Randomized phase 2 trial of peg-GCSF neutropenia prophylaxis in patients receiving mFOLFIRINOX for advanced pancreatic cancer

mFOLFIRINOX treatment can cause severe neutropenia, leading to dose reductions and worse outcomes. A phase 2 trial in South Korea evaluated pegylated granulocyte colony-stimulating factor (peg-GCSF) as neutropenia prophylaxis in patients receiving mFOLFIRINOX for treatment-naïve locally advanced or metastatic pancreatic cancer. Patients were randomized to peg-GCSF prophylaxis (n=38) or control (n=39). Co-primary endpoints were grade 3-4 neutropenia or febrile neutropenia within the first eight cycles. These endpoints were met, with grade 3-4 neutropenia in 2.6% versus 38.5% (p=0.0001) and febrile neutropenia occurring only in controls (12.8%). With a median follow-up duration of 19.7 months, survival outcomes favored peg-GCSF, although not statistically significant, whereas the patient-reported global health status/QOL scores were significantly better with peg-GCSF..