Oral chemotherapy for second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer

Table 1 Patients baseline characteristics and 5-fluorouracil exposure

Total (n = 81)	Capecitabine	S-1	P value
	(n = 41)	(n = 40)
Age
Median (Range)	61 (39-77)	63 (41-78)	0.175
Gender, n (%)
Male	24 (59)	27 (67)	0.404
Female	17 (41)	13 (33)
ECOG performance status, n (%)
0-1	30 (73)	29 (72)	0.946
2	11 (27)	11 (28)
Disease status at diagnosis, n (%)
Resectable	15 (36)	26 (65)
Locally advanced	4 (10)	2 (5)
Metastatic	19 (46)	12 (30)
Missing data	3 (7)	0
Overall disease classification, n (%)
Initially unresectable	23 (56)	14 (35)	0.057
Locally advanced	4 (9)	2 (5)
Distant metastasi	19 (46)	12 (30)
Recurrent	18 (44)	26 (65)
Prior treatment, n (%)
Surgery	18 (44)	26 (65)	0.057
Radiotherapy	17 (41)	11 (28)	0.186
Adjuvant chemotherapy	14 (34)	19 (48)	0.221
Number of previous regimens received, n (%)
1	40 (98)	36 (90)	0.201
> 2	1 (2)	4 (10)
Subsequent chemotherapy after oral chemotherapy, n (%)	12 (29)	17 (43)	0.214
Prior gemcitabine-based regimen, n (%)
Gemcitabine	8 (20)	9 (22)
Gemcitabine/erlotinib	31 (76)	7 (18)
Gemcitabine/cisplatin	2 (5)	0
Gemcitabine/nab-paclitaxel	0	24 (60)
5-Fluorouracil exposure, n (%)	13 (31)	19 (50)	0.146

ECOG: Eastern Cooperative Oncology Group.

Table 2 Relative dose intensity of the capecitabine or S-1 for advanced gemcitabine refractory pancreatic cancer

	Capecitabine (n = 41)	S-1 (n = 40)	P value
Duration of treatment, months
Median	1.7	2.0	0.120
Range	0.7-6.9	0.8-6.2
Dose intensity
Median	0.92	1.00	0.986
Range	0.70-1.00	0.50-1.00

Table 3 Response rate in each treatment regimen

	Capecitabine (n = 41)	S-1 (n = 40)	P value
Complete response	0	0
Partial response	4 (9.8)	1 (2.5)
Stable disease	5 (12.2)	10 (25.0)
Progressive disease	32 (78.0)	27 (67.5)
Not available	0	2 (5.0)
Objective response rate, n (%)	4 (9.8)	1 (2.5)	0.359
Disease control rate, n (%)	8 (19.5)	11 (21.5)	0.396

Table 4 Toxicity profile during treatment

Adverse event n, (%)	Capecitabine (n = 41)		S-1 (n = 40)
	Any grade	Grade ≥ 3	Any grade	Grade ≥ 3	P value1
Nausea	11 (26.8)	1 (2.4)	13 (32.5)	1 (2.5)	1.000
Vomiting	4 (9.8)	1 (2.4)	5 (12.5)	0	1.000
Diarrhea	4 (9.8)	0	3 (7.5)	0
Stomatitis	7 (17.1)	0	6 (15.0)	1 (2.5)	0.494
Hand-foot syndrome	13 (31.7)	6 (14.6)	2 (5.0)	0	0.026
Anemia	12 (29.3)	0	9 (22.5)	0
Neutropenia	7 (17.1)	0	3 (7.5)	0

¹P value for grade ≥ 3 adverse events.