title: Phase II study of vinorelbine monotherapy in anthracycline and taxane pre-treated metastatic breast cancer.
abstract: We performed a single-institution phase II study to evaluate the efficacy and toxicities of vinorelbine monotherapy in patients previously treated with anthracyclines and taxanes. Vinorelbine was administered at a dose level of 25 mg/m² intravenously on days 1, 8, 15 and 22, every four weeks, and responses were assessed after every two cycles of treatment. All of the patients had previously been treated with anthracyclines and taxanes. A total of 26 patients were enrolled in this study between April 2004 and August 2009. The median age of the patients was 47 years (range, 37 to 71 years), and 80.8% had an Eastern Cooperative Oncology Group performance status of 0 or 1. Out of 24 evaluable patients, five partial responses were observed, giving an overall response rate of 20.8%, with a median response duration of 2.8 months. The median time to progression was 3.7 months (range, 0.5 to 22.6 months), and median overall survival duration was 10.4 months (range, 1.3 to 57.6 months). The major toxicities observed were neutropenia, anemia and peripheral neuropathy. Grade 3 or 4 hematologic toxicities included neutropenia in 18 patients (69.2%) and anemia in four patients (15.3%). Grade 1 or 2 peripheral neuropathy was observed in 11 patients (42.3%), however there were no cases of grade 3 or 4 peripheral neuropathy. The results of this study indicate that vinorelbine monotherapy was feasible regimen with manageable toxicities in patients with metastatic breast cancer who were previously exposed to anthracyclines and taxanes.
authors: Division of Medical Oncology & Department of Internal Medicine, College of Medicine, Korea University, Seoul, Korea.
authors: Hee Yeon
authors: HY
authors: Seo
authors: Hyun Joo
authors: HJ
authors: Lee
authors: Ok Hee
authors: OH
authors: Woo
authors: Kyong Hwa
authors: KH
authors: Park
authors: Sang Uk
authors: SU
authors: Woo
authors: Dae Sik
authors: DS
authors: Yang
authors: Ae-Ree
authors: AR
authors: Kim
authors: Jae-Bok
authors: JB
authors: Lee
authors: Eun Sook
authors: ES
authors: Lee
authors: Yeul Hong
authors: YH
authors: Kim
authors: Jun Suk
authors: JS
authors: Kim
authors: Jae Hong
authors: JH
authors: Seo
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016016:Proportional Hazards Models; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D014747:Vinblastine; D000077235:Vinorelbine