Prospective Series of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver with 30-60 µm Microspheres Loaded with Irinotecan.

PURPOSE: To describe safety and clinical outcomes among patients with metastatic colorectal cancer (mCRC) to the liver treated with transarterial chemoembolization with HepaSphere™ Microspheres 30-60 µm loaded with irinotecan (ΙRI-HEP-TACE). MATERIAL AND METHODS: In this prospective study (NCT04866290), 100 adults with confirmed mCRC to the liver who were ineligible for resection were enrolled and followed up to 24 months or death. Study outcomes among Salvage (patients not tolerating more cycles of chemotherapy) and Non-salvage patients included overall survival (OS), progression-free survival (PFS), objective response (OR), objective response rate (ORR), best tumor response (BTR), adverse events (AEs), and pharmacokinetics of irinotecan and its active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38). RESULTS: The median age was 66 years (range: 31-89). Median OS was 15.08 months (95% confidence interval [CI]: 12.33-17.25). PFS was 8.52 months (95% CI: 6.0-9.0; p < 0.001). ORR was 42.2% (95% CI: 31.57-53.50) and 35.9% (95% CI: 25.57-47.62) based on modified RECIST (Response Evaluation Criteria in Solid Tumors) and RECIST 1.1 criteria. BTR was not significantly different between mRECIST and RECIST (p = 0.745). The Non-salvage group had a statistically significant difference in median OS relative to the Salvage group (15.3 vs. 3 months; p < 0.001). Pharmacokinetic analyses demonstrated no correlation of OS with plasma concentration of irinotecan and SN38 (all p > 0.05). Most AEs were Grade 2 (257/279), the most common AE was right upper abdominal pain (180/279). One major AE (tumor rupture) was reported. CONCLUSION: IRI-HEP-TACE is an alternative treatment for patients with Non-salvage mCRC to the liver.

Nocebo in fibromyalgia: meta-analysis of placebo-controlled clinical trials and implications for practice.

BACKGROUND: Nocebo refers to adverse effects (AEs) generated by negative expectations that medical treatment will likely harm instead of heal and can be assessed in placebo-controlled randomized clinical trials (RCTs). We examined AEs following placebo administration in RCTs for fibromyalgia (FM), a condition characterized by patients' poor medication adherence, which may affect outcome and/or increase healthcare costs. METHODS: Following a systematic Medline search for RCTs for FM pharmacologic treatment published between 2001 and 2010, we assessed percentages of placebo-treated patients reporting at least one AE or discontinuing because of placebo intolerance and searched for factors influencing nocebo's extent. Percentages were compared with those revealed by similar meta-analyses of RCTs for multiple sclerosis and primary headaches. RESULTS: Data were extracted from 16 RCTs fulfilling search criteria. Of 2026 placebo-treated patients, 67.2% (95%CI: 51.0-81.5%) reported at least one AE, and 9.5% (95%CI: 8.3-10.9%) discontinued placebo treatment because of intolerance. AEs in placebo arms corresponded quantitatively and qualitatively to those in active drug arms (ρ > 0.88, P < 0.0001). Younger age and larger placebo arm size were associated with increased dropout rates. Patients with depression were more likely to withdraw from trials. Nocebo dropouts in FM trials were fourfold and twofold higher than in RCTs for multiple sclerosis treatment and migraine preventive treatment, respectively. CONCLUSIONS: Nocebo is remarkably prevalent in FM patients participating in RCTs. Because nocebo contributes to drug intolerance and treatment failure in clinical practice, identification of predisposing factors and efforts to prevent nocebo by educating these patients appropriately may be important for FM outcome.

Laryngeal cancer: smoking is not the only risk factor.

AIM: To investigate the role of smoking, alcohol, coffee consumption, demographic factors, toxic agents, and occupation in laryngeal carcinogenesis. MATERIALS/METHODS: A case-control study included 70 patients with histologically confirmed laryngeal cancer and 70 controls with non-neoplastic conditions unrelated to diet/smoking/alcohol. Relative risk, odds ratio (OR), and 95% confidence intervals were estimated using multiple logistic regression. RESULTS: Current smokers had 19.46 OR of laryngeal cancer compared to non-smokers (p = 0.006). The respective OR for alcohol consumption was 3.94 (p = 0.006). While the risk increased in heavy drinkers, there was no difference in duration of alcohol consumption. There was a strong and consistent relation between laryngeal cancer and the consumption of Greek/Turkish coffee cups/day (p = 0.002, OR = 1.77). Diesel exhaust fumes also seemed to increase the risk of laryngeal cancer, although the association was found to be no longer significant after analysis with logistic regression. CONCLUSION: The present study confirmed the relation of smoking and alcohol with laryngeal cancer. However, other factors such as coffee and diesel exhaust fumes may play an important role in laryngeal carcinogenesis.

The social profile of victims of suicide in major Greek correctional facilities.

INTRODUCTION: Suicide rates in correctional institutions have been increasing during the last decades. The reasons for this increase remain unclear, yet a lot of contradictory explanations were stated: the increase might be due to mass incarceration and overcrowding of small cells resulting in high psychosocial stress, changes in psychiatric health policy which might have transferred the care for patients from mental hospitals to custodial institutions, or legislation changes that might have led to a selection of offenders at higher risk (e.g. offenders who committed high violent offences or suffered from mental disorders without being referred to psychiatric hospitals). In Greece the situation is not described in details, at least during the last few years. By law, every death of prisoner is subject to medicolegal investigation. MATERIALS & METHODS: Our study consists of the meticulous research of the data records of major Greek correctional facilities, for the time period 1999-2010. An official permission was obtained from the Hellenic Ministry of Justice, which gave us access to these restricted records. Data was also collected from the Piraeus Forensic Service, from the Department of Pathological Anatomy of the University of Athens and finally from our own records. Measures were taken to respect the anonymity of the cases. Data was collected for the social, penal, medical history as well as for the medicolegal investigation. RESULTS - CONCLUSIONS: A total of 339 cases were collected, only 259 of which had available full data records, due to weaknesses in the prison records. From the 259 cases, 70 incidents of suicide were collected. Victims of suicide in major Greek correctional facilities, appear to fulfill the expected profile, as in the general population.

Forensic investigation of suicide cases in major Greek correctional facilities.

INTRODUCTION: According to Greek legislation the medico-legal investigation of deaths occurring in prisons is mandatory. Furthermore, in cases of suicide or of suspected suicide the contribution of medico-legal investigation is of grave importance. The current paper addresses the medico-legal investigation of suicide cases in Greek correctional facilities and aims to describe the current situation. MATERIALS & METHODS: Our study consists of the meticulous research in the data records of major Greek correctional facilities, for the time period 1999-2010. Official permission was obtained by the Hellenic Ministry of Justice, which provided us the access to the records. Data was also collected from the Piraeus Forensic Service, from the Department of Pathological Anatomy of the University of Athens and finally from our own records. Measures were taken to respect the anonymity of the cases. Data was collected for the social, penal, medical history as well as for the medico-legal investigation. RESULTS-CONCLUSIONS: It appears that 85.7% of suicide cases were transferred to the Prisoner's Hospital (p < 0.0001), the forensic pathologist who conducted the PME did not perform scene investigation in none of the 70 suicide cases. In a total of 70 cases, histopathological examination, was requested only in 30 cases (42.9%). Hanging was the preferred method for those who committed suicide, followed by the poisoning due to psychoactive substances. Understanding the mistakes made during the forensic investigation of suicide cases inside correctional facilities is necessary, in order to prevent them from occurring again in the future, by implementing appropriate new policies and guidelines.