title: [Clinical trials of vnorelbine in breast cancer--its scientific usefulness and development history until regulatory approval].
abstract: Vinorelbine, a novel vinca alkaloid derivative developed in France, has been widely used for the treatment of breast cancer and non-small cell lung cancer since the 1990s in many foreign countries. In Japan, it has been available for the treatment of non-small cell lung cancer since 1999, and the additional indication of breast cancer was approved in May 2005. Japanese phase I clinical trials started in 1988. A total of six trials have been conducted in patients with advanced or recurrent breast cancer, and have provided evidence of efficacy in all groups of patients, including those receiving vinorelbine as first-line monotherapy and those previously treated with both anthracyclines and taxanes. This report reviews the data from these studies and also presents the results of combination therapy evaluated outside Japan. In addition,we explain why it took 17 years for vinorelbine to be approved despite the fact that as early as the beginning of development, it was scientifically proven to be very useful in patients with breast cancer, and that the new drug application was submitted in 1993. The relationship between healthcare professionals, patients and the regulatory agency is also discussed to point out related issues.
authors.affiliation: Dept. of Surgery, Toyosu Hospital Showa University.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D014747:Vinblastine; D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D000077235:Vinorelbine; D005472:Fluorouracil