Table 2.
Summary of Efficacy Measures by Intention-to-Treat Group
| Outcome | SOC + TNFerade (n = 187) |
SOC (n = 90) |
HR* | 95% CI | P * | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. | % | 95% CI | No. | % | 95% CI | ||||
| Overall survival, months† | 0.90 | 0.66 to 1.22 | .26 | ||||||
| Median | 10.0 | 8.8 to 11.6 | 10.0 | 7.6 to 11.2 | |||||
| 12-month survival rate | 41.0 | 33.5 to 48.3 | 36.7 | 26.3 to 47.1 | |||||
| 18-month survival rate | 23.1 | 16.9 to 29.9 | 17.7 | 10.1 to 27.0 | |||||
| 24-month survival rate | 11.3 | 0.07 to 17.1 | 10.3 | 0.05 to 18.6 | |||||
| Progression-free survival, months | 0.96 | 0.69 to 1.32 | .51 | ||||||
| Median | 6.8 | 5.5 to 8.8 | 7.0 | 4.6 to 9.2 | |||||
| Time to radiologic progression, months | 1.07 | 0.71 to 1.62 | .82 | ||||||
| Median | 11.6 | 9.6 to 14.1 | 10.8 | 7.3 to 17.2 | |||||
| Level of radiologic response‡ | 97 | 50 | .74 | ||||||
| Complete | 0 | 0 | |||||||
| Partial | 8 | 8.2 | 6 | 12.0 | |||||
| Stable disease | 72 | 74.2 | 37 | 74.0 | |||||
| Progressive disease | 17 | 17.5 | 7 | 14.0 | |||||
Abbreviations: HR, hazard ratio; SOC, standard of care.
*
According to the protocol, the comparison of the treatment groups should be stratified by site and Karnofsky performance status (KPS; ≥ 80% and < 80%). A log-rank test was used to compare the two treatments stratified by site and KPS, and the HR was estimated from a Cox regression model adjusting for site and KPS status.
†
Median and 12-month, 18-month, and 24-month survival rates were estimated by using the Kaplan-Meier method.
‡
Radiologic response was evaluated for a subgroup of 147 patients (97 from the SOC + TNFerade arm and 50 from the SOC arm) by an independent central reading laboratory that was blinded to treatment assignment.