Treatment Outcome and Safety of the TCX Regimen for Advanced Gastric Cancer: A Prospective Cohort Study

Figures & data

Figure 1 Study flow chart.

Table 1 Baseline Characteristics (n = 83)

Characteristic	Result
Sex, n (%)
Male	59 (71.1)
Female	24 (28.9)
Age (year), median (IQR)	58 (54–65)
BMI group, n (%)
Underweight	22 (26.5)
Normal BMI	53 (63.9)
Overweight / obese	8 (9.6)
History of surgery before TCX, n (%)
No surgery	51 (61.4)
Gastrectomy	16 (19.3)
Gastroenterostomy	16 (19.3)
ECOG PS, n (%)
0	41 (49.4)
1	23 (27.7)
2	19 (22.9)
Clinical presentation, n (%)
Abdominal pain	64 (77.1)
Weight loss	61 (73.5)
Anorexia	51 (61.4)
Fatigue	48 (57.8)
Early satiety	42 (50.6)
Pyloric stenosis	20 (24.1)
Nausea	13 (15.7)
Vomiting	13 (15.7)
Gastrointestinal bleeding	12 (14.5)
Dysphagia	1 (1.2)
Number of metastases, n (%)
0	25 (30.1)
1	42 (50.6)
2–3	16 (19.3)
Site of metastasis, n (%)
Liver	27 (32.5)
Peritoneum	22 (26.5)
Lung	6 (7.2)
Lymph nodes	18 (21.7)
Ovary	1 (1.2)
Supraclavicular lymph node	1 (1.2)
TNM stage, n (%)
IVa	26 (31.3)
IVb	57 (68.7)
CEA ≥5 ng/mL, n (%)	44 (53.0)
CA 72–4 ≥5 UI/mL, n (%)	38 (45.8)
White cell count (/μL), median (IQR)	7.6 (6.1–8.6)
Hemoglobin level (g/L), median (IQR)	122.0 (105.0–134.0)
Platelet count (/mm3), median (IQR)	335.0 (254.0–403.0)
Creatinine (mmol/L), median (IQR)	76.0 (68.0–90.0)
AST, median (IQR)	24.0 (19.0–35.0)
ALT, median (IQR)	20.0 (15.0–29.0)

Abbreviations: IQR, interquartile range; ECOG PS, Eastern Cooperative Oncology Group Performance status; AST, aspartate transferase; ALT, alanine transferase; BMI, body mass index; TNM, tumor node metastasis; CEA, carcinoembryonic antigen; CA 72-4, cancer antigen 72-4; TCX, taxane carboplatin capecitabine.

Figure 2 Kaplan-Meier estimates of (A) progression-free survival and (B) overall survival among the study participants (n = 83).

Figure 3 Kaplan-Meier estimates of (A) progression-free survival and (B) overall survival among the study participants, stratified by CEA levels (n = 83).

Table 2 Univariate and Multivariable Analysis of Factors Associated with Progression-Free Survival and Overall Survival Among the Study Participants (n = 83)

Variables	Progression-Free Survival (PFS)		Overall Survival (OS)
	Univariate Analysis	Multivariable Analysis	Univariate Analysis	Multivariable Analysis
	HR (95% CI)	HR (95% CI)	HR (95% CI)	HR (95% CI)
Clinicopathologic factors
Age (≥55 versus <55)	1.33 (0.79–2.22)	1.53 (0.88–2.67)	1.17 (0.68–1.99)	0.79 (0.46–1.38)
Female	0.85 (0.51–1.42)	1.15 (0.68–1.96)	0.84 (0.49–1.45)	0.79 (0.46–1.37)
BMI	0.84 (0.48–1.49)		1.19 (0.67–2.09)
(<18.5 versus ≥18.5)
Performance status (2 versus <2)	1.02 (0.58–1.81)		0.78 (0.44–1.39)
Histological type*	0.98 (0.61–1.59)		0.99 (0.59–1.67)
CEA (≥5ng/mL versus <5ng/mL)	1.75 (1.08–2.82)	1.59 (0.97–2.62)	1.86 (1.12–3.07)	1.89 (1.13–3.17)
CA 72–4 (≥5ng/mL versus <5ng/mL)	1.08 (0.68–1.73)		1.28 (0.78–2.12)
Tumor factors
Tumor location
Cardia
Corpus	1.07 (0.33–3.46)		1.41 (0.43–4.55)
Antrum	0.97 (0.54–1.75)		1.09 (0.59–2.05)
Pretreatment tumor size (≥5cm versus <5cm)	1.01 (0.61–1.67)		1.07 (0.62–1.83)
Tumor status (T4 versus T3 or less)	2.06 (0.89–4.78)		1.59 (0.68–3.71)
Nodal status (N3 versus N2 or less)	0.65 (0.39–1.07)		0.91 (0.54–1.55)
Metastatic status (M1 versus M0)	1.77 (1.05–2.97)	1.38 (0.76–2.50)	1.27 (0.75–2.16)
TNM stage (IVb versus IVa)	1.82 (1.07–3.10)		1.33 (0.78–2.29)	1.15 (0.66–2.01)
Liver metastasis (yes versus no)	1.78 (1.09–2.89)	1.33 (0.75–2.34)	1.34 (0.80–2.25)
Peritoneal metastasis (yes versus no)	0.96 (0.57–1.63)		1.14 (0.65–1.99)

Notes: Indicators: *poorly differentiated adenocarcinoma and squamous cell carcinoma versus moderately differentiated adenocarcinoma.

Table 3 Tumor Response Rate Among the Study Participants (n = 83)

Response rate	n	%
Objective response rate	35	42.1
Partial response	31	37.3
Complete response	4	4.8
Stable disease	18	21.7
Progress disease	30	36.1

Table 4 Clinical Improvement Among the Study Participants (n = 83)

Symptoms	At Baseline	After the Treatment Course	P-value
Fatigue	48	19	<0.001
Abdominal pain	64	35	<0.001
Early satiety	42	23	<0.001
Poor eating	51	26	<0.001
Difficulty swallowing	1	0	0.31
Nausea	13	9	0.21
Vomiting	13	9	0.21
Lose weight	61	19	<0.001
Pyloric stenosis	20	10	0.008
Gastrointestinal bleeding	12	4	0.005

Table 5 Hematologic and Nonhematologic Toxicities (n = 83)

Cycle	All Grades						Grade III/IV
	1	2	3	4	5	6	1	2	3	4	5	6
Peripheral neuropathy	1 (1.2)	9 (10.8)	29 (34.9)	44 (58.7)	53 (73.6)	51 (75.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Nausea	38 (45.8)	43 (51.8)	40 (48.2)	35 (46.7)	39 (54.2)	36 (52.9)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Allergy	1 (1.2)	1 (1.2)	1 (1.2)	0 (0.0)	1 (1.4)	2 (2.9)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
HFS	0 (0.0)	14 (16.9)	34 (41.0)	46 (61.3)	50 (69.4)	53 (77.9)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Fatigue	57 (68.7)	55 (66.3)	53 (63.9)	50 (65.8)	46 (63.9)	43 (63.2)	1 (1.2)	1 (1.2)	1 (1.2)	1 (1.3)	1 (1.4)	1 (1.5)
Diarrhea	9 (10.8)	31 (37.3)	27 (32.5)	23 (30.7)	22 (30.6)	30 (44.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Stomatitis	5 (6.0)	4 (4.8)	6 (7.2)	13 (17.1)	16 (22.2)	10 (14.7)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Phlebitis	1 (1.2)	2 (2.4)	2 (2.4)	1 (1.3)	2 (2.8)	2 (2.9)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Anemia	44 (53.0)	52 (62.7)	57 (68.7)	52 (69.3)	53 (73.6)	53 (75.7)	1 (1.2)	2 (2.4)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.4)
Neutropenia	40 (48.2)	57 (68.7)	58 (69.9)	52 (69.3)	52 (72.2)	48 (68.6)	12 (14.5)	16 (19.3)	22 (26.5)	20 (26.7)	18 (25.0)	19 (27.1)
Thrombocytopenia	7 (8.4)	9 (10.8)	15 (18.1)	22 (29.3)	27 (37.5)	23 (32.9)	0 (0.0)	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.4)
Leukopenia	29 (34.9)	37 (44.6)	43 (51.8)	40 (53.3)	45 (62.5)	38 (54.3)	1 (1.2)	5 (6.0)	8 (9.6)	9 (12.0)	8 (11.1)	6 (8.6)

Abbreviation: HFS, Hand Foot Syndrome.

Table 6 Administration Due to AEs, G-CSF Uses and Treatment Discontinuation

Administration (n =466 cycles)
Administration due to all AEs, n (%)	193 (41.4)
Duration of administration (days), Median (IQR)	1 (1–4)
G-CSF uses (n = 466, cycles)
As secondary prophylactic, Median (IQR)	3 (0–4)
As subsequent courses, Median (IQR)	2 (0–4)
Treatment discontinuation
Number of patients completed 6 cycles, n (%)	70 (84.3)
Number of patients only completed 5 cycles, n (%)	2 (2.4)
Number of patients only completed 4 cycles, n (%)	3 (3.6)
Number of patients only completed 3 cycles, n (%)	8 (9.7)
Reason of discontinuation
Intolerable	3
Early withdrawal	2
Disease progression	8