TABLE 3.
Long-term relapse and second cancer risks, causes of death, and solid organ transplantation among patients treated on dexrazoxane-containing clinical trials
| Outcome (%) | DRZ-randomized trialsa |
DRZ non-randomized trialb N=242 | ||
|---|---|---|---|---|
| No DRZ-assigned N=524 | DRZ-assigned N=542 | HR (95% CI)c | ||
|
| ||||
| Relapse/progression | 96 (18.3) | 85 (15.7) | 0.84 (0.63–1.13) | 92 (38.0) |
| Original cancer mortality | 55 (10.5) | 54 (10.0) | 0.95 (0.65–1.38) | 65 (26.9) |
| Second cancer, all | 16 (3.1) | 20 (3.7) | 1.19 (0.62–2.30) | 2 (0.8) |
| Second cancer mortality | 10 (1.9) | 12 (2.2) | 1.17 (0.51–2.70) | 1 (0.4) |
| All-cause mortality | 73 (13.9) | 80 (14.8) | 1.07 (0.78–1.47) | 69 (28.5) |
| Other cause-specific mortality | ||||
| Cardiovasculard | 1 (0.2) | 1 (0.2) | - | 0 |
| Other toxicity | 3 (0.6) | 8 (1.5) | 2.59 (0.69–9.76) | 1 (0.4) |
| Other specified | 4 (0.8) | 4 (0.7) | 0.96 (0.24–3.85) | 1 (0.4) |
| Unknown | 0 | 1 (0.2) | - | 0 |
| Solid organ transplantation | ||||
| Heart | 1 (0.2) | 0 | - | 0 |
| Other organ | 1 (0.2) | 2 (0.4)e | - | 0 |
DRZ, dexrazoxane
a
P9404, P9425, P9426, and DFCI 95–01 (high-risk arm)
b
P9754, localized osteosarcoma; all DRZ-assigned
c
No DRZ-assigned as referent
d
If secondary cardiovascular contributing causes of death included, then 4 (no DRZ-assigned) and 6 (DRZ-assigned) patients affected (HR 1.45, 95% CI 0.41–5.16); no patient on P9754 had a primary or secondary cardiovascular cause of death
e
Includes one waitlisted patient not yet transplanted