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. 2024 Apr 24;16(9):1632. doi: 10.3390/cancers16091632

Table 2.

Randomized Phase II or Phase III studies on NAT for borderline resectable PC.

Author Year Intervention Comparator Primary Outcome Number of Patients Resection Rate R0 Resection Rate ITT OS
Jang et al. [37] 2018 GEM + RT + adjuvant GEM Upfront surgery + adjuvant GEM 2-year survival 27 vs. 23 63.0% vs. 78.3% 51.8% vs. 26.1% * MST: 21 mo vs. 12 mo
HR: 0.51 (0.27–0.93) *
Yamaguchi et al. [39] (NUPAT 01) 2022 mFOLFIRINOX GEM + nab-PTX R0 resection rate 26 vs. 25 88.5% vs. 80.0% 73.1% vs. 56.0% 3-year OS: 55.3% vs. 54.4%
HR: 0.95 (0.39–2.29)
Katz et al. [38]
(Alliance A021501)
2022 mFOLFIRINOX + adjuvant FOLFOX6 mFOLFIRINOX + RT + adjuvant FOLFOX6 18-month survival 65 vs. 55 49% vs. 35% 18-month OS: 66.7% vs. 47.3%
MST: 29.8 mo vs. 17.1 mo
Hewitt et al. [36] 2022 FOLFIRINOX or
GEM + nab-PTX + HAPa
FOLFIRINOX or GEM + nab-PTX + 5-FU-based CRT OS 145 vs. 158 23% vs. 26% MST: 14.3 mo vs. 14.9 mo
HR: 1.02 (0.66–1.58)
Ghaneh et al. [35]
(ESPAC 05)
2023 Arm 1: immediate surgery
Arm 2: GEM + capecitabine
Arm 3: FOLFIRINOX
Arm 4: capecitabine + RT
Recruitment rate
Resection rate
33 vs.
20 vs.
20 vs.
17
55% † vs. 68% 23% † vs. 14% 1-year OS *:
39% vs. 78% vs. 84% vs. 60%

GEM, gemcitabine; nab-PTX, nab-paclitaxel; HAP-a, HyperAcute-Pancreas; RT, radiotherapy; OS, overall survival; HR: hazard ratio; MST, median survival time; R0 resection, complete resection; FU, fluorouracil; CRT, chemoradiotherapy; mo, month(s); ITT, intention-to-treat. *: statistically significant, †: neoadjuvant groups combined.