Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and Sézary syndrome with variable CD30 expression level: A multi-institution collaborative project

Journal of Clinical Oncology

Volumn 33, Issue 32, 2015, Pages 3750-3758

  Kim, Youn H ^a   Tavallaee, Mahkam ^a   Sundram, Uma ^a   Salva, Katrin A ^b   Wood, Gary S ^b   Li, Shufeng ^a   Rozati, Sima ^a   Nagpal, Seema ^a   Krathen, Michael ^a   Reddy, Sunil ^a   Hoppe, Richard T ^a   Nguyen Lin, Annie ^a   Weng, Wen Kai ^a   Armstrong, Randall ^a   Pulitzer, Melissa ^c   Advani, Ranjana H ^a   Horwitz, Steven M ^c  

^a STANFORD CANCER INSTITUTE   (United States)

^b UNIVERSITY OF WISCONSIN MADISON   (United States)

^c MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; BRENTUXIMAB VEDOTIN; CD30 ANTIGEN; CYTOTOXIC AGENT; ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT; CD163 ANTIGEN; CD8 ANTIGEN; CELL SURFACE RECEPTOR; DIFFERENTIATION ANTIGEN; LEUKOCYTE ANTIGEN; TUMOR MARKER;

ACUTE KIDNEY FAILURE; ADULT; AGED; ALLOGENEIC STEM CELL TRANSPLANTATION; ALOPECIA; ANOREXIA; ANTIGEN EXPRESSION; ARTICLE; BLOOD SAMPLING; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONFUSION; CONTROLLED STUDY; CORRELATIONAL STUDY; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; EVENT FREE SURVIVAL; FATIGUE; FEMALE; HUMAN; IMMUNOHISTOCHEMISTRY; MALE; MIDDLE AGED; MULTICENTER STUDY; MYCOSIS FUNGOIDES; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RISK ASSESSMENT; SENSORY NEUROPATHY; SEZARY SYNDROME; SIDE EFFECT; SKIN BIOPSY; SKIN INFECTION; TISSUE LEVEL; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR ASSOCIATED LEUKOCYTE; VERY ELDERLY; WEIGHT REDUCTION; CANCER STAGING; CLINICAL TRIAL; COOPERATION; DRUG ADMINISTRATION; GENE EXPRESSION REGULATION; METABOLISM; PATHOLOGY; PERSONNEL; PROGNOSIS; RISK FACTOR; SEVERITY OF ILLNESS INDEX; SKIN NEOPLASMS;

ADULT; AGED; AGED, 80 AND OVER; ANTIGENS, CD; ANTIGENS, CD30; ANTIGENS, CD8; ANTIGENS, DIFFERENTIATION, MYELOMONOCYTIC; ANTINEOPLASTIC AGENTS; BIOMARKERS, TUMOR; COOPERATIVE BEHAVIOR; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; IMMUNOCONJUGATES; MALE; MIDDLE AGED; MYCOSIS FUNGOIDES; NEOPLASM STAGING; PROGNOSIS; RECEPTORS, CELL SURFACE; RESEARCH PERSONNEL; RISK FACTORS; SEVERITY OF ILLNESS INDEX; SEZARY SYNDROME; SKIN NEOPLASMS;

EID: 84947478718     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.60.3969     Document Type: Article

References (34)

1. th Edition of the WHO Classification of Tumours of Hematopoietic and Lymphoid Tissues. IARC: Lyon 2008
2. Horwitz SM, Olsen EA, Duvic M, et al: Review of the treatment of mycosis fungoides and Sézary syndrome: A stage-based approach. J Natl Compr Canc Netw 6:436-442, 2008
3. Olsen E, Vonderheid E, Pimpinelli N, et al: Revisions to the staging and classification of mycosis fungoides and Sézary syndrome: A proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood 110:1713-1722, 2007
4. Francisco JA, Cerveny CG, Meyer DL, et al: cAC10-vcMMAE, an anti-CD30-monomethyl auristatin E conjugate with potent and selective antitumor activity. Blood 102:1458-1465, 2003
5. Okeley NM, Miyamoto JB, Zhang X, et al: Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin Cancer Res 16:888-897, 2010
6. Younes A, Gopal AK, Smith SE, et al: Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol 30:2183-2189, 2012
7. Pro B, Advani R, Brice P, et al: Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: Results of a phase II study. J Clin Oncol 30:2190-2196, 2012
8. Horwitz SM, Advani RH, Bartlett NL, et al: Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood 123:3095-3100, 2014
9. Bartlett NL, Sharman JP, Oki Y, et al: A phase 2 study of brentuximab vedotin in patients with relapsed or refractory CD30-positve non-Hodgkin lymphomas: Interim results in patients with DLBCL and other B-cell lymphomas. Blood 122:21 (suppl; abstr 848), 2013
10. Edinger JT, Clark BZ, Pucevich BE, et al: CD30 expression and proliferative fraction in nontransformed mycosis fungoides. Am J Surg Pathol 33:1860-1868, 2009
11. Benner MF, Jansen PM, Vermeer MH, et al: Prognostic factors in transformed mycosis fungoides: A retrospective analysis of 100 cases. Blood 119:1643-1649, 2012
12. Olsen EA, Whittaker S, Kim YH, et al: Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: A consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol 29:2598-2607, 2011
13. Olsen EA, Kim YH, Kuzel TM, et al: Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol 25:3109-3115, 2007
14. National Cancer Institute: Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. http://ctep.cancer.gov/protocolDevelopment/electronic-applications/ctc.htmtc-40
15. Piekarz RL, Frye R, Turner M, et al: Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T cell lymphoma. J Clin Oncol 27:5410-5417, 2009
16. Whittaker SJ, Demierre MF, Kim EJ, et al: Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol 28:4485-4491, 2010
17. Olsen EA, Whittaker S, Kim YH, et al: Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: A consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol 29:2598-2607, 2011
18. Weng W-K, Armstrong R, Arai S, et al: Minimal residual disease monitoring with highthroughput sequencing of T cell receptors in cutaneous T cell lymphoma. Sci Transl Med 5: ra171, 2013
19. Mansfield JR, Hoyt C, Levenson RM: Visualization of microscopy-based spectral imaging data from multi-label tissue sections. Curr Protoc Mol Biol 14:14. Unit 14 19, 2008
20. Sundram U, Harvell JD, Rouse RV, et al: Expression of the B-cell proliferation marker MUM1 by melanocytic lesions and comparison with S100, gp100(HMB45), and MelanA. Mod Pathol 16:802-810, 2003
21. Ogura M, Ishida T, Hatake K, et al: Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol 32:1157-1163, 2014
22. Hoppe RT, Medeiros LJ, Warnke RA, et al: CD8-positive tumor-infiltrating lymphocytes influence the long-term survival of patients with mycosis fungoides. J Am Acad Dermatol 32:448-453, 1995
23. Vermeer MH, van Doorn R, Dukers D, et al: CD8+ T cells in cutaneous T-cell lymphoma: Expression of cytotoxic proteins, Fas ligand, and killing nhibitory receptors and their relationship with clinical behavior J Clin Oncol 19:4322-4329, 2001
24. Ni X, Hazarika P, Zhang C, et al: Fas ligand expression by neoplastic T lymphocytes mediates elimination of CD8+ cytotoxic T lymphocytes in mycosis fungoides: A potential mechanism of tumor immune escape? Clin Cancer Res 7:2682-2692, 2001
25. Chetaille B, Bertucci F, Finetti P, et al: Molecular profiling of classical Hodgkin lymphoma tissues uncovers variations in the tumor microenvironment and correlations with EBV infection and outcome Blood 113:2765-3775, 2009
26. Tiemessen MM, Mitchell TJ, Hendry L, et al: Lack of suppressive CD4+CD25 + FOXP3+ T cells in advanced stages of primary cutaneous T-cell lymphoma. J Invest Dermatol 126:2217-2223, 2006
27. Steidl C, Lee T, Shah SP, et al: Tumorassociated macrophages and survival in classic Hodgkin's lymphoma. N Engl J Med 362:875-885, 2010
28. Nam SJ, Go H, Paik JH, et al: An increase of M2 macrophages predicts poor prognosis in patients with diffuse large B-cell lymphoma with rituxmab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Leuk Lymphoma 55:2466-2476, 2014
29. Carreras J, Lopez-Guillermo A, Fox BC, et al: High numbers of tumor-infiltrating FOXP3-positive regulatory T cells are associated with improved overall survival in follicular lymphoma. Blood 108:2957-2964, 2006
30. Brody JD, Ai WZ, Czerwinski DK, et al: In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: A phase I/II study. J Clin Oncol 28:4324-4332, 2010
31. Jullié ML, Carlotti M, Vivot A Jr, et al: CD20 antigen may be expressed by reactive or lymphomatous cells of transformed mycosis fungoides: Diagnostic and prognostic impact. Am J Surg Pathol 37:1845-1854, 2013
32. Sugaya M, Miyagaki T, Ohmatsu H, et al: Association of the numbers of CD163 (+) cells in lesional skin and serum levels of soluble CD163 with disease progression of cutaneous T cell lymphoma J Dermatol Sci 68:45-51, 2012
33. Wu X, Schulte BC, Zhou Y, et al: Depletion of M2-like tumor-associated macrophages delays cutaneous T-cell lymphoma development in vivo. J Invest Dermatol 134:2814-2822, 2014
34. Tan KL, Scott DW, Hong F, et al: Tumorassociated macrophages predict inferior outcomes in classic Hodgkin lymphoma: A correlative study from the E2496 Intergroup trial. Blood 120:3280-3287, 2012