EORTC 30941 / MRC TE20

Can three cycles of BEP provide equivalent disease control to four cycles in good-prognosis metastatic germ-cell cancer while reducing treatment burden?

What changes for patients?

Three cycles of BEP produced a projected 2-year PFS of 90.4% versus 89.4% with four cycles, a 1-point difference. The trial was designed to rule out a clinically important loss of efficacy and established three cycles as sufficient for good-prognosis disease. Three cycles also reduced treatment burden. NNT is not appropriate for an equivalence comparison.

NNT: Not applicable; equivalence trial

Quality-of-life and treatment burden

NNH: Not quantifiable from the primary endpoint; fewer cycles improved several short-term quality-of-life measures

HR: 0.93

80% CI 0.71–1.24; equivalence criterion met

Three cycles of BEP are sufficient for good-prognosis metastatic germ-cell cancer; a fourth cycle adds treatment burden without a meaningful disease-control gain in this group.

• de Wit R, et al. J Clin Oncol. 2001;19:1629–1640.
• Primary publication / source