Introduction. Effectiveness of adjuvant dose-dense (dd) chemotherapy has been proven in numerous clinical trials and meta-analysis. However, it remains unclear whether densifi cation of AC (doxorubicin/cyclophosphamide) regimen affects the rate of achieving pathological complete response (pCR) in the HER2+ subtype, since the effectiveness of ddAC-THP (docetaxel/trastuzumab/pertuzumab) regimen with dual anti-HER2 blockade in neoadjuvant chemotherapy (NACT) has not been studied. Treatment regimens containing anthracyclines (A) – AC-THP and non-anthracycline containing (non-A) (TCHP – docetaxel/carboplatin/trastuzumab/pertuzumab) are considered to be equally effective, although to date there are no full-scale direct comparative studies.
Objective of the study was to estimate the rate of achieving pathological complete response (pCR) using neoadjuvant chemotherapy (NACT) with ddAC (once every 2 weeks) – THP regimen compared to ACq3w (once every 3 weeks) – THP and to TCHP regimens in HER2+ stage II-III breast cancer.
Materials and Methods. The study comprised patients with HER2+ stage II-III breast cancer, who had received neoadjuvant chemotherapy (NACT) in the same center for the period from January 2017 to November 2022.
Statistical hypothesis:the study consists of two stages. The rate of achieving pathological complete response (pCR) using ddAc regimen is assumed to be ≥ 65 %, and using ACq3w ≤ 50 %. With a one-tailed type I error (α) = 0.05 and type II error (β) = 0.2, 170 patients should be included in each group. In the absence of signifi cant differences between ddAC and ACq3w, the groups can be combined into a single cohort for subsequent comparison with TCHP group. It is assumed that regimens containing A (H1 – pCR is equal to 55 %) are not inferior to non-A containing regimen (H0 – pCR is equal to 55 %). A non-inferiority design is planned, with a delta (δ) of 15 %, type I error (α) = 0,05 and type II error (β) = 0,2, 173 patients should be included in each group. This article presents preliminary results of the study.
Results. A total of 400 patients were included, of whom 138 received 4ddAC-4THP, 102 – 4ACq3w-4THP, 160 – 6TCHP. The majority of patients (77,5 %) had stage III cancer. The pCR rate in the entire ddAC-THP group was 55,8 %. After pseudorandomization 102 patients were included in each group of regimen containing A. The rate of pCR was 50 % in the ddAC group versus 48 % in the ACq3w group (p = 0,67). Subgroup analysis, that included T, N, age, ER status, G, ki67 indicators didn’t reveal any advantages of ddAC regimen in any of the subgroups. Then both groups (dose-dense and conventional) of regimen containing A, were combined, and after pseudorandomization 143 patients were included in group A and the TCHP group. The pCR rate was 53,8 % in group of regimen containing A versus 60,1 % in the TCHP group (p = 0,34). Subgroup analysis didn’t reveal any advantages of regimen containing A.
Conclusion. Preliminary results of our study certify that anthracycline-containing and anthracycline-free TCHP regimens are equivalent in terms of achieving pathological complete response (pCR). If AC-THP is chosen as neoadjuvant chemotherapy (NACT), there is no need to administer a dose-dense treatment regimen, since this does not increase effi ciency.
Keywords: breast cancer, HER2-positive, adjuvant chemotherapy, dose-dense regimen, effectiveness, tolerance
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Objective of the study is to assess diagnostic value of PET/CT with 18F-fl uoroestradiol (18F-FES) in detection of metastatic foci ER-status in breast cancer.
Materials and Methods. The data of 50 patients who had undergone PET/CT scanning with 18F-fl uoroestrdiol (18F-FES), 48 out of 50 patients also had undergone PET/CT with 18F- fl uorodeoxyglucose (18F-FDG) was analyzed retrospectively. The study comprised patients with suspected or confi rmed metastatic process of luminal breast cancer who were receiving hormone therapy.
Results. The following diagnostic values of SUVmax > 2 on PET/CT using 18F-fl uoroestradiol obtained in the detection of ER+ positive tumor tissue were: sensitivity - 85 % and specifi city – 100 %. SUVmax threshold greater than 3,2 in PET/CT with 18F-fl uorodeoxyglucose (18F-FDG) resulted in a sensitivity of 84 % and a specifi city of 97 %. With a decrease in a threshold level to SUVmax > 1,5, the sensitivity increased to 89 % with the same specifi city of 100 %.
Conclusion. PET/CT using 18F-fl uoroestradiol (18F-FES ) is a diagnostic method that allows for non-invasive assessment of estrogen receptor expression in tumor lesions, thus contributing to the fi ndings of traditional diagnostic methods, and it possesses signifi cant clinical potential.
Keywords: PET, PET/CT, breast cancer, 18F-FES, FES, 18F-FDG, FDG, fl uorodeoxyglucose, fl uoroestradiol
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Due to the rare incidence of gestational and non-gestational choriocarcinomas, the study of approaches to the treatment of these pathologies remains relevant. However, challenges in making clinical decisions may arise already at the stage of diagnosis.
A clinical case, presented in the paper, demonstrates the possibilities of differential diagnosis of malignant trophoblastic tumors and germ cell tumors of the ovaries. In addition to standard research methods (laboratory, radiological, morphological) some patients need molecular-genetic examination to identify the presence of a partner’s genetic material in the tumor.
Establishing a correct diagnosis allows to determine the optimal strategy of management of patients with choriocarcinoma. The clinical observation, presented in the paper, confi rms the literature data on the effectiveness of cisplatin-containing chemotherapy regimens for the initial treatment of patients with malignant trophoblastic tumors at high risk of drug resistance.
Keywords: malignant trophoblastic tumor, gestational choriocarcinoma, molecular-genetic examination, chemotherapy
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Objective of the study is to identify various populations of circulating tumor cells (CTC), as well as atypical/hybrid forms in the blood of patients with endometrial cancer before surgery and to evaluate their prognostic signifi cance in assessing the risk of recurrence and hematogenous metastases.
Materials and Methods. The prospective clinical trial NCT04817501 included 55 patients with stage T1a-2N0M0 endometrial cancer, mean age 57,8 ±1,7 years, who were admitted for treatment to Scientifi c Research Institute of Oncology of Tomsk National Research Medical Center or Tomsk Regional Oncologic Dispensary. The material for the study was EDTAstabilized venous blood in the volume of 5 ml. The presence and molecular profi le of circulating tumor cells (CTC) were assessed using multicolor fl ow cytometry technique.
Results. As a result of the prospective study, a prognostic model for the assessment of preoperative risk of recurrence and hematogenous metastases based on the data on the number of EpCAM+CD45- cells in blood, circulating tumor cells (CTC) with EpCAM+CD45-CD44-CD24-Ncadherin+ phenotype, stem circulating tumor cells (CTC) without EpCAM expression on the membrane (a sign of epithelial-mesenchymal transition) and atypical/hybrid forms of circulating tumor cells (CTC) with EpCAM+CD45+ phenotype was developed.
Conclusion. Thus, a minimally invasive method, that allows to predict with greater accuracy and informativity the risk of relapse and /or hematogenous metastases in endometrial cancer, which is essential for determining the strategy of management and creating a personalized approach in the treatment of such patients, has been developed.
Keywords: endometrial cancer, liquid biopsy, circulating tumor cells, atypical/hybrid Epcam+CD45+ cells, minimally invasive approaches for predicting tumor progression, relapses, hematogenous metastases, multicolored fl ow cytometry
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Objective of the study is to carry out a systematic analysis of the data available in current literature on the possibilities of the use of artifi cial intelligence (AI) for the construction of mathematical models of complex systems, including human body.
Materials and Methods. The review comprises the data of foreign and Russian scholarly articles found in PubMed on the subject, published over the past 10 years.
Results. Machine learning algorithms help to identify key variables and relationships within a system that are diffi cult or impossible for humans to detect. This paper presents various types of mathematical models: explanatory and prognostic, explains the importance and purpose of the choice and standardization of variables that make up the model, as well as the signs of the coeffi cients in the models.
Conclusion. Descriptive and prognostic models are the two common types of models of machine learning. The key difference between them is an objective of their use. Understanding these differences is essential for clinician researchers and analysts when choosing the most appropriate type of model for their research or for the integration into decision-making processes.
Keywords: artifi cial intelligence, machine learning, diagnostics, explanatory and prognostic model, medical research, multivariate logistic regression, MLR
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Objective of the study is to conduct a systematic analysis of the data available in current literature on the issues related to vulvovaginal atrophy after radical surgeries.
Materials and Methods. The review comprises the data of foreign and Russian academic articles found in PubMed on the subject published over the past 10 years.
Results. To date, there is a growing interest to the study of the course and characteristic features of atrophic processes after radical operations, in particular, after surgeries for gynecologic cancers. This article concerns distinctive features of vulvovaginal atrophy after radical operations, including morphological and microbiological intricacies. Particular emphasis is given to the novel promising treatment strategies.
Conclusion. Despite extensive research carried our worldwide, certain aspects related to vulvovaginal atrophy remain unresolved. Therefore, a challenge remains to search for new methods of diagnosis, treatment, disease prevention and active integration of the latest scientifi c achievements into medical practice.
Keywords: vulvovaginal atrophy, surgical menopause, female reproductive system malignant neoplasms
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Objective of the study is to carry out a systematic analysis of data available in current literature, on the possibilities of the use of menopausal hormone therapy in patients after the treatment of malignant neoplasms of female reproductive system organs.
Materials and Methods. The review comprises the data of foreign and Russian scholarly articles found in PubMed on the subject, published over the past 10 years.
Results. At present, pre- and postmenopausal women in Russia account for more than 21 million people. Frequency of menopausal symptoms in this population varies from 40 to 60 %. A contingent of women who underwent treatment for cancer and suffer premature ovarian failure on average 10–15 years earlier, than in general population, stands out among them. Notably, symptoms of menopause they experience are particularly severe. However, the main method of the correction for this condition — menopausal hormone therapy — gives rise to a lot of controversy and doubts, associated with various risks. This article reviews the latest data of world literature from in vitro experiments to clinical studies related to menopausal hormone therapy in survivors of female reproductive system cancers.
Conclusion. It should be emphasized, that it is not easy to assess additional risks associated with menopausal hormone therapy. Nevertheless, it is essential to continue further research in this area in order to ensure that in “individualized case-by-case decision making process” for each particular cancer patient, a clinician should have suffi cient data to base this decision.
Keywords: menopausal hormone therapy, cancer patients, female reproductive system tumors, rehabilitation
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