Table 3. Selected studies evaluating neoadjuvant treatment (NAT) in PDAC.
Study/first author | Types of study | N | Interventions | Resection rates | mOS (months) | Interpretation |
---|---|---|---|---|---|---|
BRPC/LAPC | ||||||
Sadot et al [39] | R | 0/101 | FOLFIRINOX +/- CTRT | 31 | 25 | Feasibility |
Rangelova et al [40] | R | 22/132 | FOLFIRINOX | 33(BRPC/NR (LAPC) | 31.9(BR)/21.8 (LA) | Feasibility |
Maggino et al [51] | R | 267/413 | 53% FOLFIRINOX 21% G-Nab-Paclitaxel 25% RT |
15.1 | 12.8 | Feasibility |
Katz et al [52] | Single arm, phase II | 22/0 | FOLFIRINOX + CTRT | 68 | 22 | Feasibility |
Hammel et al [61] | RCT, Phase III | 0/442 | G-Erlotinib vs. G-Erlotinib + CTRT | 4 | 16.5 vs. 15.2 | CTRT did not improve OS |
Janssen et al [38] | M | 313/0 | FOLFIRINOX | 67.8 | 22.2 | Patient level metanalysis |
Suker et al [37] | M | 0/315 | FOLFIRINOX | 25.9 | 24.2 | Patient level metanalysis |
Jang et al [54] | RCT, Phase II/III | 58/0 | NACTRT → Sx vs. upfront Sx | 52 vs. 26 | 21 vs. 12 | Improved resection rates and OS with NACTRT |
PREOPANC [55,56] | RCT, Phase III | 246 (BRPC and Resectable) | NACTRT → G --> Sx vs. Sx → G | 61 vs. 72 | 16 vs 14.3 | Neoadjuvant approach did not improve OS |
Alliance A021501 [62] | RCT, Phase II | 126 | FOLFIRINOX → Sx vs. FOLFIRINOX + SBRT → Sx | 51 vs 58 | 31 vs. 17.1 | Addition of SBRT did not improve resectability rates compared to historical controls |
Resectable PDAC | ||||||
O’ Reilly [66] | Phase II, single arm | 38 | GEMOX → Sx | 71 | 27.2 | Feasibility |
Prep-02/JSAP-05 [67] | RCT, Phase II/III | 364 | G-S1 → Sx → S1 vs. Sx→ S1 | Similar | 36.7 vs. 26.6 | NAT with G-S1 improved OS |
SWOG S1505 [68] | Phase II, Pick the winner design | 102 | FOLFIRINOX → Sx vs GN → Sx | 73 vs 70 | 23.2 and 23.6 | Both arms did not improve OS compared to historical cohorts |
N, Total no of patients; mOS, Median overall survival; Sx, Surgery; RCT, Randomized clinical trial; OS, Overall survival; G, Gemcitabine; 5 FU, 5 Fluorouracil; FOLFIRINOX, 5-fluorouracil-leucovorin-irinotecan-oxaliplatin; GEMOX, Gemcitabine-oxaliplatin; RT, Radiotherapy; NACTRT, Neoadjuvant chemoradiation; NACT, Neoadjuvant chemotherapy; NR, Not reported; SWOG, South West Oncology Group