Table 2.
Comparison of clinicopathological parameters between first-line IT and TT
| Parameter | IT (n=135) | TT (n=127) | p-value |
|---|---|---|---|
| Age, mean±SD (yr) | 56.1±11.9 | 58.5±11.2 | 0.101 |
| Sex (male/female) | 104/31 (77/23) | 100/27 (78.7/21.3) | 0.768 |
| BMI, mean±SD (kg/m2) | 23.6±3.5 | 23.3±2.7 | 0.421 |
| Underlying disease | |||
| Diabetes | 18 (13.3) | 28 (22.0) | 0.075 |
| Hypertension | 42 (31.3) | 55 (43.3) | 0.055 |
| Ischemic heart disease | 0 | 2 (1.6) | 0.234 |
| Cerebrovascular disease | 0 | 4 (3.1) | 0.054 |
| Karnofsky performance score | |||
| > 80% | 131 (97.0) | 123 (96.9) | 0.481 |
| 50%-70% | 4 (3.0) | 4 (3.1) | |
| MSKCC risk group | |||
| Favorable | 10 (7.4) | 13 (10.3) | 0.814 |
| Intermediate | 63 (46.7) | 68 (53.5) | |
| Poor | 27 (20.0) | 25 (19.7) | |
| Unknown | 35 (25.9) | 21 (16.5) | |
| Heng risk group | |||
| Favorable | 20 (14.8) | 21 (16.5) | 0.795 |
| Intermediate | 87 (64.4) | 73 (57.5) | |
| Poor | 21 (15.6) | 19 (15.0) | |
| Unknown | 7 (5.2) | 14 (11.0) | |
| Treatment duration, mean±SD (mo) | 7.2±9.8 | 9.0±12.3 | 0.204 |
| Metastatic site | |||
| Lung | 102 (75.6) | 102 (80.3) | 0.633 |
| Liver | 20 (14.8) | 24 (18.9) | 0.496 |
| LN | 52 (38.5) | 64 (50.4) | 0.099 |
| Bone | 45 (33.3) | 44 (34.6) | 0.675 |
| Brain | 9 (6.7) | 14 (11.0) | 0.433 |
| Other | 15 (11.1) | 21 (16.5) | 0.421 |
| Clinical T stage | |||
| T1 | 13 (9.6) | 12 (9.4) | 0.049 |
| T2 | 18 (13.3) | 14 (11.0) | |
| T3 | 36 (26.7) | 35 (27.6) | |
| T4 | 10 (7.4) | 11 (8.7) | |
| Tx | 60 (44.4) | 55 (43.3) | |
| Clinical N stage | |||
| N1 | 18 (13.3) | 19 (15.0) | 0.017 |
| Nx | 58 (43.0) | 51 (40.2) | |
| Renal embolization | 11 (8.1) | 5 (3.9) | 0.199 |
| Nephrectomy | 101 (74.8) | 67 (52.8) | < 0.001 |
| Primary renal tumor in situ | 25 (18.5) | 56 (43.3) | < 0.001 |
| Fuhrmann grade | |||
| 1 | 2 (1.5) | 5 (3.9) | 0.116 |
| 2 | 16 (11.9) | 26 (20.5) | |
| 3 | 47 (34.8) | 35 (27.6) | |
| 4 | 15 (11.1) | 20 (15.7) | |
| Unknown | 65 (48.1) | 41 (32.3) | |
| Histology | |||
| Clear cell, pure | 84 (62.2) | 94 (74.0) | 0.066 |
| Mixed | 6 (4.4) | 13 (10.2) | |
| Papillary | 9 (6.7) | 6 (4.7) | |
| Chromophobe | 0 | 1 (0.7) | |
| Unclassified | 0 | 5 (3.9) | |
| Unknown | 36 (26.7) | 10 (7.9) | |
| Primary treating drug | IL-2: 11 (8.1) | Sunitinib: 92 (35.1) | NA |
| IFN-α: 65 (48.1) | Sorafenib: 17 (6.5) | ||
| IL-2+IFN-α: 57 (42.2) | Pazopanib: 18 (6.9) | ||
| Others: 2 (1.5) | |||
| Best overall response | |||
| CR | 14 (10.4) | 7 (5.6) | 0.242 |
| PR | 28 (20.7) | 36 (28.3) | |
| SD | 32 (23.7) | 24 (18.9) | |
| PD | 34 (25.2) | 28 (22.0) | |
| F/U loss or death | 29 (21.5) | 32 (25.2) | |
| PFS, median (range, mo) | 6.4 (4.2-8.6) | 9.3 (6.8-11.7) | 0.026 |
| 5.7 (1.9-9.6)a) | 0.819 | ||
| IL-2: 3.3 (0.1-24.3) | Sunitinib: 8.5 (0.2-68.4) | 0.053 | |
| IFN-α: 5.8 (0.1-65.6) | Sorafenib: 9.0 (0.1-22.3) | ||
| IL-2+IFN-α: 16.3 (0.4-20.2) | Pazopanib: 11.0 (0.5-36.4) | ||
| PFS of IT, median (range) | |||
| Monotherapy (n=48) | 5.8 (0.1-65.6) | NA | 0.522 |
| Dual therapy (n=33) | 7.5 (0.1-22.5) | ||
| Triple therapy (n=46) | 6.2 (0.7-15.5) | ||
| Quadruple therapy (n=8) | 8.8 (1.7-20.2) | ||
| OS, median (range, mo) | 16.5 (0.7-156.7) | 15.8 (0.3-78.4) | 0.452 |
| 40.6 (38.2-43.0)a) | 0.014 |
IT, immunotherapy; TT, targeted therapy; SD, standard deviation; BMI, body mass index; MSKCC, Memorial Sloane Kettering Cancer Center; LN, lymph node; Tx, treatment; IL-2, interleukin 2; NA, not available; IFN-α, interferon α; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; F/U, follow-up; PFS, progression-free survival; OS, overall survival.
a)
Progression-free survival and overall survival for IT alone/IT with subsequent TT versus TT alone.