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

References

• Hu S, Xu-Monette ZY, Balasubramanyam A, et al. CD30 expression defines a novel subgroup of diffuse large B-cell lymphoma with favorable prognosis and distinct gene expression signature: a report from the International DLBCL Rituximab-CHOP Consortium Program Study. Blood. 2013;121:2715–2724.
   PubMed Web of Science ®Google Scholar
• Campuzano-Zuluaga G, Cioffi-Lavina M, Lossos IS, et al. Frequency and extent of CD30 expression in diffuse large B-cell lymphoma and its relation to clinical and biologic factors: a retrospective study of 167 cases. Leuk Lymphoma. 2013;54:2405–2411.
   PubMed Web of Science ®Google Scholar
• Slack GW, Steidl C, Sehn LH, et al. CD30 expression in de novo diffuse large B-cell lymphoma: a population-based study from British Columbia. Br J Haematol. 2014;167:608–617.
   PubMed Web of Science ®Google Scholar
• Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood. 2015;125:22–32.
   PubMed Web of Science ®Google Scholar
• Elstrom RL, Martin P, Ostrow K, et al. Response to second-line therapy defines the potential for cure in patients with recurrent diffuse large B-cell lymphoma: implications for the development of novel therapeutic strategies. Clin Lymphoma Myeloma Leuk. 2010;10:192–196.
   PubMed Web of Science ®Google Scholar
• Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010;28:4184–4190.
   PubMed Web of Science ®Google Scholar
• Martin A, Conde E, Arnan M, et al. R-ESHAP as salvage therapy for patients with relapsed or refractory diffuse large B-cell lymphoma: the influence of prior exposure to rituximab on outcome. A GEL/TAMO study. Haematologica. 2008;93:1829–1836.
   PubMed Web of Science ®Google Scholar
• Seshadri T, Stakiw J, Pintilie M, et al. Utility of subsequent conventional dose chemotherapy in relapsed/refractory transplant-eligible patients with diffuse large B-cell lymphoma failing platinum-based salvage chemotherapy. Hematology. 2008;13:261–266.
   PubMed Web of Science ®Google Scholar
• Simpson L, Ansell SM, Colgan JP, et al. Effectiveness of second line salvage chemotherapy with ifosfamide, carboplatin, and etoposide in patients with relapsed diffuse large B-cell lymphoma not responding to cis-platinum, cytosine arabinoside, and dexamethasone. Leuk Lymphoma. 2007;48:1332–1337.
   PubMed Web of Science ®Google Scholar
• 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. 2012;30:2183–2189.
   PubMed Web of Science ®Google Scholar
• 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. 2012;30:2190–2196.
   PubMed Web of Science ®Google Scholar
• Forero-Torres A, Holkova B, Goldschmidt J, et al. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015;126:2798–2804.
   PubMed Web of Science ®Google Scholar
• Gopal AK, Chen R, Smith SE, et al. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015;125:1236–1243.
   PubMed Web of Science ®Google Scholar
• Pro B, Advani R, Brice P, et al. Four-year survival data from an ongoing pivotal phase 2 study of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2014;124:3095.
   Web of Science ®Google Scholar
• Kim YH, Tavallaee M, Sundram U, et al. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and sezary syndrome with variable CD30 expression level: a multi-institution collaborative project. J Clin Oncol 2015;33:3750–3758.
   PubMed Web of Science ®Google Scholar
• Jacobsen ED, Sharman JP, Oki Y, et al. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood. 2015;125:1394–1402.
   PubMed Web of Science ®Google Scholar
• Horwitz SM, Advani RH, Bartlett NL, et al. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014;123:3095–3100.
   PubMed Web of Science ®Google Scholar
• Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579–586.
   PubMed Web of Science ®Google Scholar
• Rimsza LM, Wright G, Schwartz M, et al. Accurate classification of diffuse large B-cell lymphoma into germinal center and activated B-cell subtypes using a nuclease protection assay on formalin-fixed, paraffin-embedded tissues. Clin Cancer Res. 2011;17:3727–3732.
   PubMed Web of Science ®Google Scholar
• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10:1–10.
   PubMedGoogle Scholar
• Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–413.
   Web of Science ®Google Scholar
• Collett D, Interval-censored survival data. In: Collett D, editor. Modelling survival data in medical research. 1st ed. Boca Raton, FL: Chapman & Hall/CRC; 1994. p 237–251.
   Google Scholar
• Seattle Genetics. . ADCETRIS – brentuximab vedotin injection, powder, lyophilized, for solution; 2011 [Internet] [rev. 2016 March] April 27, 2016. Available from: [email protected] <http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3904f8dd-1aef-3490-e48f-bd55f32ed67f&type=display.
   Google Scholar
• Bossard C, Dobay MP, Parrens M, et al. Immunohistochemistry as a valuable tool to assess CD30 expression in peripheral T-cell lymphomas: high correlation with mRNA levels. Blood. 2014;124:2983–2986.
   PubMed Web of Science ®Google Scholar
• Coutinho R, Clear AJ, Mazzola E, et al. Revisiting the immune microenvironment of diffuse large B-cell lymphoma using a tissue microarray and immunohistochemistry: robust semi-automated analysis reveals CD3 and FoxP3 as potential predictors of response to R-CHOP. Haematologica. 2015;100:363–369.
   PubMed Web of Science ®Google Scholar
• Chang KC, Huang GC, Jones D, et al. Distribution patterns of dendritic cells and T cells in diffuse large B-cell lymphomas correlate with prognoses. Clin Cancer Res. 2007;13:6666–6672.
   PubMed Web of Science ®Google Scholar
• Okeley NM, Miyamoto JB, Zhang X, et al. Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin Cancer Res. 2010;16:888–897.
   PubMed Web of Science ®Google Scholar
• Li F, Ulrich M, Jonas M, et al. Tumor associated macrophages can process antibody-drug conjugates and contribute to antitumor activity in preclinical xenograft models. Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16–20; New Orleans, LA. Philadelphia (PA): AACR; 2016. Abstract 1285.
   Google Scholar
• Muller P, Martin K, Theurich S, et al. Microtubule-depolymerizing agents used in antibody-drug conjugates induce antitumor immunity by stimulation of dendritic cells. Cancer Immunol Res. 2014;2:741–755.
   PubMed Web of Science ®Google Scholar
• Hao X, Wei X, Huang F, et al. The expression of CD30 based on immunohistochemistry predicts inferior outcome in patients with diffuse large B-cell lymphoma. PLoS One. 2015;10:e0126615
   PubMed Web of Science ®Google Scholar
• Collie AMB, Hill BT, Manilich EA, Smith MR, Hsi ED. CD30 immunohistochemical expression in diffuse large b-cell lymphoma is associated with decreased overall survival and the non-germinal center molecular subtype. Blood. 2013;122:4318.
   Google Scholar