Table 5 Non-haematological acute toxicity (NCI-CTCAE v3.0) *worst toxicity observed

Stomatitis*

15/56

(27%)

12/56

(21%)

4/56

(7%)

1/56

(2%)

Grade 1

(symptomatic, regular food intake)

Grade 2

(impaired swallowing; i.v. fluids)

Grade 3

(enteral/parenteral nutrition)

Grade 4

(life-treatening consequences)

Dysphagia*

20/56

(36%)

10/56

(18%)

4/56

(7%)

0/56

-

Grade 1

(light erithema or desquamation)

Grade 2

(moderate erithema or desquamation with oedema)

Grade 3

(erithema or desquamation with induced bleeding)

Grade 4

(necrosis with spontaneous bleeding)

Dermatitis*

14/56

(25%)

3/56

(5%)

3/56

(5%)

0/56

-

Grade 1

(asymptomatic)

Grade 2

(symptomatic without respiratory distress)

Grade 3

(stridor, respiratory distress)

Grade 4

(severe compromission, tracheotomy)

Laryngeal oedema*

10/56

(18%)

0/56

-

0/56

-

2/56

(3%)

Grade 1

(light)

Grade 2

(moderate)

Grade 3

(severe)

Grade 4

(disabling)

Pain*

10/56

(18%)

5/56

(9%)

0/56

-

0/56

-

Grade 1

(flushing, or transient rash, fever < 38°)

Grade 2

(flushing, rash or orticaria, fever = 38°)

Grade 3

(bronchospasm with or without orticaria)

Grade 4

(anaphylaxis)

Allergic reactions*

1/56

(2%)

2/56

(3%)

0/56

-

0/56

-

Grade 1

(loss of appetite)

Grade 2

(lower caloric intake without weight loss)

Grade 3

(weight loss requiring enteral/parenteral nutrition)

Grade 4

(life-threatening denutrition)

Nausea*

13/56

(23%)

0/56

-

0/56

-

0/56

-

Grade 1

(no treatment required)

Grade 2

(necessity of brief liquid i.v infusion)

Grade 3

(necessity of continuative treatment > 24 h)

Grade 4

(shock)

Hypotension*

1/56

(2%)

2/56

(3%)

0/56

-

0/56

-

Grade 1

Grade 2

Alopecia*

2/56

(3%)

0/56

-