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Background: This is a single arm, multi-center, phase II study to assess the efficacy and tolerability of sorafenib, oxaliplatin and capecitabine combination for the treatment of ...advanced hepatocellular carcinoma (HCC) patients. Methods: Eligible patients received SECOX regime—sorafenib 400 mg bid (Day one-fourteen), oxaliplatin 85 mg/m
2
(Day one) and capecitabine 1700 mg/m
2
(Day one-seven) every two weeks. Response assessment was based on RECIST 1.0 criteria. The primary endpoint was time-to-progression (TTP) and the secondary endpoints were tumor response rate (RR), progression-free survival (PFS), overall survival (OS) and tolerability. Results: A total of 51 patients were enrolled in the trial.The median age was 58 years (range, 28-81) and 84% of patients were chronic hepatitis B carriers. Ninety percent of recruited patients belonged to BCLC stage C disease and 41 (80%) patients had extra-hepatic metastasis. The best RR was 16% and they were all partial response. Another 62% of patients achieved stable disease for at least eight weeks. The median TTP was 5.29 months (95% CI 3.81-5.88 months), PFS 5.26 months (95% CI 3.75-5.88 months) and OS was 11.73 months (95% CI 8.87- 15.38 months). Diarrhea (75%), Hand-foot-skin reaction (73%) and transient liver function derangement were the most commonly encountered adverse events, with the majority of patients having grade one or two. No treatment-related death was reported. Conclusions: The SECOX regime indicates preliminary promising activity and safety in Asian population with advanced HCC. Our data support a randomized trial comparing SECOX versus sorafenib alone for treatment of advanced HCC. Clinical trial information: NCT00752063.
Patients with colorectal cancer (CRC) have a different gut microbiome signature than individuals without CRC. Little is known about the viral component of CRC-associated microbiome. We aimed to ...identify and validate viral taxonomic markers of CRC that might be used in detection of disease or predicting outcome.
We performed shotgun metagenomic analyses of viromes of fecal samples from 74 patients with CRC (cases) and 92 individuals without CRC (controls) in Hong Kong (discovery cohort). Viral sequences were classified by taxonomic alignment against an integrated microbial reference genome database. Viral markers associated with CRC were validated using fecal samples from 3 separate cohorts: 111 patients with CRC and 112 controls in Hong Kong, 46 patients with CRC and 63 controls in Austria, and 91 patients with CRC and 66 controls in France and Germany. Using abundance profiles of CRC-associated virome genera, we constructed random survival forests models to identify those associated with patient survival times.
The diversity of the gut bacteriophage community was significantly increased in patients with CRC compared to controls. Twenty-two viral taxa discriminated cases from controls with an area under the receiver operating characteristic curve (AUROC) of 0.802 in the discovery cohort. The viral markers were validated in 3 cohorts, with AUROCs of 0.763, 0.736, and 0.715. Clinical subgroup analysis showed that dysbiosis of the gut virome associated with early- and late-stage CRC. A combination of 4 taxonomic markers associated with reduced survival of patients with CRC (log-rank test, P=8.1 × 10
) independently of tumor stage, lymph node metastases, or clinical parameters. We found altered interactions between bacteriophages and oral bacterial commensals in fecal samples from patients with CRC compared with controls.
In a metagenomic analysis of fecal samples from patients and controls, we identified virome signatures associated with CRC. These data might be used to develop tools to identify individuals with CRC or predict outcomes.
HYPOTHESIS Hepatic resection improves quality of life (QOL) in patients with resectable hepatocellular carcinoma (HCC). DESIGN A prospective longitudinal study. SETTING A university teaching ...hospital. PATIENTS Sixty-six consecutive patients undergoing resection of HCC, and 10 patients with unresectable HCC found after surgical exploration who were subsequently treated with transarterial chemoembolization (control group). MAIN OUTCOME MEASURE Serial measurements of preoperative and postoperative QOL using the Functional Assessment of Cancer Therapy–General (FACT-G) Questionnaire for up to 2 years after surgery (at 3, 6, 9, 12, 18, and 24 months). RESULTS Among the 66 patients with resectable HCC, the mean postoperative QOL scores at 3 months after surgery were significantly higher than the mean preoperative QOL scores in domains related to physical, social, and emotional well-being and relationship with physicians. The mean total QOL score increased from 83.5 (SD, 9.4) before surgery to 94.1 (SD, 7.7) at 3 months after surgery (P<.001). No significant change of QOL scores at 3 months after surgery was observed in the control group. Twenty patients in the resected group died of early recurrence within 2 years after surgery, but their mean postoperative QOL scores remained higher than the preoperative QOL scores for most assessment times. In contrast, in the control group, the mean total QOL scores became significantly lower than the preoperative scores, starting 9 months after surgery. Forty-six patients in the resected group completed all QOL assessments. At all postoperative assessments, their mean QOL scores were higher than preoperative scores. Recurrence developed in 13 of the 46 patients within the 2-year study, and there was significant deterioration of QOL over time among these 13 (P<.001), whereas no significant change in QOL over time was observed among the 33 recurrence-free patients. Of various clinicopathologic factors, only advanced pTNM stage was significantly predictive of deterioration of QOL over time after resection of HCC. CONCLUSIONS Hepatic resection results in significant enhancement of QOL in patients with HCC. Development of recurrence is the main factor leading to deterioration in QOL over time after resection of HCC.Arch Surg. 2001;136:693-699-->
Accumulation of fat and substantial loss of muscle mass are common phenomena in the elderly. In this study, we observed the effects of Tai Chi Chuan (TCC) and swimming, two exercises suitable for ...elderly people, on the percentage body fat and fat distribution by measuring subcutaneous adipose tissue thickness and body composition.
Subjects were divided into three groups: regular swimmers (n = 20), regular TCC practitioners (n = 32), and age-matched control subjects (n = 31). Subcutaneous adipose tissue thickness was taken using a Lange skinfold caliper at the chests, abdomens, and thighs in the men, and the triceps, suprailium, and thighs in the women. Mid-arm circumference (MAC) was measured on the non-dominant upper arm using fiberglass tape. Body composition was analyzed using the Inbody 3.0 logo, a bioelectrical impedance analysis (BIA) system.
No significant differences were found between the three test groups in relation to total body adiposity and arm muscle circumference in the men and women. There was significantly less subcutaneous adipose tissue at the abdomen (p = 0.011) and thigh (p < 0.001) of TCC-group men and at the thighs (p < 0.001) of the swimming group compared with the control group. In women, only the thigh skinfold (p = 0.002) showed a decrease in the TCC group compared with the control group.
Swimming and TCC may not decrease total fat adiposity in elderly men and women, however, they may change body fat distribution due to certain muscle group usage. The differences observed in the effects of exercise on body fat distribution between elderly women and men may be gender-related.