Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

Table 1 Characteristics of patients with locally advanced or metastatic GBC before treatment

Characteristic	Data
Total No. of patients (evaluable for response)	25 (23)
Sex (female/male)	15/10
Median age (range)	64 (42-78)
Nevin tumor stage	n (%)
III	4 (16.0)
IV	12 (48.0)
V	9 (36.0)
ECOG performance status at baseline
0	3 (12.0)
1	17 (68.0)
2	5 (20.0)
Site of metastasis
Liver	7 (28.0)
Lung	2 (8.0)
Lymph nodes	12 (48.0)
Peritoneum	3 (12.0)
Bone	2 (8.0)
Recurrence after surgical resection	5 (20.0)
Pre-treatment requiring stent or percutaneous transhepatic drainage because of obstructive jaundice,	4 (16.0)
Pre-treatment chemotherapy	4 (16.0) 5-FU-based chemotherapy
Liver and renal functions
Total bilirubin (6-20.5 μmol/L1)
Median	18
Range	7-58
Gamma-glutamyltransferase (183.4-833.5 nkat/L1)
Median	1 033.5
Range	283.4-2 583.9
Aspartate aminotransferase/Alanine aminotransferase (0-666.8 nkat/L1)
Median	950.2
Range	383.4-1 600.3
Blood urea nitrogen (3.2-7.0 mmol/L1)
Median	6.2
Range	3.6-7.8
Serum creatinine (44-140 μmol/L1)
Median	78
Range	48-121
CA19-9 (0-39 kU/L1)
Median	496
Range	7-10 463

¹Normal level.

Table 2 Combined chemotherapy-related toxicities to patients n (%)

Toxicity	NCI-CTC grade
	1	2	3	4
Leukopenia	9 (36.0)	5 (20.0)	2 (8.0)	0
Neutropenia	6 (24.0)	7 (28.0)	2 (8.0)	0
Anemia	2 (8.0)	4 (16.0)	0	0
Thrombocytopenia	7 (28.0)	5 (20.0)	6 (24.0)	2 (8.0)
Diarrhea	1 (4.0)	0	0	0
Nausea/emesis	5 (20.0)	0	0	0
Peripheral neuropathy	16 (64.0)	0	0	0
Pain	2 (8.0)	0	0	0

NCI-CTC: National Cancer Institute Common Toxicity Criteria. The combined treatment induced myelosuppression.

Table 3 Transformed scores for EORTC QLQ-C30 at different time points in patients treated with GEMOX and huachansu injection (mean ± SD)

Domain/Item	Baseline	First cycle	Third cycle	Sixth cycle	1 mo
Functioning
Physical	65.4 ± 17.0	57.0 ± 20.3	64.4 ± 21.0	70.6 ± 18.3	77.5 ± 16.4a
Role	57.1 ± 26.3	55.0 ± 24.3	58.5 ± 26.2	60.4 ± 25.4	63.4 ± 27.2
Emotional	54.3 ± 33.0	47.2 ± 36.8	59.4 ± 39.1	70.5 ± 24.2	69.4 ± 30.1a
Cognitive	66.1 ± 24.6	68.1 ± 30.2	77.4 ± 26.3	79.1 ± 24.0	79.5 ± 21.7a
Social	47.2 ± 30.4	39.4 ± 33.6	44.1 ± 29.0	41.1 ± 30.7	48.2 ± 32.6
Global QOL	52.3 ± 20.0	41.4 ± 24.3	50.6 ± 29.7	55.4 ± 30.0	65.3 ± 22.4a
symptoms
Fatigue	43.3 ± 31.2	51.2 ± 33.4	40.1 ± 27.4	42.1 ± 22.0	38.2 ± 28.6
Nausea and vomiting	7.6 ± 6.2	9.0 ± 5.1	7.4 ± 4.3	5.4 ± 2.5	3.2 ± 2.1a
Pain	44.5 ± 21.6	28.0 ± 18.3	25.5 ± 12.4	24.3 ± 9.1	26.0 ± 10.4a

Quality of life was assessed at baseline, at the end of the first, third and sixth chemotherapeutic cycles, and 1 mo after completion of chemotherapy. Scores of EORTC QLQ-C30 were converted to linear transformation ranging from 0 to 100. Higher scales for the functional and global QOL represent a better function. In contrast, higher scales for symptoms represent worse symptoms.

^aP < 0.05 vs baseline.