Table 1:

Select phase II and III trials of adjuvant or neoadjuvant treatment for resectable pancreatic ductal adenocarcinoma

Author group (trial title)	Study type	Treatment arm	No. of patients	Specific inclusion	Primary outcome	DFS	p value	OS	p value
Conroy and colleagues25 (PRODIGE24-CCTG PA6)	Phase III	Gemcitabine	493	ECOG 0–1; Age ≤ 76 yr; Baseline CA19.9 ≤ 180 U/mL	DFS	12.8	< 0.001	35	0.003
Conroy and colleagues25 (PRODIGE24-CCTG PA6)	Phase III	FOLFIRINOX	493	ECOG 0–1; Age ≤ 76 yr; Baseline CA19.9 ≤ 180 U/mL	DFS	21.6	< 0.001	54.4	0.003
Tempero and colleagues27 (APACT)	Phase III	Gemcitabine	866	ECOG 0–1; CA19.9 < 100 U/mL	DFS by independent reviewer	18.8	0.2	36.2	0.045
Tempero and colleagues27 (APACT)	Phase III	Gemcitabine plus nab-paclitaxel	866	ECOG 0–1; CA19.9 < 100 U/mL	DFS by independent reviewer	19.4	0.2	40.5	0.045
Neoptomelos and colleagues28 (ESPAC-4)	Phase III	Gemcitabine	730	WHO PS < 2	OS	13.1	0.08	25.5	0.032
Neoptomelos and colleagues28 (ESPAC-4)	Phase III	Gemcitabine plus capecitabine	730	WHO PS < 2	OS	13.9	0.08	28.8	0.032
Oettle and colleagues29 (CONKO-001)	Phase III	Observation	354	Karnofsky PS ≥ 50%	DFS	6.7	< 0.001	20.2	0.01
Oettle and colleagues29 (CONKO-001)	Phase III	Gemcitabine	354	Karnofsky PS ≥ 50%	DFS	13.4	< 0.001	22.8	0.01
Neoadjuvant trials
Motoi and colleagues30 (Prep-02/JSAP-05)	Phase II/III	Gemcitabine/S1–surgery–S1	364	Resectable and BR; ECOG 0–1	OS	NR	–	36.7	0.015
(Abstract)	Phase II/III	Surgery–S1	364	Resectable and BR; ECOG 0–1	OS	NR	–	26.6	0.015
Versteijne and colleagues31 (PREOPANC)	Phase III	Gemcitabine/radiation–surgery–gemcitabine	246	Resectable and BR	OS by intention to treat	8.1	0.03	16	0.096
Versteijne and colleagues31 (PREOPANC)	Phase III	Surgery–gemcitabine	246	Resectable and BR	OS by intention to treat	7.7	0.03	14.3	0.096
Sohal and colleagues32 (SWOG 1505) (Abstract)	Phase II	Modified FOLFIRINOX–surgery–modified FOLFIRINOX	102	Resectable	2-yr OS	10.9^*	NR	22.4	NS
Sohal and colleagues32 (SWOG 1505) (Abstract)	Phase II	Gemcitabine/nab-paclitaxel–surgery–gemcitabine/nab-paclitaxel	102	Resectable	2-yr OS	14.2^*	NR	23.6	NS

Note: BR = borderline resectable, CA19.9 = carbohydrate antigen 19.9, DFS = disease-free survival, ECOG = Eastern Cooperative Oncology Group, NR = not reported, NS = not significant, OS = overall survival, PS = Performance Status, S1 = type of chemotherapy, WHO = World Health Organization.
↵* DFS is from time of surgery.