Burden of advanced breast cancer for patients and caregivers in Europe: comparison of two treatment forms of vinorelbine, oral and intravenous

Barni, Sandro; Freier, Beata; Garau, Isabel; Mouysset, Jean-Loup; Sediva, Marcela; Zamagni, Claudio; Berdeaux, G; Agudo, C. De Almeida

doi:10.1080/03007995.2016.1211518

Cited by 9 publications

(6 citation statements)

References 9 publications

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“…Regardless of the drug formula, similar mPFSs were obtained when combined with pyrotinib. However, the oral formulation is easier to administer thus improving the quality of life in palliative settings and lowering the cost of medical care as it avoids hospitalization and reduces administration cost compared to the intravenous form (25,26). Oral vinorelbine is thus a useful alternative to the intravenous form when combined with pyrotinib and deserves further clinical investigation.…”

Section: Discussionmentioning

confidence: 99%

Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

Qiu

et al. 2021

Front. Oncol.

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IntroductionPyrotinib plus capecitabine has been approved in China for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Meanwhile, vinorelbine is another important chemotherapy option for MBC available in oral and intravenous forms. Thus, pyrotinib plus vinorelbine may represent a new treatment option, particularly for patients with failed capecitabine treatment. This study reported the first real-world data for pyrotinib plus vinorelbine therapy in HER2+ MBC.MethodsHER2+ MBC patients (n = 97) treated with pyrotinib plus vinorelbine in six institutions across China from May 2018 to June 2020 were enrolled. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and toxicity profiles were determined.ResultsSixty-seven percent of patients received more than two lines of systematic therapy. Nearly all patients (97.9%) had received trastuzumab and 50.5% were administered lapatinib. When combined with pyrotinib, 74.2% received oral and 25.8% received intravenous vinorelbine. Median PFS (mPFS) was 7.8 (range, 4.7–10.8) months for all patients. The mPFS in patients administered pyrotinib as second-line therapy and third-or-higher-line therapy were 12.0 and 6.4 months, respectively. Patients who received pyrotinib plus oral or intravenous vinorelbine had similar mPFS (7.8 vs. 6.4 months, p = 0.871). The 23 patients with brain metastases had mPFS of 6.3 (range, 3.4–9.2) months. Lapatinib-naïve patients had significantly longer PFS than lapatinib-treated patients (10.8 months vs. 5.6 months, p = 0.020). Median OS was not achieved. The ORR for 96 patients was 34.3%. Common grade 3 and 4 adverse events were diarrhea (22.7%), neutropenia (7.2%), and leukopenia (4.1%).ConclusionsPyrotinib plus vinorelbine therapy demonstrated promising effects in HER2+ MBC with tolerable toxicity, particularly in patients with second-line treatment and without prior lapatinib treatment, as well as in patients with brain metastases. Oral vinorelbine is a useful alternative to the intravenous form when combined with pyrotinib.Clinical Trial Registration[ClinicalTrials.gov], identifier [NCT04517305].

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Section: Discussionmentioning

confidence: 99%

Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

Qiu

et al. 2021

Front. Oncol.

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“…For patients with metastatic breast cancer, the oral VRL offers the advantages of an oral treatment, i.e. easier administration and better quality of life from greater convenience and comfort, without sacrificing efficacy and safety [21]. The simpler drug administration can alleviate oncology staff shortages, especially nurses and pharmacists, and provide savings in the cost of medical care.…”

Section: Discussionmentioning

confidence: 99%

“…(1) it is easier to administer, (2) improves the quality of life in the palliative setting, and (3) lowers the cost of medical care as it avoids hospitalization and reduces administration cost [20,21]. Oral VRL is thus a useful alternative to the IV form and deserves further clinical investigation.…”

Section: Introductionmentioning

confidence: 99%

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

Huang

Wang

Zhou

et al. 2019

Cancer Chemother Pharmacol

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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/m 2 for cycle 1, 80 mg/m 2 for cycles 2-6, and (IV-VRL) 25 mg/m 2 for cycle 1 and 30 mg/m 2 for cycles 2-6. EPI dose of 75 mg/m 2 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.

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“…Vinorelbine is a chemotherapeutic agent of semisynthetic vinorelbine alkaloid, which inhibits tubulin polymerization and blocks mitosis in the G2‐M phase, leading to cell death 9–11 . Compared to intravenous form, its oral form brings patients a higher quality of life and lower disease burden 12 . Oral vinorelbine monotherapy or combined with other drugs have shown the efficacy for mBC 13 .…”

Section: Introductionmentioning

confidence: 99%

The efficiency and safety of low‐dose apatinib combined with oral vinorelbine in pretreated HER2‐negative metastatic breast cancer

Huang,

Chen,

Xie

et al. 2024

Cancer Medicine

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BackgroundApatinib is an oral small‐molecule tyrosine kinase inhibitor that blocks vascular endothelial growth factor receptor‐2. Oral vinorelbine is a semisynthetic chemotherapeutic agent of vinorelbine alkaloids. Apatinib and oral vinorelbine have been proved to be effective in the treatment of metastatic breast cancer (mBC). At present, several small sample clinical trials have explored the efficacy of apatinib combined with oral vinorelbine in the treatment of mBC.MethodsThis retrospective study included 100 human epidermal growth factor receptor‐2 (HER2)‐negative mBC patients who received low‐dose apatinib (250 mg orally per day) plus oral vinorelbine until disease progression or intolerance during February 2017 and March 2023. The progression‐free survival (PFS), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR), and safety were analyzed by SPSS 26.0 software and GraphPad Prism 8 software. Cox proportional hazards regression model for univariate and multivariate was used to identify factors significantly related to PFS and OS.ResultsThe median follow‐up time for this study was 38.1 months. Among 100 patients with HER2‐negative mBC, 66 were hormone receptor (HR)‐positive/HER2‐negative and 34 were triple‐negative breast cancer (TNBC). The median PFS and OS were 6.0 months (95% CI, 5.2–6.8 months) and 23.0 months (95% CI, 19.9–26.1 months). There were no statistical differences in PFS (p = 0.239) and OS (p = 0.762) between the HR‐positive /HER2‐negative and TNBC subgroups. The ORR, CBR, and DCR were 21.0%, 58.0%, and 78.0%, respectively. Ninety‐five patients (95.0%) experienced varying grades of adverse events (AEs) and 38.0% of patients for Grades 3–4. The most common Grades 3–4 AEs that we observed were neutropenia (30.0%) and leukopenia (25.0%).ConclusionLow‐dose apatinib combined with oral vinorelbine demonstrates potential efficacy and well tolerated for pretreated HER2‐negative mBC.

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Burden of advanced breast cancer for patients and caregivers in Europe: comparison of two treatment forms of vinorelbine, oral and intravenous

Abstract: VinO showed benefits over VinIV for both patients and caregivers, particularly in health related quality of life and burden of disease. Because of its observational design, results are only informative.

Cited by 9 publications

References 9 publications

Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study

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

The efficiency and safety of low‐dose apatinib combined with oral vinorelbine in pretreated HER2‐negative metastatic breast cancer

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