TABLE 5.
Physician-assessed response in patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) according to subgroups based on the number of previous lines of treatment, the duration of previous treatment with crizotinib and dose reduction
| Radiological tumour evaluation | Previous lines of treatment | Duration of previous crizotinib treatment# | Dose reduction¶ | |||||
| ≤2 lines (n=98) | >2 lines (n=94) | <Q1 (n=47) | Q1−Q2 (n=47) | Q2−Q3 (n=46) | ≥Q3 (n=49) | With dose reduction (n=84) | Without dose reduction (n=109) | |
| Assessed response | ||||||||
| Evaluable subjects | 72 | 76 | 36 | 31 | 35 | 43 | 74 | 75 |
| CR | 5 (6.9) | 3 (3.9) | 0 (0.0) | 4 (12.9) | 2 (5.7) | 2 (4.7) | 5 (6.8) | 3 (4.0) |
| PR | 35 (48.6) | 35 (46.1) | 13 (36.1) | 12 (38.7) | 20 (57.1) | 23 (53.5) | 36 (48.6) | 34 (45.3) |
| SD | 18 (25.0) | 15 (19.7) | 10 (27.8) | 5 (16.1) | 7 (20.0) | 10 (23.3) | 17 (23.0) | 17 (22.7) |
| PD | 10 (13.9) | 9 (11.8) | 10 (27.8) | 3 (9.7) | 3 (8.6) | 3 (7.0) | 8 (10.8) | 11 (14.7) |
| Not realised | 3 (4.2) | 13 (17.1) | 3 (8.3) | 5 (16.1) | 3 (8.6) | 5 (11.6) | 6 (8.1) | 10 (13.3) |
| Not evaluable | 1 (1.4) | 1 (1.3) | 0 (0.0) | 2 (6.5) | 0 (0.0) | 0 (0.0) | 2 (2.7) | 0 (0.0) |
| ORR | 40 (55.5) | 38 (50.0) | 13 (36.1) | 16 (51.6) | 22 (62.8) | 25 (58.2) | 41 (55.4) | 37 (49.3) |
| Treatment duration | ||||||||
| Subjects | 91 | 90 | 43 | 45 | 43 | 47 | 83 | 99 |
| Duration months | 3.8 (0.4–23.0) | 3.7 (0.4–22.4) | 2.3 (0.4–15.9) | 3.0 (0.4–23.0) | 5.1 (0.4–19.9) | 7.6 (0.9–22.2) | 4.9 (0.4–22.2) | 2.7 (0.4–23.0) |
Data are presented as n, n (%) or median (range). CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease; ORR: overall response rate. #: <Q1 means <5 months of crizotinib, Q1–Q2 means 5 to <9.2 months of crizotinib, Q2–Q3 means 9.2 to <16 months of crizotinib >Q3 means >16 months of crizotinib. ¶: dose reduction is <750 mg·day−1 of ceritinib or a temporary discontinuation in the first 6 months of treatment.