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Table 1. Published phase II/III trials on neoadjuvant chemotherapy for PDAC
No Neoadjuvant chemo-
Author (year) Disease Type of study Control arm Neoadjuvant chemotherapy Main findings
pts RT
LA-PDAC
LAPACT; Philip (2020) [ 40] LA- Phase II 107 GnP followed by surgery or chemo- Optional Median PFS 10.9 months and median OS 18.8
PDAC RT or GnP months
NEOLAP-AIO-PAK-0113; LA- Phase II 130 No 4 cycles of GnP No Similar results
[41]
Kunzmann (2020) PDAC (randomized) 2 cycles of GnP followed by 4 cycles (HR 0.86, 95%CI: 0.55-1.36, P = 0.53)
of FFX
BR-PDAC
Yoo (2017) [45] BR- Phase II 18 No FFX No Median survival 16.8 months
PDAC
ESPAC-5F; Ghaneh (2020) [46] BR- Phase II 88 Upfront surgery FFX (group B) or 50.4 Gy, 1.8 Gy/fraction Better 1-year survival in the neoadjuvant arms 77%
PDAC (randomized, 4 (group A) Gemcitabine/capecitabine (group C) Concurrent with vs. 40% (HR 0.27, 95%CI: 0.13-0.55, P < 0.001)
arms) capecitabine (group 4)
NUPAT-01; Yamaguchi BR- Phase II 51 No A. FFX No OS is not significantly different between groups
[47]
(2022) PDAC (randomized) B. GnP
LA/BR-PDAC
[49]
Lee (2012) LA- Phase I/II 43 No Gemcitabine and capecitabine No Median OS 23.1 months for patients that underwent
PDAC surgery
BR-
PDAC
[48]
Reni (2018) LA- Phase II 54 No Gemcitabine, nab-paclitaxel, cisplatin No 1-year PFS 58% (Arm A) vs. 39% (Arm B)
PDAC (randomized) and capecitabine 18-month OS 69% (Arm A) vs. 54% (Arm B) (P =
BR- Nab-paclitaxel followed by not significant)
PDAC gemcitabine
[50]
Saito (2018) LA- Phase II 24 No Gemcitabine, S-1, LV No Resection rate 60.9% (R0 76.5%)
PDAC
BR-
PDAC
BR/R-PDAC
Motoi (2013) [54] BR- Phase II 36 No Gemcitabine and S-1 No Median OS 34.7 months in R0 resected patients
PDAC
R-PDAC
R-PDAC
Heinrich (2008) [52] R-PDAC Phase II 28 No Gemcitabine and cisplatin No Median DFS 9.2 months and median OS 26.5
months
[53]
O’Reilly (2014) R-PDAC Phase II 38 No Gemcitabine and oxaliplatin No Resectability 71% and median OS 27.2 months
Prep-02/JSAP05; Motoi R-PDAC Phase II/III 364 Upfront surgery Gemcitabine and S-1 No Improved median OS (36.7 vs. 26.6 months) ) (HR
[55]
(2019) 0.72, 95%CI: 0.55-0.94, P = 0.015)