KEY TAKEAWAYS
- The phase II NorPACT-1 trial aimed to evaluate the efficacy of neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer.
- The primary endpoint was OS at 18 months after randomization. The differences between the respective treatment arms were analyzed with log-rank tests.
- The study found that neoadjuvant FOLFIRINOX did not provide a survival benefit over upfront surgery for pts with resectable pancreatic head cancer.
Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) has shown promise in treating pancreatic cancer. Researchers aimed to evaluate the efficacy of neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer.
The study included 140 patients (pts) with resectable pancreatic head cancer and compared two treatment options for this condition. One option involved neoadjuvant FOLFIRINOX (n=77) followed by surgery, while the other was upfront surgery (n=63) followed by adjuvant FOLFIRINOX. The primary endpoint focused on 18-month overall survival (OS).
The median age was 66.5 years (IQR 59, 72), while 115 (82.1%) [95% CI 74.0-88.0] and 25 (17.9%) [95% CI 12.0-26.0] patients were ECOG 0 and 1, respectively. OS at 18 months was 59.7% [95% CI 48.9-70.7] in the neoadjuvant group and 73.0% [95% CI 62.0-84.0] in the upfront surgery group. Resection rates were 81.8% (63/77) [95% CI 71.4-89.4] and 88.9% (56/63) [95% CI 77.0-95.1], respectively. Neoadjuvant FOLFIRINOX resulted in a higher N0 rate (P=0.002) and R0 resection rate (P=0.011) in the per-protocol (PP) analysis. Adverse events (AE) were experienced by 57.5% (42/73) [95% CI 45.4-68.8] and 40.4% (19/47) [95% CI 27.3-55.1] of patients, respectively. Median OS was 25.1 months [95% CI 17.2-34.9] with neoadjuvant chemotherapy and 38.5 months [95% CI 27.6-not reached] with upfront surgery (P=0.096). In the PP analysis, the+ median OS was 23.0 months [95% CI 16.2-34.9] and 34.4 months [95% CI 19.4-not reached], respectively (P=0.158).
The study found that neoadjuvant FOLFIRINOX did not improve OS over upfront surgery for patients with resectable pancreatic head cancer.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.17_suppl.LBA4005
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02919787
Knut Jørgen Labori, Svein Olav Bratlie, Christina Biörserud, Bergthor Björnsson, Erling Bringeland, Nils Elander, Jon Erik Grønbech, Johan Haux, Oskar Hemmingsson, Linn Nymo, Per Pfeiffer, Ville Sallinen, Ernesto Sparrelid, Kjetil Søreide, Bobby Tingstedt, Caroline Verbeke, Leif Klint, Svein Dueland, and Kristoffer Lassen. DOI:10.1200/JCO.2023.41.17_suppl.LBA4005 Journal of Clinical Oncology 41, no. 17_suppl (June 10, 2023) LBA4005-LBA4005.
