The Absolute Effect / Evidence / MRC TE05
Germ Cell Tumours · Medical Oncology · Stage I Non-seminoma

MRC TE05

Clinical question

Can short-course BEP substantially reduce relapse in high-risk stage I non-seminoma?

Trial context
Population
114 eligible patients with high-risk clinical stage I NSGCT
Intervention
Two cycles adjuvant BEP in high-risk stage I NSGCT
Key endpoint
Relapse
Time horizon / follow-up
Median follow-up 4 years
Absolute Effect

What changes for patients?

Two cycles of BEP produced very low relapse rates in this prospective high-risk stage I cohort: two relapses occurred among 114 eligible patients, including one patient without germ-cell tumour on central pathology review; among the 104 patients confirmed to have GCT, only one relapsed. Because the study was single-arm, a causal NNT cannot be assigned. The study supports the effectiveness of short-course cisplatin-based adjuvant therapy but does not provide a randomized absolute treatment effect.

NNT: Not applicable; single-arm prospective study

Treatment burden / harm

Treatment-related toxicity

NNH: Not quantifiable as an NNH; one treatment-related cerebrovascular death occurred and pulmonary-function changes were monitored

Relative effect

Relapse rate: 1 relapse among 104 histologically confirmed GCT patients (0.96%, calculated from the reported count); 2 relapses occurred among all 114 eligible patients

95% CI excluded a true relapse rate >5% in confirmed GCT

Clinical interpretation

The single-arm cohort supports feasibility of two-cycle BEP for selected high-risk stage I NSGCT, but contemporary risk-adapted practice often uses surveillance or one-cycle BEP.

Primary publication

← Return to The Absolute Effect

Current-practice context · reviewed 14 October 2026

Two-cycle BEP is historical prospective evidence for high-risk stage I NSGCT, but contemporary risk-adapted practice commonly discusses surveillance versus one cycle of adjuvant BEP, depending on vascular invasion, follow-up reliability and patient preference. This cohort was single-arm and cannot quantify a causal treatment benefit against surveillance. Cisplatin toxicity, fertility, second malignancies and late cardiovascular effects should be discussed alongside relapse prevention.

EAU testicular-cancer guidance ↗ · MRC TE05 primary report ↗