Table 2.
Summary of Key Efficacy End Points
| End Point | Treatment Arm |
Analysis |
||
|---|---|---|---|---|
| Everolimus Then Sunitinib (n = 238) | Sunitinib Then Everolimus (n = 233) | HR | 95% CI | |
| First-line PFS, months* | 1.4 | 1.2 to 1.8† | ||
| Median | 7.9 | 10.7 | ||
| Range | 5.6-8.2 | 8.2-11.5 | ||
| PFS by MSKCC prognosis | ||||
| Favorable | 1.2 | 0.8 to 1.8 | ||
| Median | 11.1 | 13.4 | ||
| Range | 8.3-15.9 | 11.0-18.2 | ||
| Intermediate | 1.5 | 1.1 to 2.0 | ||
| Median | 5.7 | 8.2 | ||
| Range | 5.1-8.1 | 7.4-11.2 | ||
| Poor | 1.7 | 1.0 to 3.1 | ||
| Median | 2.6 | 3.0 | ||
| Range | 1.4-4.2 | 2.0-8.1 | ||
| PFS by histology | ||||
| Clear cell | 1.4 | 1.1 to 1.8 | ||
| Median | 8.1 | 10.8 | ||
| Range | 5.8-8.8 | 8.3-12.3 | ||
| Non–clear cell | 1.5 | 0.9 to 2.8 | ||
| Median | 5.1 | 7.2 | ||
| Range | 2.6-7.9 | 5.4-13.8 | ||
| Combined first-line and second-line PFS | 1.3 | 0.9 to 1.7 | ||
| Median | 21.1 | 25.8 | ||
| Range | 15.0-25.9 | 16.0-NA | ||
| First-line best response | ||||
| Complete response | ||||
| No. | 1 | 3 | ||
| % | < 1 | 1 | ||
| Partial response | ||||
| No. | 18 | 59 | ||
| % | 8 | 25 | ||
| Stable disease | ||||
| No. | 137 | 121 | ||
| % | 58 | 52 | ||
| Progression | ||||
| No. | 49 | 33 | ||
| % | 21 | 14 | ||
| Nonevaluable | ||||
| No. | 33 | 17 | ||
| % | 14 | 7 | ||
Abbreviations: HR, hazard ratio; MSKCC, Memorial Sloan-Kettering Cancer Center; NA, not available; PFS, progression-free survival.
*
Bayesian posterior probabilities for first-line PFS: Pr (HR ≤ 1.1 | data) = 0.009; Pr (HR ≤ 1.27 | data) = 0.146I.
†
80% CI, 1.24 to 1.74.