with advanced<br />

or metastatic RCC were enrolled in this study. The FDG uptake <strong>of</strong> all RCC<br />

lesions diagnosed by conventional CT was evaluated by FDG PET/CT. The<br />

impact <strong>of</strong> SUVmax on patient survival was analyzed prospectively. Results:<br />

The mean duration <strong>of</strong> observation was 461 days (range, 7-1229 days). The<br />

SUVmax before treatment <strong>of</strong> 67 patients ranged between undetectable<br />

level and 16.6 (mean 7.6�3.6). The patients with RCC tumors showing<br />

high SUVmax before treatment demonstrated poor prognosis (p�0.001<br />

hazard ratio 1.289, 95% CI 1.161-1.430). The median survival time <strong>of</strong> 36<br />

patients with RCC showing SUVmax less or 7.0 was 1229�991 days, that<br />

<strong>of</strong> 21 patients with RCC showing SUVmax between 7.0 and 12.0 was<br />

446�202 days, and that <strong>of</strong> 10 patients RCC showing SUVmax higher than<br />

12.0 was 95�43 days (�7.0 vs. 7.0� �12.0 p�0.0052, 7.0� �12.0 vs.<br />

12.0�:p�0.0169, log-rank test). SUVmax demonstrated a tendency to<br />

predict the survival compared with the Memorial Sloan-Kettering Cancer<br />

Center classification (p �0.015 vs 0.315, multivariate Cox analyses).<br />

Conclusions: The survival <strong>of</strong> patients with advanced RCC can be predicted<br />

by evaluating their SUVmax using FDG PET/CT. FDG PET/CT has potency as<br />

an “imaging biomarker” to provide helpful information for the clinical<br />

decision-making.<br />

4628 General Poster Session (Board #8C), Sun, 8:00 AM-12:00 PM<br />

Sorafenib treatment <strong>of</strong> Asian patients with advanced renal cell carcinoma<br />

(RCC) in daily practice: Subset analysis <strong>of</strong> the large non-interventional<br />

PREDICT study. Presenting Author: Dingwei Ye, Cancer Hospital, Fudan<br />

University, Shanghai, China<br />

Background: Previous studies with sorafenib in Asian patients with advanced<br />

RCC were relatively small and used strict entry criteria. Here we<br />

investigated safety and efficacy in a large subset <strong>of</strong> Asian patients in the<br />

prospective, non-interventional PREDICT study <strong>of</strong> sorafenib in routine<br />

practice (NCT 00895674). Methods: Patients were eligible based on a<br />

diagnosis <strong>of</strong> advanced RCC and the decision by the investigator to prescribe<br />

sorafenib under compliance <strong>of</strong> the local product label. Tumor status,<br />

patients’ performance and physician assessment <strong>of</strong> efficacy and tolerability<br />

were collected up to 12 months. Results: Between Jan 2007 and June<br />

2010, 1092 patients were enrolled in China (n�1033), South Korea<br />

(n�55), the Philippines (n�3) and Indonesia (n�1). In the efficacy<br />

population (n�909), baseline characteristics were: 71% male; 89% �70<br />

years old; 89% clear cell histology; 78% prior nephrectomy; 56% prior<br />

systemic therapy; 16% high MSKCC risk; 35% ECOG PS �2; 5% brain<br />

metastases. Overall, 19% <strong>of</strong> patients had �1 concomitant disease at<br />

baseline; the most frequent concomitant diseases were hypertension<br />

(14%) and diabetes (6%). Initial sorafenib dose was 800 mg daily in 97%<br />

<strong>of</strong> patients, <strong>of</strong> whom 91% were also receiving 800 mg daily as last dose.<br />

Median duration <strong>of</strong> sorafenib treatment was 9.7 months (range 0.2–24.1),<br />

and in clinically relevant subgroups was as follows: treatment-naïve, 9.7<br />

months; high MSKCC risk, 9.3 months; brain metastases, 8.4 months; age<br />

�70 years, 7.6 months; ECOG PS 2, 9.7 months; ECOG PS 3, 6.1 months.<br />

At last follow up, 63% <strong>of</strong> physicians reported good/very good efficacy and<br />

59% good/very good tolerability. Sorafenib was well tolerated; �2% <strong>of</strong> the<br />

safety population (n�1022) reported serious drug-related adverse events<br />

(SDRAEs) and only 3% discontinued due to DRAEs. In all, 35% <strong>of</strong> patients<br />

reported a DRAE, with the most frequent being hand-foot skin reaction<br />

(21%), diarrhea (7%), rash (7%), alopecia (5%), hypertension (3%).<br />

Conclusions: In this large subset <strong>of</strong> Asian patients with advanced RCC<br />

treated in daily practice settings, sorafenib was well tolerated and provided<br />

benefit, including in clinically relevant patient subgroups.<br />

4627 General Poster Session (Board #8B), Sun, 8:00 AM-12:00 PM<br />

Natural history <strong>of</strong> malignant bone disease in renal cancer: Final results <strong>of</strong><br />

an Italian bone metastases survey. Presenting Author: Daniele Santini,<br />

Dipartimento di Medicina Oncologica, Università Campus Bio-Medico di<br />

Roma, Rome, Italy<br />

Background: bone metastases (mts) are an emerging clinical problem in<br />

renal cancer patients related to survival increase. We report the final data <strong>of</strong><br />

largest survey never published in literature. Methods: 398 renal cancer<br />

patients (pts) with evidence <strong>of</strong> bone mts, all died at the moment <strong>of</strong> study<br />

inclusion, have been included. Clinico-pathological data, data on survival<br />

and Skeletal Related Events (SRE) data and skeletal related therapies have<br />

been collected and statistically analyzed. Results: 286 males/112 females;<br />

median age: 63 (16-87); pts with bone mts at the moment <strong>of</strong> renal cancer<br />

diagnosis: 31.4%; pts with single bone mts: 31.1%. Type: lytic 77%,<br />

mixed: 14.6%, blastic: 7.6 %. Sites: spine (65.8%), pelvis (38.4%), long<br />

bones (31.6%), other (18.8%). Median time to bone mts: 8 months<br />

(0-288) (all patients); 24 months (1-288) (pts without bone mts at<br />

diagnosis). Pts with at least 1 SRE: 71.1%. Types <strong>of</strong> SREs: pathologic<br />

fracture (12.6%), radiotherapy (61.8%), spinal compression (7.6%), bone<br />

surgery (14.8%), hypercalcaemia (3.2%). Median number <strong>of</strong> SRE for<br />

patient: 1 (0-4). Median time to first SRE: 2 (0-72), to second SRE: 4<br />

(0-113), to third SRE: 11 (1-108). Median survival after bone mts<br />

diagnosis: 12 (1-178). Median survival after first SRE: 10 (0-144). Median<br />

survival in pts with at least one SRE: 14 (1-178); median survival in pts<br />

without SREs: 9 (0-62). In according with MKSCC criteria median time to<br />

skeletal disease was in patients with good prognosis was 24 (0-288),<br />

intermediate was 5 (0-180) and poor prognosis was 0 (0-77). A total <strong>of</strong> 168<br />

pts received zoledronic acid until performance status worsening or death.<br />

162 pts have been analysed as control group. The median time to first SRE<br />

in the zoledronic treated pts was 3 mths (0-101) compared with 1 mth (0 -<br />

25) in the control group (p� 0.05). 5 cases <strong>of</strong> ONJ have been diagnosed.<br />

Conclusions: The present survey is the largest descriptive study concerning<br />

the natural history <strong>of</strong> bone disease in renal cancer patients. The effects <strong>of</strong><br />

biological therpies on bone met will be presented during the meeting.<br />

4629 General Poster Session (Board #8D), Sun, 8:00 AM-12:00 PM<br />

Overall survival (OS) in metastatic renal cell carcinoma (mRCC) sequentially<br />

treated with different targeted therapies (TTs): Results from a large<br />

cohort <strong>of</strong> patients. Presenting Author: Giuseppe Procopio, Fondazione<br />

IRCCS Istituto Nazionale dei Tumori, Milan, Italy<br />

Background: Targeted Therapies (TTs) have definitely improved survival in<br />

patients with mRCC. However the optimal therapeutic strategy is not<br />

shared. This study was performed to assess the overall survival (OS) in a<br />

consecutive series <strong>of</strong> mRCC patients receiving TTs. Methods: Characteristics<br />

and outcomes <strong>of</strong> 336 patients affected by mRCC receiving TTs were<br />

collected from the database <strong>of</strong> Istituto Nazionale Tumori <strong>of</strong> Milan. The<br />

main characteristics <strong>of</strong> patients were: ECOG PS 0/1/2 186 (55%)/131<br />

(39%)/19 (6 %); clear-cell histology 291 (87%); previous nephrectomy<br />

293 (87%). According to Motzer criteria 32% <strong>of</strong> patients showed low risk,<br />

48% intermediate risk and 20% poor. Overall, 167 (50%) patients<br />

received one TTs, while 116 (34%), 42 (13%) and 11 (3.3%) received 2, 3<br />

and 4 TTs, respectively. 245 (73%) patients received sorafenib (So), 212<br />

(63%) sunitinib (Su), 33 (10%) a bevacizumab regimen and 73 (22%)<br />

other TTs, including everolimus, temsirolimus and axitinib. The Kaplan<br />

Meier curves were used to describe the survival.The uni- and multi-variate<br />

analyses for OS were carried out by means <strong>of</strong> Cox proportional hazard<br />

regression analysis. Results: Ata median follow-up <strong>of</strong> 43 months, 199<br />

patients (57 %) had died. The median OS was 24 months (95%CI:<br />

20.0-27.0) and the 5-year OS was 24.6 % (95 %CI: 18.7-30.8). In<br />

univariate analyses, there were no significant differences in the hazard<br />

ratios (HR) for So followed by Su compared to Su followed by So<br />

(HRSU-SO / SO-SU � 1.16; 95%CI: 0.57-2.33) or compared with other<br />

therapies (HROther sequential th. / SO-SU � 1.21; 95%CI: 0.78-1.88;<br />

p�0.674).In the multivariate analysis, in terms <strong>of</strong> OS any statistical<br />

difference was reported as regards the sequence used (Su/So vs So/Su;<br />

p�0.05) or bevacizumab regimen as compared to Su and/or So used<br />

sequentially (p�0.05). In the uni and multivariate analysis ECOG PS,<br />

nephrectomy, Fuhrman grade and number <strong>of</strong> sites <strong>of</strong> disease are independent<br />

predictive factors <strong>of</strong> outcome (p� 0.01). Conclusions: These data<br />

suggest that TTs improve OS in mRCC without any statistical difference<br />

when using different sequences <strong>of</strong> TTs. No cross-resistance between<br />

several sequences <strong>of</strong> TTs was documented.<br />

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