Comparison of cisplatinum/paclitaxel with cisplatinum/5-fluorouracil as first-line therapy for nonsurgical locally advanced esophageal squamous cell carcinoma patients

Figures & data

Table 1 Patient and tumor characteristics

Characteristics	Group A	Group B	P-value
Number of patients	105	97
Age (range)a	61.3 (43–73)	61.1 (45–75)	0.872
Sex			0.160
Male	87 (82.9%)	87 (89.7%)
Female	18 (17.1%)	10 (10.3%)
Clinical stage			0.409
IIB	9 (8.6%)	14 (14.4%)
IIIA	58 (55.2%)	45 (46.4%)
IIIB	16 (15.2%)	19 (19.6%)
IIIC	22 (21.0%)	19 (19.6%)
Tumor length ≥5.2 cm	62 (59.0%)	59 (60.8%)	0.797
Tumor site			0.626
Cervical	2 (1.9%)	5 (5.2%)
Upper	41 (39.0%)	39 (40.2%)
Mid	52 (49.5%)	45 (46.4%)
Low	10 (9.5%)	8 (8.2%)
Radiation dose			0.423
<54 Gy	5 (4.8%)	8 (8.2%)
54–60 Gy	96 (91.4%)	83 (85.6%)
>60 Gy	4 (3.8%)	6 (6.2%)
Comorbidity present	59/105 (56.2%)	39/97 (40.2%)	0.023
Pulmonary, cardiovascular	37 (35.2%)	29 (29.9%)	0.185
and diabetes comorbidities
Type of comorbidity			0.068
None	46 (43.8%)	58 (59.8%)
Pulmonary	6 (5.7%)	9 (9.3%)
Cardiovascular	31 (29.5%)	20 (20.6%)
Diaetes	6 (5.7%)	2 (2.1%)
Otherb	16 (15.2%)	8 (8.2%)

Notes:

a Student’s t-test, all other variables were compared using a χ² test.

b Other consisted of some kind of chronic diseases such as chronic gastritis and hepatitis and so on, which were not closely related to esophageal carcinoma.

Table 2 Response among patients with locally advanced ESCC to first-line treatment

Response	Group A (n=105)	Group B (n=97)	Total (n=202)
CR (%)	18 (17.1)	7 (7.2)	25 (12.4)
PR (%)	37 (35.2)	30 (30.9)	67 (33.2)
SD (%)	46 (43.8)	55 (56.7)	101 (50.0)
PD (%)	4 (3.8)	5 (5.2)	9 (4.5)

Abbreviations: CR, complete response; ESCC, esophageal squamous cell carcinoma; PD, progressive disease; PR, partial response; SD, stable disease.

Table 3 Efficacy of first-line treatment

Response	Group A (n=105)	Group B (n=97)	P-value
RR	52.4%	38.1%	0.042
DCR	96.2%	94.8%	0.740
PFS (months)	13.0	15.9	0.016
OS (months)	23.1	33.9	0.014
1-year survival rate	82.9%	76.3%	0.246
2-year survival rate	61.9%	47.4%	0.039

Abbreviations: DCR, disease-control rate; OS, overall survival; PFS, progression-free survival; RR, response rate.

Table 4 Cox proportional hazard model for progression-free survival and overall survival

Factors	Progression-free survival			Overall survival
	HR	95% CI	P-value	HR	95% CI	P-value
Sex	1.258	0.822–1.927	0.291	1.100	0.671–1.801	0.706
Clinical stage	1.144	0.977–1.330	0.096	1.256	1.040–1.517	0.018
Radiation dose	0.349	0.217–0.560	<0.001	0.592	0.344–1.017	0.058
Chemotherapy regimen	0.603	0.442–0.822	0.001	0.694	0.487–0.989	0.043
CR	0.813	0.482–1.370	0.436	0.312	0.128–0.758	0.010
RR	0.280	0.198–0.398	<0.001	0.407	0.275–0.603	<0.001

Abbreviations: CI, confidence interval; CR, complete response; HR, hazard ratio; RR, response rate.

Figure 1 Kaplan–Meier estimates of progression-free survival according to different chemotherapy regimens.

Notes: Kaplan–Meier analysis showed that locally advanced esophageal squamous cell carcinoma patients on cisplatinum/paclitaxel regimen had longer progression-free survival than patients with cisplatinum/5-fluorouracil regimen (15.9 versus 13.0 months, P=0.016).

Figure 2 Kaplan–Meier estimates of overall survival according to different chemotherapy regimens.

Notes: Kaplan–Meier analysis showed that locally advanced esophageal squamous cell carcinoma patients on cisplatinum/paclitaxel regimen had longer overall survival than patients with cisplatinum/5-fluorouracil regimen (33.9 versus 23.1 months, P=0.014).

Figure 3 The ROC analysis of radiation dose.

Note: The optimal cutoff value for radiation dose is 59.5 Gy with 71.1% sensitivity and 41.9% specificity.
Abbreviations: AUC, area under the curve; ROC, receiver operating curve.

Table 5 Major toxicities during dCRT

Adverse reaction	Group A (%)	Group B (%)	P-value
Toxicities (CTCAE 4.0)
Overall toxicity ≥ grade 3	24 (22.9)	35 (36.5)	0.039
Grade 3	17 (16.2)	25 (25.8)	0.094
Grade 4	7 (6.7)	10 (10.3)	0.352
Hematological ≥ grade 3	11 (10.5)	16 (16.5)	0.209
Nonhematological ≥ grade 3	13 (12.4)	19 (19.6)	0.161
Hematological
Neutropenia
Grade 3	4 (3.8)	9 (9.2)	0.118
Grade 4	2 (1.9)	3 (3.1)	0.587
Thrombocytopenia
Grade 3	5 (4.8)	4 (4.1)	1.000
Grade 4	3 (2.9)	4 (4.1)	0.712
Anemia
Grade 3	1 (1.0)	5 (5.2)	0.107
Grade 4	0 (0)	1 (1.0)	0.480
Nonhematological
Nausea/vomiting	6 (5.7)	7 (7.2)	0.664
Diarrhea	3 (2.9)	2 (2.1)	1.000
Esophagitis	0 (0.0)	1 (1.0)	0.480
Pneumonia	1 (1.0)	0 (0.0)	1.000
Other	3 (2.9)	9 (9.3)	0.054

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; dCRT, definitive concurrent chemoradiotherapy.