Dose intensified hypofractionated intensity-modulated radiotherapy with synchronous cetuximab for intermediate stage head and neck squamous cell carcinoma

Figures & data

Table I. Baseline patient and disease characteristics.

	Number	(%)
Number of Patients	27	(100)
Gender
Male	20	(74)
Female	7	(26)
Age (years)
Median	63
Range	41–75
ECOG Performance Status
0	19	(70)
1	8	(30)
Smoking Status
Current	13	(48)
Former (stopped > 1 year)	7	(26)
Former (stopped > 1 year)	4	(15)
Never	3	(11)
Sub-site
Oropharynx (tonsil, base of tongue, pharyngeal wall)	17 (15,1,1)	(63)
Larynx (glottic, supraglottic, subglottic)	8 (3,5,0)	(30)
Hypopharynx (pyriform fossa, pharyngeal wall, post-cricoid)	2 (2,0,0)	(7)
Stage
II T2N0	6	(22)
III T1N1	1	(4)
T2N1	9	(33)
T3N0	8	(30)
T3N1	3	(11)
Histology
Squamous cell carcinoma	27	(100)
Differentiation
Well-moderate	14	(52)
Poor	6	(22)
Unknown	7	(26)
Oropharyngeal Cancer
Total	17	(63)
p16 positive	10	(59)
p16 negative	6	(35)
Unknown	1	(6)

Table II. Maximum physician recorded acute toxicity (CTCAE version 3) during treatment (number of patients, percentage of total in parentheses).

	Maximum CTCAE grade; Number (%)
	0	1	2	3	4
Haemoglobin	18 (67)	8 (30)	1 (3)	–	–
White cell count	26 (96)	–	1 (4)	–	–
Absolute neutrophil count	19 (70)	8 (30)	–	–	–
Platelet count	27 (100)	–	–	–	–
Weight loss	5 (18)	20 (74)	2 (7)	–	–
Pain severity	–	–	5 (18)	22 (81)	–
Dysphagia	–	–	16 (59)	11 (41)	–
Mucositis	–	–	6 (22)	21 (78)	–
Nausea	12 (45)	9 (33)	3 (11)	3 (11)	–
Vomiting	20 (74)	7 (26)	–	–	–
Dermatitis	–	12 (45)	10 (37)	5 (18)	–
Acneiform rash	2 (7)	3 (11)	20 (74)	2 (8)	–
Hypersensitivity reaction	27 (100)	–	–	–	–

Table III. Maximum physician recorded late toxicity (based on CTCAE version 3.0) from 6 months after treatment (number of patients, percentage of total in parentheses).

	Maximum CTCAE grade; Number (%)
	0	1	2	3	4
Pain severity	12 (46)	9 (35)	3 (11)	3 (11)	–
Weight loss	7 (27)	7 (27)	11 (42)	1 (4)	–
Anorexia	16 (61)	6 (23)	2 (8)	2 (8)	–
Oesophageal stricture/stenosis	22 (85)	4 (15)	–	–	–
Paranasal inflammation	23 (89)	3 (11)	–	–	–
Aspiration	23 (89)	2 (7)	1 (4)	–	–
Laryngeal oedema	18 (72)	7 (28)	–	–	–
Dentition (teeth)	15 (58)	4 (15)	5 (19)	–	–
Dentition (periodontal disease)	19 (73)	4 (15)	3 (12)	2 (8)	–
Oesteoradionecrosis	25 (96)	–	1 (4)	–	–
Mucosal ulceration	26 (100)	–	–	–	–
Skin ulceration	26 (100)	–	–	–	–
Telangiectasia	13 (50)	12 (46)	1 (4)	–	–
Skin induration/fibrosis	13 (50)	11 (42)	2 (8)	–	–
Head and neck oedema	22 (85)	4 (15)	–	–	–
Otitis	25 (96)	1 (4)	–	–	–

Table IV. Patient-reported late toxicity (based on CTCAE version 3.0) from 6 months after treatment (number of patients and percentage of total).

Symptom	Number of Patients	%
Pain
None	11	41
Mild	10	37
Moderate	2	7
Severe	3	11
Pain affecting daily living
No	20	74
Yes	4	15
Site of Pain
Mouth	10	37
Throat	14	52
Jaw	0	33
Neck	6	22
Skin	3	11
Ear	5	19
Nausea (only included for cohort 2)
No	10	71
Yes	4	29
Loss of Appetite
No	15	56
Yes	12	44
Altered Taste
No	6	22
Yes	21	78
Dry Mouth
No	3	11
Yes	24	89
Saliva
None	5	19
Slightly thick	6	22
Ropey	16	59
Difficulty opening mouth
No	17	63
Yes	10	37
Difficulty swallowing
No	8	30
Yes	19	70
Nutrition (eating)
Normal	11	41
Solid food	8	30
Soft/liquid	6	23
Cannot eat	2	7
Hoarseness
None	9	33
Mild	8	30
Moderate	7	26
Severe	2	7
Hearing Loss
No	15	56
Yes	12	44
Ringing (tinnitus)
None	14	52
Rare	3	11
Sometimes	1	4
Often	8	30

Figure 1. Patient-reported (EORTC QLQ–H&N35 questionnaire) change in mean symptoms scores from baseline at 6, 12 and 18 weeks from start of treatment and 6, 12, 18 and 24 months from completion of treamtment for A. mouth opening, B. dentition, C. dry mouth, D. taste and smell, D. swallowing, E.speech. Statistical comparisons are versus baseline scores, *p< 0.01, **p < 0.001; error bars represent 99% confidence intervals. w, weeks; m, months.

Figure 2. Kaplan-Meier estimations to show A. disease-free, B. cause-specific and C. overall survival outcomes.