1. An open‐label, dose‐ranging study of Rolontis, a novel long‐acting myeloid growth factor, in breast cancer
- Author
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Richy Agajanian, Arlene Chan, Guru Reddy, Lee S. Schwartzberg, Kimberly McGregor, István Láng, Jeffrey L. Vacirca, Meena Okera, Klára Mezei, Jerzy Hanslik, Makharadze Rostom, Mi Rim Choi, Zsolt Horváth, László Landherr, Emad N. Ibrahim, Gajanan Bhat, Clarence S. Adoo, Karen L. Tedesco, Zsuzsanna Pápai, and Steven J. Hager
- Subjects
Adult ,Cancer Research ,medicine.medical_specialty ,eflapegrastim ,Neutropenia ,Cyclophosphamide ,Filgrastim ,medicine.medical_treatment ,Antineoplastic Agents ,Breast Neoplasms ,Docetaxel ,Gastroenterology ,Drug Administration Schedule ,Polyethylene Glycols ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Internal medicine ,White blood cell ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Rolontis ,030212 general & internal medicine ,Original Research ,Aged ,Chemotherapy ,business.industry ,Clinical Cancer Research ,Middle Aged ,Dose-ranging study ,medicine.disease ,medicine.anatomical_structure ,Oncology ,030220 oncology & carcinogenesis ,Absolute neutrophil count ,Female ,business ,Pegfilgrastim ,medicine.drug - 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
- Published
- 2018