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Germ Cell Tumours · Medical Oncology · Intermediate Prognosis

EORTC 30983

In intermediate-prognosis germ-cell cancer, does adding paclitaxel to BEP improve progression-free survival?

Population337 randomized patients; 169 BEP and 168 T-BEP, with 13 patients in each arm subsequently deemed ineligible.InterventionFour cycles of paclitaxel 175 mg/m² added to BEP with G-CSF.ComparatorFour cycles of standard BEP.Primary clinical outcome3-year progression-free survival.

Absolute Effect

In the intention-to-treat population, 3-year PFS was 79.4% vs 71.1%, an absolute difference of 8.3 points (NNT ≈ 13). The primary analysis did not reach statistical significance (HR 0.73, P=.153).

Among eligible patients, the difference was 82.7% vs 70.1% (+12.6 points; HR 0.60; P=.03).

Clinical interpretation

The trial did not demonstrate the prespecified superiority target in its primary intention-to-treat analysis and was under-accrued. The eligible-patient analysis suggests a signal, but exclusion of ineligible patients cannot replace the primary randomized analysis.

Source

de Wit R, et al. J Clin Oncol. 2012;30:792–799.

Current-practice context · reviewed 14 October 2026

EORTC 30983 did not meet its prespecified superiority endpoint for adding paclitaxel to BEP in intermediate-prognosis metastatic germ-cell cancer. The eligible-patient subgroup is hypothesis-generating and should not replace the intention-to-treat result. Four cycles of BEP remain a standard regimen for intermediate-prognosis disease; use expert-centre protocols and do not extrapolate the good-prognosis three-cycle evidence to this group.

EORTC 30983 primary source ↗ · Current guideline guidance ↗