Table 2. Analyses of PFS and OS According to Patient Characteristics.
| Characteristic | Patients, No. (%) | PFS | OS | ||||
|---|---|---|---|---|---|---|---|
| Median PFS, mo | HR (95% CI) | P value | Median OS, mo | HR (95% CI) | P value | ||
| Age, y | |||||||
| <75 | 143 (69) | 5.0 | 0.77 (0.57-1.05) | .09 | 16 | 0.66 (0.45-0.97) | .03 |
| >75 | 64 (31) | 4.7 | 1 [Reference] | 12 | 1 [Reference] | ||
| Sex | |||||||
| Male | 170 (82) | 5.0 | 0.84 (0.58-1.24) | .37 | 14.4 | 0.92 (0.60-1.49) | .74 |
| Female | 37 (18) | 4.3 | 1 [Reference] | 15.6 | 1 [Reference] | ||
| Brain metastases | |||||||
| Yes | 54 (26) | 5.3 | 0.80 (0.57-1.12) | .21 | 16.6 | 0.68 (0.42-1.04) | .08 |
| No | 153 (74) | 4.8 | 1 [Reference] | 13.5 | 1 [Reference] | ||
| Eligibility criteria | |||||||
| ECOG performance status | .03 | .01 | |||||
| 0-1 | 184 (89) | 5.1 | 0.60 (0.39-0.97) | 15.6 | 0.51 (0.31-0.89) | ||
| 2-3 | 23 (11) | 4.1 | 1 [Reference] | 7.4 | 1 [Reference] | ||
| Active metastases (criteria 1a) | |||||||
| Yes | 15 (7) | 5.1 | 1.23 (0.68-2.04) | .45 | 15.6 | 0.75 (0.32-1.50) | .47 |
| No | 192 (93) | 4.9 | 1 [Reference] | 14.7 | 1 [Reference] | ||
| Active metastases (criteria 2a) | |||||||
| Yes | 39 (19) | 4.9 | 1.01 (0.70-1.48) | .97 | 14.4 | 1.18 (0.74-1.99) | .49 |
| No | 168 (81) | 4.9 | 1 [Reference] | 15.6 | 1 [Reference] | ||
| Abnormal laboratory findings | |||||||
| Yes | 18 (9) | 4.3 | 1.27 (0.74-2.03) | .34 | 10.1 | 1.26 (0.64-2.23) | .47 |
| No | 189 (91) | 5.0 | 1 [Reference] | 15.4 | 1 [Reference] | ||
| Comorbidity | |||||||
| Yes | 40 (19) | 4.8 | 1.16 (0.80-1.65) | .41 | 13.5 | 1.27 (0.80-1.94) | .30 |
| No | 167 (81) | 4.9 | 1 [Reference] | 14.7 | 1 [Reference] | ||
Abbreviations: ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; OS, overall survival; PFS, progression-free survival.
a
In criteria 1, those with untreated asymptomatic brain metastases were considered trial-eligible, while in criteria 2, they were considered trial-ineligible.