GETUG T93BP
Refining the optimal chemotherapy regimen for good-risk metastatic nonseminomatous germ-cell tumors: a randomized trial of the Genito-Urinary Group of the French Federation of Cancer Centers (GETUG T93BP)
N = 257
- Population
- Patients with good-risk metastatic nonseminomatous germ-cell tumours; 257 assessable
- Design
- Randomised trial: three cycles of BE500P versus four cycles of E500P every 3 weeks. Disease defined by the Institut Gustave Roussy prognostic model; patients retrospectively assigned to IGCCCG groups. Planned sample size 250 for an expected favourable response rate of 90% with no more than a 10% difference between arms; the authors state the trial was underpowered for survival analyses.
- Arms
- Three cycles of BE500P (control): Three cycles of bleomycin, etoposide and cisplatin every 3 weeks (abbreviation BE500P as in the paper)
- Four cycles of E500P (experimental): Four cycles of etoposide and cisplatin every 3 weeks (abbreviation E500P as in the paper)
- People
- Culine S, senior author Genito-Urinary Group of the French Federation of Cancer Center (GETUG T93BP), Genito-Urinary Group of the French Federation of Cancer Centers
Δ 48-month EFS−5 points
Show the numbers
| Endpoint | Analysis | Four cycles of E500P | Three cycles of BE500P | Effect |
|---|---|---|---|---|
| EFSAssessable patients (257) | primarymedian follow-up 53 monthsCuline 2007 | 86% at 4 y | 91% at 4 y | P=0.135Favourable response was achieved in 124 and 122 patients in the 3BE500P and 4E500P arms (P = 0.34; denominators not given in the abstract); five versus twelve deaths (P = 0.096). Reported as the 4-year event-free survival rate. Similar non-significant trends were seen in good-prognosis patients by IGCCCG. |
| Endpoint | Analysis | Four cycles of E500P | Three cycles of BE500P | Effect |
|---|---|---|---|---|
| EFSAssessable patients (257) | primarymedian follow-up 53 monthsCuline 2007 | 86% at 4 y | 91% at 4 y | P=0.135Favourable response was achieved in 124 and 122 patients in the 3BE500P and 4E500P arms (P = 0.34; denominators not given in the abstract); five versus twelve deaths (P = 0.096). Reported as the 4-year event-free survival rate. Similar non-significant trends were seen in good-prognosis patients by IGCCCG. |
Appears in
Sources
Culine S, Kerbrat P, Kramar A, Théodore C, Chevreau C, Geoffrois L, et al. Refining the optimal chemotherapy regimen for good-risk metastatic nonseminomatous germ-cell tumors: a randomized trial of the Genito-Urinary Group of the French Federation of Cancer Centers (GETUG T93BP). Ann Oncol. 2007;18(5):917-24.