Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen for Elderly Patients with Acute Myeloid Leukemia: A Phase II Single-Arm Multicenter Study

• Main Authors: Liu X, Shi H, Shen J, Li Y, Yan W, Sun Y, Liao A, Tan Y, Yang W, Wang H
• Format: Article
• Language: English
• Published: Dove Medical Press 2021-09-01
• Series: International Journal of General Medicine
• Subjects: rhtpo; elderly; acute myeloid leukemia; cag; decitabine
• Online Access: https://www.dovepress.com/dual-growth-factor-rhtpo--g-csf-and-chemotherapy-combination-regimen-f-peer-reviewed-fulltext-article-IJGM
• ISSN: 1178-7074

Xiaoyu Liu,1 Hua Shi,2 Jing Shen,1 Yang Li,1 Wei Yan,1 Ying Sun,1 Aijun Liao,1 Yehui Tan,3 Wei Yang,1,&ast; Huihan Wang1,&ast; 1Haematology Department of Shengjing Hospital, China Medical University, Shenyang, Liaoning, 110004, People’s Republic of China; 2Haematology Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University Shen Shan Central Hospital, Guangzhou, People’s Republic of China; 3Haematology Department of The First Hospital of Jilin University, Changchun, Jilin, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Wei Yang; Huihan WangHaematology Department of Shengjing Hospital, China Medical University, Shenyang, Liaoning, 110004, People’s Republic of ChinaTel [phone]; [phone]Email [e-mail]; [e-mail]: Acute myeloid leukemia (AML) is a disease affecting older adults, although optimal strategies for treating such patients remain unclear. This prospective phase II, open-label, multicenter study was designed to assess the efficacy and safety of two hematologic growth factors, recombinant human thrombopoietin (rhTPO) and granulocyte colony-stimulating factor (G-CSF), in combination with decitabine, cytarabine, and aclarubicin (D-CTAG regimen) to treat older adults with newly diagnosed AML (Identifier: NCT04168138). The above agents were administered as follows: decitabine (15 mg/m2 daily, days 1– 5); low-dose cytarabine (10 mg/m2 q12 h, days 3– 9); rhTPO (15,000 U daily, days 2, 4, 6, 8, 10– 24 or until > 50× 109/L platelets); aclarubicin (14 mg/m2 daily, days 3– 6); and G-CSF (300 μg daily, days 2– 9). We concurrently monitored historic controls treated with decitabine followed by cytarabine, aclarubicin, and G-CSF (D-CAG) only. After the first D-CTAG cycle, the overall response rate (ORR) was 84.2% (16/19), including 13 (73.7%) complete remissions (CRs) and three (15.8%) partial remissions. This CR rate surpassed that of the D-CAG treatment (p < 0.05). Median overall survival (OS) time in the D-CTAG group was 20.2 months (range, 4– 31 months), compared with 14 months in the D-CAG group, and 1-year OS was 78%. The proportion of those experiencing grade III–IV thrombocytopenia was significantly lower for D-CTAG (57.9%) than for D-CAG (88.4%; p < 0.05). Ultimately, the curative effect of adding rhTPO was not inferior to that of D-CAG, and D-CTAG proved safer for elderly patients, especially in terms of hematologic toxicity. A prospective phase III randomized study is warranted to confirm these observations.Keywords: rhTPO, elderly, acute myeloid leukemia, CAG, decitabine