Table 3.
Grade 3 Non-hematologic Toxicities by Cycle and Dose Levels&
| Cycle 1 Melphalan 200 mg/m2 |
Cycle 2 TMI 1000 cGy |
Cycle 2 TMI 1200 cGy |
Cycle 2 TMI 1400 cGy |
Cycle 2 TMI 1600 cGy |
Cycle 2 TMI 1800 cGy |
Cycle 2 TMI all dose levels |
|
|---|---|---|---|---|---|---|---|
| # of patients treated | 22* | 3 | 4 | 3 | 6 | 6 | 22 |
| Toxicities | N (%) | ||||||
| Febrile neutropenia | 6 (27) | 1 | 1 | 0 | 1 | 1 | 4 (18) |
| Fatigue/anorexia | 3 (14) | 1 | 0 | 0 | 2 | 2 | 5 (22) |
| Nausea/emesis | 2 (9) | 0 | 0 | 0 | 2† | 2 | 3 (14) |
| Mucositis | 1 (4.5) | 0 | 0 | 0 | 0 | 0 | 0 (0) |
| Enteritis/colitis | 3 (14) | 0 | 0 | 0 | 0 | 2* | 2 (9) |
| Engraftment syndrome | 0 (0) | 1 | 0 | 0 | 0 | 0 | 1 (5) |
| Pneumonitis | 0 (0) | 0 | 0 | 0 | 0 | 1* | 1 (5) |
| Congestive heart failure/hypotension | 0 (0) | 0 | 0 | 0 | 0 | 1ˆ | 1 (5) |
| Metabolic/electrolyte abnormalities | 5 (23) | 1 | 1 | 0 | 4 | 4 | 10 (45) |
TMI, total marrow irradiation
†
non-compliance with antiemetics, not DLT;
*
one case of infectious colitis [non-DLT], and one case of DLT: reversible enteritis, pneumonitis, congestive heart failure in the same patient;
ˆ
DLT: hypotension, requiring pressure support;
&
only patients who received both cycles are included