Combination of TACE and Sorafenib Improves Outcomes in BCLC Stages B/C of Hepatocellular Carcinoma: A Single Centre Experience

ABSTRACT Background & Aim. Transarterial chemoembolization (TACE) or sorafenib is recommended for hepatocellular carcinoma BCLC stages B and C respectively. We studied the role of combination of TACE and sorafenib in BCLC stages B/C. Material and methods. We undertook an observational study on a cohort of cirrhotics with HCC from August 2010 through October 2014. Patients in BCLC stages B/C who had received TACE and/or sorafenib were included. mRECIST criteria were used to assess tumor response. The primary end point was overall survival. Results. Out of 124 patients, 47.6% were in BCLC-B and 52.4% in BCLCC. Baseline characteristics were comparable. The predominant etiology was cryptogenic (37.2% and 38.5%, p = NS). 49.1% in BCLC-B and 56.9% in BCLC-C had received TACE+sorafenib. In BCLC-B, the overall survival improved from 9 months (95% CI 6.3-11.7) using TACE only to 16 months (95% CI 12.9-19.1) using TACE+sorafenib (p < 0.05). In BCLC-C, addition of TACE to sorafenib improved the overall survival from 4 months (95%CI 3-5) to 9 months (95%CI 6.8-11.2) (p < 0.0001). As per mRECIST criteria, patients on TACE+sorafenib had reduced progressive disease (37.8% vs. 83.3%), improved partial response (43.2% vs. 3.3%) and one had complete response compared to those on sorafenib alone (p < 0.0001) in BCLC-C but not in BCLC-B group. Hand foot syndrome was noted in 27.7% patients on sorafenib and post TACE syndrome in 80.2% patients, but both were reversible. No major adverse events were noted. Conclusion. TACE+sorafenib was more effective than TACE or sorafenib alone in HCC BCLC stages B or C with a significant survival benefit and improved tumour regression especially in BCLC-C patients.

Clinical and life style variables in functional dyspepsia and its sub-types.

Background: Several definitions and classifications have been designed to characterize functional dyspepsia (FD), the recent one being the ROME III criteria. There have been many studies in the western population which aimed at identifying the risk factors involved in functional dyspepsia. There are fewer studies from south Asian countries. Aim: To determine the clinical and life style variables influencing functional dyspepsia and its sub-types in patients attending a tertiary care referral centre in the Indian subcontinent. Methods: Consecutive patients with upper gastrointestinal symptoms including, epigastric pain/burning, early satiety, postprandial fullness, heartburn and/or chest discomfort, alone or in combination, on more than 3 occasions a week, within the preceding 6 months and with a normal endoscopy were included in the study. Demographic details and the symptom profile including frequency of symptoms were recorded in a pre-structured, validated, modified proforma as per the ROME III criteria and analyzed to test the study hypothesis. Results: Of the 170 patients, the median age of presentation was 49 yrs and the male to female ratio was 0.62 (65:105). The mean BMI was 23.8 kg/m2. Women had a higher BMI than men. More than half of the study subjects were from the low socio-economic groups.77.6% had ulcer type symptoms and showed a decreasing trend with age. It was more common in patients with higher per capita income. Reflux type comprised of 60.6% with predominance in women. 7% had early satiety and 13.5% had postprandial fullness. Nausea and belch as an isolated (associated) phenomenon comprised of 18.8% and 17.1% respectively. None of the lifestyle variables or demographic characteristics showed a significant influence on symptom occurrence. Conclusions: There was a considerable overlap of various sub-types of dyspepsia. There were no differences in life style characteristics or significant risk factors in the various subtypes of dyspepsia.

Dietary factors in pathogenesis of gallstone disease in southern India--a hospital-based case-control study.

BACKGROUND: Pigment or mixed gallstones are common in southern India. The etiology is not established. Known risk factors include an obese, diabetic female and a nonsmoker male. AIM: To determine the association of dietary factors with mixed/pigment gallstones amongst southern Indian patients. METHODS: Diet details were obtained from 346 patients (178 women) with gallstones and an equal number of healthy controls who were age- and sex-matched attendants of the patients, sharing similar socioeconomic and demographic characteristics, with normal abdominal ultrasonogram. Data recorded included the number of daily meals, nature of cereal used, vegetarianism, oil consumed per month, sugar consumption per day, tamarind (Garcinia camborginia ) usage per week, and per-day beverage consumption. RESULTS: There was no difference between cases and controls in consumption of non-vegetarian food, type of cereal, average oil and sugar consumption, and type of beverage consumed (tea/coffee/milk/combination). Individuals with BMI> 22 were at higher risk to develop gallstones (OR 1.49; 95% CI 1.09, 2.04; p=0.01). There was significant risk of gallstone formation with the use of tamarind when consumed > 3 times a week (OR 1.76; 95% CI 1.05, 2.96; p=0.03). Higher BMI and tamarind use were significant risk factors even on multivariate logistic regression analysis (p=0.02). CONCLUSION: Higher BMI and use of tamarind, a common ingredient of diet in southern India, are risk factors in the formation of gallstones in southern India.

Risk factors for esophageal cancer in Coimbatore, southern India: a hospital-based case-control study.

BACKGROUND: Cancer of the esophagus is common in India. The risk factors predisposing to cancer in southern Indian patients are not known. AIM: To determine the role of smoking, alcohol and their combination, and diet factors in the etiology of cancer of the esophagus. METHODS: Risk factors like alcohol consumption, smoking, tobacco chewing, and pre-illness diet details in 90 patients with cancer of the esophagus were compared with those in age- and sex-matched control subjects. RESULTS: The risk for esophageal cancer was 3.5 times higher with alcohol consumption, 2.5 times higher for tobacco users, and 2.8 times higher each for betel nut chewers and smokers. The calculated odds ratio for the social habits and diet factors was significant amongst cases of cancer esophagus. CONCLUSION: Alcoholism, smoking, and chewing of tobacco are factors predisposing to esophageal cancer in southern India.

Surgical practice in symptomatic and asymptomatic gallstone disease.

AIMS: To determine the surgical practice in individuals with symptomatic and asymptomatic gallstone disease using a questionnaire survey. METHODS: A questionnaire was sent to 724 patients with gallstone disease. Details of symptoms, duration of illness, nature of treatment including surgery, color of gallstones retrieved and postoperative follow-up particulars were obtained. RESULTS: The study group included 225 (54%) men; there was a rising trend of prevalence of gallstones in men with increasing age (p<0.05). A third of the patients (142 [34%]) were symptomatic. The mean duration of symptoms was 12.1 months. One hundred and ninety seven patients (48%), including 90 asymptomatic ones, underwent cholecystectomy. Most patients (92.5% of those symptomatic and 76.6% of those asymptomatic) underwent cholecystectomy within one year of diagnosis. Eight asymptomatic patients underwent surgery 3 years or more after diagnosis. The predominant color of stones retrieved was black or brown (57%) or mixed (39%). CONCLUSIONS: A majority of patients with gallstone disease had cholecystectomy within one year of diagnosis. Black or brown pigment stones were the dominant types of gallstones.

Community prevalence of sexually transmitted diseases and human immunodeficiency virus infection in Tamil Nadu, India: a probability proportional to size cluster survey.

BACKGROUND: Human immunodeficiency virus (HIV) infection and AIDS is threatening the survival of many nations. To evaluate ongoing interventional strategies and burden of illness estimates, valid data on the prevalence of HIV are required. Often, in the absence of community prevalence data, estimates are based on surrogate markers such as prevalence of HIV in antenatal clinics. Even though the antenatal prevalence of HIV is easier to measure and can be repeated for evaluation, it is important to establish the association between antenatal and community prevalence of sexually transmitted diseases (STDs) and HIV, so that the validity of the estimates can be verified. METHODS: A 'probability proportional to size' cluster survey was conducted in three randomly selected districts of Tamil Nadu in India. The basic unit of the survey was households from rural and urban clusters. Adults 15-45 years of age from the selected households were eligible for recruitment. Demographic, behavioural and laboratory data were collected. Clinical examination was done to identify STD syndromes and blood, urine, vaginal/urethral and endocervical swabs were taken for laboratory diagnosis of STDs from the subjects. Direct smear examination for Trichomonas vaginalis; serological tests for syphilis, hepatitis B, HIV, herpes simplex virus 2, Chlamydia trachomatis; and culture of Neisseria gonorrhoeae and Haemophilus ducreyi were performed on the collected specimens. The data were analysed adjusting for cluster effect. RESULT: We selected and screened 1981 individuals (1157 women and 824 men) for STDs and HIV from 1114 households representing the 25 million projected adult population of Tamil Nadu. The overall community prevalence of STDs including HIV and hepatitis B in Tamil Nadu was 14.6% (CI: 14.1-15.1), and 8.3% (CI: 7.9-8.6) when HIV and hepatitis B were excluded. Community prevalence of HIV and hepatitis B infection was 1.8% (CI:1.7-1.9) and 5.3% (CI: 5.1-5.5), respectively. The distribution of HIV involved both rural and urban regions of Tamil Nadu. On clinical examination, at least one STD syndrome was noted in 486 (24.5%) of the women subjects; vaginal discharge was the most common and found in 421 women (38.4%). CONCLUSION: The prevalence of STD and HIV in Tamil Nadu is higher than expected and has extended into the non-high risk population (generalized epidemic).