Table 4.
Toxicities by dose level.
Organ Assessed | DL1 (n=3) 1200 cGy | DL2 (n=3) 1350 cGy | DL3 (n=9) 1500 cGy | DL4 (n=6) 1500 cGy | DL5 (n=6) 1600 cGy | DL6 (n=6) 1700 cGy | DL7 (n=6) 1800 cGy | DL8 (n=6) 1900 cGy | DL9 lead-in (n=6) 2000 cGy | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade | Grade | Grade | Grade | Grade | Grade | Grade | Grade | Grade | ||||||||||||
1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | 3 | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | 3 | |
| ||||||||||||||||||||
Bladder toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
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Cardiac toxicity | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
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CNS toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
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GI toxicity | 2 | 0 | 3 | 0 | 6 | 0 | 3 | 0 | 0 | 5 | 1 | 1 | 1 | 6 | 0 | 5 | 0 | 4 | 2 | 0 |
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Hepatic toxicity | 0 | 0 | 0 | 1 | 0 | 3 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
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Pulmonary toxicity | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
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Renal toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1** |
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Stomatitis | 2 | 0 | 1 | 0 | 1 | 7 | 2 | 3 | 1* | 3 | 1 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 1 | 0 |
This patient had the only dose-limiting toxicity in the trial.
Renal failure was secondary to septic shock secondary to infection not related to the conditioning regimen and therefore not considered a DLT.