Demographic and baseline characteristics of the mRCC patients and treatment related adverse events
| N (%) | N (%) | ||
| Age, median (range) | 60 (41–78) | Site of Metastasis | |
| Lung | 3 (27.2) | ||
| Gender | Contralateral kidney | 4 (36.3) | |
| Male | 8 (53.3) | Pancreas | 1 (9.09) |
| Female | 7 (46.7) | CNS | 2 (18.1) |
| Ovary | 1 (9.09) | ||
| Race | |||
| White | 9 (60.0) | Previous nephrectomy | |
| Afro-Caribbean | 5 (33.3) | Yes | 12 (80.0) |
| Other | 1 (6.70) | No | 3 (20.0) |
| Pathology | Therapy before study entry | ||
| Clear cell carcinoma | 15 (100) | Cytokine (IFN-γ) | 3 (27.2) |
| RT 50 Gy | 1 (6.70) | ||
| ECOG PSa | |||
| 0 | 11 (73.3) | Adverse events‡ | Total (35/100) |
| 1 | 2 (13.3) | Pain at injection site | 11 (31.4) |
| 2 | 2 (13.3) | Asthenia | 2 (5.71) |
| Cough | 2 (5.71) | ||
| Disease stage | Anemia | 2 (5.71) | |
| II | 1 (6.70) | Vomiting | 1 (2.86) |
| III | 2 (13.3) | Fatigue | 1 (2.86) |
| IV | 12 (80.0) | Hypertension | 1 (2.86) |
| Local erythema | 1 (2.86) | ||
| MSKCC risk group† | Low-back pain | 2 (5.71) | |
| Favorable (0 factors) | 5 (33.3) | Lower limb pain | 1 (2.86) |
| Intermediate (1–2 factors) | 7 (46.7) | Elevated ALP | 3 (8.57) |
| Poor (3 or more factors) | 3 (27.2) | Elevated GGT | 3 (8.57) |
| Elevated creatinine | 2 (5.71) | ||
| Metastasis | Elevated LDH | 2 (5.71) | |
| Yes | 11 (73.3) | Elevated eosinophils | 1 (2.86) |
| No | 4 (26.7) |
*ECOG indicates (n=15 patients).
†The MSKCC prognostic risk groups was derived using five risk factors: ECOG ≤2 (Karnosfky performance score ≤60), lactate dehydrogenase level (˃1.5 times upper limit of normal), hemoglobin level g/L (˂lower limit of normal), ≥2 sites of organ metastasis, and time interval from diagnosis to treatment (˂1 year).
‡All adverse events were classified as mild or moderate (grade 1 or 2).
ALP, Alkaline phosphatase; CNS, Central Nervous System; ECOG, Eastern Cooperative Oncology Group; GGT, Gamma-glutamyl transferase; LDH, Lactate dehydrogenase; mRCC, metastatic renal cell carcinoma; MSKCC, Memorial Sloan Kettering Cancer Center.