Table 3. Toxicity (maximum grade per subject) by cohort in the phase 1 study of dose-escalated doxorubicin in cycles 1–3 ABVD.
35 mg m2 |
45 mg m2 |
55 mg m2 |
|
||||
---|---|---|---|---|---|---|---|
Grades 1-2 (%) | Grades 3-4 (%) | Grades 1-2 (%) | Grades 3-4 (%) | Grades 1-2 (%) | Grades 3-4 (%) | Published grades 3–5 toxicity rates with standard ABVD | |
Anaemia |
2 (33) |
0 (0) |
9 (75) |
1 (8) |
4 (66) |
0 (0) |
5%2 |
Neutropaenia |
2 (33) |
0 (0) |
5 (42) |
5 (42) |
1 (17) |
3 (50) |
34%2 |
Thrombocytopaenia |
1 (17) |
0 (0) |
1 (8) |
0 (0) |
1 (17) |
0 (0) |
3%2 |
Nausea |
4 (67) |
1 (17) |
9 (75) |
2 (17) |
6 (100) |
0 (0) |
13%2 |
Vomiting |
4 (67) |
1(17) |
8 (67) |
1 (8) |
5 (83) |
0 (0) |
13%2 |
Mucositis |
5 (83) |
0 (0) |
7 (58) |
0 (0) |
2 (33) |
0 (0) |
1–3%2,4 |
Diarrhoea |
4 (67) |
0 (0) |
7 (58) |
0 (0) |
2 (17) |
0 (0) |
— |
Constipation |
5 (83) |
0 (0) |
11 (92) |
0 (0) |
5 (83) |
0 (0) |
2%2 |
Neuropathy |
4 (63) |
(0) |
9 (75) |
0 (0) |
4 (67) |
2 (33) |
0–3%2,4 |
Palmar Plantar Erythema (PPE) |
0 (0) |
0 (0) |
1 (8) |
0 (0) |
1 (17) |
2 (33) |
— |
Pulmonary |
0 (0) |
0 (0) |
0 (0) |
2 (17) |
0 (0) |
1 (17) |
18–24.5%1,3 |
Infection |
3 (50) |
0 (0) |
7 (58) |
1 (8) |
3 (50) |
1 (17) |
2% |
Fatigue |
3 (50) |
1 (17 ) |
8 (75) |
0 (0) |
6 (100) |
0 (0) |
7%1 |
Other* | 1(17) | 0 (0) | 2(17) | 0(0) | 2 (33) | 0 (0) | — |
Abbreviation: ABVD=doxorubicin, bleomycin, vinblastine, dacarbazine.
Other includes back pain, tumour pain, dyspnea, hearing impairment and palpitations.
(1) Duggan et al, 2003; (2) Federico et al, 2009 (3) Martin et al, 2005 (4) Johnson et al, 2005.