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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 0.319‒0.748; P  = 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive (ER+)/HER2− ABC. Here, we present the final overall survival (OS) and updated safety results. Methods Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety. Results A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623–1.294; P  = 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to first subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%). Conclusions Palbociclib plus letrozole treatment led to a numerical but not statistically significant improvement in median OS. Pfizer Inc (NCT00721409)

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. Patients with newly diagnosed stage II/III breast cancer eligible to receive (neo) adjuvant chemotherapy with docetaxel/doxorubicin/cyclophosphamide every 3 weeks for 6 cycles were enrolled and randomized 2:1 to 6 mg of MYL-1401H or reference pegfilgrastim 24 h (+ 2-h window after the first 24 h) after the end of chemotherapy. The primary efficacy endpoint was the duration of severe neutropenia in cycle 1 (i.e., days with absolute neutrophil count (ANC) < 0.5 × 109/L). Mean (standard deviation (SD)) duration of severe neutropenia in MYL-1401H and reference pegfilgrastim groups was 1.2 days (0.93) and 1.2 days (1.10), respectively. The 95% CI for least squares mean difference (− 0.285, 0.298) was within the predefined equivalence range of ± 1 day. Secondary endpoints, including grade ≥ 3 neutropenia (frequency, 91% and 82% for MYL-1401H and reference pegfilgrastim, respectively), time to ANC nadir (mean (SD), 6.2 (0.98) and 6.3 (1.57) days), and duration of post-nadir recovery (mean (SD), 1.9 (0.85) and 1.7 (0.91) days) were comparable. Overall safety profiles of the study drugs were comparable. MYL-1401H demonstrated equivalent efficacy and similar safety to reference pegfilgrastim and may be an equivalent option for reducing incidence of neutropenia. (ClinicalTrials.gov, NCT02467868; EudraCT, 2014-002324-27).

Since modern technologies produce new global education trends, education prospects redesign, and new opportunities and threats assessments are needed. The new educational technology development phase was researched as an answer to modern world challenges. The strategic priorities of education in the EU are analyzed. New technologies, practices, and related needs: financing, digital integration, accessibility, informational security were studied and generalized. Higher education key trends and their transformation in the context of the COVID-19 crisis new opportunities and threats were researched. The analysis of the seven years of NMC Horizon and other research emerging educational technologies adoption forecasts provided in the research shows significant discrepancies related to extreme uncertainty. Five educational trend groups from the NMC Horizon report 2020 were reviewed. The author defined the remote education tools and their importance on the example of the university providing online/mixed learning. The anonymous polls among lecturers and students performed in the spring of 2020 (just after the COVID-19 quarantine announcement) show the most highly demanded tools are Google Meet, email, specific learning systems such as Moodle. The barriers to fully-fledged remote education are technical problems and occasionally poor Internet connectivity. The participants are quite ready to learn and to use digital tools for education. However, the absence of live communication increases workload during online learning, and other factors arise as the factors lowering student activity. During severe transformation, the main tasks of education are accessibility and diversity.

Research background: The article examines the peculiarities of the economy decarbonisation in Ukraine’s regions using cluster analysis, which helped to determine the composition of clusters of regions with a similar level of the economy decarbonisation and common features. The study takes into account specific indicators. Close attention is paid to the study of the dynamics of carbon dioxide emissions into the atmosphere from stationary sources per unit of gross regional product in certain clusters and to the identification of factors and measures to reduce them. The development of energy innovations is identified as a key area for decarbonisation of regional economies. The role of decentralization reform is analysed and regarded as a factor in the growth of decarbonisation and development of energy projects in united territorial communities, which, in general, increases the level of effectiveness of the regional policy on innovative development of the energy sector. Purpose of the article: to identify key factors in the growth of decarbonisation of the economy of the regions. Methods : general scientific methods were used, the main of which are: cluster analysis – to identify clusters of regions with a similar level of decarbonisation of the economy, system analysis – to apply a comprehensive approach to the study of factors influencing the growth of decarbonisation of the economy and determining an effective balanced regional policy towards innovative development of the energy sector. Findings & Value added: The directions of balancing the regional policy towards ensuring innovative development of the energy sector of the national economy in the conditions of Industry 4.0 are determined.

Since modern technologies produce new global education trends, education prospects redesign, and new opportunities and threats assessments are needed. The new educational technology development phase was researched as an answer to modern world challenges. The strategic priorities of education in the EU are analyzed. New technologies, practices, and related needs: financing, digital integration, accessibility, informational security were studied and generalized. Higher education key trends and their transformation in the context of the COVID-19 crisis new opportunities and threats were researched. The analysis of the seven years of NMC Horizon and other research emerging educational technologies adoption forecasts provided in the research shows significant discrepancies related to extreme uncertainty. Five educational trend groups from the NMC Horizon report 2020 were reviewed. The author defined the remote education tools and their importance on the example of the university providing online/mixed learning. The anonymous polls among lecturers and students performed in the spring of 2020 (just after the COVID-19 quarantine announcement) show the most highly demanded tools are Google Meet, email, specific learning systems such as Moodle. The barriers to fully-fledged remote education are technical problems and occasionally poor Internet connectivity. The participants are quite ready to learn and to use digital tools for education. However, the absence of live communication increases workload during online learning, and other factors arise as the factors lowering student activity. During severe transformation, the main tasks of education are accessibility and diversity.