Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial
N = 598
- Population
- Patients with good-risk nonseminomatous germ cell tumours
- Design
- Prospective randomised multicentre trial, September 1989 to May 1993; four cycles every 21 days, etoposide 120 mg per square metre on days 1 to 3 and bleomycin 30 U on day 2 in both arms; carboplatin dosed to a target area under the curve calculated from the glomerular filtration rate.
- Arms
- BEP (control, n = 300): Four cycles of bleomycin, etoposide and cisplatin (20 mg per square metre on days 1 to 5, or 50 mg per square metre on days 1 and 2)
- CEB (experimental, n = 298): Four cycles of carboplatin, etoposide and bleomycin
- People
- Horwich A, senior author Stenning SP, Medical Research Council/European Organization for Research and Treatment of Cancer
Δ Complete response rate−7.1 pointsΔ 12-month FFS−14 pointsΔ 36-month OS−7 points
Show the numbers
| Endpoint | Analysis | CEB | BEP | Effect |
|---|---|---|---|---|
| Complete response ratePatients assessable for response (528 of 598) | primaryHorwich 1997 | 87.3% | 94.4% | P=0.009253 of 268 and 227 of 260 assessable patients. |
| FFSAll randomised patients (598) | primaryHorwich 1997 | 77% at 12 mo (72–82%) | 91% at 12 mo (88–94%) | P<0.00130 treatment failures in 300 patients allocated to BEP and 79 in 298 allocated to CEB (log-rank chi-square 26.9). |
| OSAll randomised patients (598) | primaryHorwich 1997 | 90% at 3 y (86–94%) | 97% at 3 y (95–99%) | P=0.00310 deaths in patients allocated to BEP and 27 in those allocated to CEB (log-rank chi-square 8.77). |
| Endpoint | Analysis | CEB | BEP | Effect |
|---|---|---|---|---|
| Complete response ratePatients assessable for response (528 of 598) | primaryHorwich 1997 | 87.3% | 94.4% | P=0.009253 of 268 and 227 of 260 assessable patients. |
| FFSAll randomised patients (598) | primaryHorwich 1997 | 77% at 12 mo (72–82%) | 91% at 12 mo (88–94%) | P<0.00130 treatment failures in 300 patients allocated to BEP and 79 in 298 allocated to CEB (log-rank chi-square 26.9). |
| OSAll randomised patients (598) | primaryHorwich 1997 | 90% at 3 y (86–94%) | 97% at 3 y (95–99%) | P=0.00310 deaths in patients allocated to BEP and 27 in those allocated to CEB (log-rank chi-square 8.77). |
Appears in
Sources
Horwich A, Sleijfer DT, Fosså SD, Kaye SB, Oliver RT, Cullen MH, et al. Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial. J Clin Oncol. 1997;15(5):1844-52.