The Absolute Effect / Germ Cell Tumours / Medical
In poor-prognosis metastatic germ-cell tumours, does an intensified CBOP/BEP induction regimen produce a higher favourable response rate than standard BEP?
89 patients randomized at 16 UK centres: 43 CBOP/BEP and 46 BEP. Patients had at least one IGCCCG poor-prognosis feature; primary sites included testis and mediastinum.
Standard BEP: four cycles over 12 weeks. CBOP/BEP: 2 cycles CBOP, 2 cycles BO, then 3 cycles BEP with lower-dose bleomycin.
Favourable response was 74.4% with CBOP/BEP versus 60.9% with BEP: absolute increase 13.5 percentage points. The study was a phase II trial and was not powered for definitive between-arm PFS/OS comparison.
At 1 year, PFS was 65% versus 43% (HR 0.59, 95% CI 0.33–1.06); at 2 years, OS was 67% versus 61%.
Grade ≥3 toxicity was 96% with CBOP/BEP vs 63% with BEP. Toxicity deaths occurred in 3/43 versus 2/46 patients. The intensified regimen therefore produced a substantial acute toxicity burden.
TE23 generated a higher favourable response signal but did not establish a new standard because of major toxicity, limited sample size and lack of definitive phase III power.
European Urology 2015 / MRC TE23.
MRC TE23 was a small phase II randomized study and generated a response/PFS signal for CBOP/BEP, but the intensified schedule caused substantially more grade ≥3 toxicity and did not establish a new standard. For IGCCCG poor-prognosis metastatic germ-cell tumours, treatment should follow contemporary risk-adapted cisplatin-based protocols at experienced centres; do not substitute CBOP/BEP for standard BEP/EP-based care on the basis of this phase II study alone.
MRC TE23 primary report ↗ · EAU testicular-cancer guidance ↗