TABLE I.
Patient and Characteristics, Treatment, Response, Toxicity, and Outcomes
| Patient # | Sex | Age at enrollment (Years) |
Tumor site | Stage | Treatment regimen (g/m2) |
Metastatic site | Initial AFP | AFP normalized | DLT observed | Type of EFS event | Life status |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | M | 14 | Retroperitoneal | 3 | 1.2 | 5 | Yes | No | Progressive Disease | Alive | |
| 2 | M | 15 | Mediastinum | 3 | 1.2 | 3,200 | No | No | No event | Alive | |
| 3 | M | 2 | Mediastinum | 3 | 1.2 | 2,129 | No | No | No event | Alive | |
| 4 | F | 2 | Pelvic tumor | 4 | 1.2 | Lung and spinal canal | 52,740 | No | No | Relapse | Alive |
| 5 | F | 2 | Liver | 4 | 1.2 | Lung and abdominal lymph nodes | 4,800 | Yes | Not evaluable | No event | Alive |
| 6 | F | 1 | Vaginal wall | 3 | 1.2 | 7,737 | No | No | No event | Alive | |
| 7 | F | 1 | Orbit | 3 | 1.8 | 18,566 | No | No | No event | Alive | |
| 8 | F | 0 | Retroperitoneal | 4 | 1.8 | Liver | 108,458 | No | No | No event | Alive |
| 9 | M | 17 | Mediastinum | 3 | 1.8 | 4,950 | Yes | No | No event | Alive | |
| 10 | F | 4 | Sacrococcygeal | 4 | 1.8 | Liver and abdominal lymph nodes | 85,910 | No | No | No event | Alive |
| 11 | M | 14 | Mediastinum | 3 | 1.8 | 6 | Yes | Yes | Relapse | Alive | |
| 12 | F | 10 | Ovary | 3 | 1.8 | 7,303 | No | Not evaluable | No event | Alive | |
| 13 | M | 2 | Saccroccoygeal | 4 | 1.8 | Lung and spinal canal | 5,713 | No | No | No event | Alive |
| 14 | F | 6 | Retroperitoneal | 3 | 2.4 | 3 | Yes | Not evaluable | Progressive disease | Dead | |
| 15 | F | 0 | Saccroccoygeal | 3 | 2.4 | 23,050 | No | No | No event | Alive | |
| 16 | M | 1 | Extragonadal | 3 | 2.4 | 47,457 | No | No | No event | Alive | |
| 17 | F | 0 | Uterus | 3 | 2.4 | 7,119 | No | No | No event | Alive | |
| 18 | M | 17 | Mediastinum | 3 | 2.4 | 10,650 | No | No | No event | Alive | |
| 19 | M | 18 | Mediastinum | 3 | 2.4 | 5,034 | No | No | Relapse | Dead |