Results from the phase 2 PANDAS/PRODIGE 44 trial did not show any benefit from the addition of chemoradiation to neoadjuvant mFOLFIRINOX in patients with borderline resectable pancreatic cancer (BRPC).
Neoadjuvant (m)FOLFIRINOX is known to downstage and improve survival in patients with BRPC [1,2]. The phase 2 PANDAS/PRODIGE 44 trial (NCT02676349) evaluated the effectiveness of the addition of chemoradiation to neoadjuvant mFOLFIRINOX in patients with BRPC. Dr. Aurélien Lambert (Lorraine Cancer Institute, France) presented the results [3].
After 4 courses of neoadjuvant mFOLFIRINOX in 130 enrolled participants with BRPC, 110 participants were eventually randomized 1:1 to 2 courses of neoadjuvant mFOLFIRINOX followed by surgery (Arm A) or 2 courses of mFOLFIRINOX followed by chemoradiation (50.4 Gy/capecitabine) and surgery (Arm B). After surgery, all participants received 6 courses of mFOLFIRINOX. The primary endpoint was R0 resection rate.
In both arms, 40 participants underwent surgery. In Arm A, 37 patients had tumor resection, of whom 31 started with adjuvant mFOLFIRINOX. In Arm B, 31 participants had tumor resection, of whom 23 started with adjuvant mFOLFIRINOX. Drop-out was mainly due to disease progression or death. R0 resection was reached in 20 (50%) and 18 (45%) of the participants in Arm A and Arm B, respectively. No complete responses were observed.
Median overall survival was 32.8 months in Arm A versus 30.0 months in Arm B (P=0.9875). Median progression-free survival was 12.1 months in Arm A versus 13.6 months in Arm B (P=0.9297). In addition, no significant differences between Arm A and Arm B were observed in loco-regional recurrence-free survival and metastasis-free survival.
“The PANDAS trial did not show any benefit of adding chemoradiation to neoadjuvant mFOLFIRINOX in patients with BRPC. This confirms the current ESMO guidelines favoring mFOLFIRINOX in the neoadjuvant setting for BRPC,” concluded Dr. Lambert.
Medical writing support was provided by Marten Dooper.
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