Abstract
We assessed the clinical effectiveness and safety of CKI (compound Kushen injection) plus standard induction chemotherapy for treating adult acute leukemia (AL). We randomly assigned 332 patients with newly diagnosed AL to control (n = 165, receiving DA (daunorubicin and cytarabine) or hyper-CVAD (fractionated cyclophosphamide, doxorubicin, vincristine, and dexamethasone)) or treatment (n = 167, receiving CKI and DA or hyper-CVAD) groups. Posttreatment, treatment group CD3+, CD4+, CD4+/CD8+, natural killer (NK) cell, and immunoglobulin (IgG, IgA, and IgM) levels were significantly higher than those of the control group (p < 0.05), and CD8+ levels were lower in the treatment group than in the control group (p < 0.05). Treatment group interleukin- (IL-) 4 and IL-10 levels were significantly higher compared to the control posttreatment (both p < 0.05) as were complete remission, overall response, and quality of life (QoL) improvement rates (p < 0.05). The control group had more incidences of grade 3/4 hematologic and nonhematologic toxicity (p < 0.05). Responses to induction chemotherapy, QoL improvement, and adverse events incidence between control group patients with acute myeloid leukemia and acute lymphocytic leukemia were not significantly different. CKI plus standard induction chemotherapy is effective and safe for treating AL, possibly by increasing immunologic function.
Highlights
Acute leukemia (AL), a malignant neoplasm, is characterized by clonal blood cell proliferation within the bone marrow
After the first course of induction chemotherapy, in the control group, CD3+, CD4+, CD4+/CD8+, natural killer (NK) cell, and immunoglobulin (IgA, IgM, and IgG) levels decreased significantly (p < 0.05) and CD8+ was increased significantly (p < 0.05); in the treatment group, levels of CD3+, IgA, and IgM decreased significantly (p < 0.05), CD4+ was increased significantly (p < 0.05), and CD8+, CD4+/CD8+, NK cell, and IgG levels did not change significantly (p > 0.05). This suggests that immunity function has been decreased in AL patients with induction chemotherapy
The serum CD3+, CD4+, CD4+/CD8+, NK cells, and immunoglobulin levels were significantly lower in the control group than in the treatment group (p < 0.05, Table 2), which implies that compound Kushen injection (CKI) improves immunologic function in patients with AL
Summary
Acute leukemia (AL), a malignant neoplasm, is characterized by clonal blood cell proliferation within the bone marrow. Improved disease treatment and management have led to increased overall survival trends [1]. The Surveillance Epidemiology and End Results reported 24% and 65% 2002–2008 relative five-year survival rates in adults with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), respectively [2]. Standard chemotherapy is not always tolerated by patients; the adverse events during chemotherapy, such as myelosuppression, gastrointestinal reaction, infection, and cardiotoxicity, often lead to interruption of chemotherapy [3]; there is treatment failure. Such patients urgently need effective, lowtoxicity therapy
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