Efficacy of fosaprepitant combined with tropisetron plus dexamethasone in preventing nausea and emesis during fractionated radiotherapy with weekly cisplatin chemotherapy: interim analysis of a randomized, prospective, clinical trial using competing risk analysis.

PURPOSE: There are no well-recognized guidelines for antiemesis during concurrent chemoradiotherapy (CCRT) for cervical cancer (CC) and nasopharyngeal cancer (NPC) until now. The study was designed to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with CC or NPC. METHODS: Patients with CC or NPC were scheduled to receive fractionated radiotherapy and weekly cisplatin (25-40 mg/m2) chemotherapy for at least 5 weeks. Patients stratified by tumor type and induction chemotherapy were 1:1 randomly assigned to receive fosaprepitant, tropisetron, and dexamethasone or tropisetron plus dexamethasone as an antiemetic regimen. Efficacy was assessed primarily by the cumulative incidence of emesis after 5 weeks of treatment, and safety by adverse events (AEs). RESULTS: Between July 2020 and July 2022, 116 patients consented to the study of whom 103 were included in this interim analysis (fosaprepitant group [N = 52] vs control group [N = 51]). The cumulative incidence of emesis at 5 weeks (competing risk analysis) was 25% (95% CI 14.2-37.4) for the fosaprepitant group compared with 59% (95% CI 43.9-71.0) for the control group. There was a significantly lower cumulative risk of emesis in the fosaprepitant group (HR 0.35 [95% CI 0.19-0.64]; p < 0.001). Fosaprepitant was well tolerated as the incidences of adverse events in the two groups were comparable. CONCLUSION: The addition of fosaprepitant to tropisetron plus dexamethasone significantly reduced the risk of nausea and vomiting during 5 weeks of CCRT in patients with CC or NPC, and fosaprepitant was well tolerated. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov on October 3, 2022, number NCT05564286.

Characterizing atmospheric biological aerosols at a suburban site in Guangzhou, southern China by airborne microbes, proteins and saccharides.

Bioaerosols in ambient environment can be evaluated using various techniques. However, the results of bioaerosols obtained using different methods are rarely compared. The relationships between different bioaerosol indicators and their behaviors under the influence of environment factors are seldom investigated. Here we used airborne microbial numbers, proteins and saccharides concentrations as the indicators to characterize bioaerosols in two seasons with different source contribution, air pollution situation and meteorological conditions. The observation was conducted at a suburban site in Guangzhou, southern China, during the winter and spring periods of 2021. Airborne microbes were observed with an average of (1.82 ± 1.33) × 106 cells/m3, converted to the mass concentration level of 0.42 ± 0.30 µg/m3, comparable but lower than that of proteins (0.81 ± 0.48 µg/m3). Both of them were much higher than the average concentration of saccharides (19.93 ± 11.53 ng/m3). During the winter period, significant and good correlations were observed between the three components. In spring, a biological outbreak was observed in late March with a strong elevation of airborne microbes followed by elevations of proteins and saccharides. The retardation of proteins and saccharides could be the result of the enhanced release from microorganisms under the influence of atmospheric oxidation processes. Saccharides in PM2.5 were studied to reveal the contribution of specific sources of bioaerosols (e.g. fungi, pollen, plants and soil). Our results show that primary emissions and secondary processes should play their roles in the variations of these biological components. By comparing the results of the three methods, this study provides an insight into the applicability and variability of bioaerosol characterization in the ambient environment with respect to various influences of sources, atmospheric processes and environmental conditions.