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Median overall survival (OS) was 26 months (range 11–40). Patients showing ED
mostly received palliative chemotherapy. The overall response rate for chemotherapy
in this cohort was 75%; 2/4 achieved a complete response, 1/4 a partial response and
1/4 showed disease stabilization. After a median follow-up of 12 months, the median
PFS was 11 months (range 3–14). The median OS was 14 months (range 12–38) for
the ED cohort. However, the differences observed in PFS and OS between LD and
ED cohorts did not achieve statistical significance. In addition, patients with bladder
SCCUT showed a statistically significant longer PFS (22 months) compared to
patients with a prostatic origin (6 months).
Conclusions: Despite its chemosensitivity, SCCUT showed an aggressive clinical
course and poor prognosis in our series. Bladder origin SCCUT may have a better
prognosis than those from prostate origin. NSE serum levels may help to achieve an
early diagnosis and to provide a proper systemic treatment up-front.
Disclosure: All authors have declared no conflicts of interest.
887 PERI-OPERATIVE CHEMOTHERAPY OR SURVEILLANCE IN
UPPER TRACT UROTHELIAL CANCER (POUT - CRUK/11/027) -
A NEW RANDOMISED CONTROLLED TRIAL TO DEFINE
STANDARD POST-OPERATIVE MANAGEMENT
A.J. Birtle 1 , R. Lewis 2 , J. Chester 3 , J. Donovan 4 , M. Johnson 5 , R.J. Jones 6 ,
R. Kockelbergh 7 , T.B. Powles 8 , E. Jones 9 , E. Hall 2
1 Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Foundation
Trust, Preston, UNITED KINGDOM, 2 Clinical Trials and Statistics Unit, Institute of
Cancer Research, Surrey, UNITED KINGDOM, 3 Velindre Hospital, Cardiff
University, Cardiff, UNITED KINGDOM, 4 School of Social and Community
Medicine, University of Bristol, Bristol, UNITED KINGDOM, 5 Freeman Hospital,
Newcastle upon tyne hospitals NHS Trust, Newcastle, UNITED KINGDOM,
6 Medical Oncology, Beatson West of Scotland Cancer Centre Gartnavel General
Hospital, Glasgow, UNITED KINGDOM, 7 Department of Urology, University
Hospitals Leicester, Leicester, UNITED KINGDOM, 8 Department of Medical
Oncology, St. Bartholomew’s Hospital, London, UNITED KINGDOM, 9 Clincial
Trials and Statistics Unit, Institute of Cancer Research, Surrey,
UNITED KINGDOM
Background: The POUT trial aims to establish whether platinum-based combination
chemotherapy is superior to surveillance following nephro-ureterectomy with
curative intent for upper tract transitional cell carcinoma (utTCC).
Methods: We aim to randomise 345 participants world-wide, over a 5-year period.
Previous trials of adjuvant chemotherapy for urothelial cancers suggest that potential
challenges to recruitment include randomisation between “no treatment” vs
chemotherapy with its potential toxicity, and early identification of eligible patients.
To support trial design and the development of patient information, we therefore
conducted a survey of participating UK centres’ current standard treatment and also
held a dedicated consumer focus group. During the trial set up period, additional
sites expressed interest in participating and the survey was recirculated; results are
presented here.
Results: 26 of 44 UK centres questioned routinely place utTCC patients on
surveillance following surgery; 18 give chemotherapy if the patient is considered fit
enough. The 9 respondents who specified chemotherapy regimens give gemcitabine
and cisplatin or carboplatin, dependent on renal function. All centres discuss patients
pre-operatively in a multi-disciplinary team meeting, but 6 centres do not routinely
discuss patients post-operatively. The consumer group welcomed the opportunity for
utTCC patients to participate in research. They approved of the proposed
randomisation between surveillance and chemotherapy and supported the use of a
two stage pre- and post-operative information giving process.
Conclusions: There is no consensus among UK clinicians regarding optimum
post-operative treatment of muscle invasive utTCC. The POUT trial offers the
opportunity to standardise post-operative management of utTCC internationally and
is supported by urologists, oncologists and consumer representatives from the target
patient population. The trial design incorporates an initial two-year recruitment
optimisation phase which includes qualitative research to inform recruitment
practices.
Disclosure: All authors have declared no conflicts of interest.
888 LAPAROSCOPIC LYMPH NODE RESECTION OF
POST-CHEMOTHERAPY (POST-CHT) RESIDUAL
RETROPERITONEAL (RP) TUMOR MASSES IN PATIENTS WITH
NON-SEMINOMATOUS TESTICULAR GERM-CELL TUMORS
(NSTGCT)
I.G. Sullivan 1 , G. Anguera 1 , C. Arqueros 1 , D. Condori 1 , J. Palou 2 , J.A. Peña 2 ,
H. Villavicencio 2 , P. Maroto 1
1 Medical Oncology, Hospital de Sant Pau, Barcelona, SPAIN, 2 Urology
Department, Fundacio Puigvert, Barcelona, SPAIN
Introduction: Resection of post-CHT residual masses, usually located in
retroperitoneum, is an essential part of the management of NSTGCT. Presently,
Annals of Oncology
surgical procedure consists in an open unilateral retroperitoneal lymph node
dissection (RPLND) of a modified template. Laparoscopic procedures have reduced
morbidity compared to open surgery; in addition, limited lymphadenectomies or
resection of essentially the residual mass may help to reduce morbidity, although it
might have a higher incidence of local relapses.
Objective: To analyze relapse rate, morbidity and toxicity associated to laparoscopic
RPLND in a series of patients (pts) with NSTGCT of a single tertiary referral center
with surgeons who have extensive experience in post-CHT resection between January
2002 and January 2012.
Results: Retrospective analysis of 14 pts with a median follow-up of 40 months (m).
Median age at diagnosis was 30 (18-43) years. Pathologic evaluation of the testis
tumor revealed mixed NSTGCT with teratomatous elements in 11/14, and pure
teratoma in 1. Embryonal carcinoma was presented in 12/14. Royal Marsden staging
classification was: IIA: 2; IIB: 7; IIC: 2; IIIB: 1; IVB: 1, IVC: 1. All pts received a
median of 4 cycles of BEP and had a complete serum marker response after
induction CHT. RP masses showed a partial response in 8 and stable disease in 6 pts.
Median size of the post-CHT retroperitoneum masses was 2,5 cm (1-10). Histologic
examination showed fibrosis or necrosis in 4 (28%) and mature teratoma in 10 (64%)
pts. Toxicity: Median days of hospitalization were 4 (2-9). 5 pts showed decrease of
at least 2 points in hemoglobin, not requiring transfusion support. Chylous ascites
was reported in 1 and an infected RP hematoma in another 1 pts. 2 pts developed
ejaculatory dysfunction. Only 1 patient experienced an early relapse (3 m after
RPLND) requiring salvage laparotomy. Pathology of the RP mass in this case
reported a growing teratoma. All pts are alive and presently free of disease.
Conclusion: In our series, in a Hospital with long expertise in RP surgery,
laparoscopic RPLND provided a low rate of complications and RP relapses, reducing
morbidity comparing to historical series with open procedures.
Disclosure: All authors have declared no conflicts of interest.
889TiP SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER
(S-TRAC): A RANDOMIZED, DOUBLE-BLIND, PHASE III
STUDY OF SUNITINIB VS. PLACEBO IN SUBJECTS AT HIGH
RISK OF RECURRENT RENAL CELL CARCINOMA (RCC)
A. Ravaud 1 , R.J. Motzer 2 , H. Pandha 3 , M. Staehler 4 , D.J. George 5 , A. Pantuck 6 ,
A. Patel 7 , P. Gerletti 8 , L. Chen 9 , J. Patard 10
1 Medical Oncology, Hôpital Saint André, Bordeux, FRANCE, 2 Genitourinary
Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY,
UNITED STATES OF AMERICA, 3 Postgraduate Medical School, Postgraduate
Medical School, Surrey, UNITED KINGDOM, 4 Department of Urology, University
of Munich, Munich, GERMANY, 5 Oncology, Duke University Medical Center,
Durham, NC, UNITED STATES OF AMERICA, 6 Urology, David Geffen School of
Medicine at UCLA, Los Angeles, CA, UNITED STATES OF AMERICA,
7 Oncology, Whipps Cross University Hospital, Leytonstone, UNITED KINGDOM,
8 Pfizer Oncology Business Unit, Pfizer Italia S.r.l., Milan, ITALY, 9 Biostatistics,
Pfizer, New York, NY, UNITED STATES OF AMERICA, 10 Urology, Paris XI Bicetre
University Hospital, Paris, FRANCE
Background: Surgical resection alone may fail to cure high-risk RCC. Progression to
metastatic recurrence directly relates to tumor size in subjects with clinically localized
RCC, and 25–50% of subjects treated for localized disease eventually experience
recurrence. Sunitinib is an oral, multitargeted tyrosine kinase inhibitor approved in
2006 for the treatment of advanced RCC based on robust results from randomized
clinical trials. Sunitinib led to metastatic deposit size reduction in most cases. These
observations provided the rationale to investigate sunitinib as an adjuvant
monotherapy in subjects at high risk of recurrence after nephrectomy for clinically
localized RCC.
Methods: In this ongoing prospective, double-blind, placebo-controlled, randomized,
multicenter, phase III study, eligible subjects have histologically confirmed,
predominantly (>50%) clear cell RCC diagnosed by the UISS staging system and are
at high risk of recurrence, with no evidence of residual macroscopic disease. Within
12 weeks after nephrectomy, subjects will be randomized 1:1 to oral sunitinib 50 mg/
day on Schedule 4/2 (4 weeks on/2 weeks off) or placebo, for 1 year (9 cycles). Dose
reduction to 37.5 mg/day but not to 25 mg/day is permitted. Subjects will be followed
for disease recurrence every 12 weeks for 1–3 years and every 6 months thereafter,
until final analysis. Safety and efficacy data are under review by an independent data
monitoring committee (IDMC). The primary objective is to compare disease-free
survival (DFS) for sunitinib vs. placebo based on independent blinded review. Other
objectives include safety monitoring, overall survival (OS) and health-related quality
of life (EORTC QLQ-C30 and EQ-5D).
Results: 900 subjects were screened and 630 have been randomized (reasons for
screening failures will be presented). The trial is currently ongoing; enrolment closed
worldwide in April 2011, except in China. 615 subjects have completed 1 year of
treatment and are in follow-up for DFS and/or OS. At last review, there were no
unexpected toxicity warnings and the IDMC recommended continuing the trial.
NCT00375674
Disclosure: A. Ravaud: Advisory relationship with Pfizer, Novartis, Bayer Schering,
GSK, Astellas, Dendreon. Honoraria from Pfizer, Novartis, Bayer Schering, Roche,
GSK, Astellas, Dendreon. Research funding from Pfizer, Novartis. Travel
renumeration from Pfizer and Novartis. R.J. Motzer: Advisory relationship with
ix292 | Abstracts Volume 23 | Supplement 9 | September 2012