TABLE 1.
Demographic and Clinical Characteristics of Patients at Baseline
| Characteristic | Subcutaneous Group (n = 206) | Intravenous Group (n = 212) |
|---|---|---|
| Age, years | ||
| Median (range) | 61 (35-82) | 62 (29-81) |
| Distribution, No. (%) | ||
| <65 years | 133 (65) | 120 (57) |
| ≥65 to <75 years | 55 (27) | 70 (33) |
| ≥75 years | 18 (9) | 22 (10) |
| Sex, No. (%) | ||
| Female | 138 (67) | 141 (67) |
| Male | 68 (33) | 71 (33) |
| Race or ethnic group, No. (%) | ||
| Asian | 126 (61) | 129 (61) |
| White | 78 (38) | 77 (36) |
| Black or African American | 1 (0.5) | 3 (1) |
| Multiple | 0 | 1 (0.5) |
| Not reported | 1 (0.5) | 2 (0.9) |
| Body weight | ||
| Median, kg (range) | 61.8 (35-130) | 60.1 (33-150) |
| Distribution, No. (%) | ||
| <80 kg | 184 (89) | 184 (87) |
| ≥80 kg | 22 (11) | 28 (13) |
| Region of enrollment, No. (%)a | ||
| North America | 19 (9) | 30 (14) |
| South America | 11 (5) | 17 (8) |
| Europe | 38 (18) | 40 (19) |
| Asia | 126 (61) | 120 (57) |
| Oceania | 12 (6) | 5 (2) |
| ECOG PS, No. (%) | ||
| 0 | 58 (28) | 61 (29) |
| 1 | 148 (72) | 151 (71) |
| History of smoking, No. (%) | ||
| No | 141 (68) | 145 (68) |
| Yes | 65 (32) | 67 (32) |
| Median time from initial diagnosis, months (range) | 34.5 (2.8-191.3) | 33.7 (6.1-156.9) |
| Median time from metastatic diagnosis, months (range) | 32.7 (0.9-169.0) | 29.7 (0.6-142.6) |
| Histologic type, No. (%) | ||
| Adenocarcinoma | 204 (99) | 207 (98) |
| Large cell carcinoma | 1 (0.5) | 1 (0.5) |
| Squamous cell carcinoma | 1 (0.5) | 3 (1) |
| Other | 0 | 1 (0.5) |
| EGFR mutation type at random assignment, No. (%) | ||
| Exon 19 deletion | 135 (66) | 138 (65) |
| L858R | 71 (34) | 74 (35) |
| History of brain metastasis, No. (%) | ||
| Yes | 70 (34) | 72 (34) |
| No | 136 (66) | 140 (66) |
| Last therapy before random assignment, No. (%) | ||
| Osimertinib | 91 (44) | 96 (45) |
| Chemotherapy | 115 (56) | 116 (55) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; NSCLC, non–small cell lung cancer; TKI, tyrosine kinase inhibitor.
a
Russia was counted as part of Europe; Turkey and Israel were counted as part of Asia.