Table 3.
PFS, OS, and ORR in the ITT Population by Dose Modification Group
| Median PFS, Months (95% CI) | Median OS, Months (95% CI) | ORR, n (%) [95% CI]a | ||||
|---|---|---|---|---|---|---|
| Pazopanib (n = 554) | Sunitinib (n = 548) | Pazopanib (n = 554) | Sunitinib (n = 548) | Pazopanib (n = 554) | Sunitinib (n = 548) | |
| Dose Reduction(s) | ||||||
| None | 7.3 (5.3-8.3) | 5.5 (4.3-8.1) | 21.7 (18.1-24.7) | 18.1 (14.1-23.4) | 67 (22) [17.1-26.4] | 44 (16) [11.9-20.7] |
| Any | 12.5 (10.9-15.0) | 13.8 (11.1-16.4) | 36.8 (33.1-NE) | 38.0 (31.5-NE) | 104 (42) [36.1-48.4] | 93 (34) [28.0-39.1] |
| None versus any | HR, 1.693 (95% CI, 1.365-2.099); P < .0001 | HR, 1.872 (95% CI, 1.484-2.361); P < .0001 | HR, 2.095 (95% CI, 1.634-2.685); P < .0001 | HR, 2.138 (95% CI, 1.663-2.749); P < .0001 | Difference: 20.5% (95% CI, 12.8%-28.2%); P < .0001 | Difference: 17.3% (95% CI, 10.2%-24.4%); P < .0001 |
| 1 | 11.1 (8.3-13.5) | 11.1 (10.2-13.8) | 33.1 (27.2-NE) | 30.3 (24.7-NE) | 49 (33) [25.7-41.0] | 50 (31) [23.9-38.2] |
| ≥2 | 16.4 (11.1-18.6) | 16.5 (11.5-19.3) | NR (NE-NE) | NR (34.9-NE) | 55 (56) [45.8-65.3] | 43 (37) [28.3-45.9] |
| Dose Interruption(s) ≥7 Days | ||||||
| None | 8.2 (5.5-8.3) | 5.6 (5.4-8.2) | 21.7 (17.8-26.0) | 18.1 (14.2-23.2) | 72 (23) [18.5-27.8] | 46 (16) [12.1-20.8] |
| Any | 12.6 (9.9-16.4) | 13.8 (11.1-16.6) | NR (31.6-NE) | NR (32.1-NE) | 99 (41) [34.6-46.9] | 91 (34) [28.4-39.8] |
| None versus any | HR: 1.648 (95% CI, 1.329-2.043); P < .0001 | HR: 1.923 (95% CI, 1.529-2.418); P < .0001 | HR: 1.959 (95% CI, 1.528-2.511); P < .0001 | HR: 2.264 (95% CI, 1.762-2.909); P < .0001 | Difference: 17.6% (95% CI, 9.8%-25.3%); P < .0001 | Difference: 17.7% (95% CI, 10.5%-24.8%); P < .0001 |
| 1 | 8.3 (6.0-11.0) | 11.0 (8.2-14.0) | 31.6 (26.5-NE) | 30.5 (23.7-NE) | 42 (30) [22.8-38.1] | 40 (30) [21.9-37.3] |
| ≥2 | 16.7 (13.7-19.4) | 16.6 (13.6-19.6) | NR (36.8-NE) | NR (34.9-NE) | 57 (54) [44.8-63.8] | 51 (39) [30.3-46.9] |
Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intention to treat; NE = not estimable; NR = not reached; OS = overall survival; ORR = objective response rate; PFS = progression-free survival.
a
Percentage was calculated using the number of patients in the corresponding dose modification group (see Supplemental Table 1 in the online version) as the denominator.