Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.

BACKGROUND: Minimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer. OBJECTIVE: We aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy. STUDY DESIGN: This was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005-2017 at 18 centers in 12 countries. Eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 patients were entered into the study database. However, 69 patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental. RESULTS: Of 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20-42) years for open surgery vs 31 (18-45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0-31) mm for open surgery and 12 (0.8-40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20-16.70) years for open surgery and 3.1 years (0.02-11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.7%) with open surgery and 18 of 288 patients (6.2%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6-97.0) for open surgery and 91.5% (95% confidence interval, 87.6-95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6-99.7) for open surgery and 99.0% (95% confidence interval, 79.0-99.8) for minimally invasive surgery. CONCLUSION: The 4.5-year disease-free survival rates did not differ between open radical trachelectomy and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.

Studying the technology for obtaining pharmaceutical substances and determination of biologically active substances in them

In searching for alternatives to traditional chemical medicines, including feed antibiotics, scientists around the world are developing a new generation of medicines, phytobiotics. This work was aimed at studying the phytobiotics (pharmaceutical substances) production technology using the method of low-temperature vacuum water-ethanol extraction of Siberian medicinal plants, followed by low-temperature vacuum drying and determination of the main biologically active substances that had the required pharmacological effect on the organisms of farm animals and poultry. The objects of the study in this work were Siberian medicinal plants and ready phytobiotics (pharmaceutical substances). The article describes the technological conditions for obtaining pharmaceutical substances and their properties concerning the content of biologically active substances. It has been found that for obtaining pharmaceutical substances, extraction should be performed in three stages: two water extractions and ethanol- water extraction. The article provides a list of medicinal plants and the amounts of biologically active substances that ensure certain pharmacological effects on the set of economically useful qualities in farm animals and poultry and contained in phytobiotics (pharmaceutical substances) based on extracts from medicinal plants.

Organoleptic and physiochemical properties and safety indicators of phytobiotic fodder additives based on herbal extracts

The organoleptic and physicochemical properties and safety indicators of phytobiotic fodder additives based on extracts of herbs growing on the territory of the Siberian Federal District have been studied in the article. It has been established that the organoleptic characteristics of the phytobiotic fodder additives are determined by the specifics of the raw materials and their processing. The following physicochemical parameters of the finished phytobiotic fodder additives have been determined: moisture content, insoluble substances content in water, content of metal-magnetic admixture (particles up to 2 mm inclusive, particles over 2 mm in size and with sharp edges), and mineral impurities. The following safety indicators of the finished phytobiotic fodder additives have also been determined: the content of toxic elements (lead, cadmium, mercury, arsenic), the content of dioxins, the content of polychlorinated biphenyls, dioxin-like polychlorinated biphenyls, toxicity in bioassay test, and microbiological indicators (Salmonella, in 25 g, enterococci, in 50 g, enteropathogenic E. coli, in 1 g, anaerobes, in 50 g, pathogenic Escherichia, in 50 g, yeast and mold (total), and total bacterial contamination). The amount of biologically active substances in phytobiotic fodder additives was determined in accordance with the pharmaceutical norms and regulations.