Oral Vinorelbine in the Treatment of Non-Small Cell Lung Cancer

The Royal Marsden NHS Foundation Trust, Londinium, England, United Kingdom
Drugs (Impact Factor: 4.34). 02/2007; 67(10):1403-10. DOI: 10.2165/00003495-200767100-00003
Source: PubMed


Vinorelbine is an established treatment for advanced non-small cell lung cancer (NSCLC), both as a single agent and in combination chemotherapy. Recently, an oral form of this agent has been developed. Before accepting an established agent in a different administration form, rigorous testing is required to answer such questions as reliable bioavailability, continued safety and preservation of efficacy. In addition, an oral agent must provide patient convenience and acceptance, while being an economically sound approach.
Oral vinorelbine was found to have acceptable and reliable pharmacokinetic profiles at clinically relevant dosage levels. Oral vinorelbine was found to have approximately 40% bioavailability; thus, a dose of 80 mg/m2 orally is the equivalent of 30 mg/m2 intravenously, and 60 mg/m2 orally is the equivalent of 25 mg/m2 intravenously. Studies also concluded a lack of food effect on the administration of oral vinorelbine. In addition, no drug-drug interactions were found with a variety of commonly used antineoplastic agents.
Vinorelbine, either orally or intravenously, has been investigated in randomised phase II trials as a single agent and in combination with cisplatin or carboplatin in patients with NSCLC. In general, response and survival results with oral vinorelbine appeared similar to the intravenous agent. Adverse-effect profiles were also similar for the two formulations. Clearly, the issue of venous irritation does not exist with oral vinorelbine; however, nausea and vomiting were more frequent when vinorelbine was administered orally compared with intravenously when no planned antiemetic therapy is given.

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    • "Cisplatin can only be administered intravenously (i.v.) and is usually given every 3 weeks. Vinorelbine, a semisynthetic vinca-alkaloid, is usually administered on day 1 and 8 in a 3-week schedule and can be given both i.v. and orally (p.o.) [6] [7] [8]. "
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    ABSTRACT: Cisplatin and vinorelbine given intravenously is a well-established adjuvant chemotherapy regimen after surgery for early-stage NSCLC. Vinorelbine can also be administered orally. However, the efficacy of orally administrated vinorelbine in adjuvant treatment of NSCLC is unknown. We assessed the overall survival (OS) and disease-free survival (DFS) of patients treated with adjuvant i.v. vinorelbine or p.o. vinorelbine, in combination with i.v. cisplatin. We reviewed two time-separated cohorts of patients referred to the Department of Oncology at Aarhus University Hospital (Denmark) from 2005 to 2012 for adjuvant chemotherapy after surgery for NSCLC. Of the 265 patients included in this study, 126 patients received i.v. and 139 received p.o. vinorelbine/cisplatin. The two groups were comparable with respect to important baseline characteristics. Median OS for all patients was 78.7 months and the median DFS was 35.7 months. No statistically significant difference in OS or DFS for patients treated with i.v. or oral vinorelbine was detected. The DFS rates of the two groups were comparable across all variables in subgroup analysis. In conclusion we observed that intravenous or oral administration of vinorelbine in combination with cisplatin after surgery for NSCLC appear equally effective in terms of overall and disease-free survival. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    Full-text · Article · Feb 2015 · Lung Cancer
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    • "The response rates and survival results of oral vinorelbine are similar to intravenous vinorelbine in advanced NSCLC and breast cancer (Gralla et al, 2007; Aapro and Finek, 2011). The advantage of oral vinorelbine is home administration, so that patients, relatives and health care providers can save valuable time. "
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    ABSTRACT: Platinum-based doublet chemotherapy is the standard first-line treatment for advanced non-small cell lung cancer (NSCLC), but earlier studies have suggested that non-platinum combinations are equally effective and better tolerated. We conducted a national, randomised study to compare a non-platinum with a platinum combination. Eligible patients had stage IIIB/IV NSCLC and performance status (PS) 0-2. Patients received up to three cycles of vinorelbine 60 mg m(-2) p.o.+gemcitabine 1000 mg m(-2) i.v. day 1 and 8 (VG) or vinorelbine 60 mg m(-2) p.o. day 1 and 8+carboplatin area under the curve=5 (Calvert's formula) i.v. day 1 (VC). Patients ≥75 years received 75% of the dose. Endpoints were overall survival, health-related quality of life (HRQoL), toxicity, and the use of radiotherapy. We randomised 444 patients from September 2007 to April 2009. The median age was 65 years, 58% were men and 25% had PS 2. Median survival was VG: 6.3 months; VC: 7.0 months, P=0.802. Vinorelbine plus carboplatin patients had more grade III/IV nausea/vomiting (VG: 4%, VC: 12%, P=0.008) and grade IV neutropenia (VG: 7%, VC: 19%, P<0.001). Infections, HRQoL and the use of radiotherapy did not differ significantly between the treatment groups. The two regimens yielded similar overall survival. The VG combination had only a slightly better toxicity profile.
    Full-text · Article · Jul 2012 · British Journal of Cancer
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