Table 2.
Myeloprotective Effects According to Age Subgroups
| ITT Population | Age <65 Years | Age ≥65 Years | |||||
|---|---|---|---|---|---|---|---|
| Trilaciclib (n=123) | Placebo (n=119) | P-value | Trilaciclib (n=66) | Placebo (n=61) | Trilaciclib (n=57) | Placebo (n=58) | |
| Mean DSN in cycle 1, days (SD)* | 0 (1.8) | 4 (5.1) | P<0.001 | 0 (1.7) | 3 (4.5) | 0 (2.1) | 5 (5.6) |
| Patients with SN, n (%)* | 14 (11.4) | 63 (52.9) | P<0.001 | 7 (10.6) | 26 (42.6) | 7 (12.3) | 37 (63.8) |
| Treatment-by-age-group interaction P=0.3765† | |||||||
| Patients with grade 3/4 decreased hemoglobin, n (%) | 25 (20.3) | 38 (31.9) | P=0.0279 | 12 (18.2) | 16 (26.2) | 13 (22.8) | 22 (37.9) |
| Treatment-by-age-group interaction P=0.6957† | |||||||
| Patients with RBC transfusions on/after week 5, n (%) | 18 (14.6) | 31 (26.1) | P=0.0252 | 8 (12.1) | 11 (18.0) | 10 (17.5) | 20 (34.5) |
| Treatment-by-age-group interaction P=0.6791† | |||||||
| Number of RBC transfusions on/after week 5, event rate (per week) | 0.015 | 0.031 | P=0.0027 | 0.011 | 0.018 | 0.019 | 0.045 |
Notes: *Primary endpoint; two-sided P-value for treatment effect. †A nonsignificant treatment-by-age-group interaction indicates that trilaciclib benefits were comparable in both age groups.
Abbreviations: DSN, duration of severe (grade 4) neutropenia; ITT, intention-to-treat; RBC, red blood cell; SD, standard deviation; SN, severe (grade 4) neutropenia.