Dilemma of first line regimens in metastatic pancreatic adenocarcinoma

Table 1 Comparison of the pivotal studies approving FOLFIRINOX and gemcitabine/nab-paclitaxel in metastatic pancreatic cancer

		ACCORD/PRODIGE trial (FOLFIRINOX )[9]	MPACT trial (GNP)[10]
Study characteristics	Duration	December 2005-October 2009	May 2009-April 2012
	Location	France	Multinational
	Number of patients	342	861
	Study design	Phase 2-3	Phase 3
	Control arm	Gemcitabine	Gemcitabine
Patient and tumor characteristics	Median age	61 years	62 years
	Sex distribution	Male (62%)	Male (57%)
	ECOG	PS 0 (37.4%)	KPS 100 (16%)
		PS 1 (61.9%)	KPS 80-90 (77%)
		PS 2 (0.6%)	KPS 60-70 (7%)
	Tumor stage	Metastatic	Metastatic
	Metastatic sites	Liver (87.6%)	Liver (85%)
		Lung (19.4%)	Lung (35%)
		Peritoneum (19.4%)	Peritoneum (4%)
	Tumor location	Head (39.2%)	Head (44%)
Response	ORR (%)	31.6	23
	PR (%)	31	23
	SD (%)	38.6	27
	DCR (%)	70.2	48
	PFS (mo)	6.4	5.5
	OS (mo)	11.1	8.5
	1-yr OS (%)	48.4	35
Safety (Grade 3-4 toxicities)	Neutropenia	45.7	38
	Febrile neutropenia	5.4	3
	Thrombocytopenia	9.1	13
	Anemia	7.8	13
	Fatigue	23.6	17
	Peripheral neuropathy	9	17
	Diarrhea	12.7	6
Side effects	Toxic death	0.6	4
	Alopecia	11.2	50
	G-CSF use	42.5	26

DCR: Disease control rate; GNP: Gemcitabine/nab-paclitaxel; PR: Partial response; ORR: Overall response rate; OS: Overall survival; SD: Stable disease.