TY - JOUR
T1 - Oral vinorelbine in the treatment of non-small cell lung cancer
T2 - Rationale and implications for patient management
AU - Gralla, Richard J.
AU - Gatzemeier, Ulrich
AU - Gebbia, Vittorio
AU - Huber, Rudolf
AU - O'Brien, Mary
AU - Puozzo, Christian
N1 - Funding Information:
Dr Gralla has been a consultant to and received honoraria from Pierre Fabre and Roche. Dr Gatzemeier has no conflicts of interest directly related to the contents of this review. Dr Gebbia has received a grant from Pierre Fabre to attend an educational course. Dr Huber has received speakers fees and grants to conduct trials from Pierre Fabre. Dr O’Brien has carried out consultancies and received honoraria from the manufacturer of oral vinorelbine. Dr Puozzo is an employee of Pierre Fabre, the manufacturer of vinorelbine. Preparation of this article was supported by Pierre Fabre Pharma. Editorial assistance for the development of this manuscript was provided by Wolters Kluwer Health Medical Communications.
PY - 2007
Y1 - 2007
N2 - 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 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.
AB - 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 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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U2 - 10.2165/00003495-200767100-00003
DO - 10.2165/00003495-200767100-00003
M3 - Review article
C2 - 17600389
AN - SCOPUS:34347375530
SN - 0012-6667
VL - 67
SP - 1403
EP - 1410
JO - Drugs
JF - Drugs
IS - 10
ER -