Table 3 Non-haematologic toxicity

From: Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer: final survival analysis of the ADEBAR study

 

EC-Doc

FEC120

 

n =684

n =674

Any non-haematologic event

Grade 1–2

432 (63.2)

520 (77.2)

Grade 3–4

247 (36.1)

145 (21.5)

Elevated bilirubin levels

Grade 1–2

0 (0.0)

0 (0.0)

Grade 3–4

8 (1.2)

1 (0.1)

Elevated transaminase levels

Grade 1–2

0 (0.0)

0 (0.0)

Grade 3–4

6 (0.9)

10 (1.5)

Nausea

Grade 1–2

3 (0.4)

6 (0.9)

Grade 3–4

8 (1.2)

11 (1.6)

Vomiting

Grade 1–2

0 (0.0)

0 (0.0)

Grade 3–4

24 (3.5)

12 (1.8)

Diarrhoea

Grade 1–2

0 (0.0)

0 (0.0)

Grade 3–4

7 (1.0)

12 (1.8)

Alopecia

Grade 1–2

149 (21.8)

252 (37.4)

Grade 3–4

4 (0.6)

1 (0.1)

Cardiac toxicity

Grade 1–2

1 (0.1)

0 (0.0)

Grade 3–4

1 (0.1)

4 (0.6)

Oedema

Grade 1–2

12 (1.8)

8 (1.2)

Grade 3–4

10 (1.5)

1 (0.1)

Neurological symptoms

Grade 1–2

8 (1.2)

3 (0.4)

Grade 3–4

5 (0.7)

1 (0.1)

Pain

Grade 1–2

39 (5.7)

31 (4.6)

Grade 3–4

35 (5.1)

14 (2.1)

Skin reactions

Grade 1–2

17 (2.5)

8 (1.2)

Grade 3–4

23 (33.6)

6 (0.9)

Allergic reactions

Grade 1–2

0 (0.0)

0 (0.0)

Grade 3–4

1 (0.1)

0 (0.0)

Fever

Grade 1–2

17 (2.5)

48 (7.1)

Grade 3–4

6 (0.9)

5 (0.7)

Arthralgia/myalgia

Grade 1–2

63 (9.2)

18 (2.7)

Grade 3–4

57 (8.3)

8 (1.2)

Mucositis

Grade 1–2

123 (18.0)

146 (21.7)

Grade 3–4

52 (7.6)

59 (8.8)

  1. Abbreviations: EC-Doc=epirubicin/cyclophosphamide followed by docetaxel; FEC=fluorouracil/epirubicin/cyclophosphamide.