Table 3.
Subgroup analysis of ORR and DCR between and within biosimilar and reference groups.
| ORR(%) | DCR(%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Variable | biosimilar group | p1 | reference group | p2 | p3 | biosimilar group | p1 | reference group | p2 | p3 |
| Sex | ||||||||||
| male (n=533) | 29.18% | 0.852 | 31.58% | 0.728 | 0.551 | 88.52% | 0.419 | 85.09% | 0.115 | 0.244 |
| female (n=413) | 28.46% | 29.94% | 0.744 | 90.65% | 90.42% | 0.937 | ||||
| Age (years) | ||||||||||
| ≥60 (n=524) | 27.72% | 0.516 | 30.77% | 0.955 | 0.448 | 88.78% | 0.557 | 88.69% | 0.365 | 0.974 |
| <60 (n=422) | 30.24% | 31.03% | 0.862 | 90.32% | 85.63% | 0.954 | ||||
| Pathological type | ||||||||||
| adenocarcinoma (n=932) | 28.55% | 0.349 | 31.11% | 0.753 | 0.399 | 89.32% | 1.000 | 87.66% | 0.169 | 0.432 |
| nonadenocarcinoma (n=14) | 50.00% | 16.67% | 0.301 | 100.00% | 66.67% | 0.165 | ||||
| Stage of cancer | ||||||||||
| IIIB (n=54) | 34.38% | 0.478 | 36.36% | 0.567 | 0.880 | 87.50% | 0.938 | 90.91% | 0.851 | 1.000 |
| IV (n=892) | 28.52% | 30.56% | 0.508 | 89.60% | 87.13% | 0.254 | ||||
| Number of treatment lines | ||||||||||
| 1 (n=506) | 37.29% | 0.000* | 35.96% | 0.080 | 0.760 | 93.07% | 0.009* | 93.10% | 0.002* | 0.988 |
| 2 (n=242) | 19.72% | 26.00% | 0.248 | 85.92% | 82.00% | 0.410 | ||||
| ≥3 (n=198) | 16.98% | 25.00% | 0.165 | 83.96% | 80.43% | 0.516 | ||||
| Combined with radiotherapy | ||||||||||
| with (n=103) | 34.55% | 0.326 | 47.92% | 0.006* | 0.168 | 90.91% | 0.715 | 95.83% | 0.059 | 0.445 |
| without (n=843) | 28.23% | 28.53% | 0.923 | 89.31% | 86.17% | 0.166 | ||||
| Combined treatment regimens | ||||||||||
| combined with chemotherapy (n=690) | 27.12% | 0.001* | 27.38% | 0.003* | 0.939 | 88.77% | 0.068 | 87.38% | 0.387 | 0.575 |
| combined with another targeted therapy (n=40) | 33.33% | 50.00% | 0.602 | 94.44% | 75.00% | 0.277 | ||||
| combined with immunotherapy (n=8) | 0.00% | 50.00% | 0.250 | 50.00% | 50.00% | 1.000 | ||||
| combined with chemotherapy and another targeted therapy (n=71) | 52.94% | 65.00% | 0.357 | 92.16% | 90.00% | 1.000 | ||||
| combined with chemotherapy and immunotherapy (n=137) | 22.58% | 38.64% | 0.048* | 91.40% | 88.64% | 0.756 | ||||
| Combined chemotherapy regimens (if combined) | ||||||||||
| combined with pemetrexed (n=26) | 10.00% | 0.358 | 12.50% | 0.609 | 1.000 | 70.00% | 0.180 | 81.25% | 0.148 | 0.508 |
| combined with taxane (n=46) | 16.67% | 25.00% | 0.698 | 86.67% | 68.75% | 0.241 | ||||
| combined with gemcitabine (n=9) | 25.00% | 40.00% | 1.000 | 75.00% | 80.00% | 1.000 | ||||
| combined with pemetrexed–platinum (n=474) | 29.84% | 27.78% | 0.621 | 90.31% | 89.35% | 0.731 | ||||
| combined with taxane–platinum (n=95) | 24.14% | 32.43% | 0.377 | 89.66% | 89.19% | 0.942 | ||||
| Dose intensity | ||||||||||
| low-dose (n ≤ 7.5mg/kg) (n=461) | 33.19% | 0.061 | 29.79% | 0.567 | 0.432 | 92.48% | 0.055 | 88.09% | 0.590 | 0.112 |
| high-dose (7.5mg/kg<n ≤ 15.0mg/kg) (n=485) | 25.85% | 32.50% | 0.125 | 87.38% | 86.25% | 0.727 | ||||
| Gene mutation type | ||||||||||
| No genetic mutation (n=448) | 26.32% | 0.196 | 32.84% | 0.165 | 0.131 | 87.45% | 0.169 | 90.55% | 0.190 | 0.225 |
| EGFR exon 18 point mutation (n=4) | 100.00% | 0.00% | 0.333 | 100.00% | 100.00% | NA | ||||
| EGFR exon 19 deletion (n=162) | 23.76% | 24.59% | 0.905 | 84.16% | 88.52% | 0.440 | ||||
| EGFR exon 20 insertion (n=24) | 46.67% | 22.22% | 0.389 | 93.33% | 66.67% | 0.130 | ||||
| EGFR the L858R point mutation (n=209) | 35.20% | 29.76% | 0.412 | 90.20% | 79.38% | 0.057 | ||||
| EGFR double mutation (n=10) | 50.00% | 0.00% | 0.133 | 100.00% | 83.33% | 1.000 | ||||
| ALK rearrangement (n=26) | 28.57% | 41.67% | 0.683 | 100.00% | 91.67% | 0.462 | ||||
| ROS1 rearrangement (n=8) | 33.33% | 100.00% | 0.429 | 83.33% | 100.00% | 1.000 | ||||
| RET rearrangement (n=7) | 33.33% | 100.00% | 0.429 | 100.00% | 100.00% | NA | ||||
| BRAF mutation (n=6) | 0.00% | 0.00% | NA | 100.00% | 100.00% | NA | ||||
| HER2 mutation (n=9) | 33.33% | 66.67% | 0.524 | 66.67% | 100.00% | 0.500 | ||||
| KRAS mutation (n=26) | 29.41% | 44.44% | 0.667 | 94.12% | 100.00% | 1.000 | ||||
| MET aberration (n=7) | 0.00% | 0.00% | NA | 100.00% | 100.00% | NA | ||||
| Brain metastases | ||||||||||
| with (n=209) | 26.67% | 0.549 | 23.60% | 0.091 | 0.614 | 88.33% | 0.645 | 79.78% | 0.015* | 0.089 |
| without (n=737) | 29.47% | 33.01% | 0.306 | 89.79% | 89.54% | 0.913 | ||||
| Liver metastases | ||||||||||
| with (n=136) | 23.61% | 0.292 | 28.13% | 0.601 | 0.548 | 86.11% | 0.319 | 87.50% | 0.967 | 0.926 |
| without (n=810) | 29.65% | 31.42% | 0.589 | 89.98% | 87.31% | 0.235 | ||||
| A history of hypertension | ||||||||||
| with (n=136) | 30.86% | 0.666 | 40.00% | 0.115 | 0.272 | 91.36% | 0.550 | 90.91% | 0.391 | 0.928 |
| without (n=810) | 28.51% | 29.41% | 0.780 | 89.15% | 86.76% | 0.300 | ||||
*: p<0.05; ORR, overall/objective response rate; DCR, disease control rate;p1, hypothesis testing parameters within the biosimilar group;p2, hypothesis testing parameters within the referrence group;p3, hypothesis testing parameters between the biosimilar group and the reference group