Table 3.
Survival and incidence of any-grade CIN in FTD/TPI-treated patients who experienced treatment delays in RECOURSEa
| n (%)b | Median OS, months | OS HR versus placebo (95% CI) | OS HR versus no delay (95% CI) | Median PFS, months | PFS HR versus placebo (95% CI) | PFS HR versus no delay (95% CI) | Patients with CIN, n (%)c | CIN RRd (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|
| ≥8 days (n = 533) | 108 (20.3) | 14.4 | 0.31 (0.23–0.40)* | 0.18 (0.13–0.25)* | 5.8 | 0.16 (0.12–0.22)* | 0.16 (0.12–0.22)* | 96 (88.9) | 1.88 (1.64–2.16)* |
| ≥4 and <8 days (n = 533) | 137 (25.7) | 9.7 | 0.51 (0.41–0.64)* | 0.31 (0.23–0.40)* | 3.7 | 0.33 (0.26–0.41)* | 0.33 (0.26–0.42)* | 121 (88.3) | 1.87 (1.63–2.14)* |
| None (n = 533) | 288 (54.0) | 4.9 | 1.21 (1.01–1.44)** | — | 1.8 | 0.94 (0.78–1.12) | — | 136 (47.2) | — |
| Placebo (n = 265)e | 265 (100) | 5.3 | — | — | 1.7 | — | — | 2 (0.8) | — |
CI, confidence interval; CIN, chemotherapy-induced neutropenia; FTD, trifluridine; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; RR, relative risk; TPI, tipiracil.
Across all cycles, 289 patients (54.2%) in the FTD/TPI group had adverse events that resulted in interruptions in dosing, dose delays, and/or dose reductions compared with 36 patients (13.6%) in the placebo group.
Percentage of as-treated population in the specific treatment group.
Treatment delays may or may not be related to a specific neutropenic event.
Relative risk versus no delay.
Includes 14 placebo patients (5.3%) who experienced some cycle delay of ≥4 days.
Indicates significant (P < 0.05) improvement in survival for the extent of the dose delay group versus the placebo group.
Indicates significant (P < 0.05) improvement in survival for the placebo group versus the extent of the dose delay group.