Evaluation of optimal duration of chemotherapy in favorable-prognosis disseminated germ cell tumors: a Southeastern Cancer Study Group protocol
Phase 3N = 184
- Population
- Patients with favourable-prognosis (minimal and moderate extent) disseminated germ cell tumours; about two thirds of all disseminated germ cell tumours needing chemotherapy
- Design
- Randomised prospective phase III trial comparing four courses of cisplatin, etoposide and bleomycin over 12 weeks with the identical doses given as three courses over 9 weeks; all patients had at least 1 year of follow-up at reporting. Favourable prognosis defined as minimal or moderate extent of disease (the abstract does not name the staging system).
- Arms
- Four courses of BEP (control, n = 96): Cisplatin, etoposide (VP-16) and bleomycin, four courses over 12 weeks
- Three courses of BEP (experimental, n = 88): Same doses of cisplatin, etoposide and bleomycin, three courses over 9 weeks
- People
- Einhorn LH, senior author Greco FA, Southeastern Cancer Study Group
Δ Disease-free status after treatment+1 pointsΔ Continuous disease-free rate0 points
Show the numbers
| Endpoint | Analysis | Three courses of BEP | Four courses of BEP | Effect |
|---|---|---|---|---|
| Disease-free status after treatmentAll randomised patients (184); initial disease-free statusInitial disease-free status (no evidence of disease) | primaryEinhorn 1989 | 98% | 97% | 86 of 88 and 93 of 96 patients. |
| Continuous disease-free rateAll randomised patients (184)Patients continuously disease-free at the time of reporting (minimum follow-up 1 year) | primaryEinhorn 1989 | 92% | 92% | 81 of 88 and 88 of 96 patients; ten relapses (5%), five on each arm. |
| Endpoint | Analysis | Three courses of BEP | Four courses of BEP | Effect |
|---|---|---|---|---|
| Disease-free status after treatmentAll randomised patients (184); initial disease-free statusInitial disease-free status (no evidence of disease) | primaryEinhorn 1989 | 98% | 97% | 86 of 88 and 93 of 96 patients. |
| Continuous disease-free rateAll randomised patients (184)Patients continuously disease-free at the time of reporting (minimum follow-up 1 year) | primaryEinhorn 1989 | 92% | 92% | 81 of 88 and 88 of 96 patients; ten relapses (5%), five on each arm. |