A multicentre randomised clinical trial of chemoradiotherapy plus hyperthermia versus chemoradiotherapy alone in patients with locally advanced cervical cancer

Figures & data

Table 1. Patient characteristics.

	CRT (n = 50)	CRT + HT (n = 51)
	Mean (range), n (%)
Age (years)	62.1 (24–82)	59.9 (30–87)
Tumour size (cm)	5.5 (2.6–8.6)	5.8 (3.2–14)
FIGO stage
IIA	1 (2.0)	0
IIB	14 (28.0)	12 (23.5)
IIIA	2 (4.0)	0
IIIB	29 (58.0)	35 (68.6)
IVA	4 (8.0)	4 (7.8)
Histology
Squamous cell carcinoma	47 (94.0)	43 (84.3)
Adenocarcinoma	3 (6.0)	4 (7.8)
Adenosquamous cell carcinoma	0	1 (2.0)
Small cell carcinoma	0	2 (3.9)
Undifferentiated carcinoma	0	1 (2.0)
Treatment duration (days)	49.9 (19–88)	50.6 (35–60)
External radiotherapy^a
Whole-pelvis dose (Gy)	30.7 (20–50.5)	31.1 (20–45)
Central shield dose	22.0 (19.8–30)	21.0 (10–21.6)
Brachytherapy^a
High-dose rate (Gy)	26.5 (24–30)	25.3 (20–30)
Times of chemotherapy (cycles)^a	4.3 (1–5)	4.1 (1–5)
Total dose of CDDP (mg/m^2)^a	170.4 (30–200)	162.4 (30–200)
Number of HT treatment
1–3	–	4 (7.8)
4–6	–	47 (92.2)
Thermometry results of HT
Tmax (°C)	–	42.2 (40.1–44.6)
Tave (°C)	–	41.1 (39.6–42.5)
CEM43T90^b (min)	–	3.8 (0.1–46.6)
Follow-up duration (months)	59.0 (0.7–154.9)	69.2 (2.5–156.3)

a Summary of patients’ data who received the therapy.

b This data was calculated in 47 evaluable patients with complete thermometry data.

FIGO: International Federation of Gynecology and Obstetrics; CRT: chemoradiotherapy; HT: hyperthermia.

Figure 1. CONSORT flow diagram for 101 randomised patients with locally advanced cervical cancer.

Figure 2. Overall survival for patients treated with chemoradiotherapy or chemoradiotherapy plus hyperthermia.

Figure 3. Disease-free survival for patients treated with chemoradiotherapy or chemoradiotherapy plus hyperthermia.

Figure 4. Local relapse-free survival for patients treated with chemoradiotherapy or chemoradiotherapy plus hyperthermia.

Figure 5. Result of logistic regression analysis to predict complete response (adjusted for age, stage and histology).

Table 2. Acute-phase adverse events.

	Number (%) of patients with RTOG grade
	CRT (n = 50)				CRT + HT (n = 51)
Adverse event	Grade 1	Grade 2	Grade 3	Grade 4	Grade 1	Grade 2	Grade 3	Grade 4
HGB	3 (6.0)	17 (34.0)	11 (22.0)	5 (10.0)	2 (3.9)	29 (56.9)	11 (21.6)	3 (5.9)
WBC	1 (2.0)	10 (20.0)	29 (58.0)	4 (8.0)	2 (3.9)	18 (35.3)	17 (33.3)	8 (15.7)
PLAT	10 (20.0)	9 (18.0)	6 (12.0)	1 (2.0)	12 (23.5)	5 (9.8)	6 (11.8)	0
Nausea	15 (30.0)	7 (14.0)	0	0	14 (27.5)	0	0	0
Vomiting	2 (4.0)	4 (8.0)	0	0	4 (7.8)	0	0	0
Diarrhoea	16 (32.0)	7 (14.0)	0	0	15 (29.4)	2 (3.9)	0	0
Urinary	5 (10.0)	0	0	0	7 (13.7)	2 (3.9)	0	0
Weight loss	7 (14.0)	2 (4.0)	0	0	4 (7.8)	1 (2.0)	0	0
Fatigue	18 (36.0)	2 (4.0)	1 (2.0)	0	15 (29.4)	1 (2.0)	0	0
Nephrotoxicity	9 (18.0)	3 (6.0)	0	0	10 (9.9)	7 (13.7)	0	0
Blistering	–	–	–	–	0	0	0	0

RTOG: Radiation Therapy Oncology Group morbidity scale; CRT: chemoradiotherapy; HT: hyperthermia.

Table 3. Late-phase adverse events.

	Number (%) of patients
	CRT (n = 50)	CRT + HT (n = 51)
None	42 (84.0)	43 (84.3)
Rectal bleeding	5 (10.0)	0
Ileus	0	4 (7.8)
Urinary bladder atrophy	1 (2.0)	0
Ureter stenosis	0	1 (2.0)
Vesico-vaginal fistula	0	1 (2.0)
Nephrotoxicity	1 (2.0)	0
Leg oedema	1 (2.0)	2 (3.9)
Fat necrosis	–	0

CRT: chemoradiotherapy; HT: hyperthermia.