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Medical Research Council trial of 2 versus 5 CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis

Medical Research Council trial of 2 versus 5 CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis
Medical Research Council trial of 2 versus 5 CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis
Background: Surveillance is a standard management approach for stage 1 non seminomatous germ cell tumours (NSGCT), yet there is no agreement on the number of CT scans that are required to detect relapses. A randomised trial of 2 versus 5 CT scans was performed to determine whether the number of scans influenced the prognostic group (J Clin Oncol 15:594-603, 1997) at relapse.
Methods: 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 (clinical exams, markers, chest X-rays) carried out at equal frequency 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).
Results: 247 patients were allocated to 2 CT scans and 167 to 5 CT scans. With a median follow up of 40 months 37 (15%) relapses have occurred in the 2 scan arm and 33 (20%) in the 5 scan arm. 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%). The mean diameter of abdominal mass at relapse was 2.1 cm in the two scan arm and 2.2 cm in the five scan arm. After chemotherapy a residual mass was present in 35% in the 2 scan and 36% in the 5 scan arm. No deaths have been reported.
Conclusions: This study can exclude with 95% probability an increase in the proportion of patients relapsing with intermediate or poor prognosis disease of more than 1.6% if they have 2 rather than 5 CT scans as part of their surveillance protocol. CT scans at 3 and 12 months after orchidectomy should be considered as the new standard and will be associated with a reduction in radiation exposure.
trial, cell, tumours, patient, testis, ct, surveillance, scan, time
1527-7755
4519
Mead, G.M.
8a97f978-9c66-4a16-bb03-dd83d20b06a0
Rustin, G.J.
6a670dea-00b6-4b57-9ca4-c4f3c45eaf3c
Stenning, S.P.
322b2b99-e6c5-46e5-a581-acb46357a418
Vasey, P.
5281eaca-4f4d-48dd-896c-ba83f15e9393
Aass, N.
2c02a06d-0f92-4e2d-8cf8-cff87dd61e54
Huddart, R.
76d2b300-d66c-4b49-8bee-47755651a4a8
Sokal, M.
0d869edc-dbd6-4fcb-a31f-be053e407513
Kirk, S.
19df0e0e-bbf3-4ed1-98ca-106a8aecb413
Mead, G.M.
8a97f978-9c66-4a16-bb03-dd83d20b06a0
Rustin, G.J.
6a670dea-00b6-4b57-9ca4-c4f3c45eaf3c
Stenning, S.P.
322b2b99-e6c5-46e5-a581-acb46357a418
Vasey, P.
5281eaca-4f4d-48dd-896c-ba83f15e9393
Aass, N.
2c02a06d-0f92-4e2d-8cf8-cff87dd61e54
Huddart, R.
76d2b300-d66c-4b49-8bee-47755651a4a8
Sokal, M.
0d869edc-dbd6-4fcb-a31f-be053e407513
Kirk, S.
19df0e0e-bbf3-4ed1-98ca-106a8aecb413

Mead, G.M., Rustin, G.J., Stenning, S.P., Vasey, P., Aass, N., Huddart, R., Sokal, M. and Kirk, S. (2006) Medical Research Council trial of 2 versus 5 CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis. Journal of Clinical Oncology, 24 (18), 4519.

Record type: Article

Abstract

Background: Surveillance is a standard management approach for stage 1 non seminomatous germ cell tumours (NSGCT), yet there is no agreement on the number of CT scans that are required to detect relapses. A randomised trial of 2 versus 5 CT scans was performed to determine whether the number of scans influenced the prognostic group (J Clin Oncol 15:594-603, 1997) at relapse.
Methods: 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 (clinical exams, markers, chest X-rays) carried out at equal frequency 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).
Results: 247 patients were allocated to 2 CT scans and 167 to 5 CT scans. With a median follow up of 40 months 37 (15%) relapses have occurred in the 2 scan arm and 33 (20%) in the 5 scan arm. 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%). The mean diameter of abdominal mass at relapse was 2.1 cm in the two scan arm and 2.2 cm in the five scan arm. After chemotherapy a residual mass was present in 35% in the 2 scan and 36% in the 5 scan arm. No deaths have been reported.
Conclusions: This study can exclude with 95% probability an increase in the proportion of patients relapsing with intermediate or poor prognosis disease of more than 1.6% if they have 2 rather than 5 CT scans as part of their surveillance protocol. CT scans at 3 and 12 months after orchidectomy should be considered as the new standard and will be associated with a reduction in radiation exposure.

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More information

Published date: 20 June 2006
Keywords: trial, cell, tumours, patient, testis, ct, surveillance, scan, time

Identifiers

Local EPrints ID: 62838
URI: http://eprints.soton.ac.uk/id/eprint/62838
ISSN: 1527-7755
PURE UUID: c0b44e50-f2c8-48c6-b06b-118538f79aed

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Date deposited: 11 Sep 2008
Last modified: 13 Mar 2019 20:27

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