Research Article: Immunotherapy with or without low-intensity chemotherapy versus conventional chemotherapy as first-line treatment for newly diagnosed B-ALL patients fit for intensive chemotherapy: a propensity score-matched study
Abstract:
For B-cell acute lymphoblastic leukemia (B-ALL), the dominance of traditional chemotherapy is being rewritten, with multiple promising novel treatment approaches continually emerging. Immunotherapy (blinatumomab, Blina or inotuzumab ozogamicin, InO) has demonstrated efficacy in the induction phase for elderly patients newly diagnosed with B-ALL, but its role in newly diagnosed patients fit for intensive chemotherapy is being explored. This study aims to evaluate the efficacy and safety of immunotherapy with or without low-intensity chemotherapy in fit patients newly diagnosed with B-ALL.
We retrospectively enrolled 133 patients with newly diagnosed B-ALL who met the inclusion criteria at Qilu Hospital of Shandong University. Patients were divided into two groups based on whether Blina/InO was used in the first-line induction therapy regimen. The immunotherapy group (IG) consisted of 25 patients, while the chemotherapy group (CG) consisted of 108 patients. Propensity score matching (PSM) was performed to match the IG and CG patients in a 1:1 ratio based on age, sex, risk stratification, comorbidities and Philadelphia chromosome status. After matching, there were 25 patients in each group. Primary research objectives included remission rates and minimal residual disease (MRD) negativity rate. Secondary objectives included adverse events. Data management and statistical analysis were performed using SPSS and R software.
The IG achieved a higher MRD negativity rate (88% vs. 48%, p =?0.002). Compared with the CG, the IG had a higher median minimum of neutrophil count ( p <?0.001) and a higher median minimum of platelet count ( p =?0.001). Furthermore, the duration of neutrophil count < 0.5?×?10 9 /L ( p =?0.033), hemoglobin level < 80?g/L ( p =?0.038) and platelet count < 30?×?10 9 /L ( p =?0.006) was shorter in the IG. They also experienced fewer pulmonary infections (44% vs. 84%, p =?0.003). Additionally, the IG required fewer red blood cell transfusions (4 vs. 8 u, p =?0.012) and platelet transfusions (0 vs. 48 u, p <?0.001).
In the PSM-based retrospective cohort study, an immunotherapy-based first-line treatment strategy showed promising early treatment responses and tolerability to hematologic toxicity in fit patients newly diagnosed with B-ALL. These exploratory findings provide additional real-world evidence.
Introduction:
B-cell acute lymphoblastic leukemia is a malignant neoplastic disease originating from B-cell lymphoid progenitor cells, accounting for 20% of adult acute leukemia ( 1–3 ). Standard chemotherapy regimens achieve complete remission (CR) rates of 70–90% in newly diagnosed adult patients with B-ALL ( 4 , 5 ). However, they often result in severe bone marrow suppression and a high incidence of adverse reactions due to the narrow therapeutic window and poor selectivity ( 6 , 7 ). Some patients die during the induction…
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