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{"title"=>"A phase i dose escalation study of the triple angiokinase inhibitor nintedanib combined with low-dose cytarabine in elderly patients with acute myeloid leukemia", "type"=>"journal", "authors"=>[{"first_name"=>"Christoph", "last_name"=>"Schliemann", "scopus_author_id"=>"15045622300"}, {"first_name"=>"Joachim", "last_name"=>"Gerss", "scopus_author_id"=>"14053903200"}, {"first_name"=>"Stefanie", "last_name"=>"Wiebe", "scopus_author_id"=>"8254295900"}, {"first_name"=>"Jan Henrik", "last_name"=>"Mikesch", "scopus_author_id"=>"14058611000"}, {"first_name"=>"Nicola", "last_name"=>"Knoblauch", "scopus_author_id"=>"57191481398"}, {"first_name"=>"Tim", "last_name"=>"Sauer", "scopus_author_id"=>"8308148200"}, {"first_name"=>"Linus", "last_name"=>"Angenendt", "scopus_author_id"=>"56563061100"}, {"first_name"=>"Tobias", "last_name"=>"Kewitz", "scopus_author_id"=>"57193872206"}, {"first_name"=>"Marc", "last_name"=>"Urban", "scopus_author_id"=>"57191491862"}, {"first_name"=>"Trude", "last_name"=>"Butterfass-Bahloul", "scopus_author_id"=>"8388391000"}, {"first_name"=>"Sabine", "last_name"=>"Edemir", "scopus_author_id"=>"57191480468"}, {"first_name"=>"Kerstin", "last_name"=>"Vehring", "scopus_author_id"=>"57191484419"}, {"first_name"=>"Carsten", "last_name"=>"Müller-Tidow", "scopus_author_id"=>"7004555214"}, {"first_name"=>"Wolfgang E.", "last_name"=>"Berdel", "scopus_author_id"=>"7103214720"}, {"first_name"=>"Utz", "last_name"=>"Krug", "scopus_author_id"=>"6601987863"}], "year"=>2016, "source"=>"PLoS ONE", "identifiers"=>{"doi"=>"10.1371/journal.pone.0164499", "scopus"=>"2-s2.0-84990957272", "pui"=>"612637722", "issn"=>"19326203", "pmid"=>"27716819", "sgr"=>"84990957272"}, "id"=>"abb6f067-2081-361d-b943-fdb28300bf1c", "abstract"=>"Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-alpha/-beta, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic cells, especially when used in combination with cytarabine. This phase I study evaluated nintedanib in combination with low-dose cytarabine (LDAC) in elderly patients with untreated or relapsed/refractory acute myeloid leukemia (AML) ineligible for intensive chemotherapy in a 3+3 design. Nintedanib (dose levels 100, 150, and 200 mg orally twice daily) and LDAC (20 mg subcutaneous injection twice daily for 10 days) were administered in 28-day cycles. Dose-limiting toxicity (DLT) was defined as non-hematological severe adverse reaction CTC grade >/= 4 with possible or definite relationship to nintedanib. Between April 2012 and October 2013, 13 patients (median age 73 [range: 62-86] years) were enrolled. One patient did not receive study medication and was replaced. Nine (69%) patients had relapsed or refractory disease and 6 (46%) patients had unfavorable cytogenetics. The most frequently reported treatment-related adverse events (AE) were gastrointestinal events. Twelve SAEs irrespective of relatedness were reported. Two SUSARs were observed, one fatal hypercalcemia and one fatal gastrointestinal infection. Two patients (17%) with relapsed AML achieved a complete remission (one CR, one CRi) and bone marrow blast reductions without fulfilling PR criteria were observed in 3 patients (25%). One-year overall survival was 33%. Nintedanib combined with LDAC shows an adequate safety profile and survival data are promising in a difficult-to-treat patient population. Continuation of this trial with a phase II recommended dose of 2 x 200 mg nintedanib in a randomized, placebo-controlled phase II study is planned. The trial is registered to EudraCT as 2011-001086-41. TRIAL REGISTRATION: ClinicalTrials.gov NCT01488344.", "link"=>"http://www.mendeley.com/research/phase-i-dose-escalation-study-triple-angiokinase-inhibitor-nintedanib-combined-lowdose-cytarabine-el", "reader_count"=>11, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Librarian"=>1, "Researcher"=>1, "Student > Ph. D. Student"=>2, "Student > Master"=>2, "Student > Bachelor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Librarian"=>1, "Researcher"=>1, "Student > Ph. D. Student"=>2, "Student > Master"=>2, "Student > Bachelor"=>2}, "reader_count_by_subject_area"=>{"Engineering"=>1, "Unspecified"=>3, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>3, "Agricultural and Biological Sciences"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>2}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>3}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>3}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}}, "group_count"=>0}

CrossRef

• http://doi.org/10.1007/s00277-019-03651-9
• http://doi.org/10.1007/s10456-019-09677-x
• http://doi.org/10.1038/bcj.2017.6
• http://doi.org/10.1016/j.leukres.2017.05.020
• http://doi.org/10.1186/s13046-018-0999-5

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• {"unique-ip"=>"15", "full-text"=>"16", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"6", "cited-by"=>"0", "year"=>"2020", "month"=>"3"}
• {"unique-ip"=>"1", "full-text"=>"1", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"4"}
• {"unique-ip"=>"15", "full-text"=>"16", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"5"}
• {"unique-ip"=>"8", "full-text"=>"8", "pdf"=>"3", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"6"}
• {"unique-ip"=>"6", "full-text"=>"6", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"7"}
• {"unique-ip"=>"7", "full-text"=>"5", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"8"}
• {"unique-ip"=>"9", "full-text"=>"13", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"9"}
• {"unique-ip"=>"9", "full-text"=>"11", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"10"}
• {"unique-ip"=>"10", "full-text"=>"12", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"11"}
• {"unique-ip"=>"7", "full-text"=>"6", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"12"}
• {"unique-ip"=>"8", "full-text"=>"8", "pdf"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2021", "month"=>"1"}

F1000Prime