Purpose/Objective(s): Liver transplant, the gold standard treatment for most Hepatocellular carcinomas (HCC), was till recently not being considered as an option in patients having portal vein tumor thrombus (PVTT). These patients were offered only palliative treatments like Radio frequency ablation (RFA), Trans-arterial chemo-embolization (TACE) and conventional external beam radiation therapy (EBRT). With advent of SBRT, precise targeting and motion management has improved local control, making it possible to offer curative liver transplant post SBRT (Stereotactic Body Radiation therapy) to these cases where transplant was ruled out in the past. Materials/Methods: We present 48 of our cases, initially considered unfit for transplant and referred for SBRT to PVTT alone or with HCC lesion from April 2011 till November 2015. Adequate respiratory motion management with either deep inspiratory breath hold (DIBH) or synchrony respiratory tracking was used in all cases. Post SBRT, cases were assessed at 4, 8 and 12 weeks for transplant feasibility. Plan details and follow up data was analyzed with primary end point as amenability to liver transplant. Results: Intent of treatment was curative in 32 (66.6%) cases with limited disease and palliative in remaining 16 (33.3%) cases. Of all the cases, 38 (79%) had multi centric disease and 34 cases (70.8%) had received alternative multimodality treatment in past, before SBRT. Based on Japan cancer group classification 12.5% (n Z 6), 25% (n Z 12), 22.9% (n Z 11) and 39.5% (n Z 19) cases had Vp1, Vp2, Vp3 and Vp4 type PVTT, respectively. Twenty cases (42%) were treated on robotic radiosurgery and 28 cases (58%) on Linac with DIBH. Most frequent dose fractionation used was 60 Gy (range 25 -60 Gy) in 5 fractions (range 3-20 fr). Treatment was well tolerated with mild nausea and fatigue being the most common side effect with no RTOG grade 3 or more toxicity reported. At the time of analyses, amongst 32 curative cases, 23 (71.9%) were alive while 6 (18.8%) had expired and 3 (9.3%) were lost to follow up. Eleven (34.3% of 32 curative) cases underwent successful transplant, 2-3 months post SBRT while 5 (15.6%) are awaiting response assessment. Remaining 2 (6.2%) cases are living with stable disease and 5 (15.6%) with systemic progression. Amongst 16 palliative cases, 7 (43.75%) were still alive, 4 cases (25%) lost to follow up and 5 (31.25%) had expired. Median survival was 13 months in all 48 cases and 26 months (range 8-46 months) for transplant cases. Conclusion: Presence of PVTT is no longer considered a contraindication to liver transplant. Adequately selected cases can be offered SBRT as single modality or as a part of multimodality regime. With growing data from well-designed future studies, PVTT-SBRT promises to improve outcomes in selected HCC cases by making them amenable to liver transplant. SBRT-PVTT therefore merits attention for its potential as an integral part of multidisciplinary treatment approach towards inoperable HCC, realizing the unmet need of adequate local c...
14 Background: Docetaxel (DOC) and abiraterone (ABI) both improve overall survival (OS) in men with locally advanced or metastatic hormone-sensitive prostate cancer (HSPC) but no head to head trials compare the 2 agents. STAMPEDE, a multi-arm multi-stage platform trial, recruited patients (pts) to treatments including DOC or ABI between Nov-11 and Mar-13. There was no evidence OS differed between DOC or ABI, thus quality of life (QOL) may increasingly inform treatment options. Methods: QOL scores were analysed in pts contemporaneously randomised to receive DOC or ABI, in addition to standard of care treatment. Self-assessment QOL questionnaires EORTC QLQ C30 and PR25 were completed during treatment and follow-up. These analyses focus on average global QOL over the first 2 years after randomisation, using repeated measures analysis, plus cross-sectional analyses at 3, 6, 12 and 24 months. A score difference of ≥4 points was pre-defined as clinically meaningful. Results: 173 men randomised to DOC and 342 men randomised to ABI participated in the QOL sub-study and contributed to this analysis. Baseline characteristics and proportion of missing data were similar between groups. Baseline global QOL scores were similar (mean (sd): DOC 77.8 (20) and ABI 78.0 (19.3)). Average global QOL over 2 years was higher in pts randomised to ABI than DOC, although the difference was statistically significant it did not meet the pre-defined clinical parameter (+3.9, 95%CI 0.6 to 7.1, p=0.021). Cross-sectional analyses showed clinically meaningful superior QOL in the ABI group at 3 and 6 months (+6.6, 95%CI 2.6 to 10.7, p=0.001; +8.0, 95%CI 3.6 to 12.3, p<0.001), but not at 1 or 2 years (+1.3, 95%CI -3.0 to 5.6, p=0.545; +4.5, 95%CI -0.25 to 9.2, p=0.063). An exploratory analysis indicated average QOL for pts with metastatic disease (n=207) was better in the ABI group (+4.44, 95%CI 0.2 to 8.6, p=0.036). Conclusion: Global QOL was significantly higher in the first 2 years of treatment for the ABI group compared to the DOC group, though did not meet the pre-defined clinically meaningful threshold. The majority of difference was seen in the first year of treatment. This should be considered when discussing treatment options with pts. Clinical trial information: NCT00268476.
The proposed switching of oral acyclovir from prescription to over-the-counter (OTC) status for the 5-day episodic treatment of genital herpes was considered by a consensus panel. It was concluded that self-diagnosis/misdiagnosis, misuse, and adverse drug effects were potential problems with the OTC use of acyclovir. While acyclovir reduces asymptomatic shedding of herpes simplex virus type 2, the reduction in transmission of virus potentially resulting from increased acyclovir use was felt to be of unknown extent but likely to be of benefit overall. The availability of acyclovir would likely be improved. There were differences in opinion as to whether widespread availability of acyclovir (prescription or OTC) may speed the development of viral resistance. However, all panel members felt that granting OTC status may set an undesirable precedent for the switch from prescription to OTC use of other systemically administered antiinfective agents. The effect of this precedent, in terms of accelerating development of multidrug-resistant bacteria, was a major concern of all panel members. The consensus was that the switch of acyclovir to OTC status could not be supported.
The association between lipids and both psychological and physiological measures were examined in this study of healthy black males. The results revealed that certain psychological measures, namely, State and Trait Curiosity and Trait Anger, explained a significant proportion of the variance in high-density lipoproteins (HDL), low-density lipoproteins (LDL), and triglycerides. Although psychological factors accounted for a significant proportion of the variance in lipids (29% for HDL, 25% for LDL, 64% for LDL/HDL, 29% for triglyceride), the amount of explained variance was significantly increased by the inclusion of both psychological and physiological variables in the regression equation. However, neither of the psychological variables explained any of the variance for total cholesterol when physiological variables were included in the regression analysis. The overall pattern of the findings suggests that black males who are at increased risk for elevated lipid levels may be identified by their level of mental vigilance, the frequency at which their anger is experienced, and the presence of other traditional risk factors.
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