Table 4.
Published retrospective analyses of alemtuzumab usage in the clinic.
| Trial | Years of analysis | Country (sites) | No. enrolled | Median prior lines (range) | Primary endpoint | ORR, % (CR, %) | Median OS, months | Median PFS, months | Notes |
|---|---|---|---|---|---|---|---|---|---|
| Osuji et al. [2005] | nr | UK (nr) | 28 | 4 (1–11) | Efficacy | 54 (18) | nr | 4 | |
| Fiegl et al. [2006] | 2001–2006 | Austria (25) | 115 | 3 (1–11) | Efficacy | 23 (5) | 20.2 | 6.2 | |
| Martin et al. [2006] | 2001–2003 | USA (1) | 27 (21 CLL) | CLL: 3 (1–13) | Infection | nr | nr | nr | 9 OI and 30 non-OI; 26% infectious mortality |
| Albo et al. [2007] | 2001–2006 | Spain (5) | 24 | 3 (0–6) | Infection | nr | nr | nr | 35 infectious episodes with 14% attributable mortality; 31% CMV-R |
| Laros-Van Gorkom et al. [2007] | 2001–2005 | Netherlands (15) | 27 | 3 (0–8) | Complications | 63 (15) | nr | 8.3 | 12 infectious episode |
| Hui et al. [2008] | 2002–2006 | Canada (10) | 42 (39 CLL) | CLL: 4 (1–8) | Efficacy and safety | 50 (2) | 15.1 | 5.4 | 60% infection rate |
| Fiegl et al. [2010] | 2001–2007 | Austria (17); Italy (1); Czech Republic (1) | 105 (including 41 from Fiegl et al. [2006]) | 2 (1–8) | Efficacy | 43 (4) | 32.8 | 7 | |
| Fiegl et al. [2011] | 2002–2007 | Austria (16); Italy (1); Czech Republic (1) | 30 | 4 (2–12) | Efficacy | 47 | 20 | 6.3 | All retreatments |
| Ursuleac et al. [2011] | 2006–2010 | Romania (1) | 44 (37 CLL) | Nr | Toxicity | nr | nr | nr | CMV-R in 8: 2 deaths; 6 sepsis deaths; 5 hemorrhagic deaths |
| Vallejo et al. [2011] | nr | Spain (nr) | 102 (89 CLL) | nr | CMV-R rates | nr | nr | nr | 39% CMV-R overall; 75% CMV-R with cumulative dose > 1000 mg |
| Cortelezzi et al. [2012] | 2002–2009 | Italy (11) | 108 | 2 (1–6) | Efficacy and safety | 56 (22) | 39 | 19.4 | 7% serious infection rate |
| Total number treated | 652 (623 CLL) |
Unless otherwise noted, all patients had chronic lymphocytic leukemia (CLL).
CMV-R, cytomegalovirus reactivation; nr, not reported; OI, opportunistic infection.