Table 1.
Baseline characteristics (intent-to-treat population)
| Parameter | CT-P16 [N = 342] | EU-bevacizumab [N = 347] | Overall [N = 689] |
|---|---|---|---|
| Median age, years (range) | 62 (32–82) | 62 (26–82) | 62 (26–82) |
| Female | 119 (34.8) | 125 (36.0) | 244 (35.4) |
| Race | |||
| American Indian or Alaska Native | 9 (2.6) | 9 (2.6) | 18 (2.6) |
| Asian | 59 (17.3) | 55 (15.9) | 114 (16.5) |
| Black or African American | 2 (0.6) | 1 (0.3) | 3 (0.4) |
| White | 264 (77.2) | 264 (76.1) | 528 (76.6) |
| Other | 8 (2.3) | 18 (5.2) | 26 (3.8) |
| Median weight, kg (range) | 67 (36–131) | 69 (35–126) | 68 (35–131) |
| ECOG PS | |||
| Grade 0 | 105 (30.7) | 110 (31.7) | 215 (31.2) |
| Grade 1 | 237 (69.3) | 237 (68.3) | 474 (68.8) |
| Disease status | |||
| Recurrent | 25 (7.3) | 33 (9.5) | 58 (8.4) |
| Metastatic | 317 (92.7) | 314 (90.5) | 631 (91.6) |
| Final pathological diagnosis | |||
| Adenocarcinoma | 336 (98.2) | 340 (98.0) | 676 (98.1) |
| Large cell carcinoma | 3 (0.9) | 2 (0.6) | 5 (0.7) |
| NSCC NOS | 1 (0.3) | 1 (0.3) | 2 (0.3) |
| Adenosquamous carcinoma | 2 (0.6) | 2 (0.6) | 4 (0.6) |
| Othera | 0 | 2 (0.6) | 2 (0.3) |
| Clinical stage | |||
| IIIBb | 0 | 1 (0.3) | 1 (0.1) |
| IVA | 147 (43.0) | 164 (47.3) | 311 (45.1) |
| IVB | 170 (49.7) | 149 (42.9) | 319 (46.3) |
| Recurrent | 25 (7.3) | 33 (9.5) | 58 (8.4) |
| Prior treatment | |||
| Surgery | 27 (7.9) | 37 (10.7) | 64 (9.3) |
| Radiotherapy | 41 (12.0) | 42 (12.1) | 83 (12.0) |
| Anticancer systemic therapyc | 6 (1.8) | 10 (2.9) | 16 (2.3) |
Data are expressed as n (%) unless otherwise specified
ECOG PS Eastern Cooperative Oncology Group performance status, EU-bevacizumab European Union-approved reference bevacizumab, NSCC NOS non-small cell carcinoma not otherwise specified
aTwo patients in the EU-bevacizumab group had signet ring cell carcinoma
bOne patient in the EU-bevacizumab group was enrolled as stage IIIB adenocarcinoma and was excluded from the per-protocol population due to violation of inclusion criterion
cCytotoxic chemotherapy was the only authorized prior anticancer systemic therapy, of which cisplatin was the most frequently reported (CT-P16: n = 4 [1.2%]; EU-bevacizumab: n = 6 [1.7%])