A phase II study of paclitaxel and nedaplatin as front-line chemotherapy in Chinese patients with metastatic esophageal squamous cell carcinoma

Table 1 Patients’ characteristics (n = 39) n (%)

Characteristics	No. of patients
Age, yr (range)	Median 60 (range, 34-72)
Sex
Female	1 (2.6)
Male	38 (97.4)
ECOG performance status
0	4 (10.3)
1	32 (82.0)
2	3 (7.7)
Tumor involved site
Lymph node	25 (64.1)
Lung	14 (35.9)
Liver	16 (41.0)
Bone	7 (17.9)
Number of involved site
1	28 (71.8)
2	13 (33.3)
≥ 3	4 (10.3)
Differentiation
Poor-differentiated	10 (25.6)
Moderate-well differentiated	23 (59.0)
Unknown	6 (15.4)
Prior treatment (cases)
Treatment-naive	30 (76.9)
Radiation	4 (10.3)
Operation	5 (12.8)

ECOG: Eastern Cooperative Oncology Group.

Table 2 Tumor response (intention-to-treat analysis) n (%)

Response	n = 39
Response rate
Complete response	2 (5.1)
Partial response	16 (41.0)
Stable disease	15 (38.5)
Progressive disease	3 (7.7)
Not assessable	3 (7.7)

Table 3 Adverse events assessment n (%)

Adverse event	NCI-CTC grade (n = 39)					Grade 3/4
	1	2	3	4	Any
Hematologic
Leucopenia	15 (25.6)	13 (33.3)	4 (10.3)	2 (5.1)	34 (87.2)	15.4%
Anemia	17 (43.6)	5 (12.8)	2 (5.1)	1 (2.6)	25 (64.1)	7.7%
Thrombocytopenia	11 (28.2)	5 (12.8)	2 (5.1)	0 (0.0)	18 (46.2)	5.1%
Nonhematologic
Gastrointestinal
Nausea	11 (28.2)	8 (20.5)	4 (10.3)	0 (0.0)	23 (59.0)	10.3%
Vomiting	10 (25.6)	6 (15.4)	2 (5.1)	0 (0.0)	18 (46.2)	5.1%
Diarrhea	6 (15.4)	0 (0.0)	0 (0.0)	0 (0.0)	6 (15.4)	0.0%
Stomatitis	2 (5.1)	1 (2.6)	0 (0.0)	0 (0.0)	3 (7.7)	0.0%
Hepatic
AST	2 (5.1)	0 (0.0)	0 (0.0)	0 (0.0)	2 (5.1)	0.0%
ALT	1 (2.6)	0 (0.0)	0 (0.0)	0 (0.0)	1 (2.6)	0.0%
Renal
Serum creatine	2 (5.1)	0	0 (0.0)	0 (0.0)	2 (5.1)	0.0%
Alopecia	3 (7.7)	9 (23.1)	0 (0.0)	0 (0.0)	12 (30.8)	0.0%
Myalgia	12 (30.8)	5 (12.8)	0 (0.0)	0 (0.0)	18 (43.6)	0.0%
Fatigue	20 (51.3)	2 (5.1)	0 (0.0)	0 (0.0)	22 (56.4)	0.0%
Neutropenia fever	0 (0.0)	0 (0.0)	1 (2.6)	0 (0.0)	1 (2.6)	2.6%

AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.