Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18).

Purpose: Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2- ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.

Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.

Pegfilgrastim is indicated for reducing the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy. Here, safety and efficacy of MYL-1401H, a proposed pegfilgrastim biosimilar, were investigated as prophylaxis for chemotherapy-induced neutropenia. This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union-sourced reference pegfilgrastim.

[Investigation of the safety of the product "Rialam."].

The data on safety investigation of product "Rialam", which is proposed as biologically active food supplement are presented. Chronic experiment and single generation experiment were made on Wistar rats. It is shown that diet "Rialam" in dose 100 mg/kg of body weight didn't influence negatively on growth and development of rats blood parameters, immune status, internal organs morphology, metabolism, hadn't embryotoxic, gonadotoxic and teratogenic action.

[Changes in the serological indices of the immune status of workers in contact with raw foodstuffs contaminated by mycotoxins].

The immune status was estimated in workers engaged into the grain processing and exposed to constant hazards of the industrial environment (contact with the goods contaminated by mycotoxins). Studies revealed in workers the certain changes of serum Ig, complement fractions, proteins of the acute phase of inflammation. The importance of immunologic changes as criteria for adequate prophylactic measures was stressed.

[The effect of dietotherapy on the clinico-immunological indices of rheumatoid arthritis patients].

The main requirements for the dietotherapy of rheumatoid arthritis (RA) patients have been formulated, and for the first time a pathogenetically balanced diet has been developed that produces antiinflammatory and immunocorrective effects. The effectiveness of the dietotherapy included into the combined treatment was studied in 41 patients with classic and proved RA. The authors have studied the influence of the dietotherapy on the clinical signs characterizing the activity of inflammation in the joints, and laboratory immunological parameters (IgG, IgM, IgA, IgD, the complement components: C1-inhibitor, C3, C4, C5, C9; haptoglobin, orrhozomucoid, transferrin, ceruloplasmin, alpha 1-antitrypsin, alpha 2-macroglobulin, prealbumin).