Table 2.
Phase II initial salvage therapy with TIP in advanced GCT
| Reference | Drug doses (per cycle) | Selection Criteria | Evaluable | CR (%) | Additional Efficacy Data |
|---|---|---|---|---|---|
| Kondagunta et al 39 | Paclitaxel: 250 mg/m2 | 1st line salvage in | 46 | 32 | susCR: |
| Ifosfamide 6000 mg/m2 | pts with | (70) | 63% | ||
| Cisplatin 100 mg/m2 | favorable | 2-year PFS | |||
| featuresa | 65% | ||||
| 2-year OS | |||||
| 78% | |||||
|
| |||||
| Mead et al 40 | Paclitaxel: 175 mg/m2 | 1st line salvage | 43 | 13 | 1-year FFS |
| Ifosfamide 5000 mg/m2 | following failure | (31) | 38% | ||
| Cisplatin 100 mg/m2 | to BEP | 1-year OS | |||
| 70% | |||||
|
| |||||
| Mardiak et al 41 | Paclitaxel: 175 mg/m2 | 1st line salvage | 17 | 7 | 2-year DFS |
| Ifosfamide 6000 mg/m2 | following failure | (41) | 47% | ||
| Cisplatin 100 mg/m2 | to cisplatin- | 2-year OS | |||
| based regimens | 64% | ||||
TIP, paclitaxel, ifosfamide, cisplatin; CR, complete response; susCR, sustained CR (median follow-up 69 months); PFS, progression-free survival; FFS, failure-free survival; OS, overall survival; DFS, disease-free survival, PR, partial response.
Must meet all the following: 1) gonadal primary site, 2) maximum 6 prior cycles of cisplatin 3) CR or PR with negative tumor markers following 1st-line chemotherapy.