A phase II study on the efficacy and safety of procedural analgesia with fentanyl buccal tablet in cancer patients for the placement of indwelling central venous access systems.

BACKGROUND: Pain in cancer patients is often related to oncologic therapies and diagnostic procedures. The placement of fully implantable venous access systems is a very common procedure in oncology patients. Local anaesthesia is the method most commonly used to overcome pain related to this surgical procedure, but the local anaesthetic may be unable to completely eradicate all pain. This study investigates the effectiveness and safety of fentanyl buccal tablet (FBT), administered by OraVescent® technology, in reducing procedural pain related to the placement of indwelling central venous access systems (Ports) in opioid-naïve cancer patients. METHODS: Inpatients who required an indwelling vascular access (Port) were preoperatively assessed with a self-assessment questionnaire on anxiety and pain. A 100 µg FBT was administered 10 min before preparation of the operating field. A self-assessment scale for pain experienced during the procedure was administered at the end of the procedure. Vital signs and the presence of any side effects or bothersome symptoms were monitored during the procedure, at the end, and 4 h later. RESULTS: From October 2012 to June 2014, 65 patients were enrolled in the study. A total of 61 (93.9 %) patients perceived no or a little pain during the procedure. Four patients (6.2 %) reported a lot of pain. No patient reported very severe pain. This data is significant in terms of the lower than expected presence of pain (Fisher test p = 0.0018) as assessed in our previous experience without procedural analgesia. The most common side effects of FBT was drowsiness, experienced by 28 patients at the end of the procedure (43.1 %), significantly reduced (p < 0.01) to 8 patients after 4 h (12.5 %). Nausea was present in 6 cases at the end of the procedure (9.2 %) and in 7 cases 4 h later (10.9 %). Vomiting was present in 3 cases at the end (4.7 %) and in 2 other patients after 4 h (7.8 %). No significant change of vital parameters was observed between the baseline and the subsequent measurements in all patients studied. CONCLUSIONS: The significant improvement in the number of patients experiencing little or no pain, accompanied by a lower number of non-severe side effects, suggests that FBT is a valid, practical and safe method of procedural analgesia. It will be necessary to perform further studies, taking into account the need for standard antiemetic pre-medication to minimise the incidence of nausea and vomiting.

Screening elderly cancer patients for disabilities: evaluation of study of osteoporotic fractures (SOF) index and comprehensive geriatric assessment (CGA).

BACKGROUND: Comprehensive geriatric assessment (CGA) is a multidimensional tool aimed at detecting multiple age-related problems; the study of osteoporotic fractures (SOF) index is a 3-item instrument designed to measure frailty and pre-frailty status. The aim of this prospective cohort study was to evaluate the accuracy of the SOF index and CGA in predicting the disability status in elderly cancer patients. PATIENTS AND METHODS: Patients aged ≥ 70 years with a confirmed diagnosis of a solid or hematologic tumor underwent both CGA and SOF assessment. The sensitivity and specificity of SOF in determining the presence of frailty were analyzed using the CGA as the reference standard. The diagnostic accuracy of SOF < 80% was considered not acceptable. RESULTS: The study involved 400 patients aged ≥ 70 years (median age 77.2, range 70-97).The SOF and CGA classified, respectively, 33.2% and 31.8% of patients as fit, 67.8% and 68.2% as unfit. The SOF showed a sensibility and a specificity of 89.0 [95% confidence interval (CI) 84.7-92.5] and 81.1 (73.2-87.5) with an accuracy of 86.5 (82.8-89.7). The negative predictive value (NPV) was 103/133, i.e. 77.4% (95% CI 69.4-84.2). CONCLUSIONS: As the SOF proved to reach the end-point of our study, we support its use as a means of screening elderly cancer patients in everyday clinical practice.

Early and short-term acenocumarine or dalteparin for the prevention of central vein catheter-related thrombosis in cancer patients: a randomized controlled study based on serial venographies.

BACKGROUND: We evaluated efficacy and safety of early and short-term prophylaxis with acenocumarine or dalteparin in the prevention of non-occlusive or occlusive central vein catheter-related thrombosis (CVCrT). PATIENTS AND METHODS: Consecutive cancer patients scheduled for chemotherapy randomly received: acenocumarine 1 mg/day for 3 days before and 8 days after central vein catheter (CVC) insertion; dalteparin 5000 IU 2 h before and daily for 8 days after CVC insertion; no anticoagulant treatment (NT). All patients underwent venography on days 8 and 30, some of them on days 90, 150 and 210 after CVC. RESULTS: A total of 450 patients were randomized, 348 underwent at least two venography. Both acenocumarine and dalteparin reduced venography-detected CVCrT rate [21.9% acenocumarine versus 52.6% NT, odds ratio (OR) 0.3, P < 0.01; 40% dalteparin versus 52.6% NT, OR 0.6, P = 0.05]. Acenocumarine was more effective than dalteparin (OR 0.4, P = 0.01). The rate of occlusive CVCrT was not different in the three groups (0.9% acenocumarine, 3.3% dalteparin, 1.8% NT; P = 0.40). Most CVCrTs (95.6%) were observed on day 8 after CVC insertion and were non-occlusive. CONCLUSIONS: In this study of early and short-term prophylaxis, acenocumarine was more effective than dalteparin on non-occlusive and asymptomatic CVCrT events. The first days following CVC insertion represent the highest risk for CVCrT.

Dose intensity correlate with survival in elderly patients treated with chemotherapy for advanced non-small cell lung cancer.

INTRODUCTION: In elderly patients treated with chemotherapy for advanced non-small cell lung cancer (NSCLC), frequently an adequate dose intensity (DI) is difficult to be delivered. We therefore performed in this population a study to assess the delivered DI and its impact on clinical outcome. PATIENTS AND METHODS: Inclusion criteria were: age equal or greater than 70 years; cytological or histological diagnosis of NSCLC; stage IIIB or IV; no previous chemotherapy for advanced disease. Total relative dose intensity (RDI) was taken into account for the analysis. An RDI less than 80% was considered as suboptimal for tumor shrinkage. A survival comparison between subgroups (more or less than 80% RDI) was done. RESULTS: 107 patients were eligible for the analysis. Mean age was 74.3 years. PS was 0-1 in 92.5% of subjects. Mean number of comorbidities was 1.86. The most frequently chemotherapy regimens used were single agent vinorelbine and single agent gemcitabine. Overall mean RDI was 68%; 36% of patients received a RDI>80% of the originally planned one. The objective response rate (RR) was 55.2% and 33.3% respectively for patients receiving more or less than 80% of the RDI (p<0.01); a significant difference in overall survival between these two groups (p<0.0001) was also recorded. Baseline hemoglobin and body mass index (BMI) were the variables that significantly influenced the delivered RDI. CONCLUSIONS: These data suggest that in elderly patients treated with chemotherapy for advanced NSCLC an adequate dose intensity has a significant positive impact on both response rate and overall survival.

[Toward the ideal bag: a clinical evaluation of a new aid for ostomized patients]. / Verso la sacca ideale. Valutazione clinica di un nuovo presidio per stomizzati.

The authors report the results of a multicentre trial to evaluate the characteristics of a new bag for ostomised patients (Coloplast Alterna). While affirming that a correct technique is essential to avoid complications and to achieve good stoma function, the authors emphasise that the bag also pays an important role in giving confidence to patients and enabling them to enjoy a social life which is as similar as possible to that before surgery. In the search for the ideal bag the trial evaluated adhesive, filter and the bag and a whole. 85% of the 92 patients who tested the new bag for four weeks considered it good or excellent. Although it cannot yet be considered ideal, Alterna represents a further step towards this aim.

[Value of HME antibacterial filters in neonatal and pediatric anesthesia. Comparison with traditional heating humidifiers]. / Intérêt des filtres antibactériens HME en anesthésie néonatale et pédiatrique. Comparison avec les humidificatuers chauffants traditionnels.

HME (heat-moisture exchangers) filters (Hygrobaby DAR) have been compared with classical humidifiers (Bennett Cascade Humidifier) with regard to heating and humidification of inspired gases in anaesthetized neonates and infants. 28 young patients (2 days-12 months) have been randomized into two groups. Though traditional heaters-humidifiers offer slightly higher performances in terms of temperature and moisture, HME-filters appear to be a better choice from cost, handiness and safety considerations. Antibacterial efficacy of HME-filters is also a major quality.

[Cardiovascular effects of a combination of vecuronium and low-dose fentanyl in atropinized and non-atropinized subjects]. / Effetti cardiovascolari dell'associazione tra vecuronio e basse dosi di fentanyl in soggetti atropinizzati e non-atropinizzati.

The cardiovascular effects of the pharmacologic association of low-dose fentanyl (2 micrograms/kg) and vecuronium (120 micrograms/kg) have been studied in 38 ASA I and II atropinized and non-atropinized patients scheduled for abdominal surgery during induction of anaesthesia with thiopentone or propofol. Whatever the induction agent used, heart rate was consistently reduced in patients not receiving an anticholinergic drug, while it was unchanged in patients treated with atropine intravenously. In non-atropinized patients impressively lower minimum heart rates were observed during induction of anaesthesia with thiopentone. In this last group one patient suffered from a cardiac arrest resolved without sequelae. In patients treated with the association between vecuronium and low doses of fentanyl a pretreatment with atropine is always indicated. Propofol seems to be a better induction agent than thiopentone.