• J. Clin. Oncol. · Oct 2014

    Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study.

    • Michelle A Fanale, Steven M Horwitz, Andres Forero-Torres, Nancy L Bartlett, Ranjana H Advani, Barbara Pro, Robert W Chen, Andrew Davies, Tim Illidge, Dirk Huebner, Dana A Kennedy, and Andrei R Shustov.
    • Michelle A. Fanale, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven M. Horwitz, Memorial Sloan-Kettering Cancer Center, New York, NY; Andres Forero-Torres, University of Alabama at Birmingham, Birmingham, AL; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Ranjana H. Advani, Stanford University Medical Center, Palo Alto; Robert W. Chen, City of Hope National Medical Center, Duarte, CA; Barbara Pro, Fox Chase Cancer Center, Philadelphia, PA; Dirk Huebner, Takeda Pharmaceuticals International, Cambridge, MA; Dana A. Kennedy, Seattle Genetics, Bothell; Andrei R. Shustov, University of Washington Medical Center, Seattle, WA; Andrew Davies, University of Southampton School of Medicine, Southampton; Tim Illidge, Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom. mfanale@mdanderson.org.
    • J. Clin. Oncol. 2014 Oct 1; 32 (28): 3137-43.

    PurposeFront-line treatment of peripheral T-cell lymphomas (PTCL) involves regimens such as cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and results in a 5-year overall survival (OS) rate of less than 50%. This phase I open-label study evaluated the safety and activity of brentuximab vedotin administered sequentially with CHOP or in combination with CHP (CHOP without vincristine) as front-line treatment in patients with CD30(+) PTCL.Patients And MethodsPatients received sequential treatment (once every 3 weeks) with brentuximab vedotin 1.8 mg/kg (two cycles) followed by CHOP (six cycles) or brentuximab vedotin 1.8 mg/kg plus CHP (BV+CHP) for six cycles (once every 3 weeks). Responders received single-agent brentuximab vedotin for eight to 10 additional cycles (for a total of 16 cycles). The primary objective was assessment of safety; secondary end points included objective response rate, complete remission (CR) rate, progression-free survival rate (PFS), and OS. There were no prespecified comparisons of the two treatment approaches.ResultsAfter sequential treatment, 11 (85%) of 13 patients achieved an objective response (CR rate, 62%; estimated 1-year PFS rate, 77%). Grade 3/4 adverse events occurred in eight (62%) of 13 patients. At the end of combination treatment, all patients (n = 26) achieved an objective response (CR rate, 88%; estimated 1-year PFS rate, 71%). All seven patients without anaplastic large-cell lymphoma achieved CR. Grade 3/4 adverse events (≥ 10%) in the combination-treatment group were febrile neutropenia (31%), neutropenia (23%), anemia (15%), and pulmonary embolism (12%).ConclusionBrentuximab vedotin, administered sequentially with CHOP or in combination with CHP, had a manageable safety profile and exhibited substantial antitumor activity in newly diagnosed patients with CD30(+) PTCL. A randomized phase III trial is under way, comparing BV+CHP with CHOP (clinical trial No. NCT01777152).© 2014 by American Society of Clinical Oncology.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…