2009
A phase I study of an autologous GM-CSF-secreting breast cancer vaccine.
Anderson K, Hodi F, Sasada T, Canning C, Hassett M, Mayer E, Hannagan K, Wong J, Colson Y, Shoji B, Najita J, Sibani S, LaBaer J, Winer E, Dranoff G. A phase I study of an autologous GM-CSF-secreting breast cancer vaccine. Cancer Research 2009, 69: 4124. DOI: 10.1158/0008-5472.sabcs-4124.Peer-Reviewed Original ResearchBreast cancer vaccinesGM-CSFAutologous GM-CSFCancer vaccinesLung cancerSkin biopsiesImmune responseECOG performance status 0Antigen-specific immune responsesLocal injection site reactionsPerformance status 0Anti-tumor immunityInjection site reactionsMetastatic breast cancerMalignant pleural effusionReplication-defective adenoviral vectorMultiple tumor modelsGM-CSF secretionBreast cancer cellsTumor cell yieldGranulocyte-macrophage colonyAutologous vaccinationMeasurable diseasePrior chemotherapyStable disease
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