Neoadjuvant chemoradiation does not improve surgical outcomes or survival in pancreatic cancer

Results from the phase 2 PANDAS/PRODIGE 44 trial did not show any benefit of adding chemoradiation to neoadjuvant mFOLFIRINOX and surgery 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 adding chemoradiation to neoadjuvant mFOLFIRINOX in patients with BRPC.

After 4 courses of neoadjuvant mFOLFIRINOX in 130 enrolled participants with BRPC, 110 participants were eventually randomised 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. Dr Aurélien Lambert (Lorraine Cancer Institute, France) presented the results [3].

In both arms, 40 participants underwent surgery. In Arm A, 37 participants had tumour resection, of whom 31 started with adjuvant mFOLFIRINOX. In Arm B, 31 participants had tumour 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.

The median overall survival was 32.8 months in Arm A versus 30.0 months in Arm B (P=0.988). The median progression-free survival was 12.1 months in Arm A versus 13.6 months in Arm B (P=0.930). 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 favouring mFOLFIRINOX in the neoadjuvant setting for BRPC,” concluded Dr Lambert.

1. Petrelli F, et al. Pancreas. 2015;44:515-521.
2. Katz MHG, et al. JAMA Oncol. 2022;8:1263-1270.
3. Lambert A, et al. Preoperative modified FOLFIRINOX (mFOLFIRINOX) with or without chemoradiation (CRT) in borderline resectable pancreatic cancer (BRPC): Results from the randomized phase II trial PANDAS/PRODIGE 44. Abstract LBA62, ESMO Congress 2024, 13–17 September, Barcelona, Spain.

 

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Posted on 4 November 20244 November 2024