Table 2. Weighted linear regression analyses of correlations between surrogate end points and OS.
| No. of patients (paired arms) | Intercept | Slope | r2 (95% CI) | P-value | |
|---|---|---|---|---|---|
|
Median OS ratio
vs
median PFS ratio | |||||
| All trials | 2148 (19) | 0.032 | 0.624 | 0.66 (0.32–0.85) | <0.001 |
| Trials with gemcitabine-containing therapies | 1933 (15) | 0.050 | 0.623 | 0.78 (0.46–0.92) | <0.001 |
| Trials with targeted agents | 953 (7) | 0.112 | 0.328 | 0.78 (0.14–0.96) | 0.004 |
|
Median OS ratio
vs
RR ratio | |||||
| All trials | 2040 (17) | 0.013 | 0.282 | 0.29 (0.01–0.65) | 0.021 |
| Trials with gemcitabine-containing therapies | 1880 (14) | 0.020 | 0.268 | 0.39 (0.02–0.75) | 0.013 |
| Trials with targeted agents | 953 (7) | 0.119 | 0.155 | 0.43 (0.03–0.89) | 0.090 |
|
Median OS ratio
vs
DCR ratio | |||||
| All trials | 1989 (17) | −0.038 | 0.227 | 0.34 (0.02–0.69) | 0.011 |
| Trials with gemcitabine-containing therapies | 1832 (14) | −0.037 | 0.293 | 0.60 (0.17–0.86) | <0.001 |
| Trials with targeted agents | 953 (7) | 0.094 | 0.312 | 0.44 (0.03–0.89) | 0.086 |
|
Sensitivity analyses between PFS and OS | |||||
| Trials reporting median PFS | 1984 (16) | 0.026 | 0.596 | 0.62 (0.23–0.85) | <0.0001 |
| Trials reporting both HRs for PFS and OSa | 1287 (9) | −0.075 | 0.528 | 0.63 (0.07–0.91) | 0.006 |
| Trials with total sample size ⩾100 enroled patients | 1392 (8) | 0.037 | 0.597 | 0.60 (0.02–0.92) | 0.015 |
| Not early closed trials | 1970 (17) | 0.042 | 0.630 | 0.64 (0.27–0.86) | <0.001 |
Abbreviations: CI=confidence interval; DCR=disease control rate; HR=hazard ratio; OS=overall survival; PFS=progression-free survival; RR=response rate; r2=coefficient of determination.
The correlation between PFS HRs and OS HRs.