Table 3.
Patients with Infectious Adverse Events according to Prophylactic Antibiotic Regimen
| Chemotherapy phase (No. patients) |
Induction 1 (n = 101) |
Induction 2 (n = 100) |
GO alone (n =12) |
Consolidation 1 (n = 87) |
Consolidation 2 (n = 73) |
Consolidation 3 (n = 53) |
Total |
|---|---|---|---|---|---|---|---|
| Course duration (days): median (range) | 30 (20–54) | 33 (16–53) | 24 (15–44) | 31 (20–88) | 44 (21–121) | 41 (26–120) | |
| Any episodes | |||||||
| Patients with episodes/All patients (%) | 69/101 (68.3) | 49/100 (49.0) | 8/12 (66.7) | 45/87 (51.7) | 49/73 (67.1) | 24/53 (45.3) | 244/426 (57.3) |
| A | 22/25 (88.0) | 24/32 (75.0) | 4/5 (75.0) | 16/23 (69.6) | 19/19 (100.0) | 7/9 (77.8) | 92/113 (81.4) |
| B | 24/47 (51.1) | 22/64 (34.4) | 4/6 (66.7) | 27/62 (53.6) | 28/51 (54.9) | 17/44 (38.6) | 122/274 (44.5) |
| C | 23/29 (79.3) | 3/4 (75.0) | 0/1 (0.0) | 2/2 (100.0) | 2/3 (66.7) | 0/0 | 30/39 (76.9) |
| P-value (A vs. B) | 0.002 | 0.0002 | 1.0 | 0.05 | 0.0001 | 0.06 | <0.0001 |
| Febrile neutropenia of unknown origin | |||||||
| Patients with episodes/All patients (%) | 51/101 (50.5) | 31/100 (31.0) | 6/12 (50.0) | 21/87 (24.1) | 26/73 (35.6) | 9/53 (17.0) | 144/426 (33.8) |
| A | 14/25 (56.0) | 11/32 (34.4) | 3/5 (60.0) | 4/23 (17.4) | 6/19 (31.6) | 0/9 (0.0) | 38/113 (33.6) |
| B | 20/47 (42.6) | 18/64 (28.1) | 3/6 (50.0) | 15/62 (24.2) | 19/51 (37.3) | 9/44 (20.5) | 84/274 (30.7) |
| C | 17/29 (58.6) | 2/4 (50.0) | 0/1 (0.0) | 2/2 (100.0) | 1/3 (33.3) | 0/0 | 22/39 (56.4) |
| P-value (A vs. B) | 0.33 | 0.64 | 1.0 | 0.57 | 0.78 | 0.33 | 0.73 |
| Clinically or microbiologically documented infection | |||||||
| Patients with episodes/All patients (%) | 25/101 (24.8) | 22/100 (20.0) | 4/12 (33.3) | 27/87 (31.0) | 34/73 (46.6) | 17/53 (32.1) | 129/426 (30.3) |
| A | 10/25 (40.0) | 13/32 (40.6) | 3/5 (60.0) | 13/23 (56.5) | 17/19 (89.5) | 7/9 (77.8) | 63/113 (55.8) |
| B | 8/47 (17.0) | 7/64 (10.9) | 1/6 (16.7) | 13/62 (21.0) | 15/51 (29.4) | 10/44 (22.7) | 54/274 (19.7) |
| C | 7/29 (24.1) | 2/4 (50.0) | 0/1 (0.0) | 1/2 (50.0) | 2/3 (66.7) | 0/0 | 12/39 (30.8) |
| P-value (A vs. B) | 0.046 | 0.0013 | 0.24 | 0.003 | <0.0001 | 0.003 | <0.0001 |
| Bacteremia | |||||||
| Patients with episodes/All patients (%) | 9/101 (8.9) | 13*/100 (13.0) | 3/12 (25.0) | 19/87 (21.8) | 24/73 (32.9) | 13/53 (24.5) | 81*/426 (19.0) |
| A | 7/25 (28.0) | 12*/32 (37.5) | 2/5 (40.0) | 12/23 (52.2) | 15/19 (78.9) | 7/9 (77.8) | 55*/113 (48.7) |
| B | 0/47 (0.0) | 1/64 (1.6) | 1/6 (16.7) | 6/62 (9.7) | 8/51 (15.7) | 6/44 (13.6) | 22/274 (8.0) |
| C | 2/29 (6.9) | 0/4 (0.0) | 0/1 (0.0) | 1/2 (50.0) | 1/3 (33.3) | 0/0 | 4/39 (10.3) |
| P-value (A vs. B) | 0.0003 | <0.0001 | 0.55 | <0.0001 | <0.0001 | 0.0003 | <0.0001 |
Values are the number (%) of patients with episodes in each treatment course.
*
One patient had 2 episodes during induction 2.
GO: Gemtuzumab ozogamicin
A: Either patients received no prophylactic antibiotics or they received only prophylactic oral cephalosporins.
B: Prophylaxis with IV cefepime only or IV vancomycin plus an oral cephalosporin, oral ciprofloxacin, or IV cefepime.
C: Not evaluable.