Table 4 Response comparison of different lorlatinib real world studies and the trial data.
Trial data (Solomon et al.) | EAP South Asia and US. Zhu V et al. [18] | EAP Germany. Frost et al. [16] | EAP France. Baldacci et al. [17] | China. Lee et al. [19] | This study | |
|---|---|---|---|---|---|---|
Total number | 229* | 76 | 37 | 208 | 22 | 38 |
Number evaluable | 215 | 64 | 14 | 191 | 22 | 31 |
mFU (months) | 7.2 | 6.8 | 16.1 | 23.3 | - | 49 |
Best Response | ||||||
Progressive disease | 34 (15.8) | 13 | - | 25 (13) | 5 (23) | 5 (16) |
Complete response | 5 (2.3) | 2 | - | 8 (4) | 8 (36) | 1 (3) |
Partial response | 115 (53.5) | 19 | - | 85 (45) | 5 (23) | 5 (16) |
Stable disease | 60 (27.9) | 30 | - | 71 (37) | 4 (18) | 20 (65) |
mDOR (95% CI, months) | NR | - | 10.4 (6.5-12.8) | 14.9 (10.1 to NR) | - | - |
ORR | 51% | 33% | 42.4% | 49% | 35.7% | 19% |
DCR | 79% | 80% | 86% | 86% | 64.3% | 84% |
mPFS (months) | NR | 9.3 | 7.1 | 9.9 | 6.2 | 16 |
mOS (months) | NR | NR | 24.7 | 32.9 | NR | 21 |
Brain metastasis | N = 9 | N = 26 | N = 160 | N = 18 | N = 21 | |
mPFS (months) | NR | 9.3 | - | - | - | - |
RR (Brain mets) | 63% | 35% | 62.5% vs 35.7% | 56% | 100% | 80% |
Cause of treatment discontinuation 1. Disease progression 2. Toxicity 3. Death 4. Investigator’s decision 5. Patient ‘s decision 6. Intercurrent disease | - | - | - | 60 (29) 28 (14) 15 (7) 7 (3) 1 (1) 1 (1) | - | 12 (32) 0 (0) 12 (32) 0 0 0 |
