Brentuximab vedotin activity in diffuse large B-cell lymphoma with CD30 undetectable by visual assessment of conventional immunohistochemistry.

Abstract	This phase 2 study evaluated brentuximab vedotin monotherapy in CD30-expressing DLBCL; after several patients with little to no CD30 achieved a complete remission (CR), the study evaluated treatment of DLBCL with undetectable CD30 (CD30u) by local visual immunohistochemistry (vIHC). Sixteen of 52 CD30u DLBCL patients (31%) had an objective response (6 CRs [12%]). Median progression-free survival (PFS) was 1.4 months (range, 0.4-15.6) and median overall survival (OS) was 7.5 months (range, 0.7-18.6+). Subsequent CD30 expression quantitated by computer-assisted digital image analysis (cIHC) showed that 11 of 16 CD30u DLBCL responders had ≥1% CD30. Correlative analyses of CD30u and CD30-expressing DLBCL combined demonstrated that ≥1% CD30 expression by cIHC resulted in a trend toward a higher response rate and significantly longer median PFS and OS. A minimum CD30 expression threshold appears to be required for antitumor activity in DLBCL; however, other factors also likely contribute to activity. (NCT01421667).
Authors	Nancy L Bartlett, Mitchell R Smith, Tanya Siddiqi, Ranjana H Advani, Owen A O'Connor, Jeff P Sharman, Tatyana Feldman, Kerry J Savage, Andrei R Shustov, Catherine S Diefenbach, Yasuhiro Oki, Maria Corinna Palanca-Wessels, Mayur Uttarwar, Martha Li, Jing Yang, Eric D Jacobsen
Journal	Leukemia & lymphoma (Leuk Lymphoma) Vol. 58 Issue 7 Pg. 1607-1616 (07 2017) ISSN: 1029-2403 [Electronic] United States
PMID	27868471 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
Chemical References	Antineoplastic Agents, Immunological Biomarkers Immunoconjugates Ki-1 Antigen Brentuximab Vedotin
Topics	Adult Aged Aged, 80 and over Antineoplastic Agents, Immunological (administration & dosage, adverse effects, therapeutic use) Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use) Biomarkers Brentuximab Vedotin Drug Resistance, Neoplasm Female Humans Immunoconjugates (administration & dosage, adverse effects, therapeutic use) Immunohistochemistry Ki-1 Antigen (metabolism) Lymphoma, Large B-Cell, Diffuse (diagnosis, drug therapy, metabolism, mortality) Male Middle Aged Neoplasm Staging Recurrence Retreatment Treatment Outcome Young Adult

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