The Absolute Effect / Evidence / GETUG-13
Germ Cell Tumours · Medical Oncology · Risk-adapted Treatment
GETUG-13
Clinical question
Can early tumour-marker decline identify poor-prognosis GCT patients who benefit from intensified chemotherapy?
Trial context
Population
263 patients with IGCCCG poor-prognosis germ-cell tumours; 203 with unfavorable marker decline randomized
Intervention
Tumour-marker decline guided dose-dense chemotherapy vs continued BEP in poor-prognosis NSGCT
Key endpoint
5-year progression-free survival
Time horizon / follow-up
Median follow-up 7.1 years
Absolute Effect
What changes for patients?
Among patients with an unfavorable tumour-marker decline after one BEP cycle, switching to dose-dense intensified chemotherapy increased 5-year PFS from 46.7% to 58.9%, an absolute benefit of 12.2 points (NNT 9). Five-year OS was 70.9% vs 61.3%, HR 0.74, but this difference was not statistically significant. NNT is based on 5-year PFS.
NNT: 9
Treatment burden / harm
Grade 3 motor neurotoxicity at 1 year
NNH: Not quantifiable from the reported time-specific toxicity denominator; intensified treatment caused more neurotoxicity and hematologic toxicity
Relative effect
HR: 0.65
95% CI 0.44–0.97; P=.036
Clinical interpretation
Unfavourable marker decline after one BEP cycle identifies poor-prognosis patients in whom dose-dense intensification improved PFS versus continuing standard BEP.
Primary publication
- Fizazi K, et al. J Clin Oncol. 2024;42:3270–3276.
- Fizazi K, et al. Lancet Oncol. 2014;15:1442–1450.
- Primary publication / source
- Primary publication / source