Table 1.
Patient demographics and baseline characteristics†
| N = 64 | |
|---|---|
| Sex, n (%) | |
| Male | 44 (69) |
| Female | 20 (31) |
| Age, years, median (range) | 63 (34–80) |
| ECOG PS, n (%) | |
| 0 | 57 (89) |
| 1 | 7 (11) |
| Primary histology, n (%) | |
| Clear cell | 62 (97) |
| Papillary carcinoma | 1 (2) |
| Spindle cell | 1 (2) |
| Prior adjuvant therapy, n (%) | |
| Yes | 10 (16) |
| No | 54 (84) |
| Prior cytokine therapy for metastatic sites, n (%) | |
| Interferon | 50 (78) |
| Interleukin-2 | 3 (5) |
| Interferon/Interleukin-2 | 11 (17) |
| Duration of prior cytokine therapy, days, median (range) | 244 (2–3766) |
| MSKCC risk group,‡,§ n (%) | |
| Favorable | 10 (16) |
| Intermediate | 47 (77) |
| Poor | 4 (7) |
| Number of metastatic sites, n (%) | |
| 1 | 19 (30) |
| 2 | 18 (28) |
| 3 | 14 (22) |
| ≥4 | 13 (20) |
| Site of metastases, n (%) | |
| Lung | 53 (83) |
| Lymph node (distant) | 20 (31) |
| Bone | 12 (19) |
| Pancreas | 11 (17) |
| Kidney | 9 (14) |
| Adrenal | 8 (13) |
| Liver | 6 (9) |
| Lymph node (regional) | 6 (9) |
Adapted from Eur J Cancer, Vol 47, Tomita et al., Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: A phase II study in Japanese patients with cytokine-refractory metastatic renal cell carcinoma, pp. 2592–602, Copyright (2011), with permission from Elsevier.
Derived using five risk factors: lactate dehydrogenase >1.5 times the upper limit of normal, serum hemoglobin < the lower limit of normal, corrected serum calcium >10 mg/dL, ECOG PS 1, and the time from initial diagnosis to axitinib treatment <1 year. MSKCC risk groups were defined as favorable (0 risk factor), intermediate (1 or 2 risk factors) or poor (≥3 risk factors).
Unknown for 3 patients. ECOG PS, Eastern Cooperative Oncology Group performance status; MSKCC, Memorial Sloan-Kettering Cancer Center.