Table 3.
Association between progression-free survival (PFS)/overall survival (OS)/disease control rate (DCR) and adverse events with consideration of a-priori covariates in trifluridine/tipiracil.
| TAS | |||
|---|---|---|---|
| Cox-Regression with Consideration of A-Priori Covariates | Weightloss/Anorexia | ||
| OS | PFS | DCR | |
| HR (95% CI); p-Value | HR (95% CI); p-Value | OR (95% CI); p-Value | |
| Available Cases | n = 48 | n = 45 | n = 45 |
| Yes vs. No | 5.595 (1.286–24.344); 0.022 | 0.987 (0.259–3.764); 0.985 | 2.982 (0.425–20.906); 0.271 |
| Age | |||
| 1.004 (0.962–1.049); 0.844 | 0.981 (0.950–1.014); 0.251 | 1.021 (0.957–1.090); 0.527 | |
| Sex | |||
| Female vs. Male | 2.437 (0.695–8.546); 0.164 | 1.319 (0.540–3.223); 0.544 | 0.674 (0.148–3.065); 0.610 |
| Ras-Gen-Status | |||
| Wildtyp vs. Mutant | 1.457 (0.417–5.089); 0.555 | 1.192 (0.393–3.608); 0.757 | 1.595 (0.380–6.702); 0.524 |
| Localization | |||
| Right vs. Left | 0.920 (0.185–4.565); 0.918 | 0.920 (0.185–4.565); 0.918 | 3.547 (0.322–39.086); 0.301 |
| Constant | |||
| 0.010 (-); 0.136 | |||
| Cox-Regression with Consideration of A-Priori Covariates | Neutropenia | ||
| OS | PFS | DCR | |
| HR (95% CI); p-Value | HR (95% CI); p-Value | OR (95% CI); p-Value | |
| Available Cases | n = 48 | n = 45 | n = 45 |
| Yes vs. No | 0.193 (0.037–1.020); 0.053 | 0.345 (0.134–0.893); 0.028 | 2.250 (0.425–11.918); 0.340 |
| Age | |||
| 1.018 (0.970–1.069); 0.463 | 0.977 (0.942–1.012); 0.189 | 1.007 (0.947–1.070); 0.831 | |
| Sex | |||
| Female vs. Male | 1.720 (0.579–5.107); 0.329 | 1.537 (0.662–3.566); 0.317 | 0.438 (0.108–1.784); 0.249 |
| Ras-Gen-Status | |||
| Wildtyp vs. Mutant | 1.151 (0.340–3.890); 0.821 | 1.131 (0.496–2.578); 0.770 | 2.143 (0.467–9.827); 0.326 |
| Localization | |||
| Right vs. Left | 1.408 (0.326–6.076); 0.646 | 1.212 (0.434–3.383); 0.714 | 4.826 (0.439–53.008); 0.198 |
| Cox-Regression with Consideration of A-Priori Covariates | Leukopenia | ||
| OS | PFS | DCR | |
| HR (95% CI); p-Value | HR (95% CI); p-Value | OR (95% CI); p-Value | |
| Available Cases | n = 48 | n = 45 | n = 45 |
| Yes vs. No | 0.138 (0.017–1.095); 0.061 | 0.194 (0.066–0.575); 0.003 | 4.634 (0.847–25.355); 0.077 |
| Age | |||
| 1.010 (0.966–1.056); 0.666 | 0.971 (0.938–1.005); 0.098 | 1.007 (0.944–1.073); 0.837 | |
| Sex | |||
| Female vs. Male | 1.831 (0.620–5.413); 0.274 | 1.663 (0.713–3.878); 0.239 | 0.384 (0.089–1.667); 0.201 |
| Ras-Gen-Status | |||
| Wildtyp vs. Mutant | 1.304 (0.399–4.267); 0.661 | 1.401 (0.639–3.075); 0.401 | 2.550 (0.534–12.184); 0.241 |
| Localization | |||
| Right vs. Left | 1.221 (0.288–5.173); 0.787 | 0.858 (0.320–2.296); 0.760 | 7.940 (0.583–108.078); 0.120 |
OS overall survival, PFS progression free survival, DCR disease control rate, HR hazard ratio, OR odds ratio.