Supportive care and side effects after GO treatment
| . | Patients . | Cycles . |
|---|---|---|
| Total | 110 (100) | 264 (100) |
| Nights in hospital | ||
| 0 | 35 (32) | 135 (51) |
| 1 or more | 75 (68) | 129 (49) |
| Mean ± SD | 7 ± 8 | 4 ± 6 |
| Median (range) | 3 (1-35) | 1 (1-34) |
| No. of platelet transfusions | ||
| 0 | 60 (55) | 196 (74) |
| 1 or more | 50 (45) | 68 (26) |
| Mean ± SD | 3 ± 3 | 3 ± 3 |
| Median (range) | 2 (1-14) | 2 (1-14) |
| No. of red blood cell transfusions | ||
| 0 | 97 (88) | 248 (94) |
| 1 or more | 13 (12) | 16 (6) |
| Mean ± SD | 4 ± 3 | 3 ± 2 |
| Median (range) | 2 (1-10) | 2 (1-8) |
| Median no. of days until ANC > 0.5 × 109/L | 20 | |
| Median no. of days until platelets > 50 × 109/L | 14 | |
| Side effects with CTC grade 2-4 | ||
| Any | 62 (56) | 94 (36) |
| GI | 21 (19) | 29 (11) |
| Hepatic | 19 (17) | 25 (9) |
| Constitutional symptoms | 16 (15) | 20 (8) |
| Infections with CTC grade 2-4 | ||
| Any | 47 (43) | 68 (26) |
| Fever of unknown origin | 28 (25) | 35 (13) |
| Blood | 11 (10) | 15 (6) |
| GI tract | 11 (10) | 14 (5) |
| No. of deaths in CR* | ||
| Overall | 7 | |
| During first year | 4 |
| . | Patients . | Cycles . |
|---|---|---|
| Total | 110 (100) | 264 (100) |
| Nights in hospital | ||
| 0 | 35 (32) | 135 (51) |
| 1 or more | 75 (68) | 129 (49) |
| Mean ± SD | 7 ± 8 | 4 ± 6 |
| Median (range) | 3 (1-35) | 1 (1-34) |
| No. of platelet transfusions | ||
| 0 | 60 (55) | 196 (74) |
| 1 or more | 50 (45) | 68 (26) |
| Mean ± SD | 3 ± 3 | 3 ± 3 |
| Median (range) | 2 (1-14) | 2 (1-14) |
| No. of red blood cell transfusions | ||
| 0 | 97 (88) | 248 (94) |
| 1 or more | 13 (12) | 16 (6) |
| Mean ± SD | 4 ± 3 | 3 ± 2 |
| Median (range) | 2 (1-10) | 2 (1-8) |
| Median no. of days until ANC > 0.5 × 109/L | 20 | |
| Median no. of days until platelets > 50 × 109/L | 14 | |
| Side effects with CTC grade 2-4 | ||
| Any | 62 (56) | 94 (36) |
| GI | 21 (19) | 29 (11) |
| Hepatic | 19 (17) | 25 (9) |
| Constitutional symptoms | 16 (15) | 20 (8) |
| Infections with CTC grade 2-4 | ||
| Any | 47 (43) | 68 (26) |
| Fever of unknown origin | 28 (25) | 35 (13) |
| Blood | 11 (10) | 15 (6) |
| GI tract | 11 (10) | 14 (5) |
| No. of deaths in CR* | ||
| Overall | 7 | |
| During first year | 4 |
Data are n (%) unless otherwise noted. No significant trends of more or higher-grade side effects or infections with sequence of GO cycle or with age of the patient.
The duration of recovery showed no relation with the sequence number of the GO cycle or with age.
ANC indicates absolute neutrophil count; CR, complete remission; CTC, common terminology criteria; GI, gastrointestinal; and GO, gemtuzumab ozogamicin.
There were 2 deaths in CR in the control arm at 3 months and 21 months after randomization attributable to intracerebral hemorrhage and unknown cause. There were 7 deaths in CR in the GO arm attributable to acute liver failure (at 0.6 months after randomization and 11 days after first cycle of GO), infection (at 4 months after randomization and 53 days after GO), hemorrhage (at 9 months), infections after surgery for colon adenocarcinoma (at 10 months), secondary malignancy (at 30 months), and 2 unknown causes at 41 months and 52 months. Both hemorrhages appeared after platelet recovery. In addition, another patient died from veno-occlusive disease; however, he died not in first remission but after additional chemotherapy for relapse. He had attained a CR after cycle 1 and relapsed at 20 months. He died at 25 months after diagnosis.