Short-course preoperative radiotherapy combined with chemotherapy, delayed surgery and local hyperthermia for rectal cancer: a phase II study

Figures & data

Figure 1. Yachta-4” hyperthermia intraluminal applicator.

Figure 2. Temperature distribution model.

Table 1. Patient characteristics.

Characteristic	n	%
No. of patients enrolled	81	100
Sex
Male	34	42
Female	47	58
Median age, years	57
Range	24–79
Histology
Well differentiated adenocarcinoma	5	6.2
Moderately differentiated adenocarcinoma	60	74.1
Mucinous adenocarcinoma	16	19.8
Distance from external anal verge
0–5 cm	19	23.5
5–10 cm	37	45.7
10–15 cm	25	30.9
cTNM stage
cT2N0M0	7	8.6
cT3N0M0	30	37
cT2N + M0	1	1.2
cT3N + M0	43	53.1
Median time to surgery, weeks	6
4–7 weeks	65	81.3
8–10 weeks	15	18.7
Type of surgery
No operation (watch and wait)	1	1.2
Anterior resection	35	43.2
Low anterior resection with coloanal anastomosis	41	50.6
Intersphincteric resection	1	1.2
Abdominoperineal resection	2	2.5
Hartmann procedure	1	1.2

Table 2. Treatment toxicity (NCI-CTC v. 3.0).

Adverse event	G0 (n)	G1(n)	G2(n)	G3(n)	G4(n)
Nausea	54	10	11	6	–
Vomiting	60	4	12	4	1
Diarrhoea	49	5	20	7	–
Leukopenia	78	2	1	–	–
ALT elevation	80	–	–	1	–
AST elevation	80	–	–	1	–
Proctitis	73	3	2	3	–
Cystitis	78	1	2	–	–

Table 3. Pathology.

Characteristic	n	%
R0	79	98.8
R1	1	1.2
ypTNM
T0N0M0	16	20
T1N0M0	3	3.8
T2N0M0	13	16.3
T3N0M0	27	33.8
T2N1M0	4	5
T3N1M0	11	13.8
T3N2M0	6	7.5
Tumour regression (Dworak)
IV	16	20
III	22	27.5
II	33	41.3
I	9	11.3