Table 3 Randomised trials of neoadjuvant treatment for resectable pancreatic cancer.
From: New implications from long-term outcomes of perioperative therapy in resectable pancreatic cancer
Trial | Recruitment period | Treatment arms | Number of patients | Median overall survival (months) | Comments |
|---|---|---|---|---|---|
Germany multi-centre [77] | 2003–2009 | CRT + surgery + GEM | 33 | 17.4 | Terminated—slow recruitment. |
Surgery + GEM | 33 | 14.4 (P = 0.79) | |||
Bologna [78] | 2007–2014 | CRT + surgery | 18 | 19.5 | Terminated—slow recruitment. |
Surgery only | 20 | 22.4 Not significant | |||
PACT-15 [79] | 2010–2015 | PEXG + surgery + PEXG | 26 | – | ≤75 years, stage I–II, protocol event-free at 1 year: 6 (23%, 95% CI, 7–39) of 30; 15 (50%, 32–68) of 30; 19 (66%, 49–83) of 29. |
Surgery + GEM | 30 | – | |||
Surgery + PEXG | 32 | – | |||
2013–2017 | CRT + GEM + Surgery + GEM | 65 | 14.6 | Longterm follow-up median OS HR 0.79 (95% CI, 0.54–1.16). | |
Surgery + GEM | 68 | 15.6 (P = 0.83) | |||
SWOG S1505 [82] | 2015–2018 | mFOLFIRINOX + Surgery + mFOLFIRINOX | 55 | 23.2 | Primary end point >2-year OS of 40%: 47 (95% CI, 31–61)% for arm 1 and 48 (31–63)% for arm 2. |
GEM-NabP + Surgery + GEM-NabP | 47 | 23.6 Not significant | |||
NEONAX-AIO-PAK-0313 [83] | 2015–2021 | GEM-NabP + surgery + GEM-NabP | Resected 48/63 | 25.2 | Planned 166 patients. Primary endpoint median DFS rate of 55% at 18 months double negative result: neoadjuvant 32.2%: adjuvant 41.4%. |
Surgery + GEM | Resected 51/64 | 16.7 Not significant | |||
PANACHE01-PRODIGE48 [84] | 2017–2020 | mFOLFIRINOX + Surgery + CTX | 70 | 30.6 | CTX = Initially GEM, 5FU and GEMCAP, but latterly and mostly mFOLFIRINOX. |
FOLFOX + Surgery + CTX | 50 | 31.3 | |||
Surgery + CTX | 26 | 36 Not significant | |||
NORPACT-1 [85] | 2017–2021 | mFOLFIRINOX + Surgery + mFOLFIRINOX | 77 | 25.1 | Primary endpoint was patients alive at 18 months: 60% in the neoadjuvant group versus 73% in the upfront surgery group (p = 0·032); upfront surgery had longer survival. |
Surgery + mFOLFIRINOX | 63 | 38.5 (P = 0.050) | |||
PREOPANC2 [86] | 2018–2021 | FOLFIRINOX + Surgery | Resected 99/120 | – | For all cases mixed resectable and borderline median survival = 21.9 months chemo vs 21.3 months CRT, p = 0.32. |
GEM + CRT + Surgery + GEM | Resected 95/121 | – | |||
NEPAFOX [87] | 2015–2018 | Surgery + GEM | 21 | 25.7 | Mixed resectable (76%) and borderline resectable (79%); trial closed due to slow accrual target = 126 patients. |
mFOLFIRINOX + Surgery + mFOLFIRINOX | 19 | 10.0 | |||
Prep-02/JSAP-05 [88] | 2013–2016 | GEM + S1 +Surgery+ S1 | 131 | HR = 0.73 (95% CI = 0.56, 0.95; P = 0.018) | Adjuvant CTX ‘advised ‘ but not required. ECOG = 0/1, <80 years. The study includes both resectable (n = 163) and borderline (n = 68), results are not cleanly separated. |
Surgery + S1 | 132 | ||||
Zhejiang [89] | 2018–2024 | GEM-NabP + mFOLFIRINOX+ Surgery+ Gem-CAP or mFOLFIRINOX | Resected 135/162 | 35.4 (95% CI = 27.9, 5.1) | Left pancreatectomies in 147 (52%); CA19-9 > 500 KU/L in 138 (43%); R0 in 237 (83%). CTX ‘recommended’ but not required; 169 (52%) ‘completed’ CTX. Short follow-up median = 18.7 months. |
Surgery+ Gem-CAP or mFOLFIRINOX | Resected 149/162 | 27.2 (95% CI = 19.8, 33.5) (P = 0.048) |
