IT-94
Needs reviewA randomised trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours
Phase 3N = 280NCT00002566
- Population
- Patients with advanced germ cell tumours who had incomplete remission or relapse after first-line platinum chemotherapy
- Design
- Phase 3 randomised trial, 43 institutions in 11 countries, February 1994 to September 2001: four conventional cycles versus three conventional cycles followed by one course of high-dose carboplatin, etoposide and cyclophosphamide with haematopoietic stem-cell support.
- Primary endpoint
- EFS
- Arms
- Conventional salvage (arm A) (control): Four cycles of cisplatin, ifosfamide and etoposide (or vinblastine)
- Conventional salvage then high-dose (arm B) (experimental): Three cycles of cisplatin, ifosfamide and etoposide (or vinblastine) followed by high-dose carboplatin, etoposide and cyclophosphamide (CarboPEC) with haematopoietic stem-cell support
- People
- Pico JL, senior author European Group for Blood and Marrow Transplantation (EBMT), European Group for Blood and Marrow Transplantation (EBMT)
Δ 36-month EFS+7 pointsΔ ORR0 pointsΔ Toxic death rate+4 pointsΔ 36-month DFS+20 points
Show the numbers
| Endpoint | Analysis | Conventional salvage then high-dose (arm B) | Conventional salvage (arm A) | Effect |
|---|---|---|---|---|
| EFSRandomised patients (280); analysis population not stated in the abstract | primaryPico 2005 | 42% at 3 y | 35% at 3 y | P=0.16The abstract gives '35% versus 42%' without naming the arms; values are assigned in the order of the arm listing (A then B). The primary endpoint is not stated in the abstract. 3-year overall survival was 53% (95% CI 46% to 59%), reported as one figure without a per-arm difference. |
| ORRRandomised patients (280); analysis population not stated in the abstractComplete plus partial response rate | primaryPico 2005 | 56% | 56% | The abstract reports similar complete and partial response rates in both arms (56%; 95% CI 50% to 62%); the interval is given once for the figure and is not attributed to a single arm. |
| Toxic death rateRandomised patients (280); analysis population not stated in the abstract | primaryPico 2005 | 7% | 3% | Reported as 3% and 7% toxic deaths in arms A and B. |
| DFSComplete responders | exploratoryPico 2005 | 75% at 3 y | 55% at 3 y | P<0.04Subgroup of complete responders; the abstract reports 'P <0.04'. Not a randomised comparison of all patients. |
| Endpoint | Analysis | Conventional salvage then high-dose (arm B) | Conventional salvage (arm A) | Effect |
|---|---|---|---|---|
| EFSRandomised patients (280); analysis population not stated in the abstract | primaryPico 2005 | 42% at 3 y | 35% at 3 y | P=0.16The abstract gives '35% versus 42%' without naming the arms; values are assigned in the order of the arm listing (A then B). The primary endpoint is not stated in the abstract. 3-year overall survival was 53% (95% CI 46% to 59%), reported as one figure without a per-arm difference. |
| ORRRandomised patients (280); analysis population not stated in the abstractComplete plus partial response rate | primaryPico 2005 | 56% | 56% | The abstract reports similar complete and partial response rates in both arms (56%; 95% CI 50% to 62%); the interval is given once for the figure and is not attributed to a single arm. |
| Toxic death rateRandomised patients (280); analysis population not stated in the abstract | primaryPico 2005 | 7% | 3% | Reported as 3% and 7% toxic deaths in arms A and B. |
| DFSComplete responders | exploratoryPico 2005 | 75% at 3 y | 55% at 3 y | P<0.04Subgroup of complete responders; the abstract reports 'P <0.04'. Not a randomised comparison of all patients. |