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Vinorelbine

A Review of its Pharmacological Properties and Clinical Use in Cancer Chemotherapy

  • Drug Evaluation
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An Erratum to this article was published on 01 August 1995

Summary

Synopsis

Vinorelbine is a semisynthetic vinca alkaloid with a broad spectrum of antitumour activity. The drug is effective as a single agent in inoperable/advanced non-small cell lung cancer (NSCLC), producing objective response rates of about 15 to 30%, and as first-line or later chemotherapy for metastatic spread in advanced breast cancer. Combining vinorelbine with standard chemotherapeutic regimens improves response rates in these indications compared with vinorelbine monotherapy: in NSCLC response rates increase to 30 to 50% when vinorelbine is administered with cisplatin. Importantly, survival was prolonged by a further 9 weeks with this combination in a trial in >600 patients with NSCLC.

Comparative trials evaluating vinorelbine in women with advanced breast cancer are few at present. However, results suggest greater efficacy for vinorelbine than for melphalan as second-line chemotherapy, and similar efficacy for vinorelbine plus doxorubicin compared with doxorubicin plus 2 other drugs as first-line chemotherapy.

Vinorelbine has tended to yield superior response rates when compared with vindesine, and appears to have greater haematological toxicity (i.e. granulocytopenia) but less neurological toxicity (peripheral neuropathy, constipation, loss of deep tendon reflexes) than this agent. Myelosuppression is the most frequent cause of vinorelbine treatment delay or dose reduction. Other consequences of vinorelbine therapy are those typically seen with antineoplastic agents, such as diarrhoea, nausea and vomiting, and alopecia. However, these are rarely severe.

Early clinical investigations indicate that the antitumour effects of vinorelbine in other malignancies including ovarian carcinoma, lymphoma and head and neck cancer warrant further exploration, as does the efficacy of the drug relative to standard approaches and its possible beneficial effects on quality of life of cancer patients. Clarification is also required of the feasibility of an oral dosage form, which in preliminary investigations has shown some efficacy in NSCLC, but a variable response rate and high incidence of gastrointestinal disturbances in women with breast cancer.

Thus, vinorelbine as a single agent or combined palliative therapy is effective against advanced NSCLC, and as first-or second-line chemotherapy in advanced breast cancer. This semisynthetic vinca alkaloid has a manageable tolerability profile and potential for use in other malignancies and as an oral formulation. With these attributes, vinorelbine is a valuable option which extends the range of treatments available for these difficult-to-treat malignancies.

Pharmacodynamic Properties

Vinorelbine is a semisynthetic vinca alkaloid with cytostatic activity against a broad range of tumour cell lines. It appears more active than vinblastine, vindesine and vincristine against non-small cell lung cancer (NSCLC), as active as vinblastine against ovarian carcinoma, and less active than vinblastine and vincristine against leukaemia in vitro. Vinorebine has generally also shown similar effects to vindesine in in vivo models of NSCLC. Against breast cancer tumours, vinorelbine appeared less active than vinblastine but at least as active as vindesine and vincristine in vivo. Cross-resistance between vinorelbine and other vinca alkaloids is predicted to be low, based on in vitro and in vivo findings.

Like other vinca alkaloids, vinorelbine is a mitotic inhibitor (‘spindle poison’) believed to exert its antitumour effects by binding to tubulin, thus inhibiting microtubule assembly and eventually preventing metaphasic tumour cell division. Its lesser activity than other vinca alkaloids against axonal microtubules is proposed to account for its reduced tendency to cause neurotoxicity compared with some other members of its class, although a direct relationship has not been proven as yet.

Pharmacokinetic Properties

Following intravenous administration, vinorelbine is widely distributed to body tissues, particularly to excretory organs and lung: it is present in healthy lung tissue in concentrations up to 30-fold higher than those in plasma. Vinorelbine crosses the placenta in rats, binds to erythrocytes and is 70 to 80% bound to human plasma proteins. The activity of deacetylvinorelbine, the only metabolite detected in humans, is unknown. Both vinorelbine and this metabolite are taken up by the liver and excreted mainly in bile. The elimination half-life (t½β) of about 40 to 45 hours calculated for vinorelbine is intermediate between values reported for vindesine and vinblastine (20 to 25 hours), and for vincristine (85 hours).

Bioavailability of oral vinorelbine formulations has been determined to be 24 or 40%, depending on the formulation tested. Although disposition of vinorelbine after oral administration is less well studied, values of pharmacokinetic parameters (systemic clearance, volume of distribution, t½β) generally approximate those for intravenously injected drug.

Clinical Use

The largest body of evidence with vinorelbine has been obtained in patients with NSCLC and advanced breast cancer, who tend to be older. Vinorelbine shows efficacy as a single agent in advanced breast cancer and inoperable/advanced NSCLC comparable to that reported in the literature for standard chemotherapeutic options. Objective response rates are in the range of 30 to 50% for chemotherapy-naive women with advanced breast cancer (first-line chemotherapy) and about 15 to 30% in those receiving the drug as second-line or later chemotherapy. Median response duration was 21 to 39 weeks, and 14 to 34 weeks, respectively, for these patient groups.

Combining vinorelbine with other agents (e.g. doxorubicin, epirubicin, fluorouracil, mitomycin or mitoxantrone) increases response rates to 55 to 75% as first-line and 30 to 50% as second-line chemotherapy in women with breast cancer. The few comparative trials available suggest better efficacy for vinorelbine (notably 4 weeks longer survival) than for melphalan as single agent second-line chemotherapy, and similar efficacy for vinorelbine plus doxorubicin to that for doxorubicin plus fluorouracil and cyclophosphamide as first-line chemotherapy.

In previously untreated patients with primarily stages III and IV NSCLC, response rates are approximately 15 to 30% for vinorelbine as a single agent and approximately 30 to 50% when combined with cisplatin. Survival duration with vinorelbine as a single agent has ranged from 25 to 33 weeks. While 1 group of investigators found no survival differences between vinorelbine alone and vinorelbine plus cisplatin, a survival advantage of 9 weeks for combined therapy was demonstrated in a large trial in >600 patients, which used a larger dosage of cisplatin. In addition, patients survived a median of 8 weeks longer with vinorelbine plus cisplatin than with vindesine plus cisplatin.

Indeed, vinorelbine with or without other agents has tended to yield a superior response rate to that seen with vindesine in similar regimens, in most directly comparative trials. As single agent chemotherapy, vinorelbine was as effective as vindesine plus cisplatin (14 vs 19% response) and produced a greater median survival duration (30 vs 22 weeks) than fluorouracil plus calcium folinate (folinic acid; leucovorin calcium). Generally, response rates similar to those found with vinorelbine plus cisplatin have been demonstrated for multidrug regimens incorporating vinorelbine and cisplatin plus fluorouracil and etoposide, or with vinorelbine plus ifosfamide/mesna or carboplatin, in noncomparative trials.

Improved quality of life was reported in 47% and relief of symptoms in 65% of women with advanced breast cancer receiving vinorelbine in 2 studies; vinorelbine resembled melphalan for relief of symptoms. Quality-of-life assessment favoured vinorelbine over fluorouracil plus calcium folinate for symptom distress, but not for other measures, in patients with NSCLC. Although these results suggest a positive effect of vinorelbine on quality of life, reporting methods have been inadequate to assess their value.

Other indications in which intravenous vinorelbine has shown promise include advanced ovarian carcinoma, lymphoma and head and neck cancer. Use of oral formulations has also been investigated. Preliminary reports imply oral vinorelbine has variable activity in advanced breast cancer, but a response rate and median duration of survival at the lower end of the range obtained with intravenous formulations were recorded among 95 patients with NSCLC.

Tolerability

Myelosuppression is the major dose-limiting toxicity of vinorelbine. Granulocytopenia, occurring in >80% of individuals and rated as moderate to severe in 30 to 40%, may necessitate hospitalisation for related fever/sepsis in 9% of patients. Granulocyte counts reach nadirs within 2 weeks of an initial dose during weekly administration and recover over a similar period. Supportive treatment with recombinant human granulocyte colony-stimulating factor (rhG-CSF) may aid dose intensification of vinorelbine-containing regimens by limiting neutropenia.

Neurotoxicity typical of vinca alkaloids as a class is another important feature of the tolerability profile of vinorelbine. Peripheral neuropathy develops in 20 to 30% of patients, constipation in 35% and loss of deep tendon reflexes in 5%. These effects are severe in <2% of patients. Vinorelbine appears to cause greater haematological toxicity but less neurotoxicity than vindesine, as shown in comparative clinical trials. A brief report of a cost analysis found vinorelbine to achieve modest savings of about 6% compared with vindesine, attributable largely to the decreased cost of treating adverse effects.

In addition, vinorelbine therapy is associated with mild to moderate nausea/vomiting (40% of patients), diarrhoea, anorexia and stomatitis (each <20%), and mild, reversible alopecia (12%) — consequences typical of virtually all chemotherapeutic regimens. Other events documented during vinorelbine therapy include chest pain in patients with a history of cardiovascular disease or chest tumours (7%), injection site reactions (30%) and, rarely, allergic-type acute pulmonary reactions. The tolerability profile of oral vinorelbine formulations tested to date appears similar to that seen after intravenous use, with the exception of a higher incidence of gastrointestinal intolerance, notably diarrhoea, with oral use (>50% of patients).

Dosage and Administration

Vinorelbine is usually initiated at a dose of 30 mg/m2 by weekly intravenous push or infusion over 6 to 10 minutes. Dose reduction is necessary in patients with compromised granulocyte counts (see table X), and in those with hepatic dysfunction. In some countries vinorelbine is contraindicated in patients with granulocyte counts <1 × 109/L (1000 cells/mm3). Guidelines are not available for oral preparations undergoing investigation: dosages used in clinical trials have ranged from 40 to 130 mg/m2/week.

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    Karen L. Goa & Diana Faulds

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Various sections of the manuscript reviewed by: D. Bisset, CRC Department of Medical Oncology, University of Glasgow, Glasgow, Scotland; C. Bokemeyer, Abkeilung Hämatologie/Onkologie, Medizinische Hochschule, Hannover, Germany; D. R. Budman, North Shore University Hospital, Cornell University Medical College, Manhasset, New York, USA; G. N. Hortobagyi, Department of Medical Oncology, M. D.Anderson Cancer Center, University of Texas, Houston, Texas, USA; N. Ibrahim, Department of Medical Oncology, M. D. Anderson Cancer Centre, University of Texas, Houston, Texas, USA; H. Niitani, Department of Internal Medicine 4, Nippon Medical College, Tokyo, Japan; A. Photiou, Melanoma Unit, Department of Medical Oncology, Charing Cross Hospital, London, England; P. Potier, Centre National de la Recherche Scientifique, Institut de Chimie des Substances Naturelles, Gif-sur-Yvette, France; A. Romero, Grupo Oncológico Cooperativo del Sur, Bahia Bianca, Argentina; C. Twelves, Clinical Oncology Unit, Guy’s Hospital, London, England.

An erratum to this article is available at http://dx.doi.org/10.1007/BF03258535.

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Goa, K.L., Faulds, D. Vinorelbine. Drugs & Aging 5, 200–234 (1994). https://doi.org/10.2165/00002512-199405030-00006

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