Cancer medicine
Combined Active Bone Marrow-Sparing Radiotherapy and Prophylactic PEG-rhG-CSF to Reduce Severe Neutropenia During Platinum-Doublet Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: A Phase II Trial
By Wang S, Liu J, Zhong H and 5 others.
Abstract
Background
Platinum-doublet concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is frequently complicated by severe neutropenia. This Phase II trial investigated whether combining active bone marrow-sparing (ABMS) radiotherapy with prophylactic pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) could reduce the incidence of grade ≥ 3 neutropenia below a prespecified historical benchmark of 30%.
Methods
Patients with FIGO 2018 stage IIA2-IVA LACC received SPECT-guided ABMS radiotherapy (45 Gy external beam plus 30 Gy brachytherapy) concurrent with paclitaxel/carboplatin every 21 days for 4 cycles followed by prophylactic PEG-rhG-CSF. Using Simon's two-stage design (α = 0.05, β = 0.20), we tested whether grade ≥ 3 neutropenia could be reduced from a historical benchmark of 30% to ≤ 15%. The primary endpoint was grade ≥ 3 neutropenia incidence; secondary endpoints included other cytopenias, treatment completion, and survival outcomes.