An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer.

ABSTRACT: This randomized, open-label, active-controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid growth factor, versus pegfilgrastim in breast cancer patients being treated with docetaxel and cyclophosphamide (TC). The primary efficacy endpoint was duration of severe neutropenia (DSN) during the first cycle of treatment. Patients who were candidates for adjuvant/neoadjuvant TC chemotherapy were eligible for participation. TC was administered on Day 1, followed by 45, 135, or 270 μg/kg Rolontis or 6 mg pegfilgrastim on Day 2. Complete blood counts were monitored daily when the absolute neutrophil count (ANC) fell to <1.5 × 10⁹ /L. Up to four cycles of TC were investigated. The difference in DSN (time from ANC <0.5 

SUBMITTER: Vacirca JL 

PROVIDER: S-EPMC5943466 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature