Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer

Table 4 Clinical trials of second-line treatment for gemcitabine pre-treated unresectable pancreatic cancer

Author (yr)	Type of study	Regimen	Patients, n	KPS ≥ 90 or ECOG ≤ 1, %	MPC, %	ORR, %	DCR, %	PFS/TTP, mo	OS, mo
Yoo et al[15] 2009	II	Modified FOLFOX	30	97	100	7	17	6.0 wk	14.9 wk
		Modified FOLFIRI.3	31	100	100	0	23	8.3 wk	16.6 wk
Novarino et al[14] 2009	II	Oxaliplatin/5-FU/LV	23	73.9	69.6	0	23.5	11.6 wk1	17.1 wk
Pelzer et al[5] 2011	III	BSC	23	52.2	69.6	0	NA	NA	2.3
		Oxaliplatin/5-FU/LV (OFF)	23	47.8	73.9	0	NA	NA	4.8 (P = 0.008)
Chung et al[23] 2013	II	FOLFOX4	44	NA	100	11.4	40.9	9.9 wk1	31.1 wk
Oettle et al[6] 2014	III	5-FU/LV (FF)	84	47.6	88.1	NA	NA	2	3.3
		Oxaliplatin/5-FU/LV (OFF)	84	53.9	88.2	NA	NA	2.9 (P = 0.019)	5.9 (P = 0.01)
Zaanan et al[17] 2014	Prospective cohort	FOLFOX2	27	44.4	100	0	36.4	1.7	4.3
Wang-Gillam et al[7] 2016	III	5-FU/LV	119	48	100	1	NA	1.5	4.2
		Nal-IRI/5-FU/LV	117	59	100	16	NA	3.1 (P < 0.001)	6.1 (P = 0.01)
		Nal-IRI	151	57	100	6	NA	2.7 (P = 0.1)	4.9 (P = 0.94)
Gill et al[24] 2016	III	Modified FOLFOX6	54	88.9	92.6	13.2	44.7	3.1	6.1
		Infusional 5FU/LV	54	94.3	94.4	8.5 (P = 0.36)	55.3	2.9 (P = 0.99)	9.9 (P = 0.02)
Present study	II	FOLFIRINOX with RIO	48 (MPC: 38)	95.8	79.2	18.8 (MPC: 23.7)	62.5 (MPC: 57.9)	5.8 (MPC: 5.4)	9 (MPC: 8.4)

¹Time to progression;

²First line therapy was GEM alone or FOLFIRI.3 alternating with GEM. KPS: Karnofsky Performance Scale; ECOG: Eastern Cooperative Oncology Group performance status; MPC: Metastatic pancreatic cancer; ORR: Objective response rate; DCR: Disease control rate; PFS: Progression-free survival; TTP: Time to progression; OS: Overall survival; 5-FU: 5-fluorouracil; LV: Leucovorin; NA: Not available; II: Phase II study; III: Phase III study; BSC: Best supportive care; Nal-IRI: Nanoliposomal irinotecan; RIO: Reduced dosage of irinotecan and oxaliplatin.