Table 1.
Selected Phase II trials for high-dose chemotherapy in the salvage setting.
| Study (year) |
Regimen | high-dose part | Cycles of HDCT (n; patients receiving full %) |
Patients (n) |
Patient selection criteria | CR (%) |
Other efficacy end points |
Ref. |
|---|---|---|---|---|---|---|---|---|
| Broun et al. (1992) | HD CE × 2 (Phase I/II) | Carboplatin (900–2000 mg/m2) Etoposide (1200 mg/m2) Ifosfamide (10 g/m2) in three patients |
2 (65) | 40 | Recurrence after second-line, or refractory to first-line cisplatin-based chemotherapy | 30 | CR: ≥2 years: 15% | [27] |
| Siegert et al. (1994) | PEI × 2, then HD CEI × 1 (Phase I/II) | Carboplatin (1500–2000 mg/m2) Etoposide (1200–2400 mg/m2) Ifosfamide (10 g/m2) |
1 (92) | 68 | Recurrence after ≥1 cycle cisplatin-based chemotherapy, or IR to first-line | 51 | CR: ≥1 year: 19% 2-year OS (%): 44% |
[28] |
| Motzer et al. (1996) | HD CECy × 2 (Phase I/II) | Carboplatin (1500 mg/m2) Etoposide (1200 mg/m2) Cyclophosphamide (60–150 mg/kg) |
2 (47) | 58 | IR to first-line cisplatin-based chemotherapy or IR to/relapse after cisplatin-based salvage | 40 | 2-year OS: 31% | [29] |
| Rick et al. (2001) | TIP × 3, ± T × 1, followed by HD CETh × 1 | Carboplatin (1500 mg/m2) Etoposide (2400 mg/m2) Thiotepa (450–750 mg/m2) |
1 (78) | 80 | Relapse or progression after cisplatin-based chemotherapy | 45 | 3-year OS: 30% 3-year EFS: 25% |
[30] |
| Feldman et al. (2010) | TI × 2, followed by HD CE × 3 | Carboplatin (AUC 24) Etoposide (1200 mg/m2) |
3 (77) | 107 | Recurrence after ≥1 cycle cisplatin-based chemotherapy, and one of the following: extragonadal primary, or IR to first-line, or prior CDCT salvage | 50 | 5-year DFS: 47% 5-year OS: 52% |
[31] |
In all trials, high-dose therapy was followed by autologous stem cell rescue.
ASCT: Autologous stem cell transplantation; CR: Complete remission; DFS: Disease-free survival; HD CE: High-dose carboplatin/etoposide; HD CECy: High-dose carboplatin/etoposide/cyclophosphamide; HD CEI: High-dose carboplatin/etoposide/ifosfamide; HD CETh: High-dose carboplatin/etoposide/thiotepa; IR: Incomplete response; OS: Overall survival; PEI: Cisplatin/etoposide/ifosfamide; TI: Paclitaxel/ifosfamide; TIP: Paclitaxel/ifosfamide/cisplatin.