Importance of bleomycin in combination chemotherapy for good-prognosis testicular nonseminoma: a randomized study of the European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group
N = 419
- Population
- Patients with good-prognosis metastatic nonseminomatous testicular cancer; 395 were eligible
- Design
- Prospective randomised trial: four cycles of cisplatin 20 mg per square metre on days 1 to 5 plus etoposide 120 mg per square metre on days 1, 3 and 5, with or without weekly bleomycin 30 mg.
- Arms
- BEP (control, n = 200): Four cycles of bleomycin, etoposide and cisplatin (etoposide 360 mg per square metre per cycle)
- EP (experimental, n = 195): Four cycles of etoposide and cisplatin without bleomycin
- People
- de Wit R, senior author Sylvester R, European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group
Δ Complete response rate−8 points
Show the numbers
| Endpoint | Analysis | EP | BEP | Effect |
|---|---|---|---|---|
| Complete response rateEligible patients (395 of 419)Complete response with chemotherapy alone or after postchemotherapy surgery | primaryde 1997 | 87% | 95% | P=0.0075189 of 200 allocated to BEP and 169 of 195 allocated to EP, as eligible patients; arm sizes shown are these eligible counts. After a median follow-up of 7.3 years, 8 patients (4%) on each arm relapsed; time to progression (P = .136) and survival (P = .262) did not differ significantly. |
| Endpoint | Analysis | EP | BEP | Effect |
|---|---|---|---|---|
| Complete response rateEligible patients (395 of 419)Complete response with chemotherapy alone or after postchemotherapy surgery | primaryde 1997 | 87% | 95% | P=0.0075189 of 200 allocated to BEP and 169 of 195 allocated to EP, as eligible patients; arm sizes shown are these eligible counts. After a median follow-up of 7.3 years, 8 patients (4%) on each arm relapsed; time to progression (P = .136) and survival (P = .262) did not differ significantly. |
Appears in
Sources
de Wit R, Stoter G, Kaye SB, Sleijfer DT, Jones WG, ten Bokkel Huinink WW, et al. Importance of bleomycin in combination chemotherapy for good-prognosis testicular nonseminoma: a randomized study of the European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group. J Clin Oncol. 1997;15(5):1837-43.