TABLE 3
FROM:
A phase 1 study of tazarotene in adults with advanced cancer
P H Jones, R D Burnett, I Fainaru, P Nadolny, P Walker, Z Yu, D Tang-Liu, T S Ganesan, D C Talbot, A L Harris and G J S Rustin
BACK TO ARTICLETable 3. Symptomatic adverse events and biochemical abnormalities of frequency
10%, related to tazarotene treatment
| Dose level (mg day-1) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1.4 | 2.1 | 2.8 | 4.2 | 8.4 | 16.8 | 25.2 | 33.6 | Cumulative | |||||||||||||||||||
| (n=6) | (n=5) | (n=3) | (n=2) | (n=2) | (n=3) | (n=7) | (n=6) | (n=34) | |||||||||||||||||||
| NCI toxicity grade | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 | 1 | 2 | 3/4 |
| Cheilitis | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 3 | 0 | 4 | 1 | 0 | 13 | 4 | 0 |
| Asthenia | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 1 | 2 | 3 | 0 | 5 | 8 | 3 |
| Dry skin | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 3 | 1 | 0 | 5 | 1 | 0 | 12 | 2 | 0 |
| Anorexia | 2 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 5 | 4 | 0 |
| Pruritus | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 2 | 2 | 0 | 7 | 2 | 0 |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 5 | 3 | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 5 | 3 | 0 |
| Back pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 2 | 0 | 1 | 5 | 1 |
| Headache | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 5 | 2 | 0 |
| Stiffness in joints | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 4 | 3 | 0 |
| Rhinitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 0 | 4 | 2 | 0 |
| Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 3 | 0 | 2 | 4 | 0 |
| Mouth ulcer | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 1 | 0 |
| Blocked ears | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 0 | 3 | 2 | 0 |
| Alopecia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 3 | 0 | 0 | 5 | 0 | 0 |
| Sore nose | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 2 | 2 | 0 |
| Abdominal pain | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 |
| Biochemical | |||||||||||||||||||||||||||
| Hypertriglyceridaemia | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 2 | 2 | 0 | 3 | 1 | 1 a | 14 | 4 | 1 a |
| Hypercholesterolaemia | 0 | 2 | 1 b | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 4 | 0 | 0 | 2 | 2 | 0 | 10 | 6 | 1 b |
| Hypercalcaemia | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 5 | 0 | 1 |
| Number of patients with any toxicity>grade 1 at dose-escalation assessmentc | 2 | 1 | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 2d | 0 | 3 | 1 | 4 | 2 | |||||||||||
a NCI grade 4 toxicity is shown in bold. bNCI grade 4, with grade 2 elevation at baseline. cDose escalation was after 12 weeks treatment for 1.4 and 2.1 mg dose levels and 4 weeks treatment for other dose levels. dOne of the two patients with grade 2 toxicity at 16.8 mg had a single 24 h episode of nausea and vomiting at 2 weeks, which, although possibly treatment-related, was not assessed in the dosage-escalation decision.
