Table 1. Patients characteristics and pretreatment.
|
Treatment
|
|||
|---|---|---|---|
| Characteristics | Arm Aa (n) | Arm Ba (n) | All patients (n) |
| Entered | 135 | 68 | 203 |
| Age (years) | |||
| Median | 59 | 60 | 59 |
| Range | 31–77 | 38–77 | 31–77 |
| Sex | |||
| Male | 97 | 54 | 151 |
| Female | 38 | 14 | 52 |
| Radical nephrectomy | 135 | 68 | 203 |
| Stratum | |||
| pT3b/c pN0 or T4pN0 | 50 | 27 | 77 |
| pN+ | 28 | 8 | 36 |
| R0 | 57 | 33 | 90 |
| Local | 9 | 4 | 13 |
| Lymph nodes | 5 | 5 | 10 |
| Organ metastases | 37 | 22 | 59 |
| Site unknown | 6 | 2 | 8 |
| Histological subtype | |||
| Clear cell | 84 | 41 | 125 |
| Granular | 3 | 2 | 5 |
| Sarkomatoid | 2 | 1 | 3 |
| Papillary | 1 | 1 | 2 |
| Mixed | 22 | 8 | 30 |
| Unknown | 23 | 15 | 38 |
| Systemic pretreatment | |||
| Chemotherapy | 0 | 1 | 1 |
| Immunotherapyb | 4 | 6 | 10 |
| Naturopathic therapy | 1 | 0 | 1 |
| Unknown | 6 | 0 | 6 |
a
Arm A (8 weeks of sc-rIL-2/sc-rIFN-α /iv 5-FU); Arm B (observation).
b
Including IL-2/IFN-α2, IL-2/Vaccine, and Vaccine.
sc-rIL-2=subcutaneous interleukin-2; sc-rIFN-α2=subcutaneous interferon-alpha2a, and iv-5-FU=intravenous 5-fluorouracil.