title: Oral vinorelbine in the treatment of non-small cell lung cancer: rationale and implications for patient management.
abstract: 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/m(2) orally is the equivalent of 30 mg/m(2) intravenously, and 60 mg/m(2) orally is the equivalent of 25 mg/m(2) 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.
authors.affiliation: New York Lung Cancer Alliance, New York, NY 10024-5129, USA. rgralla@att.net
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Gralla
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gatzemeier
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Rudolf
authors.initials: R
authors.lastname: Huber
authors.forename: Mary
authors.initials: M
authors.lastname: O'Brien
authors.forename: Christian
authors.initials: C
authors.lastname: Puozzo
mesh_terms: D000284:Administration, Oral; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003131:Combined Modality Therapy; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine