Adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone for resected pancreatic ductal adenocarcinoma: A single center experience in China

Table 1 Demographic and clinical characteristics of the patients at baseline, n (%)

Characteristic	AG	GEM	P value
Age in yr	57 (40-72)	59 (31-67)
Sex			0.787
Male	19 (63)	20 (67)
Female	11 (37)	10 (33)
Performance status			0.791
0	19 (63.3)	18 (60)
1	11 (36.7)	12 (40)
Diabetes			0.559
No	23 (77)	21 (70)
Yes	7 (23)	9 (30)
Operative procedure			0.605
Pancreatoduodenectomy	15 (50)	17 (57)
Distal pancreatectomy	15 (50)	13 (43)
Residual tumor status			0.687
R0	27 (90)	26 (87)
R1	3 (10)	4 (13)
Primary tumor status			0.638
T1	6 (20.0)	3 (10.0)
T2	17 (56.7)	20 (66.7)
T3	5 (16.6)	6 (20.0)
T4	2 (6.7)	1 (3.3)
Regional lymph node status			0.273
N0	22 (73)	18 (60)
N1	8 (27)	12 (40)
Pathological stage			0.405
I (IA/IB)	17 (5/12, 56.7)	13 (1/12, 43.4)
II (IIA/IIB)	11 (4/7, 36.6)	16 (5/11, 53.3)
III	2 (6.7)	1 (3.3)
Tumor grade			0.105
Well differentiated	3 (10)	2 (6.7)
Moderately differentiated	23 (76.7)	17 (56.7)
Poorly differentiated	4 (13.3)	11 (36.6)
Pre-adjuvant CA19-9, median	48.2	24.6	0.795
≤ 37 U/mL	13 (43.4)	14 (46.7)
> 37 U/mL	17 (56.6)	16 (53.3)

AG: Nab-paclitaxel plus gemcitabine; GEM: Gemcitabine.

Table 2 Adverse events with nab-paclitaxel plus gemcitabine and gemcitabine alone

	AG			GEM			P value	P value
	Grade 1/2 (%)	Grade 3/4 (%)	Grade 5 (%)	Grade 1/2 (%)	Grade 3/4 (%)	Grade 5 (%)		Grade ≥ 3
White blood cell count decreased	8 (26.7)	9 (30.0)	0	7 (23.3)	6 (20.0)	0	0.549	0.371
Neutropenia	5 (16.7)	13 (43.3)	0	4 (13.3)	9 (30.0)	0	0.435	0.284
Anemia	10 (33.3)	3 (10.0)	0	6 (20.0)	3 (10.0)	0	0.489	1.000
Thrombocytopenia	5 (16.7)	3 (10.0)	0	2 (6.7)	2 (6.7)	0	0.394	0.639
Fatigue	9 (30.0)	4 (13.3)	0	6 (20.0)	2 (6.7)	0	0.382	0.385
Vomiting	10 (33.3)	3 (10.0)	1 (3.3)	8 (26.7)	0	1 (3.3)	0.168	0.148
Diarrhea	8 (26.7)	1 (3.3)	0	6 (20.0)	0	0	0.392	1.000
Fever	8 (26.7)	2 (6.7)	0	5 (16.7)	1 (3.3)	0	0.496	0.550
Febrile neutropenia	2 (6.7)	4 (13.3)	1 (3.3)	3 (10.0)	1 (3.3)	0	0.296	0.073
Infection	2 (6.7)	1 (3.3)	1 (3.3)	1 (3.3)	1 (3.3)	0	0.615	0.550
Sensory neuropathy	14 (46.7)	15 (50.0)	1 (3.3)	7 (23.3)	0	0	< 0.001	< 0.001

AG: Nab-paclitaxel plus gemcitabine; GEM: Gemcitabine.