Long-term local control and survival after preoperative radiochemotherapy in combination with deep regional hyperthermia in locally advanced rectal cancer

Figures & data

Table 1. Patient characteristics.

	RCT group	HRCT group	p
Number of patients	43	60
Age			0.052
Mean (years)	68.56	64.33
Range (years)	43–87	38–89
Sex			n.s.
Male	29 (67.4%)	34 (56.7%)
Female	14 (32.6%)	26 (43.3%)
Tumour distance from anal verge			0.007
Mean (cm)	7.62	5.89
0–5 cm	13 (30.2%)	28 (46.7%)	0.04
6–10 cm	23 (53.5%)	30 (50%)
11–15 cm	7 (16.3%)	2 (3.3%)
Clinical stage			n.s.
cT3 cN0 cM0	7 (16.3%)	10 (16.7%)
cT3 cN+ cM0	29 (67.4%)	45 (75%)
cT4 cN0 cM0	1 (2.3%)	1 (1.7%)
cT4 cN+ cM0	6 (14%)	4 (6.7%)
Tumour grade			n.s.
G1	3 (7%)	8 (13.3%)
G2	36 (79.1%)	46 (76.7%)
G3	6 (14%)	6 (10%)

RCT, radiochemotherapy; HRCT, radiochemotherapy plus hyperthermia; n.s., not significant.

Table 2. Hyperthermia related parameters.

	Min	Max	Median
CEMT43 (min)	0.0	9.2	1.1
T90 (°C)	37.1	40.6	39.3
Number of treatments	1.0	9.0	4.0
Treatment time (min)	9.0	636.0	247.0

Figure 1. (a) Overall survival, (b) disease-free survival, (c) local control, and (d) distant metastases-free survival after preoperative radiochemotherapy alone (dashed line) or in combination with deep regional hyperthermia (solid line).

Table 3. Five-year survival estimates and univariate analysis.

	Total N	5 years OS	p	5 years DFS	p	5 years LC	p	5 years DMFS	p
Treatment
RCT	43	0.76	0.17	0.73	0.95	0.87	0.22	0.75	0.98
HRCT (1–3 treatments)	60	0.94		0.74		1.00		0.74
HRCT (4 or more treatments)	60	0.85		0.78		0.97		0.78
Sex
Female	40	0.86	0.54	0.73	0.54	0.94	0.97	0.75	0.74
Male	63	0.82		0.76		0.96		0.76
Age
<60 years	28	0.85	0.75	0.65	0.16	0.83	0.01	0.67	0.29
>60 years	75	0.83		0.80		0.98		0.80
<70 years	55	0.90	0.04	0.75	0.96	0.91	0.29	0.77	0.80
>70 years	48	0.75		0.75		0.97		0.75
Location of tumour
0–5 cm	41	0.84	0.90	0.75	0.77	0.93	0.78	0.77	0.79
6–10 cm	53	0.83		0.77		0.95		0.77
11–15 cm	9	0.78		0.67		0.89		0.67
T-category
T3	91	0.85	0.37	0.77	0.15	0.94	0.35	0.77	0.40
T4	12	0.70		0.62		0.89		0.70
N-category
cN0	19	0.72	0.10	0.79	0.61	0.92	0.85	0.79	0.69
cN+	84	0.86		0.74		0.94		0.75
Post-operative T-category
ypT0 or ypT1	22	0.95	0.13	0.95	0.02	1.00	0.18	0.95	0.03
ypT2 or ypT2 or ypT3	81	0.80		0.69		0.91		0.70
Post-operative N-category
ypN0	75	0.89	0.03	0.84	<0.01	0.97	0.09	0.84	<0.01
ypN+	28	0.68		0.51		0.84		0.54
pCR
No	90	0.82	0.43	0.72	0.17	0.92	0.34	0.73	0.18
Yes	13	0.92		0.92		1.00		0.92
Tumour grade
G1	12	0.81	0.88	0.61	0.30	1.00	0.39	0.61	0.26
G2 or G3	91	0.83		0.77		0.93		0.78
CEM43
<1 or no hyperthermia	88	0.83	0.79	0.74	0.45	0.92	0.35	0.75	0.49
≥1	15	0.86		0.84		1.00		0.84
T90
<39 °C or no hyperthermia	58	0.79	0.12	0.71	0.43	0.90	0.26	0.73	0.54
≥39 °C	45	0.89		0.80		0.97		0.80
<40 °C or no hyperthermia	94	0.82	0.22	0.74	0.49	0.93	0.48	0.75	0.52
≥40 °C	9	1.00		0.89		1.00		0.89

OS, overall survival; DFS, disease-free survival; LC local control; DMFS, distant metastases-free survival.

Table 4. Multivariate analysis.

	HRCT for OS	p	HRCT for DFS	p	HRCT for LC	p	HRCT for DMFS	p
Age
<60 years vs >60 years					7.19	0.09
<70 years vs >70 years	0.32	0.04
Post-operative T-category
ypT0/ypT1 vs ypT2/ypT3/ypT4			0.15	0.06			0.15	0.07
Post-operative N-category
ypN0 vs ypN+	0.33	0.03	0.27	<0.01			0.29	0.01

HRCT, hyperthermia plus radio radiochemotherapy; OS, overall survival; DFS, disease-free survival; LC local control; DMFS, distant metastases-free survival.