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Updated results of a randomised trial of 2 versus 5 CT scans in the surveillance of patients with stage 1 non-seminomatous germ cell tumours of the testis: Medical Research Council Trial TE08, ISRCTN56475197
Gordon J Rustin1, Graham M Mead2, Fay H Cafferty3, Rhian Gabe3, Sally P Stenning3, For the TE08 collaborators1
1Mount Vernon Cancer Centre, Middlesex, UK; 2Southampton General Hospital, UK; 3Medical Research Council Clinical Trials Unit, London, UK
Background
Surveillance is a standard management approach for stage 1 non-seminomatous
germ cell tumours (NSGCT) but a variety of schedules have been followed.
Initial results of the TE08 trial of 2 versus 5 CTs [Rustin et al, JCO 2007],
indicated that a 2 CT scan schedule was safe and effective. An updated
analysis was planned when all patients had been followed-up for at least 5
years after orchidectomy.
Method
Patients with clinical stage 1 NSGCT opting for surveillance were
randomised to chest and abdominal CT scans at either 3 and 12 or 3, 6,9,12, and
24 months, with all other investigations identical in the two arms. 3/5
patients were allocated to the 2 scan schedule. 400 patients were
required to exclude a 3% increase in the proportion of patients relapsing with
IGCCCG intermediate or poor prognosis disease with 90% power at the 5%
significance level (1-sided). Updated follow-up data has been requested
regularly since the initial analysis.
Results
Between 1998 and 2003, 247 patients were allocated to 2 CT scans and 167 to
5 CT scans. With a median follow up of 67 months, 37 (15%) relapses have
occurred in the 2 scan arm (unchanged since the original analysis) and 36 (22%)
in the 5 scan arm (3 further relapses since the original analysis at 36, 96 and
113 months after orchidectomy). No patients were poor prognosis at relapse but
2 (0.8%) of those relapsing in the 2 scan arm were intermediate prognosis
compared to 1 (0.6%) in the 5 scan arm, a difference of 0.2% (90%CI -1.2%,
1.6%). No disease-related deaths have been reported.
Conclusion
With no further intermediate or poor prognosis relapses, the original
conclusions are confirmed. CT scans at 3 and 12 months after orchidectomy
should be considered standard for post-operative surveillance of stage 1 NSGCT.
