Table A1.
Survival Summary
| Therapy Setting | Full Analysis Set |
Per-Protocol Set |
||
|---|---|---|---|---|
| Cy/GVAX Plus CRS-207 | Cy/GVAX | Cy/GVAX Plus CRS-207 | Cy/GVAX | |
| All patients, No. | 61 | 29 | 45 | 21 |
| Median survival, months | 6.1 | 3.9 | 9.7 | 4.6 |
| HR | 0.59 | 0.53 | ||
| One-sided log-rank P | .0172 | .0167 | ||
| Probable survival > 12 months, % | 24 | 12 | 33 | 16 |
| Difference | 12 | 16 | ||
| 95% CI | −5 to 30 | −7 to 40 | ||
| Second line | 18 | 11 | 13 | 8 |
| Median survival, months | 7.7 | 3.8 | 9.8 | 7.2 |
| HR | 0.62 | 0.51 | ||
| One-sided log-rank P | .1468 | .1148 | ||
| Probable survival > 12 months, % | 22 | 30 | 31 | 42 |
| Difference | −8 | −11 | ||
| 95% CI | −45 to 29 | −58 to 36 | ||
| ≥ Third line | 32 | 14 | 24 | 10 |
| Median survival, months | 5.7 | 3.7 | 8.3 | 4.0 |
| HR | 0.30 | 0.22 | ||
| One-sided log-rank P | < .001 | < .001 | ||
| % Probable survival > 12 months | 21 | 0 | 29 | 0 |
| Difference | 21 | 29 | ||
| 95% CI | N/A | N/A | ||
Abbreviations: Cy, cyclophosphamide; HR, hazard ratio; N/A, not applicable.