1.Real world study of ixazomib combined with lenalidomide and dexamethasone in treatment of multiple myeloma
Fengdi WANG ; Jianming YU ; Fei ZHAO ; Haiming KOU ; Lin LIU ; Fang LIU ; Chun ZHANG
Journal of Leukemia & Lymphoma 2022;31(2):87-91
Objective:To investigate the efficacy and safety of ixazomib combined with lenalidomide and dexamethasone (IRd) regimen in treatment of multiple myeloma (MM) patients in the real world practice.Methods:The clinical data of 24 MM patients treated with IRd regimen from January 2019 to January 2021 in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology were retrospectively analyzed, and their efficacy and adverse reactions were analyzed. Among the 24 patients, 5 patients were relapsed and refractory (relapsed/refractory group), and 19 newly treated patients (conversion group) who responded to bortezomib induction therapy but converted to IRd regimen due to adverse reactions or other reasons.Results:The 24 patients were treated for a median of 4 cycles (2-7 cycles), with 8 cases of complete remission (CR), 6 cases of very good partial remission (VGPR), 8 cases of partial remission (PR), 1 case of disease progression (PD), 1 case of minimal response (MR), and the overall response rate (ORR) was 91.7% (22/24); the median progression-free survival (PFS) time was 15 months (95% CI 6.6-23.4 months); 6 CR patients were negative for minimal residual disease (MRD). The common adverse reactions were hematological adverse reactions, peripheral neuropathy, fatigue, gastrointestinal reactions, and infections. The incidence rate of grade 3-4 adverse reactions was 25.0% (6/24). In the relapsed/refractory group, the best efficacy was VGPR in 1 case, PR in 3 cases, and MR in 1 case, all patients withdrew from the IRd regimen therapy due to PD after transient remission or poor effect; in the conversion group, the best efficacy was CR in 8 cases, VGPR in 5 cases, PR in 5 cases, and PD in 1 case, 57.9% (11/19) patients maintained their original best response, and 36.8% (7/19) patients improved their best response to CR; the difference in median PFS time between the two groups was statistically significant (7 months vs. not reached, P = 0.018). Conclusions:The IRd regimen is safe and effective for MM patients, especially for the conversion patients after effective bortezomib induction therapy. Although patients with relapsed/refractory MM who have previously used multi-line therapy respond to IRd regimen, the duration of remission is limited.
2.Infectious complications following chimeric antigen receptor T-cell therapy for a hematologic malignancy within 28 days
Yingnan LI ; Mengyi DU ; Chenggong LI ; Yinqiang ZHANG ; Wenjing LUO ; Haiming KOU ; Heng MEI ; Yu HU
Chinese Journal of Hematology 2021;42(9):739-746
Objective:To explore the incidence, clinical and microbiological characteristics and risk factors of infection in patients with acute lymphoblastic (ALL) , non-Hodgkin lymphoma (NHL) , and multiple myeloma (MM) within 28 days after CAR-T cell infusion. It provides data support for early identification of infection and the rational use of antibacterial drugs in these patients.Methods:We retrospectively analyzed the baseline data of 170 patients with ALL, NHL and MM who received chimeric antigen receptor-modified T (CAR-T) -cell treatment in the Department of Hematology of Wuhan Union Hospital from January 2016 to December 2020, and the clinical characteristics of infection within 28 days after infusion, including 72 patients with ALL, 56 patients with NHL, and 42 patients with MM; we used Poisson regression and Cox proportional hazard regression models to assess high-risk factors for infection before and after infusion, respectively.Results:Among 170 patients, 119 infections occurred in 99 patients within 28 days, with a cumulative infection rate of 58.2%. Seventy-eight patients had 98 bacterial infections and the cumulative incidence of bacterial infection was 45.9%. The infection density was 2.01, and the median time for the first infection was about 12 days after infusion. The adjusted baseline characteristic model showed that ALL patients, previous 30 days of infection history, refractory disease, absolute neutrophil count (ANC) <0.5×10 9/L before infusion and ≥4 prior antitumor treatment regimens had a higher infection density within 28 days; grade 3 or 4 CRS was the only high-risk factor related to infection after infusion in the multivariate analysis. Conclusion:Infection is a common complication of CAR-T cell therapy in patients with hematologic malignancy. Bacterial infections occur in most patients regardless of the type of disease. ALL patients, previous 30 days of infection history, refractory disease, ANC<0.5×10 9/L before infusion and grade 3 or 4 CRS are risk factors for infection. Chinese Clinical Trial Register::ChiCTR-OIC-17011180, ChiCTR1800018143