In a randomized phase II trial, researchers assessed whether perioperative chemotherapy improved overall survival (OS) for patients with pancreatic cancer who underwent surgery.
This multicenter trial sought to measure two-year OS in patients with pancreatic ductal adenocarcinoma (PDA) who underwent chemotherapy in the 12 weeks prior to and following pancreatic resection. An OS noninferiority threshold of 40% was established for analysis.
A total of 102 patients with PDA were eligible for inclusion and randomized to two treatment arms. Arm 1 included 55 patients who received perioperative chemotherapy with fluorouracil, irinotecan, and oxaliplatin, and arm 2 had 47 patients who received treatment with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel).
Across the two cohorts, 84% of patients in arm 1 and 85% arm two completed 24 weeks of perioperative chemotherapy; 73% and 70% underwent pancreatic resection; and 49% and 40% completed all treatment. Adverse events included hematologic toxicity, fatigue, and gastrointestinal toxicity.
At two-year follow-up, median OS was 47% for arm 1 (95% confidence interval [CI], 31-61) and 48% for arm 2 (95% CI, 31-63). Median OS was 23.2 months (95% CI, 17.6-45.9) and 23.6 months (95% CI, 17.8-31.7) for arms 1 and 2, respectively. Median progression free survival following resection was 10.9 months in arm 1 and 14.2 months in arm 2.
Overall, neither treatment arm was able to achieve an estimated OS significantly higher than the 40% noninferiority threshold.
“This phase II randomized clinical trial did not demonstrate an improved OS with perioperative chemotherapy, compared with historical data from adjuvant trials in resectable pancreatic cancer,” the researchers concluded. “The trial also demonstrated adequate safety and high resectability rates with perioperative chemotherapy.”
This study was published in JAMA Oncology.
In a phase II trial, perioperative chemotherapy with either mFOLFIRINOX or gemcitabine/nab-paclitaxel for PDAC led to a 2-year OS of ~47% (mOS ~23 months), which is not significantly better than historical data from adjuvant trials: https://t.co/kJNI8OSImb #PancSM
— NatureRevClinOncol (@NatRevClinOncol) January 27, 2021
— OncLive.com (@OncLive) January 27, 2021