Table 2. Participants characteristics of included randomized controlled trials.
| Author, yr, page (study name; NCT no.) | Group | Age, yr, median (range)* | Male, % | Current smoking,% | Never smoked,% | Brain or CNS metastases, % | ECOG0, % | ECOG 1, % | ECOG2, % | Adenocarcinoma, % |
|---|---|---|---|---|---|---|---|---|---|---|
| Treatment naive | ||||||||||
| Zhou 2019[29] (ALESIA; NCT02838420) | Crizotinib | 49 (IQR 41–59) | 55 | 5 | 73 | 37 | 98** | 2 | 97 | |
| Alectinib | 51 (IQR 43–59) | 51 | 3 | 67 | 35 | 97** | 3 | 94 | ||
| Wu 2018[28] (PROFILE 1029; NCT01639001) | Chemotherapy | 50 (23–69) | 42 | 9 | 70 | 31 | 96** | 4 | 98 | |
| Crizotinib | 48 (24–67) | 48 | 7 | 75 | 20 | 96** | 4 | 96 | ||
| Camidge 2018[25] (ALTA-1L; NCT02737501) | Crizotinib | 60 (29–89) | 41 | 5 | 54 | 30 | 96** | 4 | 99 | |
| Brigatinib | 58 (27–86) | 50 | 3 | 61 | 29 | 96** | 4 | 92 | ||
| Soria 2017, p. 917 (ASCEND-4; NCT01828099) | Chemotherapy | 54.0 (22–80) | 39 | 8 | 65 | 33 | 37† | 56† | 6† | 98 |
| Ceritinib | 55.0 (22–81) | 46 | 8 | 57 | 31 | 37 | 57 | 7 | 95 | |
| Peters 2017[5] (ALEX; NCT02075840) | Crizotinib | 54.0 (18–91) | 42 | 3 | 65 | 38 | 93** | 7 | 94 | |
| Alectinib | 58.0 (25–88) | 45 | 8 | 61 | 42 | 93** | 7 | 90 | ||
| Solomon 2014[17] (PROFILE 1014; NCT01154140) | Chemotherapy | 54 (19–78) | 37 | 3 | 65 | 27 | 95** | 5 | 94 | |
| Crizotinib | 52 (22–76) | 40 | 6 | 62 | 26 | 94** | 6 | 94 | ||
| Treatment experienced | ||||||||||
| Novello 2018[26] (ALUR; NCT02604342) | Chemotherapy | 59 (37–80) | 49 | 6 | 46 | 74 | 31 | 54 | 14 | 100 |
| Alectinib | 55.5 (21, 82) | 57 | 3 | 49 | 65 | 40 | 51 | 8 | 100 | |
| Hida 2017[21] (J-ALEX; JAPICcti-132316) | Crizotinib | 59.5 (25–84) | 39 | 3 | 59 | 28 | 46 | 52 | 2 | 99 |
| Alectinib | 61.0 (27–85) | 40 | 2 | 54 | 14 | 52 | 46 | 2 | 97 | |
| Kim 2017[22] (ALTA; NCT02094573) | BRI 90 QD | 50.5 (18–82) | 45 | NR | 63 | 71 | 30 | 63 | 6 | 96 |
| BRI 180 QD | 56.5 (20–81) | 42 | NR | 57 | 67 | 41 | 51 | 8 | 98 | |
| Shaw 2017[23] (ASCEND-5; NCT01828112) | Chemotherapy | 54.0 (47.0–64.0)¶ | 47 | 1 | 53 | 59 | 44† | 52† | 4† | 97 |
| Ceritinib | 54.0 (44.0–63.0)¶ | 41 | 3 | 62 | 57 | 49 | 43 | 8 | 97 | |
| Hida 2016[19] (JP28927; JapicCTI-132186) | Alectinib (cross-over) | 45.0 (21–78) | 46 | 3 | 60 | NR | 43 | 57 | NR | 100 |
| Zhao 2015[18] | Chemotherapy | 58.1 (13.2)‡ | 64 | NR | NR | NR | NR | NR | NR | 29 |
| Crizotinib | 55.3 (12.7)‡ | 57 | NR | NR | NR | NR | NR | NR | 43 | |
| Shaw 2013[16] (PROFILE 1007; NCT00932893) | Chemotherapy | 49 (24–85) | 45 | 5 | 64 | 34 | 37 | 55 | 8 | 94 |
| Crizotinib | 51 (22–81) | 43 | 3 | 62 | 35 | 42 | 49 | 9 | 95 | |
BRI = brigatinib, CNS = central nervous system, ECOG = Eastern Cooperative Oncology Group, IQR = interquartile range, NR = not reported, QD = once daily, SD = standard deviation.
*Unless otherwise stated.
†WHO performance score.
‡Mean (SD).
¶Median (IQR).
**ECOG0 or ECOG1.