Table 3. Individual patient DLTs (during DLT period, cycle 1, day 1–21) and proportion of patients with any grade 3 and 4 toxicity, possibly, probably, and definitely related to treatment.
|
Patients with grade 3 or 4 toxicity by category (%)
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| Cohort (dacarbazine/dasatinib) | DLT category (N) | DLT (%) | Heme | Pulm | Card | Bleed | Infect | GI | Cons |
| 1. 800/50 b.i.d. | — | 0 | — | — | — | — | — | — | — |
| 2. 800/70 b.i.d. | — | 0 | 9/19 (47) | 1/19 (5) | — | — | — | — | — |
| 3. 1000/70 b.i.d. | Heme (1) NF (2)a | 21.4 | 10/14 (71) | 1/14 (7) | 1/14 (7)b | — | 2/14 (14)c | 1/14 (7)d | — |
| 4. 1000/140 q.d. | Pulm (1) Heme (1) | 33 | 1/3 (33) | 2/3 (67) | — | — | — | — | — |
| 5. 1000/100 q.d. | — | 0 | 5/11 (45) | — | — | 1/11 (9)e | — | — | 1/11 (9)f |
| Total | 25/50 (50) | 3/50 (6) | 1/50 (2) | 1/50 (2) | 2/50 (4) | 1/50 (2) | 1/50 (2) | ||
Abbreviations: Bleed=bleeding; Card=cardiac; Cons=constitutional; DLT=dose-limiting toxicity; GI=gastrointestinal; Heme=hematologic; Infect=infection; NF=neutropenic fever; Pulm=pulmonary.
a
Patients in expansion cohort.
b
Myocardial infarction, possibly related.
c
Febrile neutropenia.
d
Diarrhoea.
e
GI bleeding in the setting of thrombocytopenia.
f
Fatigue.