Immediate adjuvant chemotherapy versus observation with treatment at relapse in pathological stage II testicular cancer
N = 195
- Population
- Patients with completely resected pathological stage II testicular cancer (positive retroperitoneal lymph nodes) after orchiectomy and lymph node dissection
- Design
- International multicentre randomised study, 1979 to 1984: after orchiectomy and dissection of the retroperitoneal lymph nodes, 195 evaluable patients with completely resected pathological stage II disease were randomised to two cycles of immediate adjuvant cisplatin-based chemotherapy or monthly observation with treatment at relapse. Median follow-up 4 years.
- Arms
- Observation (control, n = 98): Monthly observation with treatment at relapse
- Adjuvant chemotherapy (experimental, n = 97): Two cycles of immediate cisplatin-based adjuvant chemotherapy
- People
- Williams SD
Δ Relapse rate−43 points
Show the numbers
| Endpoint | Analysis | Adjuvant chemotherapy | Observation | Effect |
|---|---|---|---|---|
| Relapse rateEvaluable patients | primaryWilliams 1987 | 6% | 49% | Adjuvant arm: 6 of 97 recurred, only 1 of whom had received adjuvant chemotherapy before the recurrence; 3 died (one of testicular cancer) and 94 of 97 survived. Observation arm: 48 of 98 relapsed; almost all were effectively treated and 93 of 98 were alive and disease-free, with 3 deaths from testicular cancer. No identifiable factor was strongly associated with the risk of relapse. |
| Endpoint | Analysis | Adjuvant chemotherapy | Observation | Effect |
|---|---|---|---|---|
| Relapse rateEvaluable patients | primaryWilliams 1987 | 6% | 49% | Adjuvant arm: 6 of 97 recurred, only 1 of whom had received adjuvant chemotherapy before the recurrence; 3 died (one of testicular cancer) and 94 of 97 survived. Observation arm: 48 of 98 relapsed; almost all were effectively treated and 93 of 98 were alive and disease-free, with 3 deaths from testicular cancer. No identifiable factor was strongly associated with the risk of relapse. |