Oral vinorelbine versus intravenous vinorelbine, in combination with epirubicin as first-line chemotherapy in Chinese patients with metastatic breast cancer

Autor: Shiying Yu, Zefei Jiang, Yongsheng Wang, Yunpeng Liu, Jifeng Feng, Lijun Di, Liheng Zhou, Zhongsheng Tong, Zhimin Shao, Kunwei Shen, Xiangqun Song, Liang Huang, Xiaojia Wang, Hong Zheng, Hongyu Zheng
Rok vydání: 2019
Předmět:
Oncology
Cancer Research
Administration
Oral
030204 cardiovascular system & hematology
Toxicology
law.invention
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Antineoplastic Combined Chemotherapy Protocols
Tissue Distribution
Pharmacology (medical)
Prospective Studies
Intravenous vinorelbine
Chinese patients
Carcinoma
Ductal
Breast
Vinorelbine
Middle Aged
Prognosis
Metastatic breast cancer
Adenocarcinoma
Mucinous
030220 oncology & carcinogenesis
Injections
Intravenous
Female
Original Article
Open label
First line chemotherapy
Epirubicin
medicine.drug
Adult
China
medicine.medical_specialty
Adolescent
Maximum Tolerated Dose
Breast Neoplasms
Young Adult
03 medical and health sciences
Pharmacokinetics
Internal medicine
medicine
Humans
Neoplasm Invasiveness
Oral vinorelbine
Aged
Pharmacology
business.industry
medicine.disease
Carcinoma
Lobular
business
Follow-Up Studies
Zdroj: Cancer Chemotherapy and Pharmacology
ISSN: 1432-0843
0344-5704
Popis: Oral VRL offers easier administration, better quality of life, and cost saving. This study aimed to evaluate the treatment efficacy in terms of tumor response of the two formulations of vinorelbine (VRL, oral and IV) in combination with epirubicin (EPI); and the effect of EPI co-administration on VRL pharmacokinetics (PK) in Chinese patients with metastatic breast cancer (MBC) using a phase 2, open label, randomized trial. Patients were aged 18–70 years, had histologically confirmed MBC, Karnofsky Performance Status ≥ 70%, and life expectancy ≥ 12 weeks. The treatment consisted of 6 cycles of 3 weeks each. VRL dose was: (Oral-VRL) 60 mg/m2 for cycle 1, 80 mg/m2 for cycles 2–6, and (IV-VRL) 25 mg/m2 for cycle 1 and 30 mg/m2 for cycles 2–6. EPI dose of 75 mg/m2 was given on day 1 in both arms for all cycles. 133 patients were enrolled: 66 in Oral-VRL and 67 in IV-VRL arms. The median age for Oral-VRL and IV-VRL arms was 48.4 and 50.0 years, respectively. Objective response rates were 50.0% (95% CI 37.4–62.6%) for Oral-VRL and 53.7% (95% CI 41.1–66.0%) for IV-VRL. Both treatment arms met the efficacy objective target of at least 31 responses, demonstrating efficacy as first-line treatment for MBC. Similar blood PK profiles, exposures, and VRL clearance were observed between VRL + EPI vs VRL-only modalities for both arms. Oral VRL is comparable to IV VRL and an effective first-line treatment for Chinese patients with MBC. The activity of VRL + EPI combination is unaltered when VRL is given orally at recommended doses.
Databáze: OpenAIRE
Externí odkaz: