Locally advanced head and neck cancer treated with accelerated radiotherapy, the hypoxic modifier nimorazole and weekly cisplatin. Results from the DAHANCA 18 phase II study

Figures & data

Table I. Patient and tumour characteristics.

	All patients (n = 227)		p16 unknown (n = 49)		p16 pos (n = 117)		p16 neg (n = 61)
Patient/tumour data	n	(%)	n	(%)	n	(%)	n	(%)	p*
Age (years)
Median	57		60		56		58
Range	(31–82)		(43–75)		(33–82)		(31–71)
Gender
Female	49	22	5	10	28	24	16	26	n.s.
Male	178	78	44	90	89	76	45	74
Tumour site
Larynx	28	12	10	20	3	3	15	25	< 0.001
Hypopharynx	26	12	17	35	1	1	8	13
Oropharynx	150	66	9	18	112	96	29	47
Cavum Oris	23	10	13	27	1	1	9	15
Tumour stage
T1–2	144	63	26	53	93	79	25	41	< 0.001
T3–4	83	37	23	47	24	21	36	59
Nodal stage
N0	5	2	1	2	1	1	3	5	0.08
N1–3	222	98	48	98	116	99	58	95
Disease stage
I–II	47	21	13	27	23	20	11	18	n.s.
III–IV	180	79	36	73	94	80	50	82

n.s., not significant.

*Chi-squared test for comparison between p16 pos and p16 neg tumours.

Figure 1. DAHANCA 18. Compliance to weekly cisplatin in 227 patients treated with concomitant accelerated chemoradiotherapy and nimorazole.

Figure 2. DAHANCA 18. Outcome on all patients (n = 227) at a median follow-up time of 55 months.

Figure 3. DAHANCA 18. Loco-regional control according to site.

Figure 4. DAHANCA 18. Loco-regional control (4A) and overall survival (4B) for the p16 pos versus the p16 neg oropharyngeal carcinomas.

Table II. Acute and late radiation-related morbidity.

	Acute (during treatment) (n = 227)		Chronic 1 year after treatment (n = 200)		Chronic 2 years after treatment (n = 181)
Side effect	n	%	n	%	n	%
Acute mucositis	173	76
Need of feeding tube	146	64	11	6	6	3
Dysphagia, only fluid nutririon	168	74	17	9	17	9
Severe dryness of mouth/throat			32	16	35	19
Severe mucosal atrophy			2	1	4	12
Pronounced fibrosis of the neck			19	10	25	14