Toxicity, Disease Control, and Survival Outcomes of Intensified Preoperative Chemoradiotherapy in Patients with Locally Advanced Rectal Cancer: A Single-Institution Study

Figures & data

Table 1 Baseline Characteristics

Characteristic	No.	%
Age, years
Mean (IQR)	60
Range	51–66.25
Sex
Male	109	60.22%
Female	72	39.78%
Distance from anal verge
≤5cm	81	44.75%
>5–10cm	72	39.78%
>10cm	19	10.50%
Uncertain	9	4.97%
Clinical T category
cT1	1	0.55%
cT2	15	8.29%
cT3	150	82.87%
cT4a	8	4.42%
cT4b	7	3.87%
Clinical N category
cN0	14	7.9%
cN1	90	49.72%
cN2	77	42.54%
Pathologic T category
ypT0	38	23.75%
ypT1–2	52	32.5%
ypT3–4	70	43.75%
ypN0	113	70.63%
ypN1-2	47	29.37%
Perineural invasion
Absent	10	6.25%
Present	150	93.75%
Lymphovascular invasion
Absent	7	4.38%
Present	153	95.62%
EMVI
Absent	35	19.34%
Present	146	80.66%
mrCRM
Absent	99	54.70%
Present	82	45.30%
CEA
Normal	149	82.32%
Abnormal	32	17.68%

Table 2 Treatment Compliance with Preoperative Chemoradiotherapy and Consolidation Chemotherapy

Treatment Compliance	N(%)
Radiotherapy (45Gy) complete rates	180 (99.45)
Concurrent chemotherapy
Full dose	175 (96.69)
Monotherapy in second cycle	5 (3.31)
No. of chemotherapycyclesduring intermission between the end of chemoradiatherapy and surgery
1	142 (88.75)
2–4	18 (11.25)
No. of consolidation chemotherapy cycles
0	20 (12.5)
1–2	39 (24.37)
3–4	66 (41.25)
>5	35 (21.88)

Figure 1 Flow chart of preoperative chemoradiotherapy in patients with rectal cancer.

Table 3 Subgroup Analysis for Overall Survival (OS)

	Univariate HR(95% CI)	P	Multivariate HR(95% CI)	P
Age (<65 vs≥65years=	3.564 (1.177–10.789)	0.025	5.263 (1.607–17.233)	0.006
Sex (female vs male)	0.286 (0.063–1.293)	0.104	–	–
cT (cT1-2 vs T3-4)	0.91 (0.117–7.093)	0.928	–	–
cN (cN0 vs cN1-2)	23.089 (0.005–115,016.914)	0.470	–	–
ypN (ypN0 vs ypN1-2)	4.442 (1.508–13.084)	0.007	–	–
ypTNM (0 vs 1 vs 2 vs 3)	2.779 (1.352–5.712)	0.005	2.499 (1.133–5.510)	0.023
Distance from anal verge (≤5cm vs>5–10cm vs>10cm)	1.059 (0.567–1.978)	0.858	–	–
Postoperative chemotherapy	1.427 (0.316–6.447)	0.644	–	–
Intervals between end of preoperative chemoradiotherapy and surgery (≤8w vs>8w)	0.677 (0.227–2.018)	0.484	–	–
Perineuralinvasion (Absent vs Present)	1.984 (0.156–25.215)	0.597	–	–
Lymphovascular invasion (Absent vs Present)	1.352 (0.061–29.807)	0.849	–	–
Tumor regression grade	2.459 (1.151–5.252)	0.02	2.732 (1.131–6.597)	0.025
EMVI (Absent vs Present)	0.371 (0.046–2.973)	0.350	–	–
mrCRM (Absent vs Present)	1.088 (0.153–7.767)	0.933	–	–

Notes: P<0.05 display in bold font.

Abbreviation: HR, hazard ratio.

Figure 2 Overall survival (OS). (A) All patients in the study. (B) Achieved pCR vs None achieved pCR, P = 0.013. (C) Sphincter preservation vs Non- sphincter preservation in patients with low rectal cancer, P = 0.740.

Table 4 Acute Adverse Effects in Patients After Received Preoperative Chemoradiotherapy

Toxicity	Grade 1–2	Grade 3–4	Total
Leukocytes	131	20	151
Platelets	68	6	74
Hemoglobin	51	7	58
Diarrhea	64	1	65
Proctitis	42	1	43
Nausea	28	0	28
Obstipation	21	0	21
Anorexia	20	0	20
Regurgitation of gastric acid	15	0	15
Indigestion	5	0	5
Intestinal spasm	2	0	2
Radiocystitis	2	0	2
Radiation enteritis	1	0	1
Hepatic dysfunction	1	0	1
Ileus	0	1	1

Table 5 Postoperative Complications in Patients After Received Preoperative Chemoradiotherapy

Complications	n
Infection	7
Anastomotic leakage	6
Wound-healing problems	4
Pelvic cavity effusion	3
Ileus	3
Anastomotic stenosis	2
Fistula (small bowel)	2
Voiding dysfunction	1
Small-bowel mesenteric Hemorrhage	1
Voiding dysfunction	1
Intestinal adhesion	1
Incisional hernia	1
Hydronephrosis	1