Efficacy and safety of gemcitabine-based chemotherapies in biliary tract cancer: A meta-analysis

Table 1 Study characteristics

Ref.	Year	Treatment	n	Male (%)	Age	DRR	DCR	PFS	OS
					mean (range), yr	(%)	(%)	(mo)	(mo)
Valle et al[10]	2010	GEM + CIS	204	52.9	63.9 (32.8-81.9)	21.6	81.4	8.0	11.7
		GEM	206	52.4	63.2 (23.4-84.8)	15.5	71.8	5.0	8.0
Okusaka et al[18]	2010	GEM + CIS	41	43.9	65 (43-80)	19.5	68.3	5.8	11.2
		GEM	42	50.0	66.5 (49-78)	11.9	50.0	3.7	7.7
Sasaki et al[12]	2013	GEM + S-1	30	53.3	68 (47-83)	20.0	70.0	5.6	8.9
		GEM	32	66.7	75 (55-86)	9.4	62.5	4.3	9.2
Kornek et al[14]	2004	GEM + MMC	25	32.0	67 (44-75)	21.7	60.9	4.2	6.7
		MMC + CAPE	26	38.5	65 (45-75)	33.3	70.8	5.3	9.3
Sharma et al[17]	2010	GEM + OX	26	19.2	49	30.7	68.7	8.5	9.5
		FUFA	28	17.9	47	14.3	21.4	3.5	4.6
Kang et al[11]	2012	GEM + CIS	49	63.3	59 (32-77)	19.6	71.7	5.7	10.1
		S-1 + CIS	48	64.6	60 (36-77)	23.8	85.7	5.4	9.9
Morizane et al[13]	2013	GEM + S-1	50	54.0	66 (39-78)	36.4	59.1	7.1	12.5
		S-1	51	47.1	62.5 (49-79)	17.4	39.1	4.2	9.0

CAPE: Capecitabine; CIS: Cisplatin; DCR: Disease control rate; DRR: Disease response rate; FUFA: Fluorouracil-folinic acid; GEM: Gemcitabine; MMC: Mitomycin C; OS: Overall survival; OX: Oxaliplatin; PFS: Progression-free survival.

Table 2 Percentage of cases with grade 3 or 4 toxicity n (%)

Ref.	Treatment	Leukopenia	Neutropenia	Anemia	Thrombo-cytopenia	Increased ALT level	Nausea	Vomiting	Anorexia	Diarrhea
Valle et al[10]	GEM + CIS	15.7	25.3	7.6	8.6	9.6	4.0	5.1	3.0	NR
	GEM	9.5	16.6	3.0	6.5	17.1	3.5	5.5	2.5	NR
Okusaka et al[18]	GEM + CIS	29.3	56.1	36.6	39.0	24.4	0.0	0.0	0.0	2.4
	GEM	19.0	38.1	16.6	7.2	16.7	0.0	0.0	2.8	0.0
Sasaki et al[12]	GEM + S-1	33.0	33.0	10.0	7.0	3.0	3.0	0.0	3.0	0.0
	GEM	19.0	22.0	6.0	6.0	0.0	0.0	0.0	6.0	0.0
Kornek et al[14]	GEM + MMC	17.0	13.0	0.0	13.0	40.0	44.0	NR	NR	28.0
	MMC + CAPE	17.0	17.0	0.0	17.0	45.0	42.0	NR	NR	28.0
Sharma et al[17]	GEM + OX	38.5	38.5	38.5	10.0	15.4	NR	7.7	NR	NR
	FUFA	7.1	7.1	7.1	2.0	0.0	NR	7.1	NR	NR
Kang et al[11]	GEM + CIS	24.4	49.0	22.4	22.4	4.1	4.1	4.1	0.0	0.0
	S-1 + CIS	0.0	31.8	2.3	4.5	0.0	2.1	0.0	0.0	4.3
Morizane et al[13]	GEM + S-1	29.4	60.7	11.8	11.8	13.7	2.0	2.0	7.8	2.0
	S-1	2.0	4.0	4.0	4.0	12.0	4.0	0.0	6.0	6.0

ALT: Alanine aminotransferase; CAPE: Capecitabine; CIS: Cisplatin; FUFA: Fluorouracil-folinic acid; GEM: Gemcitabine; MMC: Mitomycin C; NR: No record; OX: Oxaliplatin.

Table 3 Jadad scores of the included studies

Study	Randomization	Concealed allocation	Double-blind	Complete description
Valle et al[10]	1	1	0	1
Okusaka et al[18]	1	1	0	1
Sasaki et al[12]	1	1	0	1
Kornek et al[14]	2	1	0	1
Sharm et al[17]	1	1	0	1
Kang et al[11]	1	1	0	1
Morizane et al[13]	2	2	0	1