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. 2021 May 7;27(17):1847–1863. doi: 10.3748/wjg.v27.i17.1847

Table 1.

Studies of second-line treatment in metastatic pancreatic ductal adenocarcinoma

Ref.
Type of study
Patients (n)
1st-line regimen
2nd-line regimen
Median 2nd-line OS (mo)
Median 2nd-line PFS (mo)
2nd-line ORR (%)
2nd-line DCR (%)
Pelzer et al[35], 2011 Phase III 461 GEM monotherapy OFF; BSC 4.8; 2.3 - - -
Oettle et al[36], 2014, CONKO-003 Phase III 160 GEM monotherapy OFF; FF 5.9; 3.3 2.9; 2.0 - -
Gill et al[37], 2016, PANCREOX Phase III 108 GEM-based (approximately 75% monotherapy) mFOLFOX6; FU/LV 6.1; 9.9 3.1; 2.9 13.2; 8.5 60; 63.8
Wang-Gillam et al[37], 2016, NAPOLI-1 Phase III 417 GEM-based2 Nal-IRI; FU/LV; Nal-IRI + FU/LV 4.9; 4.2; 6.1 2.7; 1.5; 3.1 6; 1; 16 44; 24; 52
Chung et al[29], 2018 Phase II 48 GEM-based mFOLFIRINOX 9.0 5.8 18.8 62.5
Tsavaris et al[33], 2005 Phase II 30 GEM OX 50 mg/mq + FU/LV (1-h iv infusion), weekly 6.25 - 23.3 53.3
Pelzer et al[32], 2009 Phase II 37 GEM OFF 5.5 3.0 6 49
Yoo et al[34], 2009 Phase II 61 GEM-based mFOLFIRI.3; mFOLFOX 3.9; 3.5 1.9; 1.4 0; 7 23; 17
Zaniboni et al[49], 2012 Phase II 50 GEM ± platinoid FOLFIRI 5 3.2 8 36
Chung et al[29], 2018, SWOG S1115 Phase II 137 GEM-based Selumetinib+ MK-2206; mFOLFOX 3.9; 6.7 1.9; 2.0 1.7; 8 22.4; 30.6
Portal et al[22], 2015 Prospective cohort 57 FOLFIRINOX NabGem 8.8 5.1 17.5 58
Zaanan et al[47], 2014 Prospective cohort 46 GEM/FOLFIRI.3 in FIRGEM trial FOLFOX 4.3 1.7 0 36
Wainberg et al[45], 2020 Meta-analysis 454 GEM-based FOLFOX; Nal-IRI 6.3; 6.1 - - -
Sonbol et al[51], 2017 Meta-analysis 895 GEM-based FPOX; FPIRIFP FPIRI vs FP: HR OS 0.7, PFS 0.64; FPOX vs FP: HR OS 1.0, PFS 0.81
Citterio et al[52], 2018 Meta-analysis 1587 GEM-based FP, OX or IRI-based Most effective IRI-based regimens (results cannot be translated into the table)
Rahma et al[43], 2013 Systematic analysis 1503 GEM-based GEM + platinum; FPOXBSC 6.0; 5.7; 2.8 4; 2.9; - - -
Petrelli et al[53], 2017 Systematic analysis - GEM-based OX-based; IRI-based 5.3; 5.5 2.9; 2.7 11.9; 8.7 41.1; 29.4
Berk et al[48], 2012 Comparative 85 GEM-based FOLFOX4; XELOX 5.8; 4.9 3.7; 3.7 17; 18 43; 59
Zhang et al[19], 2018 Retrospective 146 FOLFIRINOX NabGem; Gem alone 5.69; 3.82 3.61; 2.51 - -
Chae et al[21], 2020 Retrospective 102 FOLFIRINOX NabGem 9.8 4.6 8.5 73.6
Viaud et al[17], 2017 Retrospective 96 FOLFIRINOX GEM monotherapy 3.7 2.1 - 40
Gilabert et al[18], 2017 Retrospective 72 FOLFIRINOX GEM monotherapy - 2.5 11 -
Pointet et al[38], 2020 Retrospective 137 NabGem FOLFOX; FOLFIRI; FOLFIRINOX 3.5; 9.7; 6.1 2; 6.6; 3.4 0; 9.5; 6.3 29.2; 61.9; 50
Lee et al[41], 2020 Retrospective 120 GEM-based FPOX; FP 7.04; 7.43 2.89; 3.81 6.4; 5.4 52.6; 59.5
Neuzillet et al[50], 2012 Retrospective 63 GEM ± platinoid FOLFIRI 6.6 3.0 7.9 39.7
Kieler et al[24], 2019 Retrospective 52 GEM-based Nal-IRI + FU/LV 6.79 3.84 19.2 46.2
1

The trial was prematurely stopped due to insufficient accrual.

2

Approximately 45% of gemcitabine alone and 55% in combination. About 30% of patients had received ≥ 2 previous lines for metastatic disease, with 45% of patients pretreated with fluorouracil/leucovorin-based regimens. GEM: Gemcitabine; DCR: Disease control rate; BSC: Best supportive care; OFF: Oxaliplatin, folinic acid and 5-fluorouracil; 5FU: 5-Fluorouracil; OX: Oxaliplatin; LV: Leucovorin; FF: Folinic acid and 5-fluorouracil; Nal-IRI: Liposomal irinotecan; FOLFIRINOX: 5-Fluorouracil, folinic acid, irinotecan and oxaliplatin; FOLFOX: 5-fluorouracil + leucovorin + oxaliplatin; FPOX: Fluoropyrimidine and oxaliplatin-based regimens; HR: Hazard ratio; OS: Overall survival; NabGem: Nb-paclitaxel and gemcitabine; FP: Fluoropyrimidine; IRI: Irinotecan.