Results of a Phase II Trial of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-Resectable Pancreatic Cancer (NUPAT-01)


For a study, researchers sought to determine the high frequency of side effects associated with multidrug chemotherapy, the survival benefit, and the feasibility of employing neoadjuvant chemotherapy to treat pancreatic cancer. Patients with borderline resectable pancreatic cancer were enrolled and given either FOLFIRINOX or gemcitabine with nab-paclitaxel (GEM/nab-PTX) as neoadjuvant treatment. When possible, patients had surgical resection after completing treatment. The R0 resection rate was the primary outcome of this study (NUPAT-01), which was a randomized phase II experiment. A total of 51 individuals [FOLFIRINOX (n=26) and GEM/nab-PTX (n=25)] were enrolled in this study. In the end, 84.3% (n=43/51) of the patients underwent surgery, with R0 resection achieved in 67.4% (n=33/51) of the patients. In 45.1% of the patients (n=23/51) who had neoadjuvant treatment, adverse events (grade >3) occurred, and serious surgical complications occurred in 30.0% (n=13/43) of the patients, with no mortality. According to the intention-to-treat analysis, the 3-year overall survival rate was 54.7%, with a median survival time of 39.4 months, and there was no significant difference in overall survival between the FOLFIRINOX and GEM/nab-PTX groups. These findings showed that neoadjuvant chemotherapy with FOLFIRINOX or GEM/nab-PTX was safe and effective, with an R0 resection rate of 67.4%. In the intention-to-treat analysis, patient survival was even determined to be positive.

Souce:journals.lww.com/annalsofsurgery/Abstract/2022/06000/Results_of_a_Phase_II_Study_on_the_Use_of.4.aspx



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