Regional hyperthermia added to intensified preoperative chemo-radiation in locally advanced adenocarcinoma of middle and lower rectum

Figures & data

Table I.  Patient characteristics (n = 76).

	n (%)
Age, years
Median	60
Range	38–82
Sex
Male	50 (65.7)
Female	26 (34.2)
ECOG performance status
0	48 (63.2)
1	28 (36.8)
Tumor distance from anal verge, cm
Median	6
Range	1–12
TNM clinical stage
T3 N0 M0	29 (38.1)
T3 N+ M0	39 (51.3)
T4 N0 M0	6 (7.9)
T4 N+ M0	2 (2.7)
Baseline tumor assessment
Pelvic CT scan	34 (44.7)
Trans–Rectal Ultrasonography (TRUS)	4 (5.3)
CT plus TRUS	8 (10.5)
CT plus MRI	19 (25)
CT plus TRUS plus MRI	11 (14.5)

Figure 1. Scheme of the trial.

Table II.  HT toxicity score, from B. Rau et al. [29].

	Toxicity score for regional hyperthermia
Grade	Criteria
0	General discomfort (bolus pressure, systemic stress); no limitation of heat treatment
1	Local discomfort (hot-spot phenomenon, positioning), which requires rearrangement of treatment set-up; heat treatment can be accomplished with some restrictions in total power and power distrbution
2	More severe local discomfort or systemic stress, which persists after the end of treatment and evidently limits the efficiency
3	Every kind of toxicity, which causes the patient to refuse further heat treatments (hot-spots, musculoskeletal syndrome, claustrophobia, etc.)
4	Bums or tissue damage or any other complication related to the heat treatment

Table III.  CRT–related acute toxicity according to RTOG–EORTC scoring criteria [35], observed in all patients (n = 76).

	Toxicity grade, %
Toxicity	I	II	III	IV
Nausea	5.2 (4/76)	–	–
Vomiting	–	–	–	–
Diarrhoea	5.2 (4/76)	9.2 (7/76)	1.3 (1/76)	–
Neurotoxicity	–	5.2 (4/76)	–	–
Dermatitis	–	–	–	–
Anemia	4 (3/76)	2.6 (2/76)	–	5.2 (4/76)
Thrombocytopenia	–	–	–	–
Neutropenia	–	–	1.3 (1/76)	–
Cistitis	1.3 (1/76)	2.6 (2/76)	–	–
Regional HT	4 (3/76)	2.6 (2/76)	–	5.2 (4/76)

Figure 2. T_max and T₉₀ values in patients who underwent pCR and in those who did not (n = 76).

Table IV.  Clinical stage at diagnosis and subsequent pathological stage after neo–adjuvant HT plus CRT and surgery for all patients (n = 76).

	n	(%)
cT3 N0
ypT0 ypN0 (CR)	12	15,8
ypTmic ypN0 (PR)	2	2,6
ypTmic ypN0 M+ (PD)	2	2,6
ypT1 ypN0 (PR)	1	1,3
ypT2 ypN0 (PR)	8	10,5
ypT3 ypN0 (SD)	2	2,6
ypT3 ypN+(PD)	2	2,6
cT3 N+
ypT0 ypN0 (CR)	5	6,6
ypTmic ypN0 (PR)	2	2,6
ypTmic ypN+ (SD)	2	2,6
ypT1 ypN0 (PR)	8	10,5
ypT1 ypN+ (PR)	2	2,6
ypT2 ypN0 (PR)	3	4,0
ypT2 ypN1 (PR)	1	1,3
ypT3 ypN+ (SD)	16	21,0
cT4 N0
ypT0 ypN0 (CR)	1	1,3
ypTmic ypN0 (PR)	4	5,3
ypT3 ypN0 (PR)	1	1,3
cT4 N+
ypT3 ypN0 (PR)	2	2,6

Figure 3. Kaplan-Meier OS estimates for all patients (n = 76).

Figure 4. DFS estimates for all patients (n = 76).

Figure 5. Comparison between DFS estimates for patients with ypN0 status (n = 53) and patients with ypN+ status (n = 23) (log-rank test: p = 0.0008).

Figure 6. Comparison between DFS estimates for patients with pCR (n = 18) and patients with no pCR (n = 58) after neoadjuvant treatment (log-rank test: p = 0.03).

Figure 7. Comparison between DFS estimates for patients with ypT0-2 status (n = 53) and patients with ypT3 status (n = 23) after neoadjuvant treatment (log-rank test: p = 0.002).

Rau B, Wust P, Hohenberger P, Löffel J, Hünerbein M, Below C, Gellermann J, Speidel A, Vogl T, Riess H, et al. Preoperative hyperthermia combined with radiochemotherapy in locally advanced rectal cancer: A phase II clinical trial. Ann Surg 1998; 227: 380–389

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