Table 3.
Main Phase II/III studies evaluating peri-operative chemotherapy protocols.
| Type of Chemotherapy | Design of the Study | DFS Results | OS Results | Reference |
|---|---|---|---|---|
| Gemcitabine | Randomized phase III multicentric (N = 248) Patients with (borderline) resectable pancreatic cancer Arm A: immediate surgery Arm B: preoperative CRT Both followed by adjuvant gemcitabine. The preoperative CRT consisted of 15 times of 2.4 Gy combined with gemcitabine 1000 mg/m2 on days 1, 8 and 15, preceded and followed by a cycle of gemcitabine. |
Median DFS Arm A: 7.7 months Arm B: 8.1 months; HR 0.73; p = 0.032. |
Median OS Arm A: 13.5 months Arm B: 17.1 months; HR 0.71; p = 0.047. |
PREOPANC-1 [34,38] |
| Gemcitabine vs. mFOLFIRINOX | Randomized phase II multicentric trial (N = 102) Patients with resectable pancreatic cancer. Peri-op CT (12 weeks pre-, 12 weeks post-op) with either mFOLFIRINOX (Arm 1) or Gem/nab (Arm 2). |
Median DFS: Arm 1: 10.9 months Arm 2: 14.2 months p = 0.87 |
Median OS: Arm 1: 22.4 months Arm 2: 23.6 months |
SWOG S1505 [49] |
| S1 | Randomized phase II/III multicentric trial (N = 364) Resectable PDAC Neoadjuvant chemotherapy with gemcitabine + S1 or upfront surgery. Adjuvant S-1 was administered for 6 months to patients with curative resection. |
Median DFS: not yet communicated | Median OS Neoadjuvant Gemcitabine + S1: 36.7 month Upfront surgery+adjuvant S1: 26.6 months; HR 0.72 (95% CI 0.55–0.94); p = 0.015. |
JSAP-05 [50,51] |
CRT: chemoradiotherapy, CT: chemotherapy, Gy: Gray, OS: overall survival.