Table 4. Summary of the clinical trials reporting the efficacy results with crizotinib in ALK positive patients.
pI (12,42) |
pII (43,44) |
pIII (45) |
|||
---|---|---|---|---|---|
crizotinib | crizotinib | crizotinib | Chemotherapy (PEM+DOC) | ||
n | 82 [119] | 135 [261] | 173 | 174 | |
Overall RR (%) | 61% | 51% | 65% | 20% (PEM29%; DOC6.9%) | P<0.001 |
Duration of response (median, weeks) | 48 | 42.9 | |||
Duration of treatmente (median, weeks or cycles) | 32 w | 22 w | 11 cycles | 4 cycles | |
6 months PFS | 72% | NR | NR | NR | |
mPFS (median, months) | NR | 8.1 (6.8-9.7) | 7.7 | 3 (PEM4.2; DOC2.6) | HR 0.49 (0.37-0.64), P<0.0001 |
mOS | NR | NR | 20.3 | 22.8 | HR 1.02 (0.68-1.5), P=0.5394 |
OS rates 6 m, 12 m | NR | 90%, 81% | NR | NR |
DOC, docetaxel; m, months; m-PFS, median progression-free survival; mOS, median overall survival; n, number of patients included; PEM, pemetrexed; NR, no reported; RR, response rate; w, weeks