Importance of bleomycin in favorable-prognosis disseminated germ cell tumors: an Eastern Cooperative Oncology Group trial
N = 178
- Population
- Patients with minimal- or moderate-stage disseminated germ cell tumours (Indiana staging); 171 were fully assessable for response and survival
- Design
- Prospective randomised trial, three cycles of cisplatin plus etoposide (PVP16) with or without weekly bleomycin (9 weeks). Patients with residual radiographic disease after three cycles underwent surgery; those with persistent carcinoma received two further cycles. Indiana staging system.
- Arms
- Cisplatin, etoposide and bleomycin (PVP16B) (control): Cisplatin 20 mg per square metre and etoposide 100 mg per square metre on days 1 to 5 with weekly bleomycin 30 IU for 9 weeks, three cycles
- Cisplatin and etoposide (PVP16) (experimental): Cisplatin 20 mg per square metre and etoposide 100 mg per square metre on days 1 to 5, three cycles
- People
- Loehrer PJ Sr, senior author Trump D, Eastern Cooperative Oncology Group
Δ Disease-free status after treatment−6 pointsΔ FFS−17 pointsΔ OS−9 points
Show the numbers
| Endpoint | Analysis | Cisplatin and etoposide (PVP16) | Cisplatin, etoposide and bleomycin (PVP16B) | Effect |
|---|---|---|---|---|
| Disease-free status after treatmentFully assessable patients (171 of 178)Disease-free status with chemotherapy and/or surgery | primaryLoehrer 1995 | 88% | 94% | 81 of 86 and 75 of 85 patients. The abstract reports a significant difference in overall adverse outcome (treatment failures including persistent carcinoma in resected residual disease and relapses from complete remission), P = .004. |
| FFSFully assessable patients (171 of 178) | primaryLoehrer 1995 | 69% | 86% | P=0.01Reported as rates without a stated time point; the abstract reports P = .01. |
| OSFully assessable patients (171 of 178) | primaryLoehrer 1995 | 86% | 95% | P=0.01Reported as rates without a stated time point; the abstract reports P = .01. |
| Endpoint | Analysis | Cisplatin and etoposide (PVP16) | Cisplatin, etoposide and bleomycin (PVP16B) | Effect |
|---|---|---|---|---|
| Disease-free status after treatmentFully assessable patients (171 of 178)Disease-free status with chemotherapy and/or surgery | primaryLoehrer 1995 | 88% | 94% | 81 of 86 and 75 of 85 patients. The abstract reports a significant difference in overall adverse outcome (treatment failures including persistent carcinoma in resected residual disease and relapses from complete remission), P = .004. |
| FFSFully assessable patients (171 of 178) | primaryLoehrer 1995 | 69% | 86% | P=0.01Reported as rates without a stated time point; the abstract reports P = .01. |
| OSFully assessable patients (171 of 178) | primaryLoehrer 1995 | 86% | 95% | P=0.01Reported as rates without a stated time point; the abstract reports P = .01. |