Aims: The aim of this exploratory analysis of European Quality Audit of Opioid Treatment data was to identify areas of improvement for current opioid maintenance treatment (OMT) approaches. Methods: Factors facilitating treatment entry, retention and refusal were compared between 8 European countries and between OMT patient (OMT-P) and active opioid user (AOU) sample groups. Both groups were divided into those who had never had OMT before (un-experienced OMT-P (n = 573) and AOU (n = 360)) and those who had been maintained at least once prior to this investigation (experienced OMT-P (n = 746) and AOU (n = 377)). Results: The European comparison showed that motives for starting OMT vary distinctly between countries (p ≤ 0.001). Transnationally, experienced AOU reported concerns about their ability to follow treatment rules and negative treatment experiences as decisive reasons for staying out of OMT. Greater flexibility, less pressure to reduce their treatment dose and greater treatment structure were ranked significantly higher by experienced compared to un-experienced OMT-P as factors that might facilitate treatment retention (p ≤ 0.05). Conclusion: Increasing awareness of potential shortcomings of OMT delivery systems is crucial to optimally match treatment approaches to patient needs and also to reduce the considerable economic burden of addiction to society.
Purpose: This phase I study evaluated safety, tolerability, pharmacokinetics, and preliminary activity of the PI3K/mTORC1/2 dual inhibitor gedatolisib combined with carboplatin and paclitaxel. Patients and Methods: Patients with advanced solid tumors treated with ≤ 2 prior chemotherapies received intravenous gedatolisib on days 1, 8, 15, and 22 (95, 110, or 130 mg according to dose level); carboplatin (AUC5) on day 8 (day 1 following protocol amendment); and paclitaxel at 80 mg/m2 on days 8, 15, and 22 (1, 8, and 15 after amendment), every 28 days. Patients without progressive disease after cycle 6 received maintenance gedatolisib until progression. Results: Seventeen patients were enrolled [11 ovarian (10 clear cell ovarian cancer, CCOC), 4 endometrial, 2 lung cancers]. Median number of prior chemotherapies was 1 (range, 0–2). Median number of administered cycles was 6 (range, 2–16). Dose-limiting toxicities occurred in 4 patients: 2 (cycle 2 delay due to G2–G3 neutropenia) at 110 mg leading to a change in the treatment schedule, 2 at 130 mg (G2 mucositis causing failure to deliver ≥ 75% of gedatolisib at cycle 1). The recommended phase II dose is gedatolisib 110 mg on days 1, 8, 15, and 22 with carboplatin AUC5 on day 1 and paclitaxel 80 mg/m2 on days 1, 8, and 15. The most frequent ≥G3 treatment-related adverse events were neutropenia (35%), anemia (18%), and mucositis (12%). The overall response rate was 65% (80% in CCOC). Pharmacokinetic parameters of gedatolisib were consistent with single-agent results. Conclusions: Gedatolisib combined with carboplatin and paclitaxel is tolerable, and preliminary efficacy was observed especially in CCOC.
Background Fatigue is a complex and frequent symptom in cancer patients, influencing their quality of life, but it is still underestimated and undertreated in clinical practice. The aims of this study were to detect the presence of fatigue in cancer patients, describe how patients and nurses perceived it and how nurses managed fatigue. Methods This is a mixed methods study. Data were collected in two oncological wards using the Brief Fatigue Inventory (BFI), an ad hoc questionnaire, patient interviews, focus groups with nurses and the review of nursing records. Interviews and focus groups were analysed through thematic analysis. We used SPSS 22.0 for quantitative data and Nvivo 10 for qualitative data analysis. Results A total of 71 questionnaires were analysed (39 males, mean age 65.7 years). Fatigue was reported 5 times (7%) in nursing records, while in 17 cases (23.9%) problems associated to it were reported. Twelve patients were interviewed. Five themes were identified: feeling powerless and aggressive, my strategies or what helps me, feeling reassured by the presence of family members, feeling reassured by nurses’ gestures, and being informed. Three themes were identified through the focus groups: objectivity and subjectivity in the assessment of fatigue, nurses’ contribution to the multidisciplinary management of fatigue, and difficulty in evaluating outcomes. Conclusions The approach to the management of fatigue was unstructured. Patients were satisfied with the care they received but needed more information and specific interventions. Useful aspects were identified that could be used to change health professionals’ approach towards the management of fatigue.
AUC 0-N ) was taken as measure of exposure for DAB and trough plasma concentration (C min ) for TRAM. Efficacy endpoint was progression free survival (PFS). Univariable and multivariable exposure-response analyses were performed, taking into account WHO status, prior treatment lines and brain metastases.Results: In total, 140 pts were included, of whom 468 PK samples were collected.Median DAB AUC per pt was 4608 mg/L*h (IQR 4214 e 5156 mg/L*h) and median TRAM C min 13.2 mg/L (IQR 10.0 e 18.1 mg/L). For DAB, median PFS was 7.1 vs. 7.7 months (mo) for pts with median AUC < 4608 mg/L*h and 4608 mg/L*h, respectively (log rank test, p¼0.5). Multivariable analysis yielded similar results. For TRAM, the previously proposed threshold of 10.6 mg/L did not discriminate in median PFS (7.1 vs. 8.3 mo, p¼0.8). However, when using C min thresholds of 13.0 e 15.5 mg/L significant and relevant differences in PFS were found. Median PFS in patients with C min above 15.5 mg/L (n¼51) was 12.1 vs. 6.2 mo for those with C min below this threshold (n¼89, p¼0.03). Multivariable analysis resulted in a HR of 1.84 (95% CI 1.20 e 2.82, p¼0.005). Of the pts with median TRAM C min < 15.5 mg/L, 9 pts (10%) received a prior dose reduction or interruption due to toxicity (i.e. 90% would be potentially eligible for TRAM dose escalation).Conclusions: PFS is significantly prolonged in pts with TRAM C min 15.5 mg/L, while an exposure-response relationship could not be demonstrated for DAB. Therefore, therapeutic drug monitoring of TRAM could be used to individualize treatment and improve treatment outcomes.Legal entity responsible for the study: Netherlands Cancer Institute.
The COVID-19 pandemic is a major public health problem with millions of confirmed cases and deaths described. Nurses are among the health care professionals most involved at the front line, caring for those affected by COVID-19. Patients and families have been subjected to a high emotional burden of fear, anxiety, and uncertainty. The COVID-19 pandemic has had a significant impact on the approach to patients, the organisation of care, and communication with patients and their families, all requiring considerable adaptation on the part of nurses and health care professionals. The overall aim of this research was to find out the needs of patients with COVID-19, the nursing interventions provided and their outcomes, and to explore the experiences of the nurses, patients, and caregivers. A mixed method study will be performed with a convergent design. The study was divided into three phases. Quantitative methods involved nurses and patients affected by COVID-19 with a questionnaire. Qualitative methods involved nurses, patients, and caregivers with interviews and finally a quantitative analysis of the nursing documentation of the interviewed patients. We hope that this study will help us to understand and identify the main nursing and support needs expressed by patients and their families at different stages of their illness.
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