High-dose-rate intraluminal brachytherapy during preoperative chemoradiation for locally advanced rectal cancers

Table 1 Characteristics of the study patients n (%)

Variable	Group A (intraluminal brachytherapy) (n = 17)	Group B (control arm) (n = 19)
Median age (yr)	34.7 (range 17-55)	34.7 (range 17-55)
Gender
Male	13 (76.5)	14 (73.7)
Women	4 (23.5)	5 (26.3)
Site of primary tumor
Upper rectum	8 (47.1)	9 (47.4)
Lower rectum	9 (52.9)	10 (52.6)
Clinical/radiological stage
T2 N+	1 (5.9)	1 (5.3)
T3 N0	2 (11.8)	3 (15.8)
T3 N+	7 (41.1)	8 (42.1)
T4 N0	5 (29.4)	6 (31.5)
T4 N+	2 (11.8)	1 (5.3)
Performance status (ECOG)
0	13 (76.5)	12 (63.2)
1	4 (23.5)	7 (36.8)

ECOG: Eastern Cooperative Oncology Group.

Table 2 Toxicity profiles (grade 3 or worse) in group A and group B n (%)

Type of toxicity	Group A (HDR-ILBT)	Group B (EBRT boost)	P value
Hematologic			0.3
Leucopenia	2 (11.7)	2 (10.5)
Neutropenia	2 (11.7)	2 (10.5)
Thrombocytopenia	1 (5.9)	1 (5.3)
Non-hematologic
Hand-foot syndrome	1 (5.9)	1 (5.3)
Nausea/vomiting	3 (17.6)	5 (26.3)	0.02
Diarrhea	7 (41.2)	5 (26.3)	0.001
Rectal pain	12 (70.6)	4 (21.1)	0.001
Wound complications	2 (11.8)	3 (15.8)
Cystitis	2 (11.8)	3 (15.8)

Group A: High dose rate intraluminal brachytherapy boost; Group B: External beam radiation therapy boost. HDR-ILBT: High dose rate intraluminal brachytherapy; EBRT: External beam radiotherapy.

Table 3 Pathologic response in both groups n (%)

Pathologic stage	Group A (HDR-ILBT) (n = 17)	Group B (control arm) (n = 19)	P value
yp T stage
ypT0	10 (58.8)	3 (15.8)	0.0001
ypT1	3 (17.6)	6 (31.6)
ypT2	1 (5.9)	4 (21)
ypT3	2 (11.8)	5 (26.3)
ypT4	1 (5.9)	1 (5.3)
yp N stage
ypN0	6 (60)	5 (50)	0.02
ypN+	4 (30)	5 (50)

Group A: High dose rate intraluminal brachytherapy boost; Group B: External beam radiation therapy boost. HDR-ILBT: High dose rate intraluminal brachytherapy.

Table 4 Selected trials of intraluminal brachytherapy during preoperative chemoradiation or as preoperative monotherapy in patients with locally advanced rectal cancer

Study, period of study (type of study)	No. of patients	Follow up (mo)	Treatment, protocol	Sphincter preservation rates	ypT0	Local recurrence rate	Distant metastasis	Acute toxicity (ileitis, proctitis), all grades	Disease free survival
Yanagi et al[6], 1986-1995 (retrospective)	Arm A: 96	60	Arm A: MDR-ILBT→surgery	Arm A: 72%		Arm A: 8%	Arm A: 23%	38%	Arm A: 72%
	Arm B: 19		ArmB: HDR-ILBT→surgery	Arm B: 63%	-	Arm B: 5%	Arm B: 16%	74%	Arm B: 68%
	Arm C: 115		Arm C: surgery alone	Arm C: 42%		Arm C: 21%	Arm C: 17%		Arm C: 65%
Kusunoki et al[10], 1986-1995 (case series)								Perforation
	Arm A: 59	5-108	Arm A: MDR-ILBT→surgery	Arm A: 74%				Arm A: 0%
	Arm B: 65		Arm B: HDR-ILBT→surgery	Arm B: 63%	-	-	-	Arm B: 11%	-
Vuong et al[22], 1998-2001 (case series)	49	29 (16-48)	HDR-ILBT→surgery→ chemoradiation	-	64%	2%	4.10%	Grade 2 proctitis 100%	-
								Grade 4 dermatitis 4%
Ishikawa et al[23], 1988-1997 (case series)	41	79.2	EBRT 30 Gy→HDR-ILBT 10 Gy × 4→surgery	-	-	15%	10%	61%	71.80%
Jakobsen et al[24] (case series)	50	Not mentioned	CRT 45 Gy→HDR-ILBT boost→surgery	-	27%	-	-	30%	-
Present study	36	18 (5-22)	Arm A: CRT 45 Gy→ILBT boost 5.5-7 Gy × 2→surgery	Arm A: 66.7%	Arm A: 58.8%		N/A	Arm A: 70.6%	-
			Arm B: CRT 45 Gy→EBRT boost 5.4 Gy→surgery	Arm B: 50%	Arm B: 15.80%	N/A		Arm B: 42.1%

MDR: Moderate dose rate; HDR-ILBT: High dose rate intraluminal brachytherapy; EBRT: External beam radiotherapy; CRT: Chemoradiation; ypT0: Post chemoradiation pathologic T0 stage; N/A: Not available.