1999
Inability to escalate vinorelbine dose intensity using a daily × 3 schedule with and without filgrastim in patients with metastatic breast cancer
Havlin K, Ramirez M, Legler C, Harris L, Matulonis U, Hohneker J, Hayes D, Winer E. Inability to escalate vinorelbine dose intensity using a daily × 3 schedule with and without filgrastim in patients with metastatic breast cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 68-72. PMID: 9923543, DOI: 10.1007/s002800050864.Peer-Reviewed Original ResearchConceptsDana-Farber Cancer InstituteDuke University Medical CenterDose-limiting toxicityGrowth factor supportGrade III neurotoxicityMetastatic breast cancerFebrile neutropeniaBreast cancerFactor supportNonhematologic toxicityStarting doseDose intensityDay 4Stage IV breast cancerMajor dose-limiting toxicityAddition of filgrastimAlternative treatment regimenGrade III stomatitisGrade III vomitingGrade IV mucositisGrade IV thrombocytopeniaGreater nonhematologic toxicityPerformance status 0Prior chemotherapy regimensSemisynthetic vinca alkaloid
1994
Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors.
Rowinsky EK, Noe DA, Trump DL, Winer EP, Lucas VS, Wargin WA, Hohneker JA, Lubejko B, Sartorius SE, Ettinger DS. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal Of Clinical Oncology 1994, 12: 1754-63. PMID: 8083697, DOI: 10.1200/jco.1994.12.9.1754.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseOral administrationOral formulationOral vinorelbineGrade 3Large first-pass effectLower starting doseSemisynthetic vinca alkaloidChronic oral administrationHepatic blood flowPhase II evaluationPharmacokinetic studyDivided-dose scheduleMaximum plasma concentrationFirst-pass effectSteady-state volumeGelatin capsulesPlasma drug dispositionPharmacologic exposuresPrincipal toxicityStarting doseDose escalationOral dosesOral doseCancer patients