Table 1.
Baseline Patient Demographics and Clinical Characteristics
| Characteristic | Sunitinib (n = 375) | IFN-α (n = 375) |
|---|---|---|
| Median age, years | 62 | 59 |
| Sex, % | ||
| Male | 71 | 72 |
| Female | 29 | 28 |
| ECOG PS, %* | ||
| 0 | 62 | 61 |
| 1 | 38 | 38 |
| 2 | 0 | 1 |
| MSKCC risk factors, % | ||
| 0 | 38 | 34 |
| 1-2 | 56 | 59 |
| ≥ 3 | 6 | 7 |
| Previous nephrectomy, % | 91 | 89 |
| Previous radiotherapy, % | 14 | 14 |
| No. of disease sites, % | ||
| 1 | 15 | 19 |
| 2 | 28 | 30 |
| ≥ 3 | 57 | 51 |
| Site of metastasis, % | ||
| Lung | 78 | 79 |
| Liver | 26 | 24 |
| Bone | 30 | 30 |
| Lymph nodes | 58 | 53 |
| QOL scores, mean ± SD | ||
| FACT-G | 82.30 ± 15.2 | 81.25 ± 16.04 |
| FKSI-DRS | 29.74 ± 5.24 | 29.55 ± 5.03 |
| EQ-VAS | 73.80 ± 18.50 | 71.43 ± 19.51 |
Abbreviations: IFN-α, interferon alfa; ECOG PS, Eastern Cooperative Oncology Group performance status; MSKCC, Memorial Sloan-Kettering Cancer Center; QOL, quality of life; SD, standard deviation; FACT-G, Functional Assessment of Cancer Therapy–General scale; FKSI-DRS, Functional Assessment of Cancer Therapy–Kidney Symptom Index–Disease-Related Symptoms subscale; EQ-VAS, EuroQol Group's visual analog scale.
* All patients had an ECOG PS of 0 or 1 at the time eligibility was determined; four patients in the IFN-α group had an ECOG PS of 2 on the day study treatment started.