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

308s Genitourinary Cancer
4626 General Poster Session (Board #8A), Sun, 8:00 AM-12:00 PM
Impact of maximum standardized uptake value (SUVmax) evaluated by
18-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography
(FDG PET/CT) on survival for patients with advanced renal cell
carcinoma. Presenting Author: Noboru Nakaigawa, Department of Urology,
Yokohama City University Graduate School of Medicine, Yokohama, Japan
Background: In this era of molecular targeting therapy when various
systematic treatments can be selected, prognostic biomarkers are required
for the purpose of risk-directed therapy selection. Numerous reports of
various malignancies have revealed that 18-Fluoro-2-deoxy-D-glucose
( 18F-FDG) accumulation, as evaluated by positron emission tomography,
can be used to predict the prognosis of patients. The purpose of this study
was to evaluate the impact of the maximum standardized uptake value
(SUVmax) from 18-fluoro-2-deoxy-D-glucose positron emission tomography/
computed tomography (FDG PET/CT) on survival for patients with advanced
renal cell carcinoma (RCC). Methods: A total of 67 patients with advanced
or metastatic RCC were enrolled in this study. The FDG uptake of all RCC
lesions diagnosed by conventional CT was evaluated by FDG PET/CT. The
impact of SUVmax on patient survival was analyzed prospectively. Results:
The mean duration of observation was 461 days (range, 7-1229 days). The
SUVmax before treatment of 67 patients ranged between undetectable
level and 16.6 (mean 7.6�3.6). The patients with RCC tumors showing
high SUVmax before treatment demonstrated poor prognosis (p�0.001
hazard ratio 1.289, 95% CI 1.161-1.430). The median survival time of 36
patients with RCC showing SUVmax less or 7.0 was 1229�991 days, that
of 21 patients with RCC showing SUVmax between 7.0 and 12.0 was
446�202 days, and that of 10 patients RCC showing SUVmax higher than
12.0 was 95�43 days (�7.0 vs. 7.0� �12.0 p�0.0052, 7.0� �12.0 vs.
12.0�:p�0.0169, log-rank test). SUVmax demonstrated a tendency to
predict the survival compared with the Memorial Sloan-Kettering Cancer
Center classification (p �0.015 vs 0.315, multivariate Cox analyses).
Conclusions: The survival of patients with advanced RCC can be predicted
by evaluating their SUVmax using FDG PET/CT. FDG PET/CT has potency as
an “imaging biomarker” to provide helpful information for the clinical
decision-making.
4628 General Poster Session (Board #8C), Sun, 8:00 AM-12:00 PM
Sorafenib treatment of Asian patients with advanced renal cell carcinoma
(RCC) in daily practice: Subset analysis of the large non-interventional
PREDICT study. Presenting Author: Dingwei Ye, Cancer Hospital, Fudan
University, Shanghai, China
Background: Previous studies with sorafenib in Asian patients with advanced
RCC were relatively small and used strict entry criteria. Here we
investigated safety and efficacy in a large subset of Asian patients in the
prospective, non-interventional PREDICT study of sorafenib in routine
practice (NCT 00895674). Methods: Patients were eligible based on a
diagnosis of advanced RCC and the decision by the investigator to prescribe
sorafenib under compliance of the local product label. Tumor status,
patients’ performance and physician assessment of efficacy and tolerability
were collected up to 12 months. Results: Between Jan 2007 and June
2010, 1092 patients were enrolled in China (n�1033), South Korea
(n�55), the Philippines (n�3) and Indonesia (n�1). In the efficacy
population (n�909), baseline characteristics were: 71% male; 89% �70
years old; 89% clear cell histology; 78% prior nephrectomy; 56% prior
systemic therapy; 16% high MSKCC risk; 35% ECOG PS �2; 5% brain
metastases. Overall, 19% of patients had �1 concomitant disease at
baseline; the most frequent concomitant diseases were hypertension
(14%) and diabetes (6%). Initial sorafenib dose was 800 mg daily in 97%
of patients, of whom 91% were also receiving 800 mg daily as last dose.
Median duration of sorafenib treatment was 9.7 months (range 0.2–24.1),
and in clinically relevant subgroups was as follows: treatment-naïve, 9.7
months; high MSKCC risk, 9.3 months; brain metastases, 8.4 months; age
�70 years, 7.6 months; ECOG PS 2, 9.7 months; ECOG PS 3, 6.1 months.
At last follow up, 63% of physicians reported good/very good efficacy and
59% good/very good tolerability. Sorafenib was well tolerated; �2% of the
safety population (n�1022) reported serious drug-related adverse events
(SDRAEs) and only 3% discontinued due to DRAEs. In all, 35% of patients
reported a DRAE, with the most frequent being hand-foot skin reaction
(21%), diarrhea (7%), rash (7%), alopecia (5%), hypertension (3%).
Conclusions: In this large subset of Asian patients with advanced RCC
treated in daily practice settings, sorafenib was well tolerated and provided
benefit, including in clinically relevant patient subgroups.
4627 General Poster Session (Board #8B), Sun, 8:00 AM-12:00 PM
Natural history of malignant bone disease in renal cancer: Final results of
an Italian bone metastases survey. Presenting Author: Daniele Santini,
Dipartimento di Medicina Oncologica, Università Campus Bio-Medico di
Roma, Rome, Italy
Background: bone metastases (mts) are an emerging clinical problem in
renal cancer patients related to survival increase. We report the final data of
largest survey never published in literature. Methods: 398 renal cancer
patients (pts) with evidence of bone mts, all died at the moment of study
inclusion, have been included. Clinico-pathological data, data on survival
and Skeletal Related Events (SRE) data and skeletal related therapies have
been collected and statistically analyzed. Results: 286 males/112 females;
median age: 63 (16-87); pts with bone mts at the moment of renal cancer
diagnosis: 31.4%; pts with single bone mts: 31.1%. Type: lytic 77%,
mixed: 14.6%, blastic: 7.6 %. Sites: spine (65.8%), pelvis (38.4%), long
bones (31.6%), other (18.8%). Median time to bone mts: 8 months
(0-288) (all patients); 24 months (1-288) (pts without bone mts at
diagnosis). Pts with at least 1 SRE: 71.1%. Types of SREs: pathologic
fracture (12.6%), radiotherapy (61.8%), spinal compression (7.6%), bone
surgery (14.8%), hypercalcaemia (3.2%). Median number of SRE for
patient: 1 (0-4). Median time to first SRE: 2 (0-72), to second SRE: 4
(0-113), to third SRE: 11 (1-108). Median survival after bone mts
diagnosis: 12 (1-178). Median survival after first SRE: 10 (0-144). Median
survival in pts with at least one SRE: 14 (1-178); median survival in pts
without SREs: 9 (0-62). In according with MKSCC criteria median time to
skeletal disease was in patients with good prognosis was 24 (0-288),
intermediate was 5 (0-180) and poor prognosis was 0 (0-77). A total of 168
pts received zoledronic acid until performance status worsening or death.
162 pts have been analysed as control group. The median time to first SRE
in the zoledronic treated pts was 3 mths (0-101) compared with 1 mth (0 -
25) in the control group (p� 0.05). 5 cases of ONJ have been diagnosed.
Conclusions: The present survey is the largest descriptive study concerning
the natural history of bone disease in renal cancer patients. The effects of
biological therpies on bone met will be presented during the meeting.
4629 General Poster Session (Board #8D), Sun, 8:00 AM-12:00 PM
Overall survival (OS) in metastatic renal cell carcinoma (mRCC) sequentially
treated with different targeted therapies (TTs): Results from a large
cohort of patients. Presenting Author: Giuseppe Procopio, Fondazione
IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Background: Targeted Therapies (TTs) have definitely improved survival in
patients with mRCC. However the optimal therapeutic strategy is not
shared. This study was performed to assess the overall survival (OS) in a
consecutive series of mRCC patients receiving TTs. Methods: Characteristics
and outcomes of 336 patients affected by mRCC receiving TTs were
collected from the database of Istituto Nazionale Tumori of Milan. The
main characteristics of patients were: ECOG PS 0/1/2 186 (55%)/131
(39%)/19 (6 %); clear-cell histology 291 (87%); previous nephrectomy
293 (87%). According to Motzer criteria 32% of patients showed low risk,
48% intermediate risk and 20% poor. Overall, 167 (50%) patients
received one TTs, while 116 (34%), 42 (13%) and 11 (3.3%) received 2, 3
and 4 TTs, respectively. 245 (73%) patients received sorafenib (So), 212
(63%) sunitinib (Su), 33 (10%) a bevacizumab regimen and 73 (22%)
other TTs, including everolimus, temsirolimus and axitinib. The Kaplan
Meier curves were used to describe the survival.The uni- and multi-variate
analyses for OS were carried out by means of Cox proportional hazard
regression analysis. Results: Ata median follow-up of 43 months, 199
patients (57 %) had died. The median OS was 24 months (95%CI:
20.0-27.0) and the 5-year OS was 24.6 % (95 %CI: 18.7-30.8). In
univariate analyses, there were no significant differences in the hazard
ratios (HR) for So followed by Su compared to Su followed by So
(HRSU-SO / SO-SU � 1.16; 95%CI: 0.57-2.33) or compared with other
therapies (HROther sequential th. / SO-SU � 1.21; 95%CI: 0.78-1.88;
p�0.674).In the multivariate analysis, in terms of OS any statistical
difference was reported as regards the sequence used (Su/So vs So/Su;
p�0.05) or bevacizumab regimen as compared to Su and/or So used
sequentially (p�0.05). In the uni and multivariate analysis ECOG PS,
nephrectomy, Fuhrman grade and number of sites of disease are independent
predictive factors of outcome (p� 0.01). Conclusions: These data
suggest that TTs improve OS in mRCC without any statistical difference
when using different sequences of TTs. No cross-resistance between
several sequences of TTs was documented.
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