Radiotherapy versus carboplatin for stage I seminoma: Updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214).

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Meetings

Abstracts

2008 ASCO Annual Meeting

Radiotherapy versus carboplatin for stage I seminoma: Updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214).

Sub-category:

Germ Cell / Testicular Tumors

Category:

Genitourinary Cancer

Meeting:

2008 ASCO Annual Meeting

Abstract No:

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 (1^o outcome) and there was a reduction in contralateral testicular gem cell cancers (GCT). Because late relapses and 2^nd 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 1^o 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 2^nd 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):

1. Radiotherapy versus Carboplatin for stage I seminoma: updated analysis of the MRC/EORTC randomised trial (ISRCTN27163214)

Meeting: 2008 Best of ASCO Boston
Speaker: R. Oliver
Session: General Session II: Genitourinary Cancers

2. Radiotherapy versus carboplatin for stage I seminoma: Updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214).

Meeting: 2008 ASCO Annual Meeting
Presenter: R. T Oliver, MD
Session: Plenary Session including Science of Oncology Award and Lecture (Plenary Presentation)

Other Abstracts in this Sub-Category:

		1. Relapse patterns in 2,466 stage 1 seminoma patients (pts) entered into Medical Research Council randomised trials. Meeting: 2008 ASCO Annual Meeting Abstract No: 5020 First Author: G. M. Mead Category: Genitourinary Cancer - Germ Cell / Testicular Tumors
		2. Risk-adapted treatment in clinical stage 1 (CS1), non-seminomatous germ cell testicular cancer (NSGCT). Meeting: 2008 ASCO Annual Meeting Abstract No: 5034 First Author: T. Tandstad Category: Genitourinary Cancer - Germ Cell / Testicular Tumors
		3. Long-term cognitive function among testicular cancer survivors treated with chemotherapy. Meeting: 2008 ASCO Annual Meeting Abstract No: 5035 First Author: J. Skoogh Jr. Category: Genitourinary Cancer - Germ Cell / Testicular Tumors
		More...

Abstracts by R. T. Oliver :

		1. Evaluation of quality-of-life side effects and duration of therapy in a phase III study of intermittent monotherapy versus continuous combined androgen deprivation. Meeting: 2008 ASCO Annual Meeting Abstract No: 5064 First Author: F. E. Calais da Silva Category: Genitourinary Cancer - Prostate Cancer
		2. Five years survival and risk of death in a phase III study of intermmittent monotherapy versus continuous combined androgen deprivation. Meeting: 2008 ASCO Annual Meeting Abstract No: 16034 First Author: F. M. Calais da Silva Category: Genitourinary Cancer - Prostate Cancer
		3. Phase II screening study of a LHRH analogue, dexamethasone and somatostatin analogue versus LHRH analogue with dexamethasone in HRPC. Meeting: 2008 ASCO Annual Meeting Abstract No: 16082 First Author: M. Silva Category: Genitourinary Cancer - Prostate Cancer
		More...

Presentations by R. T. Oliver :

		1. Radiotherapy versus carboplatin for stage I seminoma: Updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214). Meeting: 2008 ASCO Annual Meeting Presenter: R. T Oliver, MD Session: Plenary Session including Science of Oncology Award and Lecture (Plenary Presentation)
		2. Radiotherapy vs Carboplatin for Stage I Seminoma: updated analysis of the MRC/EORTC Randomized Trial Meeting: 2008 ASCO Annual Meeting Participant: R. T Oliver, MD Session: Screening and Treatment Advances Press Briefing (Press Program)
		3. A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982. Meeting: 2004 ASCO Annual Meeting Presenter: Roderick Timothy Oliver, MD Session: Genitourinary (Nonprostate) Cancer (Oral Presentation)
		More...

Educational Book Manuscripts by R. T. Oliver :

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