Table 1.
Demographics and baseline disease characteristics
| Category | Part 1 |
Part 2 |
|||
|---|---|---|---|---|---|
| Cohort 1 (E/P+trilaciclib 200 mg/m2) (N = 10) | Cohort 2 (E/P+trilaciclib 240 mg/m2) (N = 9) | E/P+placebo (N = 38) | E/P+trilaciclib 240 mg/m2 (N = 39) | Total (N = 77) | |
| Age (years) | |||||
| Mean (SD) | 70 (11.6) | 62 (8.6) | 65 (9.5) | 65 (8.4) | 65 (8.9) |
| Median | 74 | 61 | 66 | 64 | 66 |
| Min, Max | 45, 80 | 51, 76 | 39, 86 | 49, 82 | 39, 86 |
| Age group, n (%) | |||||
| <65 | 2 (20.0%) | 5 (55.6%) | 17 (44.7%) | 20 (51.3%) | 37 (48.1%) |
| ≥65 | 8 (80.0%) | 4 (44.4%) | 21 (55.3%) | 19 (48.7%) | 40 (51.9%) |
| Sex, n (%) | |||||
| Male | 4 (40.0%) | 7 (77.8%) | 27 (71.1%) | 27 (69.2%) | 54 (70.1%) |
| Female | 6 (60.0%) | 2 (22.2%) | 11 (28.9%) | 12 (30.8%) | 23 (29.9%) |
| Body surface area (m2) | |||||
| Mean (SD) | 1.76 (0.165) | 2.06 (0.266) | 1.91 (0.210) | 1.89 (0.223) | 1.90 (0.216) |
| ECOG score, n (%) | |||||
| 0–1 | NA | NA | 35 (92.1%) | 35 (89.7%) | 70 (90.9%) |
| 2 | NA | NA | 3 (7.9%)a | 4 (10.3%) | 7 (9.1%) |
| Weight loss in 6 months before randomizationb | |||||
| Yes | 7 (70.0%) | 3 (33.3%) | 14 (36.8%) | 16 (41.0%) | 30 (39.0%) |
| >5% | 6 (85.7%) | 0 | 7 (50.0%) | 10 (62.5%) | 17 (56.7%) |
| ≤5% | 1 (14.3%) | 3 (100.0%) | 7 (50.0%) | 6 (37.5%) | 13 (43.3%) |
| Brain metastases, n (%)c | |||||
| Present | 2 (20.0%) | 1 (11.1%) | 8 (21.1%) | 5 (12.8%) | 13 (16.9%) |
| Baseline LDH, n (%) | |||||
| ≤ULN | 1 (10.0%) | 3 (33.3%) | 18 (47.4%) | 16 (41.0%) | 34 (44.2%) |
| >ULN | 9 (90.0%) | 6 (66.7%) | 17 (44.7%) | 21 (53.8%) | 38 (49.4%) |
| Missing | 0 | 0 | 3 (7.9%) | 2 (5.1%) | 5 (6.5%) |
| Any prior radiation therapy, n (%) | |||||
| Yes | 2 (20.0%) | 0 | 4 (10.5%) | 3 (7.7%) | 7 (9.1%) |
| Smoking status, n (%) | |||||
| Never smoked | 0 | 0 | 0 | 0 | 0 |
| Former smokers | 8 (80.0%) | 7 (77.8%) | 25 (65.8%) | 25 (64.1%) | 50 (64.9%) |
| Current smokers | 2 (20.0%) | 2 (22.2%) | 12 (31.6%) | 14 (35.9%) | 26 (33.8%) |
| Missing | 0 | 0 | 1 (2.6%) | 0 | 1 (1.3%) |
Due to data discrepancies, one patient in the placebo group was labeled as having an ECOG performance score of 2 at randomization but had an ECOG performance score of 0 on Cycle 1 Day 1.
Percentages are based on the number of patients with weight loss.
Patients with brain metastases at baseline could enroll if they were asymptomatic, did not require urgent treatment, and were off all steroids, i.e., did not require treatment prior to enrollment.
E/P, standard of care (etoposide + carboplatin); SD, standard deviation; Min, minimum; Max, maximum; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; ULN, upper limit of normal; mg, milligram; m2, meter squared; N, number of patients.