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Sub-category:
Germ Cell / Testicular Tumors
Category:
Genitourinary Cancer
Meeting:
2008 ASCO Annual Meeting
Session Type and Session Title:
null, General Session II: Genitourinary Cancers
Plenary Presentation, Plenary Session including Science of Oncology Award and Lecture
Abstract No:
1
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 1)
Author(s):
R. T. Oliver, G. M. Mead, P. J. Fogarty, S. P. Stenning, MRC TE19 and EORTC 30982 trial collaborators
Abstract:
Background: At ASCO 2004 we reported a randomised trial (MRC TE19, EORTC 30982) comparing 1 course carboplatin (C) at AUCx7 with adjuvant radiotherapy (RT) for stage I seminoma. With median follow-up (FU) of 4 yrs, C was shown to be non-inferior for relapse free rate (1o outcome) and there was a reduction in contralateral testicular gem cell cancers (GCT). Because late relapses and 2nd GCT can occur beyond 5 and 10 yrs we have continued FU of these patients (pts). We report the updated results, and further analysis of C dose and outcome in relation to method of assessing renal function. Methods: The 1o randomisation was RT versus one injection of C dosed at 7x (GFR+25) based on EDTA (n=357) and 90% of this dose if based on creatinine clearance (n=202). The trial was powered to exclude absolute differences in the 2 yr relapse-free rates (RFR) of > 3%. RFR were determined by the Kaplan-Meier method, and hazard ratios (HR) from the Cox regression model; HR>1 favors RT. Results: Between 1996-2001, 1,447 pts were randomised in a 3:5 ratio (C=573, RT=904). Median FU is now 6.5 yrs with documented minimum 5 yr FU on 1,148 pts. RFRs at 5 yrs are 95% (C) and 96% (RT) (HR 1.25, 90% CI 0.83, 1.89); an increase in 5yr RFR of >3.6% can be excluded with 95% confidence. Only one death from seminoma (RT) has been reported. There was a significant difference in the rate of new GCTs (2 on C vs 15 on RT), giving a HR of 0.22 (95% CI 0.05, 0.95 p=0.03). High levels of pre-treatment FSH (>12 iu/L) were associated with an increased risk of developing a 2nd GCT (HR: 8.57 (95% CI 1.82 - 40.38)). Analysing the variation in dose received in the C group, showed that those who received at least 99% of the 7AUC dose (n=347) ignoring GFR method had 5 yr RFR of 96.1% (95% CI 93.4-97.7) compared with 92.6% (88.0-95.5) in those who received lower doses (n=212, HR: 0.51 (0.24 - 1.07) p=0.08)). Analysis of the available data on pathological risk factors demonstrated that larger tumours (>4cm) had poorer RFR (HR: 3.68 (1.49 - 9.13)). Conclusions: With prolonged FU this trial confirms the non-inferiority of single dose C (AUC7) vs RT in terms of RFR but with a reduced risk of 2nd GCT in the C arm. The observation on the impact of C dosage, though not significant in its own right, reinforces the safety of adequately dosed C and may support studies of higher dose C.
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by R. T. Oliver :
Presentations by R. T. Oliver :
Educational Book Manuscripts by R. T. Oliver :
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