Abstract
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.
Highlights
Liang Huang and Xiaojia Wang are co-first authors.Extended author information available on the last page of the articleIn China, breast cancer is the most common cancer in women, especially among those aged between 30 and 59 years and in urban areas, which had twice the incidence rate compared with rural areas [1, 2]
The two arms were similar in their age distribution profiles
The results were consistent with treatment responses reported in a number of phase II/III studies of VRL as a first-line treatment (38–50% [30,31,32,33,34,35]) and as a combination therapy with EPI (70.6% [17], 64% [24]) for metastatic breast cancer (MBC)
Summary
Liang Huang and Xiaojia Wang are co-first authors.Extended author information available on the last page of the articleIn China, breast cancer is the most common cancer in women, especially among those aged between 30 and 59 years and in urban areas, which had twice the incidence rate compared with rural areas [1, 2]. Liang Huang and Xiaojia Wang are co-first authors. An estimated 1.6 million people in the country were diagnosed with breast cancer. Cancer Chemotherapy and Pharmacology (2020) 85:205–215 in 2014 and 1.2 million people succumbed to the disease annually [3]. This accounted for 12.2% of newly diagnosed breast cancers and 9.6% of deaths from breast cancer worldwide, and the incidence of breast cancer continues to rise by 1.1% annually [1]. 25–30% of patients without, and 75–80% with histological axillary node involvement were expected to have recurrent and/or metastatic breast cancer (MBC) within 10 years and eventually succumb to the disease [4]. Incremental improvements in the duration of survival (estimated at ~ 20 months, range 13.2–29.5 months) have been achieved in the first-line treatment of advanced breast cancer, coincident with the use of new therapies and augmented with supportive care and improved diagnostic techniques [6]
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