Efficacy and safety of navelbine oral (NVBO) in first line metastatic breast cancer (MBC)

Amadori, Dino; Koralewski, P.; Tekiela, A.; Simon, Anna; Llombart, A; Sommer, H.; Scheffold, Christian; Maheut, L.; Micheaux, Sylvie Lafaye de

doi:10.1016/s0959-8049(01)81205-3

Cited by 15 publications

(6 citation statements)

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“…These data have been confirmed by Amadori et al [63] who reported a Phase II study of oral vinorelbine as first-line therapy in 72 patients with ABC. Dose escalation from 60 mg/ m 2 /week to 80 mg/m 2 /week was done in 85% of cases.…”

Section: Breast Cancersupporting

confidence: 64%

Oral versus intravenous vinorelbine: clinical safety profile

Gebbia¹,

Puozzo²

2005

Expert Opinion on Drug Safety

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The availability of chemotherapeutic drugs administrable by oral route represents a step forward in the management of cancer patients. Among oral agents, vinorelbine is particularly interesting for its pharmacological characteristics and clinical efficacy. Oral vinorelbine is rapidly absorbed (1.5-3 hours) with an elimination half-life of approximately 40 hours. It shows a low level of binding to plasma proteins (13%), is highly bound to platelets (78%) and has a hepatic metabolism and an absolute bioavailability of 40% with a moderate and similar interpatient variability for the two forms. Food has no influence on the pharmacokinetic profile of oral vinorelbine even if nausea/vomiting is less frequent and less severe in the fed patients than in the fasting patients. Therefore, to ensure patient comfort, it is recommended that oral vinorelbine is administered with a snack. All the metabolites of oral vinorelbine have been identified and, among these, only deacetyl-vinorelbine presented activity demonstrating that for both oral and intravenous (i.v.) routes of administration the drug has the same metabolism pattern. Oral vinorelbine is eliminated mainly in a unconjugated form via the bile. In this process, the CYP 3A4 isoform of cytochrome P450 is mostly involved. Absorption of oral vinorelbine is not delayed in elderly patients. After oral administration, blood concentrations of vinorelbine in elderly patients are within the range of values observed in younger patients. The absolute bioavailability is close to 38% in elderly whereas it is close to 40% in younger patients. This difference is not significant. As compared to the intravenous drug, oral vinorelbine demonstrated linear pharmacokinetics as well an absolute bioavailability of approximately 40%, and a reliable dose-correspondence of 80 mg/m2 oral form --> 30 mg/m2 i.v. and 60 mg/m2 oral --> 25 mg/m2 i.v. Therefore, i.v. and oral forms show similar interindividual variability, same metabolism pattern, reproducible intra-patient blood exposure, and same pharmacokinetic-pharmacodynamic relationship. Oral vinorelbine has shown significant activity in advanced non-small cell lung cancer. Given at 60 mg/m2/week for the first 3 administrations and then increased to 80 mg/m2/week achieved the same efficacy as i.v. vinorelbine in terms of progression-free survival, overall survival, objective response. Mild-to-moderate gastrointestinal toxicity, easily manageable with standard treatment was recorded. Reproducible efficacy compared to previously reported results with vinorelbine i.v. Also, in advanced breast cancer, oral vinorelbine has shown significant activity with a good therapeutic index. Albeit no formal comparison between the oral and the intravenous formulations of vinorelbine has been made, however, the oral route seems to offer major advantages to patients who are faced with a clear decrease in the frequency of hospital admissions as compared to that needed to give intravenous chemotherapy.

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Section: Breast Cancersupporting

confidence: 64%

Oral versus intravenous vinorelbine: clinical safety profile

Gebbia¹,

Puozzo²

2005

Expert Opinion on Drug Safety

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“…An oral formulation of vinorelbine has been recently introduced. Its efficacy and toxicity profiles are comparable with those reported for its intravenous counterpart 5,6 .…”

Section: Introductionsupporting

confidence: 66%

Doses of capecitabine and oral vinorelbine are not relevant for efficacy in breast cancer patients: An analysis of dose intensity

Battelli

Bittoni

Pagliacci

et al. 2011

Tumori

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A total of 301 courses was given, with a median of 8 courses (range, 3-13). Median dose intensity of capecitabine was 75% of the planned dose and for vinorelbine it was 72%. We observed 18 partial response (43.9%), 15 stable disease (36.6%), and 8 progressive disease (19.5%). Median progression-free survival was 9 months (range, 1-22) and median overall survival was 27.2 months (range, 4-40). Overall response rate (complete + partial response) was not statistically different between patients who received more or less than the median dose intensity of capecitabine and vinorelbine, and there was no difference in overall survival or progression-free survival. CONCLUSIONS; Capecitabine and oral vinorelbine is an effective and well-tolerated "all-oral" regimen for advanced breast cancer patients. The use of lower doses than those currently recommended should be not detrimental in terms of efficacy.

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“…За последние десятилетия внутривенная форма винорелбина продемонстрировала высокий уровень активности с частотой объективного ответа (ЧОО) на лечение 41-50% и приемлемым уровнем токсичности [7,8]. Пероральная форма винорелбина продемонстрировала эффективность с ЧОО 26-42% [9][10][11][12].…”

Section: Clinical Observation введениеunclassified

“…В другое исследование II фазы были включены 72 пациентки, 47,2% имели висцеральные метастазы и 56,9% -мультиорганное поражение [10]. Общая частота ответа составила 26,9%.…”

Section: клинические исследования монотерапии пероральной формой винорелбина у больных метастатическим раком молочной железыunclassified

Clinical case of the use of oral metronomic vinorelbin in patient with metastatic Her2 negative breast cancer

2021

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Endocrine therapy in combination with inhibitors of cyclin-dependent kinases 4/6 in first lines is the current standard of treatment of metastatic ER positive Her2 negative breast cancer. After progression on several lines of endocrine therapy according to current principles we apply sequential lines of monochemotherapy. If possible non-toxic agents are prefered in order to maintain high quality of life. The special role in this context may play oral agents, when regular visits in clinic and intravenous injection are not needed. The efficacy of oral vinorelbine is well explored, unfortunately the standard dosage regimen сan have quite high especially hematologic toxicity. The metronomic dosing regimen is believed to be as effective as the standard, but is less toxic. In addition, the anti-angiogenic properties of the metronomic mode are described. Taking into account the increasing use of combination of endocrine therapy with CDK4/6 inhibitors in first treatment lines, it is extremely important to study the efficacy and tolerability of various regimens and drugs after progression on combined endocrine therapy. In this article, we represent a clinical case of the use of oral vinorelbine in the metronomic mode in the patient after progression on combination of fulvestrant and palbociclib. Long-term disease control with satisfactory quality of life has been demonstrated.

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Efficacy and safety of navelbine oral (NVBO) in first line metastatic breast cancer (MBC)

Cited by 15 publications

References 0 publications

Oral versus intravenous vinorelbine: clinical safety profile

Oral versus intravenous vinorelbine: clinical safety profile

Doses of capecitabine and oral vinorelbine are not relevant for efficacy in breast cancer patients: An analysis of dose intensity

Clinical case of the use of oral metronomic vinorelbin in patient with metastatic Her2 negative breast cancer

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