Disease-free survival as a surrogate endpoint for overall survival in adjuvant trials of pancreatic cancer: a meta-analysis of 20 randomized controlled trials

Nie, Run-Cong; Zou, Xue-Bin; Yuan, Shu-Qiang; Chen, Ying-Bo; Chen, Shi; Chen, Yong-Ming; Chen, Guo-Ming; Chen, Xiao-Jiang; Luo, Tian-Qi; Li, Shu-Man; Duan, Jin-Ling; Wang, Yun; Li, Yuan-Fang

doi:10.1186/s12885-020-06910-5

Table 1 Characteristics of the included studies

From: Disease-free survival as a surrogate endpoint for overall survival in adjuvant trials of pancreatic cancer: a meta-analysis of 20 randomized controlled trials

Studies	Final pub year	Trial conduct period	Type of study	Stage	Treatment arms	Number of patients	Primary endpoint	Median follow-up (months)
Kalser et al. [5]	1985	1974–1982	III	R0	CRT vs. observation	43	OS	66
Lygidakis et al. [8]	2002	1993–2000	III	Stage III	CIT vs. AC vs. observation	128	OS	NR
Takada et al. [9]	2002	1986–1992	III	Stage II-III	AC vs. observation	158	OS	60.0
Neoptolemos et al. [10]^a	2004	1994–2000	III	R0/1	CRT vs. AC vs. observation	289	2-year OS rate	47.0
Kosuge et al. [34]	2006	1992–2000	III	R0	AC vs. observation	89	OS	44.8
Smeenk et al. [20]	2007	1987–1995	III	T_1-3N_0–1aM₀	CRT vs. observation	218	OS	140.4
Morak et al. [35]	2008	2000–2007	III	Stage I-III	CAI/RT vs. observation	120	OS	17.0
Yoshitomi et al. [17]	2008	2002–2005	II	R0/1	AC vs. AC	99	DFS	21.0
Ueno et al. [6]	2009	2002–2005	III	R0/1	AC vs. observation	118	OS	60.4^b
Neoptolemos et al. [36]	2010	2000–2007	III	R0/1	AC vs. AC	1088	OS	34.2^b
Van Laethem et al. [21]	2010	2004–1007	II	R0	CRT vs. AC	90	Treatment completion	33.3
Schmidt et al .[22]^c	2012	2004–2007	III	R0/1	CRT + IFN -2b vs. CRT/AC	110	OS	45.9
Oettle et al .[7]^d	2013	1998–2004	III	T_1-4N_0–1 M₀	AC vs. observation	384	DFS	136
Shimoda et al. [37]	2015	2008–2012	II	R0/1	AC vs. AC	57	DFS	NR
Uesaka et al .[38]^c	2016	2007–2010	III	Stage I-III	AC vs. AC	377	OS	82.3
Neoptolemos et al. [39]	2017	2008–2014	III	R0/1	AC vs. AC	730	OS	43.2
Sinn et al. [18]	2017	2008–2013	III	R0	AC vs. AC	436	DFS	54.0
Reni et al. [24]	2018	2006–2008	II	R0/1	CRT vs. CRT	130	Toxicity	NR
Berlin et al. [23]	2018	2010–2015	II	Stage I–II	AC vs. AC	56	DFS	55.4
Conroy et al. [19]	2018	2012–2016	III	R0/1	AC vs. AC	493	DFS	33.6

OS overall survival, DFS disease-free survival, CRT chemoradiotherapy, AC adjuvant chemotherapy, RT radiation therapy, CIT chemoimmunotherapy, CAI celiac artery infusion, NR not reported
^aThis trial was designed as a two-by-two factorial design to test two comparisons: chemoradiotherapy, and chemotherapy. Patients were randomly assigned to chemoradiotherapy-alone group (n = 73), chemotherapy-alone group (n = 75), both chemoradiotherapy and chemotherapy group (n = 72), and observation group (n = 69)
^bFollow-up for the living patients
^cThese trials were analyzed by per-protocol population
^dThe long-term outcomes of CONKO-001 trial

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