• 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.

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