Download the ESMO 2012 Abstract Book - Oxford Journals

Table: 857P
standard, but is not available in all centres. 24h urine collection may be prone to
sampling errors. Estimating GFR by the Cockroft-Gault formula (CG) is popular
amongst oncologists but data supporting its use in this situation is limited. Reduction
of C dose by 10% in the adjuvant treatment of seminoma stage I is associated with a
trend for higher relapse rate.
Methods: Data from 202 consecutive, male patients (median age 39, range 23-68
years) with stage I seminoma with complete documentation of GFR by TC99m
DTPA, serum-creatinine, age, height and weight were evaluated. Actual C doses
(ACD) based on GFR measurement by TC99m DTPA were compared with estimated
C doses (ECD) based on GFR estimation using CG formula. Differences between the
ACD and ECD were correlated to age and body mass index (BMI) using Fisher’s
Exact test, Pearson correlation and linear regression.
858P ADDITION OF DARBEPOETIN ALFA TO SEQUENTIAL HIGH
DOSE VIP CHEMOTHERAPY FOR PATIENTS WITH ADVANCED
METASTATIC GERM CELL CANCER
J.T. Hartmann 1 , B. Metzner 2 , C. Binder 3 , H. Mergenthaler 4 , O. Rick 5 ,
H.G. Sayer 6 , A. Lorch 7 , W.E. Berdel 8 , C. Bokemeyer 9 , T.C. Gauler 10
1 Medical Oncology, Christian-Albrechts-Universität zu Kiel, Kiel, GERMANY,
2 Abt. Onkologie/haematologie, Klinikum Oldenburg, Oldenburg, GERMANY,
3 Hämatologie und Onkologie, Universitätsmedizin Göttingen, Göttingen,
GERMANY, 4 Klinik F. Onkologie, Klinikum Stuttgart - KatharinenhospitalKlinik
f. Onkologie, Stuttgart, GERMANY, 5 Oncology, Klinik Reinhardshoehe, Bad
Wildungen, GERMANY, 6 Klinik für Innere Medizin II, Universitätsklinikum Jena,
Jena, GERMANY, 7 Urologische Klinik, Universitätsklinikum Düsseldorf,
Düsseldorf, GERMANY, 8 Medizinische Klinik A, Universitaetsklinikum Münster,
Münster, GERMANY, 9 Oncology, Haematology and Bone Marrow
Transplantation, UKE II. Medizinische Klinik und PoliklinikMedizinische Klinik II.,
Hamburg-Eppendorf, GERMANY, 10 Oncology, University Hospital, Essen,
GERMANY
Background: High-dose VIP chemotherapy (HD-VIP) plus ABSCT given as first line
treatment might be a strategy in patients with advanced germ cell tumors (GCT)
with poor prognosis. The objective of the trial was to investigate the addition of
darbepoetin alfa to HD-VIP in order to reduce anemia/red blood cell (RBC)
transfusions.
Methods: This was a randomized, open-label multicenter phase 2 study conducted in
20 hospitals. Darbepoetin 2,25 mcg/kg weekly or 500 mcg Q3W s.c., started with
HD-VIP (dose level 6), was applied in arm B (arm A: HD-VIP alone). The primary
objective was freedom from blood transfusions (FFT). Secondary objectives included
objective remission rate (ORR) after chemotherapy, 24-mos PFS and OS, median
course of hemoglobin (Hb) levels during 3 HD-VIP cycles as well as drug safety.
Results: Between 7/2003 and 11/2008 108 pts were allocated to the study, and 102
were included in the intention-to-treat (ITT) analysis. By March 2012, the median
follow-up time after randomization was 62 (range, 3–100) mos for surviving patients.
Localisation of primary was gonadal in 66%, retroperitoneal in 19% and mediastinal
in 14%s. A favourable treatment outcome (CR/NED/PR m-) in conjunction with
secondary surgery (n = 76 pts) was achieved in 58% of pts with no difference between
arms A and B. Overall FFT occurred in 2 pts (4.2%) in arm A and 3 pts (5.6%) in
arm B, and in 23%/15%/15% and 15%/17%/19% of pts during cycles 1-3,
respectively. No differences in baseline Hb, severity of anemia, number of RBC
transfusions and area under the curve of Hb levels during HD-VIP was observed. Pts
assigned to darbepoetin had similar treatment toxicity compared to those assigned to
HD-VIP alone. 5-year OS in arm A was 74.0% compared to 63.0% (P = .18) in Arm
B. 5-year DFS was 60.5% in arm A vs 53.1% in Arm B (P = 0.54). Darbepoetin was
generally well tolerated with 2 pts discontinuing treatment due to thrombosis. A
per-protocol (PP) analysis revealed comparable outcomes (OS 74.4 vs 67.5, P = 0.38;
DFS 60.4 vs 58.3, P = 0.70).
Conclusions: Based on ITT and PP analysis, the addition of darbepoetin alfa to
HD-VIP compared to HD-VIP alone does not appear to impact FFT, ORR, and
survival in poor prognosis GCT pts (NCT00204633).
Results: 202 patients were included in the correlation analysis and 181 patients in
the comparison of different subgroups, respectively. Lower BMI and higher age were
significantly associated with lower ECD, Pearson correlation coefficients 0.59 (p <
0.001) and –0.36 (p < 0.001), respectively. Tables show potential under- and
overdosing of C when using CG (ECD expressed as percentage of ACD) in different
age groups (Exact test p = 0.001) and groups with different BMI (Exact test p = 0.026)
Discussion: CG significantly underestimates GFR in leaner and older patients.
According to our data over a third of patients with BMI 20–25 or aged 41–50 would
be at risk for undertreatment if CG were used routinely. Physicans need to be aware
of these limitations when using CG to calculate C dose in patients with stage I
seminoma.
Disclosure: All authors have declared no conflicts of interest.
Disclosure: All authors have declared no conflicts of interest.
859P MANAGEMENT OF POST ORCHIDECTOMY STAGE I
CLASSICAL SEMINOMA: 11 YEAR OUTCOME DATA
OF A UK REGIONAL CANCER UNIT
Annals of Oncology
Age (years) 110% ACD BMI (kg/m 2 ) 110% ACD
21-30 n = 29 14% 4 72% 21 14% 4 20-25 n = 60 35% 21 57% 34 8% 5
31-40 n = 84 14% 12 68% 57 18% 15 25-30 n = 81 21% 17 69% 56 10% 8
41-50 n = 68 40% 27 56% 38 4% 3 30-40 n = 33 15% 5 58% 19 27% 9
A.J. McPartlin 1 ,R.Roy 1 , D. Muskett 2 , M. Witkowski 3 , A.J. Birtle 1
1 Oncology, Royal Preston Hospital, Preston, UNITED KINGDOM,
2 Histopathology, East Lancashire Hospitals NHS Trust, blackburn, UNITED
KINGDOM, 3 Pathology, Morcombe bay Hospital Trust, Morcombe Bay,
UNITED KINGDOM
Introduction: Stage I classical seminoma has a 95% 5yr OS. Post-orchidectomy
treatment options include para-aortic radiotherapy, single agent carboplatin or active
surveillance. This retrospective study reviewed changing practice and outcomes over a
11 year period in a regional cancer unit.
Patients and methods: 188 consecutive patients seen from January 2000 to
December 2010 were identified. Initial risk factors, treatment received and post
treatment response were recorded and relapse free and overall survival calculated
Results: Adjuvant radiotherapy was given to 106 patients (56.4%), adjuvant
chemotherapy to 56 (29.8%) and active surveillance to 26 (13.8%). Five year RFS by
group was 97.2%, 89.9% and 76.9%. Fifteen patients relapsed with one dying despite
third line treatment. Overall CSS was 99.4%. In the period before 2005 tumour size
and rete testis invasion was documented in 9% of patients and active surveillance
offered to none. After this time the two risk factors were documented in 82% and
surveillance offered to 19.5%. Management and outcome stratified by presence of risk
factor.
Management
Adjuvant
Adjuvant Relapse
Risk factor Surveillance Chemotherapy XRT rate
None
(51 patients)
47.1% 25.6% 27.4% 7.5%
One (24) 22.0% 42.0% 36.0% 14.0%
Two (12) 0% 58.3% 41.7% 12.5%
Conclusion: This review’s outcomes broadly correspond with published data
although with increased incidence of relapse following standard adjuvant
chemotherapy- presumably an artifact of small numbers. Adjuvant treatment
increases 5yr RFS compared to active surveillance but excellent CSS is achieved after
either. The vast majority of radiotherapy (85%)was offered in the first two thirds of
the study period and reflects older practice. The absence of risk factors appears to
reduce the rate of relapse and should guide treatment decisions. The increasing
awareness of the importance of assessing risk factors when deciding on treatment is
reflected in their improved identification in later patients and the increasing use of a
surveillance strategy in those at lower risk of relapse.
Disclosure: All authors have declared no conflicts of interest.
ix284 | Abstracts Volume 23 | Supplement 9 | September 2012