Table 1. Baseline patient characteristics.
| Characteristic | Sunitinib (N=4543) |
|---|---|
| Median age (range), years | 59.0 (19.0–89.0) |
| Age ⩾65 years, n (%) | 1485 (33) |
| Male/female, n (%) | 3364/1179 (74/26) |
|
ECOG performance status,
n
(%)a | |
| 0 | 1868 (41) |
| 1 | 1949 (43) |
| 2 | 547 (12) |
| 3 | 80 (2) |
| 4 | 7 (<1) |
|
Histology,
n
(%)a | |
| Clear cell | 4010 (88) |
| Non-clear cell | 532 (12) |
| Prior nephrectomy, n (%)a | 4044 (89) |
|
Disease sites,
n
(%) | |
| Lung | 3469 (76) |
| Lymph nodes | 2333 (51) |
| Bone | 1593 (35) |
| Liver | 1236 (27) |
| Brain | 338 (7) |
|
Prior systemic therapy,
n
(%) | |
| Antiangiogenicb | 440 (10) |
| Cytokine | 3096 (68) |
|
Modified risk groups based on published MSKCC data,
n
(%)a,c | |
| Favourable | 915 (20) |
| Intermediate | 1495 (33) |
| Poor | 1177 (26) |
|
Risk groups based on the IMDC prognostic model,
n
(%)a,d | |
| Favourable | 988 (22) |
| Intermediate | 2188 (48) |
| Poor | 889 (20) |
Abbreviations: ECOG=Eastern Cooperative Oncology Group; IMDC=International Metastatic Renal-Cell Carcinoma Database Consortium; LLN=lower limit of normal; MSKCC=Memorial Sloan-Kettering Cancer Center; ULN=upper limit of normal.
Number (%) of patients with missing data: ECOG performance status=92 (2), histology=1 (<1), prior nephrectomy =199 (4), modified risk groups based on published MSKCC data (Motzer et al, 2002, 2004)=956 (21), risk groups based on the IMDC prognostic model (Heng et al, 2009, 2013)=478 (11).
Included sorafenib and bevacizumab.
Risk factors were ECOG performance status ⩾2, haemoglobin <LLN, and corrected serum calcium >10 mg dl−1; patients without prior cytokine treatment also had lactose dehydrogenase >1.5 × ULN and time to interferon-alfa use of <1 year as risk factors (Motzer et al, 2002, 2004). Patients with prior cytokine therapy were assigned to favourable, intermediate, or poor risk groups if 0, 1, or >1 risk factors were present, respectively. Patients without prior cytokine treatment were assigned to favourable, intermediate, or poor risk groups if 0, 1 or 2, or >2 risk factors were present, respectively.
Risk factors were ECOG performance status >1, time from diagnosis to study treatment <1 year, haemoglobin<LLN, calcium>ULN, neutrophil count >ULN, and platelet count > ULN (Heng et al, 2009, 2013). Patients with 0, 1 or 2, or >2 risk factors were assigned to the favourable, intermediate, or poor risk groups, respectively.