@article{ToppvanMeertenHouotetal.2021, author = {Topp, Max S. and van Meerten, Tom and Houot, Roch and Minnema, Monique C. and Bouabdallah, Krimo and Lugtenburg, Pieternella J. and Thieblemont, Catherine and Wermke, Martin and Song, Kevin W. and Avivi, Irit and Kuruvilla, John and D{\"u}hrsen, Ulrich and Zheng, Yan and Vardhanabhuti, Saran and Dong, Jinghui and Bot, Adrian and Rossi, John M. and Plaks, Vicki and Sherman, Marika and Kim, Jenny J. and Kerber, Anne and Kersten, Marie Jos{\´e}}, title = {Earlier corticosteroid use for adverse event management in patients receiving axicabtagene ciloleucel for large B-cell lymphoma}, series = {British Journal of Haematology}, volume = {195}, journal = {British Journal of Haematology}, number = {3}, doi = {10.1111/bjh.17673}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-258342}, pages = {388-398}, year = {2021}, abstract = {Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed or refractory large B-cell lymphoma (R/R LBCL). To reduce axi-cel-related toxicity, several exploratory safety management cohorts were added to ZUMA-1 (NCT02348216), the pivotal phase 1/2 study of axi-cel in refractory LBCL. Cohort 4 evaluated the rates and severity of cytokine release syndrome (CRS) and neurologic events (NEs) with earlier corticosteroid and tocilizumab use. Primary endpoints were incidence and severity of CRS and NEs. Patients received 2 × 106 anti-CD19 CAR T cells/kg after conditioning chemotherapy. Forty-one patients received axi-cel. Incidences of any-grade CRS and NEs were 93\% and 61\%, respectively (grade ≥ 3, 2\% and 17\%). There was no grade 4 or 5 CRS or NE. Despite earlier dosing, the cumulative cortisone-equivalent corticosteroid dose in patients requiring corticosteroid therapy was lower than that reported in the pivotal ZUMA-1 cohorts. With a median follow-up of 14·8 months, objective and complete response rates were 73\% and 51\%, respectively, and 51\% of treated patients were in ongoing response. Earlier and measured use of corticosteroids and/or tocilizumab has the potential to reduce the incidence of grade ≥ 3 CRS and NEs in patients with R/R LBCL receiving axi-cel.}, language = {en} } @article{DimopoulosWeiselSongetal.2015, author = {Dimopoulos, Meletios A. and Weisel, Katja C. and Song, Kevin W. and Delforge, Michel and Karlin, Lionel and Goldschmidt, Hartmut and Moreau, Philippe and Banos, Anne and Oriol, Albert and Garderet, Laurent and Cavo, Michele and Ivanova, Valentina and Alegre, Adrian and Martinez-Lopez, Joaquin and Chen, Christine and Spencer, Andrew and Knop, Stefan and Bahlis, Nizar J. and Renner, Christoph and Yu, Xin and Hong, Kevin and Sternas, Lars and Jacques, Christian and Zaki, Mohamed H. and San Miguel, Jesus F.}, title = {Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone}, series = {Haematologica}, volume = {100}, journal = {Haematologica}, number = {10}, doi = {10.3324/haematol.2014.117077}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-140349}, pages = {1327 -- 1333}, year = {2015}, abstract = {Patients with refractory or relapsed and refractory multiple myeloma who no longer receive benefit from novel agents have limited treatment options and short expected survival. del(17p) and t(4;14) are correlated with shortened survival. The phase 3 MM-003 trial demonstrated significant progression-free and overall survival benefits from treatment with pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone among patients in whom bortezomib and lenalidomide treatment had failed. At an updated median follow-up of 15.4 months, the progression-free survival was 4.0 versus 1.9 months (HR, 0.50; P<0.001), and median overall survival was 13.1 versus 8.1 months (HR, 0.72; P=0.009). Pomalidomide plus low-dose dexamethasone, compared with high-dose dexamethasone, improved progression-free survival in patients with del(17p) (4.6 versus 1.1 months; HR, 0.34; P < 0.001), t(4;14) (2.8 versus 1.9 months; HR, 0.49; P=0.028), and in standard-risk patients (4.2 versus 2.3 months; HR, 0.55; P<0.001). Although the majority of patients treated with high-dose dexamethasone took pomalidomide after discontinuation, the overall survival of patients treated with pomalidomide plus low-dose dexamethasone or highdose dexamethasone was 12.6 versus 7.7 months (HR, 0.45; P=0.008) in patients with del(17p), 7.5 versus 4.9 months (HR, 1.12; P=0.761) in those with t(4;14), and 14.0 versus 9.0 months (HR, 0.85; P=0.380) in standard-risk subjects. The overall response rate was higher in patients treated with pomalidomide plus low-dose dexamethasone than in those treated with high-dose dexamethasone both among standard-risk patients (35.2\% versus 9.7\%) and those with del(17p) (31.8\% versus 4.3\%), whereas it was similar in patients with t(4; 14) (15.9\% versus 13.3\%). The safety of pomalidomide plus low-dose dexamethasone was consistent with initial reports. In conclusion, pomalidomide plus low-dose dexamethasone is efficacious in patients with relapsed/refractory multiple myeloma and del(17p) and/or t(4;14).}, language = {en} }