2016ASH-ALCANZA研究 T细胞淋巴瘤.pptVIP

ALCANZA: Brentuximab Vedotin vs Methotrexate or Bexarotene in Patients With CD30-Positive Cutaneous T-Cell Lymphoma New Findings in Hematology: Independent Conference Coverage of ASH 2016*; December 3-6, 2016; San Diego, California *CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs. This activity is supported by educational grants from Amgen, Celgene Corporation, Incyte, Merck, and Seattle Genetics. ALCANZA: Background CTCL: heterogeneous group of TCLs with skin involvement[1,2] Generally chronic with quality of life affected by debilitating pruritus and skin infections MF and pcALCL most common CD30+ CTCLs Current treatments for advanced disease not associated with consistent long-term responses[3] Brentuximab vedotin: anti-CD30 mAb conjugated to monomethyl auristatin E[4] Phase II studies found clinical activity in MF and pcALCL with reasonable safety profile[4,5] Current ALCANZA trial evaluated efficacy and safety of brentuximab vedotin vs methotrexate or bexarotene in treatment-experienced pts with CD30+ CTCL[6] 1. Swerdlow SH, et al. Blood. 2016;127:2375-2390. 2. Rosen ST, et al. Hematology Am Soc Hematol Educ Program. 2006:323-330. 3. Jawed SI, et al. J Am Acad Dermatol. 2014;70:223.e1-17. 4. Duvic M, et al. J Clin Oncol. 2015;33:3759-3765. 5. Kim YH, et al. J Clin Oncol. 2015;33:3750-3758. 6. Kim YH, et al. ASH 2016. Abstract 182. Slide credit: ALCANZA: Study Design Open-label, randomized, phase III trial[1] Primary endpoint: ORR4 by independent review Secondary endpoints Rate of CR PFS Symptom burden/pt-reported outcomes (quality-of-life measurement with Skindex-29[2]) Slide credit: 1. Kim YH, et al. ASH 2016. Abstract 182. 2. Chren MM, et al. Arch Dermatol. 1997;133:1433-1440. Pts with CD30+ MF or pcALCL*; ≥ 1 prior systemic tx (MF) or prior radiotherapy or ≥ 1 prior system tx (pcALCL); no prior progression on both me