Meta-analysis on inoperable pancreatic cancer: A comparison between gemcitabine-based combination therapy and gemcitabine alone

doi:10.3748/wjg.v12.i43.6973

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Clinical Research

World J Gastroenterol. Nov 21, 2006; 12(43): 6973-6981
Published online Nov 21, 2006. doi: 10.3748/wjg.v12.i43.6973

Table 1 Randomized controlled trials (GEM combination vs GEM alone)

Studies	Intervention	Patients	OS (d)	6-mo survival (%)	1-yr survival (%)	6-mo TTP/PFS/TTF rate (%)	ORR (CR + PR) %	CBR	Jadad score
Scheithauer 2003[8]	Gem	42	246	59.4	37.2	24.6 (PFS)	6/42	10/30	3
Scheithauer 2003[8]	Gem + Capecitabine	41	285	67.7	31.8	36.9	7/41	15/31
Colucci 2002[9]	Gem	54	140	31.5	11	18 (TTP)	5/48	21/43	3
Colucci 2002[9]	Gem + DDP	53	210	47	11.3	28	14/45	20/38
Wang XY 2002[10]	Gem	20	-	81.3	31.3	-	1/16	14/16	3
Wang XY 2002[10]	Gem + DDP	22	-	61.6	11.1	-	2/18	14/20
Gansauge 2002[11]	Gem	28	144	32	11	-	1/28	-	3
Gansauge 2002[11]	Gem + NSC-631570	28	279	64	29	-	6/28	-
Berlin 2002[12]	Gem	162	162	42	15.5	32/160 (PFS)	9/162	-	3
Berlin 2002[12]	Gem + 5-FU	160	201	55	21.9	41/158	11/160	-
Bramhall 2002[13]	Gem + placebo	119	164	43	17	23 (TTF)	14/88	-	5
Bramhall 2002[13]	Gem + marimastat	120	165.5	47	18	29	11/97	-
Cutsem 2004[14]	Gem + placebo	347	182	49	24	-	28/347	-	5
Cutsem 2004[14]		341	193	53	27	-	20/341	-
Louvet 2005[15]	Gem	156	213	60.4	27.8	27.4 (PFS)	27/156	26.9	3
Louvet 2005[15]	Gem¹ + Oxaliplatin	157	270	68	34.7	43	42/157	38.2
Reilly 2004[16]	Gem	174	186	51	21	27 (TTP)	9/127	-	3
Reilly 2004[16]	Gem + DX-8951f	175	201	54	23	39	12/147	-
Richards 2004[17]	Gem	282	189	50.9	20.1	27.6 (PFS)	20/220	-	3
Richards 2004[17]	Gem + Pemetrexed	283	186	50.9	21.4	32.1	42/230	-
Li CP 2004[18]	Gem	25	138	20.3	13.6	11.8 (TTP)	3/25	9/25	3
Li CP 2004[18]	Gem + DDP	21	168	31.1	6.3	11.8	2/21	6/21
Reni 2004[19]	Gem	47	-	63.9	21.3	12.9 (PFS)	4/47	5/20	3
Reni 2004[19]	Gem + 5-FU + DDP + EPI	52	-	64.6	38.5	37.4	20/52	15/23
Viret 2004[20]	Gem	41	201	58.3	25.1	10 (TTF)	2/41	-	3
Viret 2004[20]	Gem + DDP	42	241	55.5	32.4	14	3/42	-
Rocha Lima 2004[21]	Gem	180	198	52.9	22	21.9 (TTP)	8/180	-	3
Rocha Lima 2004[21]	Gem + Irinotecan	180	189	50.7	21	30.6	29/180	-
Costanzo 2001[22]	Gem	49	217	59	14.5	-	4/48	-	3
Costanzo 2001[22]	Gem + 5-FU	44	210	59	23.3	-	5/43	-
Heinemann 2003[23]	Gem	97	180	48.6	22.5	25.6 (TTP)	8/93	-	3
Heinemann 2003[23]	Gem + DDP	95	228	59.4	27.5	39.3	10/92	-
Kulke 2004[24]	Gem²	45	-	24/45	-	-	-	-	3
	Gem + DDP	45	-	23/45	-	-	-	-
	Gem + Docetaxel	49	-	22/49	-	-	-	-
	Gem + Irinotecan	44	-	21/44	-	-	-	-
Richards 2002[25]	Gem + Placebo	88	213	62.9	20.4	25.9 (TTF)	5/63	-	5
Richards 2002[25]	Gem + CI-994	86	191	60.8	18.5	16.7	1/61	-
Moore 2005[26]	Gem + Erlotinib	285	191	58	24	32 (PFS)	23/268	-	5
Moore 2005[26]	Gem + placebo	284	177	49	17	25	21/262	-
Stathopoulos 2005[27]	Gem	70	195	50	21.82	-	7/70	-	3
Stathopoulos 2005[27]	Gem + Irinotecan	60	192	60	24.29	-	9/60	-
Riess 2005[28]	Gem	236	186	53	20	30 (TTP)	17/236	-	3
Riess 2005[28]	Gem + 5-FU/CF	230	175.5	49	20	29	11/230	-
Herrmann 2005[29]	Gem	157	219	62	27	42 (PFS)	12/152³	-	3
Herrmann 2005[29]	Gem + Capecitabine	159	252	60	31	42	15/148	-

¹Gemcitabine 1 g/m² as a 100-min infusion;

²Gemcitabine 1500 mg/m² at a fixed dose rate of 10 mg/m² per minute;

³RECIST criteria.

Table 2 Toxic effects recorded from randomized controlled trials (Grade 3-4 toxic effects)

Studies	Intervention	Neutrophils	Platelets	Anemia	Infection	Nausea/vomit	Mucositis	Diarrhea
Scheithauer2003[8]	Gem	3/39	1/39	0	0	0	0	0
Scheithauer2003[8]	Gem + Capecitabine	4/40	0	2/40	0	0	0	2/40
Colucci 2002[9]	Gem	5/53	1/53	2/53	-	1/53	1/53	0
Colucci 2002[9]	Gem + DDP	9/51	1/51	3/51	-	1/51	0	2/51
Wang XY 2002[10]	Gem	5/19	7/19	2/19	-	0	-	-
Wang XY 2002[10]	Gem + DDP	7/21	8/21	9/21	-	2/21	-	-
Gansauge2002[11]	Gem	-	-	-	-	3/28	-	1/28
Gansauge2002[11]	Gem + NSC-631570	-	-	-	-	1/18	-	0
Berlin 2002[12]	Gem	8/158	17/158	16/158	-	30/158	3/158	/158
Berlin 2002[12]	Gem + 5-FU	11/158	30/158	16/158	-	29/158	2/158	/158
Bramhall 2002[13]	Gem + placebo	9/119	-	7/119	12/119	16/119	-	-
Bramhall 2002[13]	Gem + marimastat	3/120	-	3/120	11/120	13/120	-	-
Cutsem 2004[14]	Gem + placebo	103/342	41/342	55/342	-	58/342	-	10/342
Cutsem 2004[14]	Gem + R115777	132/331	50/331	66/331	-	46/331	-	13/331
Louvet 2005[15]	Gem	2/156	5/156	16/156	-	12/156	-	2/156
Louvet 2005[15]	Gem + Oxaliplatin	2/157	22/157	10/157	-	30/157	-	9/157
Reilly 2004[16]	Gem	24/157	7/157	13/157	-	17/157	-	2/157
Reilly 2004[16]	Gem + DX-8951f	50/168	28/168	11/168	-	33/168	-	6/168
Richards 2004[17]	Gem	35/273	17/273	8/273	-	18/273	-	2/273
Richards 2004[17]	Gem + Pemetrexed	123/273	49/273	38/273	-	18/273	-	8/273
Li CP 2004[18]	Gem	2/25	1/25	2/25	-	-	-	-
Li CP 2004[18]	Gem + DDP	4/21	5/21	2/21	-	-	-	-
Reni 2004[19]	Gem	9/47	1/47	2/47	-	4/47	1/47	-
Reni 2004[19]	Gem + 5-FU + DDP + EPI	22/52	15/52	2/52	-	3/52	2/52	-
Viret 2004[20]	Gem	16/40	5/40	11/40	-	3/40	-	-
Viret 2004[20]	Gem + DDP	23/41	14/41	14/41	-	9/41	-	-
Rocha Lima 2004[21]	Gem	54/169	24/169	22/169	-	31/169	-	3/169
Rocha Lima 2004[21]	Gem + Irinotecan	65/173	34/173	27/173	-	53/173	-	33/173
Costanzo 2001[22]	Gem	1/49	0	3/49	-	0	0	0
Costanzo 2001[22]	Gem + 5-FU	1/41	1/41	3/41	-	1/41	2/41	0
Heinemann 2003[23]	Gem	8/97	10/97	10/97	2/97	6/97	2/97	4/97
Heinemann 2003[23]	Gem + DDP	10/95	4/95	13/95	1/95	21/95	4/95	3/95
Kulke 2004[24]	Gem	27/58	15/58	6/58	6/58	13/58	-	1/58
	Gem + DDP	29/62	27/62	11/62	2/62	24/62	-	0/62
	Gem + Docetaxel	19/65	7/65	8/65	8/65	10/65	-	5/65
	Gem + Irinotecan	12/60	9/60	4/60	4/60	17/60	-	10/60
Moore2005[26]	Gem + Erlotinib	71/282	28/282	34/282	45/282	20/282	<1	17/282
Moore2005[26]	Gem + placebo	73/280	34/280	34/280	39/280	20/280	0	6/280
Stathopoulos 2005[27]	Gem	8/70	0/70	2/70	0	1/70	0	2/70
Stathopoulos 2005[27]	Gem + Irinotecan	10/60	2/60	2/60	0	1/60	0	2/60
Riess 2005[28]	Gem	27/225	15/225	15/225	19/225	16/225	-	9/225
Riess 2005[28]	Gem + 5-FU/CF	26/220	28/220	18/220	12/220	30/220	-	8/220
Herrmann 2005[29]	Gem	30/153	7/153	9/153	-	5/153	1/153	3/153
Herrmann 2005[29]	Gem + Capecitabine	34/155	8/155	9/155	-	8/155	0/155	8/155

5-FU: 5-fluororacil; EPI: Epirubicin.

Table 3 Subgroup analyses on 6-mo survival rate

Subgroups	Trials	Patients	Mode	RD [95% CI]	P
GEM plus targeted drug vs GEM alone	[13, 14, 26]	1496	Fixed	0.06 [0.01, 0.11]	0.02
GEM plus DDP vs GEM alone	[9, 10, 18, 20, 23, 24]	560	Fixed	0.05 [-0.03, 0.13]	0.24
GEM plus 5-FU vs GEM alone	[12, 22, 28]	881	Random	0.04 [-0.09, 0.17]	0.57
GEM plus topoisomerase I inhibitor vs GEM alone	[16, 21, 24, 27]	928	Fixed	0.01 [-0.05, 0.08]	0.72
GEM plus capecitabine vs GEM alone	[8, 29]	399	Fixed	0.00 [-0.08, 0.10]	0.97

Citation: Xie DR, Liang HL, Wang Y, Guo SS, Yang Q. Meta-analysis on inoperable pancreatic cancer: A comparison between gemcitabine-based combination therapy and gemcitabine alone. World J Gastroenterol 2006; 12(43): 6973-6981
URL: https://www.wjgnet.com/1007-9327/full/v12/i43/6973.htm
DOI: https://dx.doi.org/10.3748/wjg.v12.i43.6973