Safety/tolerability
Neuropathy, neutropenia, febrile neutropenia, Cancer
ADVERSE EVENT, NEUTROPENIA, FEBRILE NEUTROPENIA, NEUROPATHY, CANCER
Safety evaluations at baseline and subsequent visits included AEs, clinical laboratory tests, physical examination, and vital signs. AEs were assessed and AE severity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0). Both agents were held for grade 3 or febrile neutropenia (ANC < 1000/μL). Filgrastim or pegylated-filgrastim myeloid growth factor support was encouraged for ANC < 1500/μL and was allowed at the discretion of the treating physician in order to maintain adequate blood counts. Filgrastim was given for ANC < 1000/μL at any time, or as prophylaxis in patients at risk for neutropenia. Neuropathy was assessed using the 10-point Modified Total Neuropathy Score at the start of each cycle and at study termination.