Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer.

• DOI: 10.1200/jco.1997.15.4.1395
• Publication Date: 2017-02-24T09:45:45Z
• Authors: R B Livingston; G K Ellis; J R Gralow; M A Williams; R White; C McGuirt; B B Adamkiewicz; C A Long
• Keywords: Vinorelbine; Refractory (planetary science)

PURPOSE We evaluated weekly single-agent intravenous (IV) vinorelbine as salvage therapy for metastatic breast cancer. After the first five patients, all received elective growth factor support with granulocyte colony-stimulating (G-CSF; filgrastim) in an attempt to maximize delivered dose-intensity (DDI). Objective tumor response, DDI, and toxicity were assessed, well time progression (TTP) survival. PATIENTS AND METHODS This single-center nonrandomized trial enrolled 40 patients. Anthracycline exposure subsequent common 38 of paclitaxel-refractory. Vinorelbine was given initially at 30 mg/m2/wk, then 35 mg/m2/wk a phase I/II design, which involved intermittent (6 days 7) continuous (daily) administration G-CSF 5 micrograms/kg. RESULTS The maximum-tolerated starting dose support. mean DDI 27.7 There two complete responses (CRs) eight partial (PRs) assessable patients overall response rate 25% (95% confidence interval [CI], 13% 41%). median TTP 13 weeks survival 33 weeks. dose-limiting neutropenia, delay or reduction required 14 27 entered mg/m2. Febrile neutropenia that hospitalization unusual (three 8%). no treatment-related deaths. Grade 3/4 thrombocytopenia occurred nine (23%) 26 (65%) RBC transfusions anemia. Seven (18%) had reversible grade nonhematologic complications, primarily related neurotoxicity. > = 3 mucositis absent. CONCLUSION Concurrent vinoralbine daily is feasible permits increase 43% 76% over reported series without rate, TTP, data are encouraging heavily pretreated not cross-resistant paclitaxel should be considered further trials dose-intensified mode made possible by G-CSF, alone combined other agents.