Table 1.
Oncology Studies with Azoximer bromide.
| Nosology | Scheme/dose | Subjects | Results |
|---|---|---|---|
| Colon cancer, III-IV stages | Adjuvant regimen, Double-blind placebo-controlled study Group 1; 6 mg + 5 FU, Group 2; 12 mg + 5 FU, Group 3; 12 mg + 5 FU | 49 | Positive changes in immunological indicators over time (87.2% of treatment patients in all experimental groups). Significant increase of relative and absolute white blood cell (CD3, CD4, CD8) count (60). |
| Breast cancer | |||
| Nodular breast cancer (stage T1- 2N0M0) | AZB monotherapy, 6 mg every other day (10 injections) | 96 | Normalization of immune system’s humoral components and cellular- mediated indicators (61). |
| Underwent FAC chemotherapy + some radiation therapy | Adjuvant regimen, 6 mg (9 injections between chemotherapy courses) | 94 | Improving chemotherapy tolerance (according to NCI-CTC V3.0), and quality of life (FACT-G questionnaires), absence of adverse events. Increased activation of immunity indicators (CD50, CD38, CD95 and CD11b) on blood lymphocytes. Absolute increase in the number of immunity parameters (mature B-cells, CD 45 RA+ cells, T-helper cells). Stimulating leukopoiesis due to increase of pro-inflammatory induction (62). |
| Underwent core-biopsy | Neoadjuvant regimen, 12 mg every other day (5 injections) | 20 | Absence of complications and side effects. Therapeutic pathomorphosis of varying degree and changes in the composition of intratumoral lymphocytes (in 30% of cases) (63, 64). |
| Primary operable breast cancer | Neoadjuvant regimen, 12 mg every other day (5 injections) | 75 | Therapeutic pathomorphosis of varying degree in the primary tumor and metastasic lymph nodes (63). |
| Chronic lymphocytic leukemia | CT + AZB or AZB monotherapy | 21 | Increased T-cell counts and phagocytic activity of neutrophils and immunoglobulin levels over time. Increased the efficiency of standard chemotherapy, and increased antibacterial therapy in the development of infectious and inflammatory complications (65). |
| Hodgkin’s lymphoma | CT + AZB; 6 mg (children >5 years; 3 mg), for 2 weeks 3x per week, 2 courses | 16 | Decreased T-killer counts, partial normalization of immunoregulatory cells ratio, activation of humoral immunity indicators, and increased phagocytic activity. Significant reduction in the size of tumor peripheral lymph nodes by 30–60% (66). |
| Kidney cancer | AZB monotherapy, adjuvant regimen | 72 | Increased immunoregulatory cells ratio and normalization of immunity indicators (67). |
| Langerhans cell histiocytosis | CT + AZB; 6 mg (children >5 years; 3 mg), for 2 weeks 3x per week, then for 6 weeks 2x per week | 12 | Increased T-cell counts, neutrophil and bactericidal activity. Activation of humoral immunity. Normalization of immunity indicators, Significant reduction in the size of tumor volume by 20–30% (66). |
| Lung cancer | |||
| Advanced lung cancer | CT + AZB | 129 | Significant increase of overall survival rate (p=0.0164) and reduced frequency and severity of infectious complications during chemotherapy (68). |
| Localized lung cancer | AZB monotherapy | 56 | Normalization of immunity indicators, and significant reduction of metastatic frequency (p=0.017). Sings of activation of specific T-cells and non-specific cell mediated immunity (67). |
| Skin melanoma | AZB monotherapy, adjuvant regimen 6–12 mg every other day for 3 months | 40 | High drug efficacy and increase of 3-year survival rate of patients (92.5%). Decrease in the frequency of cytogenetic disorders and the probability of disease relapsing (47.5%) (69, 70). |
| Solid tumors in children (ES, NB, rhabdomyosarcoma, germ cell tumors) | CT + AZB subcutaneously 0.15 mg for 5 days | 20 | Significant decrease in the incidence of incidence of infectious bacterial (1.8%) and viral (12.5%) complications (p<0.05). Reduction of immunosuppression severity and significant improvement of immunity indicators (p<0.05) (71). |