Endoscopic debulking resection with additive chemoradiotherapy: Optimal management of advanced inoperable esophageal squamous cell carcinoma

Table 1 Clinical characteristics of enrolled patients

Characteristics	Total (41)	EdR + CRT (28)	EdR (13)	P value
Age, median (range), yr	69 (38-91)	67 (38-87)	74 (61-91)	0.519
Sex, n (%)				0.524
Male	25 (61)	18 (43.9)	7 (17.1)
Female	16 (39)	10 (24.4)	6 (14.6)
Location, n (%)				0.184
≤ 25 cm	22 (54)	17 (41.5)	5 (12.5)
> 25 cm	19 (46)	11 (26.8)	8 (19.2)
TNM stage, n (%)				0.400
IB	16 (39)	10 (24)	6 (15)
IIA	18 (43.9)	14 (34.1)	4 (9.8)
IIB	1 (2.4)	1 (2.4)	0 (0)
IIIA	1 (2.4)	0 (0)	1 (2.4)
IIIB	3 (7.3)	2 (4.9)	1 (2.4)
IVA	0 (0)	0 (0)	0 (0)
IVB	2 (4.9)	1 (2.4)	1 (2.4)
T stage, n (%)				0.348
T1b	17 (41.5)	11 (26.8)	6 (14.7)
T2	23 (56.1)	17 (41.5)	6 (14.6)
T3	1 (2.4)	0 (0)	1 (2.4)
T4	0 (0)	0 (0)	0 (0)
N stage, n (%)				0.52
N0	34 (82.9)	24 (58.5)	10 (24.4)
N1	2 (4.9)	1 (2.45)	1 (2.45)
N2	5 (12.2)	3 (7.3)	2 (4.9)
M stage, n (%)				0.539
M0	39 (95.1)	27 (65.9)	12 (29.2)
M1	2 (4.9)	1 (2.45)	1 (2.45)

CRT: Chemoradiotherapy; EdR: Endoscopic debulking resection.

Table 2 Outcomes and adverse events of endoscopic debulking resection and chemoradiotherapy

Procedure details and outcomes of EdR
Technical success, n (%)
Success	41 (100)
Failure	0 (0)
R0 resection, n (%)
Yes	10 (24.4)
No	31 (75.6)
Procedure time [mean ± SD (range), min]	65 ± 29 (25-150)
Intraoperative complications, n (%)
Mild subcutaneous emphysema	1 (2.4)
None	40 (97.6)
Post-operative complications, n (%)
Delayed bleeding	2 (4.9)
Esophageal stenosis	19 (46.3)
Tracheoesophageal fistula	2 (4.9)
None	18 (43.9)
Complications of CRT after EdR, n (%)
Myelosuppression	7 (25)
Radiation pneumonia	3 (10.7)
Mucous toxicity	3 (10.7)
None	15 (53.6)
Follow-up period [median (range), mo]	36 (1-83)

CRT: Chemoradiotherapy; EdR: Endoscopic debulking resection.

Table 3 Univariate and multivariate Cox regression analyses on overall survival and progression-free survival

Characteristics	OS, n = 41				PFS, n = 41
	Univariate analysis		Multivariate analysis		Univariate analysis		Multivariate analysis
	HR (95%CI)	P value	HR (95%CI)	P value	HR (95%CI)	P value	HR (95%CI)	P value
Clinical stage (> IIB vs ≤ IIB)	18.908 (4.629-77.235)	0.000	18.908 (4.629-77.235)	0.000	11.311 (3.397-37.622)	0.000	11.311 (3.397-37.622)	0.000
Intervention (EdR vs EdR + CRT)	4.861 (1.213-19.487)	0.026		0.198		0.063		0.411
T stage (≥ 2 vs < 2)	68.037 (0.304-15204.04)	0.126			66.824 (0.505-8840.4)	0.092
N stage (≥ 1 vs 0)	13.329 (3.309-53.7)	0.000		0.737	4.937 (1.621-15.031)	0.005		0.318
M stage (≥ 1 vs 0)	9.13 (1.82-45.775)	0.007		0.876	7.035 (1.481-33.418)	0.014		0.906
Margin (positive/vague vs negative)	7.281 (0.84-63.144)	0.072				0.258

CRT: Chemoradiotherapy; EdR: Endoscopic debulking resection; OS: Overall survival; PFS: Progression-free survival.