dc.contributor.author | Fathi, Amir T. | en_US |
dc.contributor.author | Wander, Seth A. | en_US |
dc.contributor.author | Blonquist, Traci M. | en_US |
dc.contributor.author | Brunner, Andrew M. | en_US |
dc.contributor.author | Amrein, Philip C. | en_US |
dc.contributor.author | Supko, Jeffrey | en_US |
dc.contributor.author | Hermance, Nicole M. | en_US |
dc.contributor.author | Manning, Amity L. | en_US |
dc.contributor.author | Sadrzadeh, Hossein | en_US |
dc.contributor.author | Ballen, Karen K. | en_US |
dc.contributor.author | Attar, Eyal C. | en_US |
dc.contributor.author | Graubert, Timothy A. | en_US |
dc.contributor.author | Hobbs, Gabriela | en_US |
dc.contributor.author | Joseph, Christelle | en_US |
dc.contributor.author | Perry, Ashley M. | en_US |
dc.contributor.author | Burke, Meghan | en_US |
dc.contributor.author | Silver, Regina | en_US |
dc.contributor.author | Foster, Julia | en_US |
dc.contributor.author | Bergeron, Meghan | en_US |
dc.contributor.author | Ramos, Aura Y. | en_US |
dc.contributor.author | Som, Tina T. | en_US |
dc.contributor.author | Fishman, Kaitlyn M. | en_US |
dc.contributor.author | McGregor, Kristin L. | en_US |
dc.contributor.author | Connolly, Christine | en_US |
dc.contributor.author | Neuberg, Donna S. | en_US |
dc.contributor.author | Chen, Yi-Bin | en_US |
dc.date.accessioned | 2017-07-24T18:35:27Z | |
dc.date.issued | 2017 | en_US |
dc.identifier.citation | Fathi, A. T., S. A. Wander, T. M. Blonquist, A. M. Brunner, P. C. Amrein, J. Supko, N. M. Hermance, et al. 2017. “Phase I study of the aurora A kinase inhibitor alisertib with induction chemotherapy in patients with acute myeloid leukemia.” Haematologica 102 (4): 719-727. doi:10.3324/haematol.2016.158394. http://dx.doi.org/10.3324/haematol.2016.158394. | en |
dc.identifier.issn | | en |
dc.identifier.uri | http://nrs.harvard.edu/urn-3:HUL.InstRepos:33490922 | |
dc.description.abstract | Aberrant expression of aurora kinase A is implicated in the genesis of various neoplasms, including acute myeloid leukemia. Alisertib, an aurora A kinase inhibitor, has demonstrated efficacy as monotherapy in trials of myeloid malignancy, and this efficacy appears enhanced in combination with conventional chemotherapies. In this phase I, dose-escalation study, newly diagnosed patients received conventional induction with cytarabine and idarubicin, after which alisertib was administered for 7 days. Dose escalation occurred via cohorts. Patients could then receive up to four cycles of consolidation, incorporating alisertib, and thereafter alisertib maintenance for up to 12 months. Twenty-two patients were enrolled. One dose limiting toxicity occurred at dose level 2 (prolonged thrombocytopenia), and the recommended phase 2 dose was established at 30mg twice daily. Common therapy-related toxicities included cytopenias and mucositis. Only three (14%) patients had persistent disease at mid-cycle, requiring “5+2” reinduction. The composite remission rate (complete remission and complete remission with incomplete neutrophil recovery) was 86% (nineteen of twenty-two patients; 90% CI 68–96%). Among those over age 65 and those with high-risk disease (secondary acute leukemia or cytogenetically high-risk disease), the composite remission rate was 88% and 100%, respectively. The median follow up was 13.5 months. Of those treated at the recommended phase 2 dose, the 12-month overall survival and progression-free survival were 62% (90% CI 33–81%) and 42% (90% CI 17–65%), respectively. Alisertib is well tolerated when combined with induction chemotherapy in acute myeloid leukemia, with a promising suggestion of efficacy. (clinicaltrials.gov Identifier:01779843). | en |
dc.language.iso | en_US | en |
dc.publisher | Ferrata Storti Foundation | en |
dc.relation.isversionof | doi:10.3324/haematol.2016.158394 | en |
dc.relation.hasversion | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395112/pdf/ | en |
dash.license | LAA | en_US |
dc.title | Phase I study of the aurora A kinase inhibitor alisertib with induction chemotherapy in patients with acute myeloid leukemia | en |
dc.type | Journal Article | en_US |
dc.description.version | Version of Record | en |
dc.relation.journal | Haematologica | en |
dash.depositing.author | Fathi, Amir T. | en_US |
dc.date.available | 2017-07-24T18:35:27Z | |
dc.identifier.doi | 10.3324/haematol.2016.158394 | * |
dash.authorsordered | false | |
dash.contributor.affiliated | Wander, Seth | |
dash.contributor.affiliated | Amrein, Philip | |
dash.contributor.affiliated | Brunner, Andrew | |
dash.contributor.affiliated | Hobbs, Gabriela | |
dash.contributor.affiliated | Fathi, Amir | |
dash.contributor.affiliated | Graubert, Timothy | |
dash.contributor.affiliated | Supko, Jeffrey | |
dash.contributor.affiliated | Chen, Yi-Bin | |
dash.contributor.affiliated | Neuberg, Donna | |