Table I.
Characteristics of included studies.
| First author/s, year | Type of study | Patients, n | Setting (%) | PS 0-1, % | Median age, years | Topotecan schedule, mg/m2 | Exp arm | OS, months (Ctr vs. Exp) | PFS, months (Ctr vs. Exp) | ORR, % (Ctr vs. Exp) | G3-4 anemia, % (Ctr vs. Exp) | G3-4 thrombocy topenia, % (Ctr vs. Exp) | FN, % (Ctr vs. Exp) | G3-4 neutropenia, % (Ctr vs. Exp) | Risk of bias | (Refs.) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baize, 2020 | Phase 3 | 162 | Sensitive (100) | 92.5 | 64.5 | Oral 2.3 d1-5 q21 | Carboplatin + Etoposide | - | 2.7 vs. 4.7 | 25 vs. 49 | 21 vs. 24 | 36 vs. 31 | 13 vs. 6 | 24 vs. 13 | Low | (5) |
| Chiappori, 2016 | Phase 2 | 44 | Refractory (54.6); sensitive (45.4) | 36 | 64 | iv 1.5 d1-5 q21 | Linsitinib | 5.3 vs. 3.4 | 3 vs. 1.2 | 13.3 vs. 0 | 7.1 vs. 3.6 | 28.6 vs. 7.1 | - | 28.6 vs. NR | Uncertain | (14) |
| Evans, 2015 | Phase 2 | 179 | Refractory (49); sensitive (51) | 99.4 | 61 | iv 1.5 d1-5 q21 | Cabazitaxel | 6.8 vs. 5.2 | 3 vs. 1.4 | 10.1 vs. 0 | 26.1 vs. 3.4 | 45.5 vs. 4.5 | 22.7 vs. 18 | 78.4 vs. 56.8 | Moderate | (13) |
| Goto, 2016 | Phase 3 | 180 | Sensitive (100) | 97.2 | 64 | iv 1 d1-5 q21 | Cisplatin + Etoposide + Irinotecan | 12.5 vs. 18.2 | 3.6 vs. 5.7 | 25.5 vs. 33.8 | 27 vs. 85 | 28 vs. 41 | 7 vs. 31 | 85 vs. 84 | Low | (12) |
| Inoue, 2008 | Phase 2 | 59 | Refractory (39); sensitive (61) | 85 | 69 | iv 1 d1-5 q21 | Amrubicina | 8.4 vs. 8.4 | 2.2 vs. 3.5 | 13 vs. 38 | 30 vs. 21 | 40 vs. 28 | 3 vs. 14 | 87 vs. 93 | Moderate | (11) |
| Jotte, 2011 | Phase 2 | 76 | Sensitive (100) | 89.4 | 65.5 | iv 1.5 d1-5 q21 | Amrubicina | 7.6 vs. 9.2 | 3.3 vs. 4.5 | 15.4 vs. 44 | 30 vs. 25 | 61 vs. 39 | 9 vs. 10 | 78 vs. 71 | Moderate | (10) |
| O'Brien, 2006 | Phase 3 | 141 | Refractory (54); sensitive (46) | 70.2 | 59.2 | Oral 2.3 d1-5 q21 | BSC | 6.4 vs. 3.4 | 4 vs. NR (TTP) | 7 vs. 0 | 25 vs. 0 | 38 vs. 0 | 3 vs. 0 | 61 vs. 0 | Low | (3) |
| Von Pawel, 1999 | Phase 3 | 211 | Sensitive (100) | 78.6 | - | iv 1.5 d1-5 q21 | Cyclophosp hamide + Doxorubicin + Vincristine (CAV) | 6.2 vs. 6.1 | 3.3 vs. 3 (TTP) | 24.3 vs. 18.3 | 42.3 vs. 19.8 | 57.6 vs. 14.9 | - | 88.5 vs. 86.9 | Low | (4) |
| Von Pawel, 2014 | Phase 3 | 637 | Refractory (46.4); sensitive (53.6) | 97.9 | 61.5 | iv 1.5 d1-5 q21 | Amrubicina | 7.8 vs. 7.5 | 3.5 vs. 4.1 | 16.9 vs. 31.1 | 31 vs. 16 | 54 vs. 21 | 3 vs. 10 | 54 vs. 41 | Low | (9) |
PS, performance status; OS, overall survival; PFS, progression-free survival; ORR, overall response rate; FN, febrile neutropenia; TTP, time to progression; NR, not reported.