The high pCR rate of sandwich neoadjuvant treatment in locally advanced rectal cancer may translate into a better long-term survival benefit: 5-year outcome of a Phase II clinical trial

Figures & data

Figure 1 Treatment schedules of the sandwich neoadjuvant treatment in LARC.

Abbreviation: LARC, locally advanced rectal cancer.

Figure 2 Patients enrolled in this study.

Abbreviations: NACRT, neoadjuvant chemoradiotherapy; TME, total mesorectal excision.

Table 1 Univariate survival analysis of patients according to different factors

Characteristics	5-year survival (%)
	OS	P-Value	DFS	P-Value	RFS	P-Value	MFS	P-Value
All patients	91.1 (41/45)		80.0 (36/45)		97.8 (44/45)		82.2 (37/45)
Clinical T stage
cT1-2	100 (2/2)	0.661	50.0 (1/2)	0.309	100 (2/2)	0.819	50.0 (1/2)	0.266
cT3-4	90.7 (39/43)		81.4 (35/43)		97.7 (42/43)		83.7 (36/43)
Clinical N stage
cN0	91.7 (11/12)	0.948	83.3 (10/12)	0.839	100 (12/12)	0.564	83.3 (10/12)	0.680
cN1-2	90.9 (30/33)		78.8 (26/33)		97.0 (32/33)		81.8 (27/33)
Clinical stage
II	91.7 (11/12)	0.948	83.3 (10/12)	0.839	100 (12/12)	0.564	83.3 (10/12)	0.680
III	90.9 (30/33)		78.8 (26/33)		97.0 (32/33)		81.8 (27/33)
Perineural invasion
Yes	100 (1/1)	0.759	0 (0/1)	0.000	100 (1/1)	0.873	0 (0/1)	0.000
No	90.9 (40/44)		81.8 (36/44)		97.7 (43/44)		84.1 (37/44)
Pathological T stage
ypT0	95.2 (20/21)	0.217	85.7 (18/21)	0.816	100 (21/21)	0.135	85.7 (18/21)	0.687
ypT1-2	100 (8/8)		75.0 (6/8)		87.5 (7/8)		87.5 (7/8)
ypT3-4	81.3 (13/16)		75.0 (12/16)		100 (16/16)		75.0 (12/16)
Pathological N stage
ypN0	97.4 (38/39)	0.000	87.2 (34/39)	0.000	97.4 (38/39)	0.776	89.7 (35/39)	0.000
ypN1-2	50.0 (3/6)		33.3 (2/6)		100 (6/6)		33.3 (2/6)
CEA / ng/mL
£5	92.9 (26/28)	0.600	78.6 (22/28)	0.840	96.4 (27/28)	0.463	82.1 (23/28)	0.637
>5	88.2 (15/17)		82.4 (14/17)		100 (17/17)		82.4 (14/17)
CA19–9/U/mL
£35	91.9 (34/37)	0.680	86.5 (32/37)	0.028	97.3 (36/37)	0.645	89.2 (33/37)	0.017
>35	87.5 (7/8)		50.0 (4/8)		100 (8/8)		50.0 (4/8)

Abbreviations: CA19-9, carbohydrate antigen 19-9; CEA, carcinoembryonic antigen; DFS, disease-free survival; MFS, metastasis-free survival; OS, overall survival; RFS, local recurrence-free survival.

Figure 3 Results of follow-up evaluations.

Notes: Panel A: OS, DFS, RFS and distant MFS of the 45 LARC patients treated with NACRT and TME. Panel B: Distant metastasis and local recurrence rates of the 45 LARC patients treated with NACRT and TME.

Abbreviations: DFS, disease-free survival; LARC, locally advanced rectal cancer; MFS, metastasis-free survival; NACRT, neoadjuvant chemoradiotherapy; OS, overall survival; RFS, local recurrence-free survival; TME, total mesorectal excision.

Table 2 Results of multivariate analysis on 5-year DFS and 5-year distant MFS

	Factor	P-Value	B	HR	95% CI for HR
5y-DFS	Perineural invasion	0.114	2.333	10.313	0.573–185.530
	ypN	0.001	3.045	21.010	3.238–136.323
	CA19-9)	0.005	2.436	11.422	2.054–63.506
5y-MFS	Perineural invasion	0.129	2.229	9.291	0.521–165.569
	ypN	0.002	3.800	44.701	4.153–481.150
	CA19-9	0.006	3.134	22.972	2.506–210.570

Abbreviations: CA19-9, carbohydrate antigen 19–9; ypN, postsurgical pathological N stage; HR, hazard ratio; DFS, disease-free survival; MFS, metastasis-free survival.