Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients

BackgroundProtroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT).Patients and MethodsOf the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed.ResultsNine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis (n = 222) had febrile neutropenia of grade 3–4 (5 patients) or infection of grade 3–4 (4 patients); 1/26 of those receiving secondary prophylaxis had an event. Dose reductions were performed in 9.5% of the patients. Postponement of cancer CT cycles for >3 days occurred in <15% of patients; 10.8% (92/851 AEs) and 8% (2/25 SAEs) of documented adverse events and serious adverse events, respectively, were related to lipegfilgrastim.ConclusionsApplication of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.     

Culture of epithelial cells derived from the oviduct of different species

This study proposes a procedure for the isolation and cultureof oviduct epithelial cells of several species. In-vitro cultureon such a feeder seems to allow full embryonic development andviability. The inner linings of Fallopian tubes from mouse,rabbit, cow and human were trypsinized and the epithelial cellswere enriched with Percoll gradient. Isolated cells, obtainedin high yield with good viability, were maintained in monolayerculture in B2-Menezo medium supplemented with serum, which alsosupports early embryonic development in vitro. The plated primarycultures reached confluence within 8 days, producting a monolayerof cohesive polygonalcells. Associated with this large epithelialcall population, ciliated cells as wellas polykaryotic cellsand few fibroblastic nestswere observed. After the first sub-culture,the ciliated cells disappeared and the epithelial cell monolayergrew rapidly to confluence with in 3 days and displayed contactinhibition. No epithelial cell growth could be obtained inculturein the absence of serum. The addition of oestrogens had no effecton any of the cultured oviductal epithelial cells. A sponotaneousalteration was observed in morphology and growth after severalpassages, the number of which depends mainly upon the species     

Giant abdominopelvic epithelioid angiomyolipoma associated with tuberous sclerosis: Report of a case

(Received for publication on July 16, 1998; accepted on Mar. 11, 1999)     

Compliance with consensus recommendations for systemic therapy is associated with improved survival of women with node-negative breast cancer.

PURPOSE: The impact of consensus recommendations for systemic therapy on outcome of disease is unclear. We evaluated if compliance with guidelines for systemic adjuvant treatment is associated with improved survival of women with node-negative breast cancer. PATIENTS AND METHODS: The study population included women diagnosed with invasive node-negative breast cancer in Québec, Canada, in 1988 to 1989, 1991 to 1992, and 1993 to 1994. Information was collected by chart review, linkage with administrative databases, and queries to attending physicians. Guidelines from the 1992 St Gallen conference were used as standard of care. Survival was estimated by Kaplan-Meier and Cox proportional hazards analyses. RESULTS: Among 1,541 women, 358 died before December 1999. Median follow-up was 6.8 years. Seven-year event-free and overall survivals were 66% and 81%, respectively. Survival was 88%, 84%, and 74% in women at minimal, moderate, or high risk of recurrence. Virtually all women at minimal risk were treated according to the consensus (98.4% of 370). In comparison, adjusted hazard ratios of death were 1.0 (95% CI, 0.6 to 1.7) and 2.3 (95% CI, 1.3 to 4.0) among women at moderate risk treated according to the consensus or not, respectively. Among women at high risk, adjusted hazard ratios of death were 2.0 (95% CI, 1.4 to 2.8) and 2.7 (95% CI, 1.9 to 3.9), respectively. Both risk category (P <.0005) and compliance with guidelines (P <.0005) were independent significant predictors of survival. CONCLUSION: Treatment according to consensus recommendations is associated with improved survival of women with breast cancer in the community. Promoting the adoption of guidelines for treatment is an effective strategy for disease control.     

Efficacy of the Sentinox Spray in Reducing Viral Load in Mild COVID-19 and Its Virucidal Activity against Other Respiratory Viruses: Results of a Randomized Controlled Trial and an In Vitro Study

Sentinox (STX) is an acid-oxidizing solution containing hypochlorous acid in spray whose virucidal activity against SARS-CoV-2 has been demonstrated. In this paper, results of a randomized controlled trial (RCT) on the efficacy of STX in reducing viral load in mild COVID-19 patients ({"type":"clinical-trial","attrs":{"text":"NCT04909996","term_id":"NCT04909996"}}NCT04909996) and a complementary in vitro study on its activity against different respiratory viruses are reported. In the RCT, 57 patients were randomized (1:1:1) to receive STX three (STX-3) or five (STX-5) times/day plus standard therapy or standard therapy only (controls). Compared with controls, the log₁₀ load reduction in groups STX-3 and STX-5 was 1.02 (p = 0.14) and 0.18 (p = 0.80), respectively. These results were likely driven by outliers with extreme baseline viral loads. When considering subjects with baseline cycle threshold values of 20–30, STX-3 showed a significant (p = 0.016) 2.01 log₁₀ reduction. The proportion of subjects that turned negative by the end of treatment (day 5) was significantly higher in the STX-3 group than in controls, suggesting a shorter virus clearance time. STX was safe and well-tolerated. In the in vitro study, ≥99.9% reduction in titers against common respiratory viruses was observed. STX is a safe device with large virucidal spectrum and may reduce viral loads in mild COVID-19 patients.     

The Effect of Ramadan and COVID-19 on the Relationship between Physical Activity and Burnout among Teachers

The objective of this study was to explore the effect of COVID-19 and Ramadan on physical activity (PA) and burnout in teachers and the relationship between them. A total of 57 secondary school teachers from public education centers participated in the present study. They were aged between 29 and 52 years. To determine the effect of Ramadan and COVID-19 on PA and burnout, participants completed the online questionnaires before COVID-19, one week before Ramadan and during the second week of Ramadan. The International Physical Activity Questionnaire-BREF and the Maslach Burnout Inventory-Human Services Survey were used to assess PA intensities and burnout, respectively. The data revealed that total PA (p < 0.001, p < 0.05, respectively) vigorous metabolic equivalent of task (MET) (p < 0.001, p < 0.05, respectively), moderate MET (p < 0.001, p < 0.01, respectively) were higher before COVID-19 and before Ramadan than during Ramadan. Regarding burnout subscales, emotional exhaustion (p < 0.001, p < 0.01, respectively) was higher before Ramadan than before COVID-19 and during Ramadan. A lower personal accomplishment was reported before Ramadan than before COVID-19 and during Ramadan (both p < 0.05). In addition, low to high correlations were observed between PA intensities and burnout subscales, except for the correlation between depersonalization and all PA intensities. In conclusion, Ramadan intermittent fasting along with PA was highly recommended for teachers and the general population to improve positive emotions and general health.     

Hospital recovery following Thermachoice ablation is not dependent on setting (outpatient or daycase) or rescue analgesia: unexpected result

BACKGROUND: Thermal balloon endometrial ablation (TBEA) is increasingly being performed in the outpatient setting under local anaesthesia (LA) rather than in a daycase setting under general anaesthesia (GA). Our aim was to compare the post operative rescue analgesia requirements and duration of hospital stay in women undergoing outpatient (LA) and daycase (GA) TBEA. METHODS: Prospective observational study of consecutively recruited women who underwent outpatient (LA) TBEA (n=51) and daycase (GA) TBEA (n=50) over the same time period. Analgesia that was provided additional to the standard administered analgesic regimen was considered rescue analgesia. The main outcome measures were requirement for rescue analgesia and duration of hospital stay in both cohorts. RESULT(S): LA compared to GA cohorts had shorter hospital stays (11h [95% CI 9-13] vs. 17h [95% CI 14-20]) and lower analgesia requirements. However, multivariate regression, correcting for all known confounders, showed that duration of stay was independent of setting for ablation or amount of rescue analgesia. CONCLUSION(S): Duration of hospital stay is not entirely dependent on whether outpatient or daycase endometrial ablation is considered. This unexpected preliminary finding deserves to be validated in future confirmatory trials that compare outpatient and daycase treatments. We also discuss the confounding factors that should be considered when designing such trials.