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Annals of Oncology
multiple locations. As 1 st line therapy, 24% had cytokine or immunotherapy based
therapies, 52% sunitinib and 17% sorafenib. The duration of 1 st line therapy was 7.0
months in median for all patients (including cytokines) and 7.8 and 13.7 months for
those treated with sunitinib or sorafenib, respectively. 50 patients achieved a second
line therapy prior to everolimus, 22 patients were treated with sorafenib and 26
patients with sunitinib dependent on the 1 st line therapy. Most patients treated with
everolimus in 2 nd or 3 rd line therapy had an ECOG of 1 (49.4%) followed by ECOG
0 (39.5%) and ECOG 2 (9.9%). The median duration of treatment with everolimus
was 4.5 months (0.6–22.5), 36% of the patients were more than 6 months on
treatment with everolimus. Best response was CR in 2.5%, PR in 12% and SD in 47%
of the patients (CBR 61%). Reasons for discontinuation were PD (72%), intolerance
(16%), patients request (6%) and others (6%). 77/81 patients (95%) received a further
therapy after discontinuation of everolimus. The agents administered beyond
everolimus were sunitinib (29%), sorafenib (29%) and 36% received other therapies
as temsirolimus, pazopanib or dovitinib. Best reported responses have been CR (1%),
PR (9%), SD (48%) of the reported patients. 27 patients received an additional
sequence of therapy (4 th to 5 th line). In summary, these data confirm the results of
the RECORD-1 trial in clinical practice and demonstrate a clinical benefit of
therapies beyond everolimus. 58% of the patients were still alive at time of evaluation.
Disclosure: L. Bergmann: The retrospective analysis was supported by a grant of
Novartis Pharma. The presenter has been an advisor for Novartis Pharma. V.
Grünwald: Advisory board Novartis. S. Weikert: Advisory board Novartis. T.C. Gauler:
Advisary board Novartis. All other authors have declared no conflicts of interest.
876 EFFICACY AND SAFETY OF SEQUENTIAL USAGE OF
EVEROLIMUS IN PATIENTS WITH METASTATIC RENAL CELL
CARCINOMA (MRCC) PREVIOUSLY TREATED WITH
BEVACIZUMAB +/- INTERFERON (INF) THERAPY. RESULTS
FROM THE EUROPEAN AVATOR RETROSPECTIVE STUDY
A. Vuillemin 1 , C. Theodore 2 , L. Jacobasch 3 , J. Schmitz 4 , A. Guillot 5 ,
C. Papandreou 6 , C. Emmanouilides 7 , K. Slimane 8 , M. Ktiouet 8 , T. Nguyen 1
1 Medical Oncology, Hôpital Jean Minjoz, Besançon, FRANCE, 2 Medical
Oncology, HÔPITAL FOCH, Suresnes, FRANCE, 3 Hematology/Oncology, Private
Practice for Hematology/Oncology, Dresden, GERMANY, 4 Hematology/
Oncology, Fachklinik Lindenberg/Ried, Lindenberg, GERMANY, 5 Medical
Oncology, Institut de Cancérologie de la Loire, Saint Priest en Jarez Cedex,
FRANCE, 6 Department of Medical Oncology, University Hospital of Larissa,
Larissa, GREECE, 7 Oncology, Iatriko Diavalkaniko Thessalonikis, Thessaloniki,
GREECE, 8 Oncology, Novartis Pharmaceuticals, Rueil-Malmaison, FRANCE
Background: EVE (Afinitor®) has demonstrated activity in the treatment of mRCC
after failure of VEGF-targeted tyrosine kinase inhibitors. However, to this date, there
is no published data evaluating its activity/safety after failure of first line BEV-based
therapy.
Methods: Our non-interventional multicenter international study reports
retrospective data on EVE in routine use. Eligible patients had mRCC; were given
EVE after 1 prior first-line systemic therapy with BEV +/- INF. The data were
provided by each center and centralised. The pts were evaluated for differences in
baseline characteristics and prognostic factors (PFs) validated in mRCC.
Results: Here are the results from an interim analysis: 20 sites included 43 pts
between October 2011 and February 2012. Baseline patient characteristics included
median age of 69 [38–90] years old; 64.3% male; 97.5% with prior nephrectomy.
First-line therapy was BEV + INF in 69% of patients, only BEV for 31%. Prognostic
groups at the time of EVE initiation according to Heng (1) and to MSKCC (2) were
respectively: (1): good 25%, intermediate 59.4% and poor prognosis 15.6% and (2)
good 28.1%, intermediate 56.3% and poor 15.6%. Median duration of treatment with
first line therapy was 7.5 months, it was discontinued for disease progression in 61.9
% of pts. Median EVE treatment duration with was 5 [3.0–7.0] months. Median
progression free survival (PFS) has not yet been reached as 15 pts are still receiving
EVE. Overall response rate was 9.5 % and disease stabilization rate was 50%. At least
one adverse event (AE) occurred in 73.8 % of pts with 13 serious AEs. All grade
common AEs were consistent with the toxicity profile of EVE with 31% of stomatitis,
16.7% of pneumonitis, 31% of fatigue.
Conclusions: This study provided encouraging results for the activity and safety
profile of EVE in second line mRCC setting and warrants further investigation after
1 prior first-line therapy with bevacizumab-based regimen. Final results with mature
PFS data and median overall survival from initiation of first-line therapy will be
available in 2013.
Disclosure: A. Vuillemin: Consulting fees : Novartis, Sanofi-Aventis, Ferring Member
of Novartis Advisory board Honorarium study NovartisC. Theodore: Research grant
from Novartis Consulting fees from Novartis Honorarium study NovartisL.
Jacobasch: Honorarium study NovartisA. Guillot: Member of Novartis Advisory
board Speaker at Novartis regional meetings Honorarium study NovartisC.
Papandreou: Participated to advisory boards for NovartisC. Emmanouilides: Research
grants : Novartis, Pfizer, GSKK. Slimane: Novartis employeeM. Ktiouet: Novartis
EmployeeT. Nguyen: Honorarium study NovartisAll other authors have declared no
conflicts of interest.
877 A REVIEW OF RADIOLOGICAL ASSESSMENT RESPONSE IN
METASTATIC RENAL CELL CARCINOMA TREATED WITH
ANTIANGIOGENIC THERAPY- ARE WE HITTING THE TARGET?
T. Montella 1 , D. Herchenhorn 2
1 INCA, Rio de Janeiro, BRAZIL, 2 Medical Oncology, Brazilian National Cancer
Institute, Rio de Janeiro, BRAZIL
Background: Targeted therapy has changed the treatment landsacpe of metastatic
renal cell carcinoma (RCC) in the last years. However, despite the positive results
with antiangiogenic drugs in the treatment of metastatic RCC, the evaluation of
response to these therapies remains undefined. This study aimed to review different
proposed radiologic methods used for response evaluation with antiangiogenic agents
in RCC.
Methods: A no systematic literature review using electronic databases PubMed/
MEDLINE, EMBASE, Cochrane Library and LILACS with the terms “renal cell
carcinoma”, “response criteria” and “targeted therapy” and its variables.
Results: A total of 53 articles were identified, of which 12 were selected and 41
excluded. After evaluation of the references of the 12 selected studies, two new
studies were included. The 14 studies were published from August 2009 to October
2011, 11 of them using computed tomography as a method of response evaluation,
one with doppler ultrasound and two others with positron emission tomography. A
total of 927 patients were studied. The drugs used for analysis in the different studies
were sunitinib, sorafenib, cediranibe, bevacizumab and interferon alpha; but sunitinib
and sorafenib are variously present in all studies. The retrospective design was the
basis for most of the analysis (71%) and endpoints analysed for method comparison
were time to disease progression (TTP) or progression-free survival (PFS). All studies had
RECIST as the assessment parameters (control). Proposed new methods of radiographic
response criteria in this context were present in 11 studies (78%). In 3 studies (21%) only
one radiologist reviewed the images, in the other at least 2 radiologists participated in the
evaluation. Most studies evaluated a small number of patients and 8 studies (57%)
included more than one antiangiogenic drugs in its analysis.
Conclusion: Antiangiogenic drugs are considered standard therapy in the treatment
of metastatic RCC. Phase III trials are needed to validate the best radiological
response criteria in this context, new proposed methods should be incorporated as
secondary end-points in future prospective trials.
Disclosure: All authors have declared no conflicts of interest.
878 THE ROLE OF NEPHRECTOMY IN METASTATIC RENAL CELL
CARCINOMA – A SINGLE CENTRE ANALYSIS
J. Neves 1 , I. Fernandes 2 , J. Ribeiro 2 , D. Macedo 2 , L. Costa 2
1 Faculty of Medicine, University of Lisbon, Lisbon, PORTUGAL, 2 Oncology
Division, Santa Maria Hospital (HSM-CHLN), Lisbon, PORTUGAL
The approval of new therapeutic options has increased the survival of metastatic
renal cell carcinoma (mRCC) patients (pts). These drugs were mostly studied in pts
who underwent nephrectomy (Sx) prior to the diagnosis of metastatic disease (MD).
Sx is also indicated for pts with MD who are suitable and have good performance
status (PS). The aim of this work is to retrospectively analyse the benefit of Sx in the
pts with mRCC referred to the Oncology Division at Santa Maria Hospital from 01/
2006 to 10/2010. Two groups of pts were defined: pts who had Sx and pts who had
no Sx. The first group was further divided into pts who had Sx whilst with non-MD
(SxNMD) and pts who did it whilst with MD (SxMD). With significance set at p =
0.05 and the aid of IBM® SPSS® Statistics 20, statistical analysis was performed using
descriptive statistics and Fisher’s exact test. Overall survival (OS) - time from
diagnosis of MD to death - was plotted using the Kaplan–Meier method and
compared by log-rank test. The population had 44 pts: 72,7% (n = 32) male, 59,1%
(n = 26) under 65 years old, 90,9% (n = 40) with Karnofsky PS (KPS) ≥80 and 59,1%
(n = 26) with clear cell carcinoma. Half were diagnosed with non-MD (NMD) (n =
22) and progressed to MD in a mean of 45,9 months (m). Thirty-eight pts (86,4%)
did medical therapy, of those 86,8% (n = 33) had favourable or intermediate risk
according to the Memorial Sloan Kettering Cancer Center (MSKCC) criteria and
86,8% (n = 33) did target therapy. Thirty pts underwent Sx (68,2%) and 14 didn’t
(31,8%). There was no statistical difference between groups regarding gender, age,
KPS, histology, MSKCC risk and medical therapy. The median OS was 14 and 27 m
respectively for the no Sx group versus the Sx group (p = 0,027). In the pts who had
Sx, 21 (70%) were part of the SxNMD group and 9 (30%) of the SxMD group.
Except for Fuhrman grade (p = 0,022), there was no statistical difference between
groups regarding gender, age, KPS, histology, MSKCC risk and medical therapy. The
median OS for SxNMD had not been reached while the median OS for SxMD was
21 m (p = 0,682). In the population studied there was no difference in OS curves
between the SxNMD group and the SxMD group. This suggests that Sx has a
valuable role in pts diagnosed with MD in addition to medical therapy, namely
target therapy.
Disclosure: All authors have declared no conflicts of interest.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds399 | ix289