AUO AH 01/94
Randomized phase III trial comparing retroperitoneal lymph node dissection with one course of bleomycin and etoposide plus cisplatin chemotherapy in the adjuvant treatment of clinical stage I Nonseminomatous testicular germ cell tumors: AUO trial AH 01/94 by the German Testicular Cancer Study Group
Phase 3N = 382
- Population
- Patients with clinical stage I non-seminomatous germ-cell tumours of the testis after orchidectomy
- Design
- Randomised phase III trial, 1996 to 2005: after orchidectomy, 382 patients were randomly assigned to RPLND or one course of BEP. The primary end point was the rate of recurrence; the trial was powered to detect a 7% reduction (from 10% to 3%) in recurrence with chemotherapy compared with surgery.
- Primary endpoint
- Relapse rate
- Arms
- RPLND (control, n = 191): Retroperitoneal lymph node dissection
- BEP x 1 (experimental, n = 191): One course of bleomycin, etoposide and cisplatin
- People
- Albers P, German Testicular Cancer Study Group
RFSHR 7.937 (95% CI 1.808–34.480)Δ 24-month RFS+7.59 points
Show the numbers
| Endpoint | Analysis | BEP x 1 | RPLND | Effect |
|---|---|---|---|---|
| RFSIntention-to-treat population2-year recurrence-free survival rate as reported in the abstract; the primary end point was the rate of recurrence. | primarymedian follow-up 4.7 yearsAlbers 2008 | 99.46% at 2 y (96.20–99.92%) | 91.87% at 2 y (86.87–95.02%) | HR 7.937 (95% CI 1.808–34.480)P=0.0011Two recurrences with chemotherapy and 15 with surgery. The hazard ratio is for recurrence with surgery as opposed to chemotherapy. Difference in 2-year recurrence-free survival rate 7.59% (95% CI 3.13% to 12.05%). The authors describe RPLND as performed according to community standards and state that one course of BEP is not standard treatment but merits further investigation. |
| Endpoint | Analysis | BEP x 1 | RPLND | Effect |
|---|---|---|---|---|
| RFSIntention-to-treat population2-year recurrence-free survival rate as reported in the abstract; the primary end point was the rate of recurrence. | primarymedian follow-up 4.7 yearsAlbers 2008 | 99.46% at 2 y (96.20–99.92%) | 91.87% at 2 y (86.87–95.02%) | HR 7.937 (95% CI 1.808–34.480)P=0.0011Two recurrences with chemotherapy and 15 with surgery. The hazard ratio is for recurrence with surgery as opposed to chemotherapy. Difference in 2-year recurrence-free survival rate 7.59% (95% CI 3.13% to 12.05%). The authors describe RPLND as performed according to community standards and state that one course of BEP is not standard treatment but merits further investigation. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| RFS | 7.937 | 1.808–34.48 |
Appears in
Sources
Albers P, Siener R, Krege S, Schmelz HU, Dieckmann KP, Heidenreich A, et al. Randomized phase III trial comparing retroperitoneal lymph node dissection with one course of bleomycin and etoposide plus cisplatin chemotherapy in the adjuvant treatment of clinical stage I Nonseminomatous testicular germ cell tumors: AUO trial AH 01/94 by the German Testicular Cancer Study Group. J Clin Oncol. 2008;26(18):2966-72.