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. 2023 Jan 9;12:1036906. doi: 10.3389/fonc.2022.1036906

Table 1.

Clinical characteristics and treatment exposure of patients.

Total (n=946) biosimilar group (n=551) reference group (n=395) P
Sex
Male 533 (56.34%) 305 (55.35%) 228 (57.72%) 0.469
Female 413 (43.66%) 246 (44.65%) 167 (42.48%)
Age (years)
≥60 524 (55.39%) 303 (54.99%) 221 (55.95%) 0.770
<60 422 (44.61%) 248 (45.01%) 174 (44.05%)
Pathological type
adenocarcinoma 932 (98.52%) 543 (98.55%) 389 (98.48%) 0.933
Nonadenocarcinoma 14 (1.48%) 8 (1.45%) 6 (1.52%)
Stage of cancer
IIIB 54 (5.71%) 32 (5.81%) 22 (5.57%) 0.876
IV 892 (94.29%) 519 (94.19%) 373 (94.43%)
Gene mutation type
No genetic mutation 448 (48.41%) 247 (44.83%) 201 (50.89%) 0.066
EGFR exon 18 point mutation 4 (0.42%) 2 (0.36%) 2 (0.51%) 0.738
EGFR exon 19 deletion 162 (17.12%) 101 (18.33%) 61 (15.44%) 0.245
EGFR exon 20 insertion 24 (2.54%) 15 (2.72%) 9 (2.28%) 0.669
EGFR the L858R point mutation 209 (21.04%) 125 (22.69%) 84 (21.27%) 0.604
EGFR double mutation 10 (1.06%) 4 (0.73%) 6 (1.52%) 0.335
ALK rearrangement 26 (2.75%) 14 (2.54%) 12 (3.04%) 0.645
ROS1 rearrangement 8 (0.85%) 6 (1.09%) 2 (0.51%) 0.480
RET rearrangement 7 (0.74%) 6 (1.09%) 1 (0.25%) 0.249
BRAF mutation 6 (0.63%) 4 (0.73%) 2 (0.51%) 1.000
HER2 mutation 9 (0.95%) 6 (1.09%) 3 (0.76%) 0.742
KRAS mutation 26 (2.75%) 17 (3.09%) 9 (2.28%) 0.454
MET aberration 7 (0.74%) 4 (0.73%) 3 (0.76%) 1.000
with brain metastases
Yes 209 (21.88%) 120 (21.78%) 89 (22.03%) 0.783
No 737 (78.12%) 431 (78.22%) 306 (77.97%)
with liver metastases
Yes 136 (14.38%) 72 (13.07%) 64 (16.20%) 0.175
no 810 (85.62%) 479 (86.93%) 331 (83.80%)
with a history of hypertension
yes 136 (14.38%) 81 (14.70%) 55 (13.92%) 0.737
no 810 (85.62%) 470 (85.30%) 340 (86.08%)
the mean duration of exposure (m) 7.54 6.98 8.31 0.121
the mean number of doses 7.64 7.53 7.81 0.364
the mean dose intensity (mg/kg) 8.07 8.37 7.64 0.823