Combined Thalidomide and Recombinant Human Interferon-α-1b and Interleukin-2 for Acute Myeloid Leukemia of Various Disease Status: A Multi-Center Prospective Study

Objectives: This study investigated the therapeutic effects of combined recombinant human interferon-α-1b (IFN-α1b), thalidomide, and recombinant interleukin-2 (IL-2) in treating acute myeloid leukemia (AML) in patients of various disease status and vulnerabilities. Methods: Patients with AML (n = 166) were treated with combined recombinant IFN-α1b, thalidomide, and recombinant IL-2 (ITI regimen). The rates of partial and complete remission, minimal residual disease (MRD) status, quality of life, and long-term survival were compared among 3 patient groups. Lymphocyte profiles and relevant cytokine levels determined from peripheral blood samples of patients (pre- and post-treatment) and healthy individuals were compared. (Registration number: ChiCTR-ONC-14004688; Registered 23 May 2014, www.chictr.org.cn)Results: Sixty patients with primary AML who were unable to receive chemotherapy, or with relapsed/refractory AML, showed a total response rate of 30% after undergoing the ITI regime, and maintained a good quality of life. Eighteen patients with morphologically complete remission and consistently positive MRD achieved a response rate of 72.2%: the MRD converted to negative or was mitigated in 9 and 4 patients, respectively; 5 patients did not respond. For 88 patients with initial complete remission and negative MRD, 11 failed to maintain the negative MRD, and the relapse rate was 12.5%. The ITI regime was associated with substantial anti-leukemic changes in peripheral blood lymphocyte profiles and cytokine levels. Conclusions: The ITI regimen may be an effective and affordable option for patients with AML who cannot tolerate conventional chemotherapy, including those with relapsed/refractory disease, or complete remission status but MRD-positive, or after initial complete remission.