Recent developments in palliative chemotherapy for locally advanced and metastatic pancreas cancer

Table 1 Progression-free and overall survival analyses from the ECOG 6201 trial[11]

Parameter	PFS		OS
	Median (mo)	Log-rank P	Median (mo)	Log-rank P
All eligible patients (n = 824)	2.9		5.6
Gem (n = 275)	2.6		4.9
FDR Gem (n = 277)	3.5	0.09	6.2	0.15
GemOx (n = 272)	2.7		5.7

PFS: Progression-free survival; OS: Overall survival; ECOG: Eastern Cooperative Oncology Group; Gem: Gemcitabine; GemOx: Gem and oxaliplatin.

Table 2 Phase III trials of gemcitabine doublets

Phase III trial	Combination	OS (mo)	P	PFS (mo)	P
Berlin et al[12] (n = 322)	Gem + FU	6.7	0.09	3.4	0.022
	Gem	5.4		2.2
Herrmann et al[16] (n = 319)	Gem + Cap	8.4	0.234	4.8	0.0207
	Gem	7.2		4.0
Heinemann et al[19] (n = 219)	Gem + Cisplatin	7.6	0.12	5.3	0.053
	Gem	6.0		3.1
Colucci et al[20] (n = 107)	Gem + Cisplatin	6.9	0.48	5	0.048
	Gem	4.6		2
Louvet et al[23] (n = 326)	GemOx	9.0	0.13	5.8	0.04
	Gem	7.1		3.7
Poplin et al[11] (n = 824)	GemOx	5.7	0.09	2.7	0.15
	Gem	4.9		2.6
	Gem FDR	6.2		3.5
Rocha Lima et al[27] (n = 342)	IRINOGEM	6.3	0.789	3.5	0.352
	Gem	6.6		3.0
O'Reilly et al[29] (n = 339)	Gem + Exatecan	6.7	0.52	3.9	0.22
	Gem	6.2		4.0

FU: Fluorouracil.

Table 3 Phase I/III trials of gemcitabine in combination with novel targeted therapies

	Combination	OS (mo)	P	PFS (mo)	P	ORR (%)	SD (%)
Phase II trial
Xiong et al[41] (n = 61)	Gem + Cetuximab	7.1		3.8		12.2	63.4
Fogelman et al[47] (n = 50)	GemOx + BEV	12.1		NR		NR	39
Kim et al[48] (n = 82)	GemOx + BEV	8.1		5.7		11.3	NR
Ko et al[49] (n = 57)	Gem + Cetuximab + BEV	NR		3.5		10.7	29
	Cetuximab + BEV			1.8		0	24
Kindler et al[50] (n = 139)	Gem + BEV + Erlotinib	7.8		5.0		23	49
	Gem + BEV + Cetuximab	7.2		5.1		18	45
Phase III trial
Moore et al[40] (n = 569)	Gem + Erlotinib	6.37	0.038	NR	0.004
	Gem	5.91
Philip et al[43] (n = 735)	Gem + Cetuximab	6.5	0.14	3.5	0.058
	Gem	6.0		3.0
Kindler et al[45] (n = 602)	Gem + BEV	5.7	NS	4.8	NS
	Gem	6.0		4.3
Vervenne et al[46] (n = 607)	Gem + BEV	7.1	NS	4.6	0.0002
	Gem	6.0		3.6

ORR: Overall response rate; SD: Stable disease; NR: Not reported; NS: Not significant; BEV: Bevacizumab; Gem: Gemcitabine; Gem FDR: Gemcitabine fixed-dose rate; GemOx: Gemcitabine 1000 mg/m² iv over 100 min on day 1 plus oxaliplatin 100 mg/m² on day 2 every 14 d.