Abstract Context Oxycodone and morphine are recommended as first-choice opioids for moderate/severe cancer pain, but evidence about their relative tolerability has significant methodological ...limitations. Objectives This study was mainly aimed at comparing the risk of developing adverse events (AEs) with controlled-release oral morphine vs. oxycodone; secondary aims were comparing their analgesic efficacy and testing heterogeneity in tolerability across different age and renal function subgroups. Methods An open-label multicenter RCT (EudraCT number: 2006-003151-21) was carried out in patients with moderate/severe cancer pain. At baseline, 7 and 14 days, patients scored on 0–10 rating scales (0–10 numerical rating scale) the intensity of pain and of a list of common opioid side effects. The primary end point was the percentage of patients reporting an AE (a worsening ≥ 2 points on any of the listed side effects); tolerability by subgroups and average follow-up pain intensity were compared through regression models. Results One hundred eighty-seven patients were enrolled (47% of originally planned). Intention to treat (ITT) analysis ( N = 185, morphine 94, oxycodone 91) did not show any difference in the risk of developing AEs (risk difference −0.6%, 95% CI −11.0% to 9.9%) nor in analgesia (0–10 numerical rating scale pain intensity difference −0.28, 95% CI −0.83 to 0.27). No evidence of heterogeneity of tolerability across age and renal function patient subgroups emerged. Conclusion This trial failed to show any difference in tolerability and analgesic efficacy of morphine and oxycodone as first-line treatment for moderate/severe cancer pain but results interpretation is difficult due to lack of power, potential bias from open-label design, and concerns about assay sensitivity. These data, however, can significantly contribute to future meta-analyses comparing WHO Step-III opioids and are relevant in designing future randomized studies.
Abstract Background The role of extracorporeal life support (ECLS) in primary cardiogenic shock (PCS) is well established. In this study, we evaluated the impact of etiology on outcomes. Methods ...Between January 2009 and March 2013, we implanted a total of 249 patients with ECLS; we focused on 64 patients for whom peripheral ECLS was the treatment for PCS. Of these, 37 cases (58%) were “acute” (mostly acute myocardial infarction: 39%); 27 (42%) had an exacerbation of “chronic” heart failure (dilated cardiomyopathy: 30%; post-ischemic cardiomyopathy: 9%; and congenital: 3%). Results In the group with chronic etiology, 23 patients were bridged to a left ventricular assist device (52%) or heart transplantation (33%). In the group with acute etiology, ECLS was used as a bridge-to-transplantation in 3 patients (8%), a bridge-to-bridge in 9 (24%), and a bridge-to-recovery in 18 (49%). One patient in each group was bridged to conventional surgery. Recovery of cardiac function was achieved in only the group with acute primary cardiogenic shock (18 vs 0 patients, P = .0001). A mean flow during support of ≤60% of the theoretic flow (body surface area × 2.4) was a predictor of successful weaning ( P = .02). Median duration of ECLS support was 7 days (range: 2-11.5 days). Nine patients (14%) died during support; 30-day overall survival was 80% (51 of 64 patients); and 59% of patients were discharged, in whom survival at 48 months was 90%. Thirty-day survival was correlated with duration of ECLS support. Conclusions In “chronic” heart failure, ECLS represents a bridge to a ventricular assist device or heart transplantation, whereas in “acute” settings, it offers a considerable chance of recovery, and is often the only required therapy.
Abstract This study aims at developing an innovative theranostic approach for lung tumor and metastases treatment, based on Boron Neutron Capture Therapy (BNCT). It relies on to the use of low ...density lipoproteins (LDL) as carriers able to maximize the selective uptake of boron atoms in tumor cells and, at the same time, to quantify the in vivo boron distribution by magnetic resonance imaging (MRI). Tumor cells uptake was initially assessed by ICP-MS and MRI on four types of tumor (TUBO, B16-F10, MCF-7, A549) and one healthy (N-MUG) cell lines. Lung metastases were generated by intravenous injection of a Her2 + breast cancer cell line (i.e. TUBO) in BALB/c mice and transgenic EML4-ALK mice were used as primary tumor model. After neutron irradiation, tumor growth was followed for 30-40 days by MRI. Tumor masses of boron treated mice increased markedly slowly than the control group. From the Clinical Editor In this article, the authors described an improvement to existing boron neutron capture therapy. The dual MRI/BNCT agent, carried by LDLs, was able to maximize the selective uptake of boron in tumor cells, and, at the same time, quantify boron distribution in tumor and in other tissues using MRI. Subsequent in vitro and in vivo experiments showed tumor cell killing after neutron irradiation.
Abstract Context Intravenous fluid administration with peripherally inserted central venous catheters (PICCs) and midline catheters in palliative care. Objectives To evaluate distress and pain ...perceived by patients during the positioning of a PICC or midline catheter, both in the home and hospice settings. Methods This was a prospective observational study performed by the Palliative Care Network of Pordenone. In addition to evaluating distress and pain, we monitored patient quality of life and the devices used. Quality of life was measured with the European Organization for Research and Treatment of Cancer-Core 15-Palliative scale. Results From May 2012 to July 2013, 48 patients were enrolled in the study. The level of distress during the procedure was null or very low in 95.8% of the patients and completely absent after one week. Pain during insertion was null or very little in 93.8% of the patients and zero after one week in 98% of the patients. Quality of life was significantly improved after one week for certain specific parameters and also globally. The number of catheter days monitored was 3097. The weekly monitoring of the devices revealed a series of minor complications. Only two catheters were removed for serious complications. Conclusion Our results showed a low impact on pain and distress, a low level of local and systemic complications and a favorable impact on patients' quality of life. However, other studies are necessary to evaluate the cost-effectiveness of the use of these devices and their role in palliative care.
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