Intracavity hyperthermia in nasopharyngeal cancer: A phase III clinical study

Figures & data

Figure 1. (A) Instrument used for hyperthermia and temperature monitor; (B) patient being treated with hyperthermia; (C) temperature curve during hyperthermia therapy.

Table I.  Patients’ characteristics.

	Hyperthermia	Conventional	p-value
Number of patients	90	90
Mean age (age range)	51.3 (21–70)	50.2 (19–68)	0.46
Sex
Male	52	59
Female	38	31	0.28
Histology
Keratinised	12	13
Non-keratinised	78	77	0.83
Paranasopharyngeal space involved
None	30	28
Unilateral	47	48
Bilateral	13	14	0.94
Gross tumour status
1	15	14
2	35	39
3	32	30
4	8	7	0.94
Lymph node status
0	20	21
1	42	37
2	23	26
3	5	6	0.89
TNM stage
1	4	7
2	31	29
3	42	40
4	13	14	0.81

Table II.  Complete response (CR) rate among different tumour stages. Numbers in parentheses are patient numbers.

	CR rate (%)
Tumour stage	Hyperthermia	Control	p-value
T1	100 (15/15)	100 (14/14)
T2	97.1 (34/35)	79.5 (31/39)	0.03
T3	96.9 (31/32)	76.7 (23/30)	0.02
T4	75 (6/8)	71.4 (5/7)	1.0

Figure 2. (A) Progression-free survival curves of hyperthermia group (upper curve) versus conventional group (lower curve) (p = 0.039). (B) Kaplan-Meier analyses of overall survival curves of hyperthermia group (upper curve) versus conventional group (lower curve) (p = 0.14).

Table III.  Acute mucosa toxicity in the two groups.

Grade	Hyperthermia No. of patients (%)	Control No. of patients (%)	p-value
Total	90	90
1	10 (11.1)	9 (10)
2	21 (23.3)	24 (26.7)
3	55 (61.1)	54 (60)
4	4 (4.4)	3 (3.3)	0.94

Table IV.  Late adverse reaction in the two groups.

	Hyperthermia No. of patients (%)	Control No. of patients (%)	p-value
Xerostomia	65 (72.2)	70 (77.8)	0.389
Opening mouth(≤ 2 cm)	13 (14.4)	10 (11.1)	0.503
Dental caries	21 (23.3)	22 (24.4)	0.861
Hearing impairment	29 (32.2)	25 (27.8)	0.515