Cisplatin plus oral etoposide (EoP) combination is more effective than paclitaxel in patients with advanced breast cancer pretreated with anthracyclines: a randomised phase III trial of Turkish Oncology Group

Our objective was to determine whether oral etoposide and cisplatin combination (EoP) is superior to paclitaxel in the treatment of advanced breast cancer (ABC) patients pretreated with anthracyclines. From December 1997 to August 2003, 201 patients were randomised, 100 to EoP and 101 to paclitaxel arms. Four patients in each arm were ineligible. The doses of etoposide and cisplatin were 50 mg p.o. twice a day for 7 days and 70 mg m−2 intravenously (i.v.) on day 1, respectively, and it was 175 mg m−2 on day 1 for paclitaxel. Both treatments were repeated every 3 weeks. A median of four cycles of study treatment was given in both arms. The response rate obtained in the EoP arm was significantly higher (36.3 vs 22.2%; P=0.038). Median response duration was longer for the EoP arm (7 vs 4 months) (P=0.132). Also, time to progression was significantly in favour of the EoP arm (5.5 vs 3.9 months; P=0.003). Median overall survival was again significantly longer in the EoP arm (14 vs 9.5 months; P=0.039). Toxicity profile of both groups was similar. Two patients in each arm were lost due to febrile neutropenia. The observed activity and acceptable toxicity of EoP endorses the employment of this combination in the treatment of ABC following anthracyclines

The additional value of patient-reported health status in predicting 1-year mortality after invasive coronary procedures: A report from the Euro Heart Survey on Coronary Revascularisation

Objective: Self-perceived health status may be helpful in identifying patients at high risk for adverse outcomes. The Euro Heart Survey on Coronary Revascularization (EHS-CR) provided an opportunity to explore whether impaired health status was a predictor of 1-year mortality in patients with coronary artery disease (CAD) undergoing angiographic procedures. Methods: Data from the EHS-CR that included 5619 patients from 31 member countries of the European Society of Cardiology were used. Inclusion criteria for the current study were completion of a self-report measure of health status, the EuroQol Questionnaire (EQ-5D) at discharge and information on 1-year follow-up, resulting in a study population of 3786 patients. Results: The 1-year mortality was 3.2% (n = 120). Survivors reported fewer problems on the five dimensions of the EQ-5D as compared with non-survivors. A broad range of potential confounders were adjusted for, which reached a p<0.10 in the unadjusted analyses. In the adjusted analyses, problems with self-care (OR 3.45; 95% CI 2.14 to 5.59) and a low rating (≤ 60) on health status (OR 2.41; 95% CI 1.47 to 3.94) were the most powerful independent predictors of mortality, among the 22 clinical variables included in the analysis. Furthermore, patients who reported no problems on all five dimensions had significantly lower 1-year mortality rates (OR 0.47; 95% CI 0.28 to 0.81). Conclusions: This analysis shows that impaired health status is associated with a 2-3-fold increased risk of all-cause mortality in patients with CAD, independent of other conventional risk factors. These results highlight the importance of including patients' subjective experience of their own health status in the evaluation strategy to optimise risk stratification and management in clinical practice

Prevalence of modifiable cardiovascular risk factors remain high after coronary bypass graft surgery: A multicentre study among Turkish patients

PubMedID: 12394329Background The measures of secondary prevention in patients undergoing coronary bypass graft surgery (CABG) remains largely undetermined in Turkey. Design We designed a multicentre cross-sectional study to estimate the prevalence of cardiovascular risk factors in patients after CABG and to evaluate the association of demographic-socio-economic factors with secondary prevention in these patients. Methods A total of 622 patients who underwent CABG between 1 January 1999 and 15 January 2000 at four centres in Adana, Turkey; 273 (ages 35-77, 208 men) were interviewed and examined 1.0-2.2 years after the procedure. Results Of 273 patients interviewed, 81.5% were overweight, 65.5% had unhealthy food choices for a lipid-lowering diet, 56.0% were physically inactive, 28.8% were obese and 17.6% were current smokers. Hypercholesterolaemia, elevated blood pressure and fasting blood glucose were found in 65.6, 34.1 and 19.8%, respectively. Of diabetic patients, 63.8% had elevated fasting blood glucose. The use of angiotensin-converting enzyme inhibitors, beta-blockers and statins was low. Women had a higher rate of obesity and physical inactivity; smoking was less prevalent in females. More women were taking antihypertensive and lipid-lowering drugs than men. Logistic regression analysis revealed an association between hypercholesterolaemia and low educational level. Conclusion Turkish patients have a high prevalence of modifiable risk factors related to unhealthy lifestyle and ineffective prophylactic drug use 1 year or more after CABG. Low educational level has a significant influence in this situation. © 2002, European Society of Cardiology. All rights reserved

Metabolic syndrome in patients after coronary bypass surgery: Prevalence and compliance with treatment [Koroner Baypas Sonrasi Hastalarda Metabolik Sendrom Sikligi ve Tedaviye Uyum Oranlari]

PubMedID: 15033610Objective: The aim of this study was to evaluate the prevalence of metabolic syndrome (MS) and its components, to determine the patients' compliance with pharmacologic therapy and lifestyle modification, and to clarify the association of demographic and socioeconomic factors with the MS in Turkish patients with prior coronary artery bypass surgery (CABG). Methods: Two hundred and seventy-three patients (age range 35-77, 208 men) were interviewed and examined 1.0-2.2 years after CABG. Results: The prevalence of MS was 44.8% (55.4% among women and 41.3% among men). The most prevalent metabolic risk factor was visceral obesity among females, and elevated blood pressure among males. Rates for regular physical activity were lower in patients with MS, compared with those without MS (%36.9 vs. %47.7, p<0.05). Compared with patients without MS, use of aspirin was lower among patients with MS (%84.4 vs. %93.4, p<0.05). Logistic regression analysis revealed an independent association of age ?65 years and low educational level with MS. Conclusion: We found a high prevalence of metabolic syndrome and its components among patients with prior CABG. Patients with MS had lower rate of regular physical activity and aspirin use, compared with those without MS

Detection of insulin resistance in Turkish adults: A hospital-based study

PubMedID: 12630938Aim: The aim of the present study was to investigate the usefulness of insulin sensitivity check indices in our hospital population. Methods: Both HOMA (insulin X glucose in mmol/l/22.5) and QUICKI (1/log insulin in µu/ml + log glucose in mg/dl) indices were calculated from fasting values in 1774 subjects from the medical records of Baskent University Adana Hospital. Results: Subjects with diabetes, hyperlipidaemia and central obesity were characterized by significantly higher HOMA and lower QUICKI indices than those of healthy subjects. A fall in the QUICKI index (0.3469 ± 0.028 in healthy subjects and 0.3247 ± 0.025 in non-obese diabetics) as well as an increase in HOMA index (2.24 ± 1.26 in healthy subjects and 3.59 ± 2.08 in non-obese diabetics) corresponded to metabolic and clinical manifestations of insulin resistance in various groups of subjects. Age, low HDL cholesterol, male sex, type 2 DM and hypertension were independent risk factors for CAD. Age, male sex, waist circumference and CAD were found to be risk factors for hypertension. Fasting insulin and glucose levels contain sufficient information to assess insulin sensitivity over a wide range in a diverse population. The following can be accepted as mean values to assess insulin resistance in our hospital population: 0.3469 ± 0.028 for the QUICKI index and 2.24 ± 1.26 for the HOMA index. Conclusions: HOMA and QUICKI indices are simple and reproducible methods for determining insulin sensitivity in humans

A phase II study on the safety and efficacy of 5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by paclitaxel in the adjuvant treatment of breast cancer

The incorporation of a taxane into an anthracycline-containing regimen in the adjuvant treatment of breast cancer is a promising approach. In this study, we aimed to evaluate the safety and efficacy of four cycles of FEC (fluorouracil 500 mg/m(2), epirubicin 70 mg/m(2), cyclophosphamide 500 mg/m(2), every 3 weeks) followed by four cycles of paclitaxel (175 mg/m(2) every 3 weeks) in the adjuvant treatment of node-positive and other high-risk breast cancer patients. A total of 88 female patients were enrolled. Mean age (&PLUSMN; SD) of the patients was 47 &PLUSMN; 10 (min: 24; max: 71). The patients were followed for a median of 48 months ( min: 20; max: 64). The most common side effects were nausea-vomiting ( grade I-II: 91%; grade III: 2%), as well as hematological toxicity ( grade I-II: 70%; grade III: 3%). Although all patients experienced some degree of toxicity, it was severe enough to be classified as grade III or IV in only 10 (11%) of the cases. Of note, six (8%) patients had grade I and only one (1%) had grade II cardiotoxicity. No grade III or IV cardiotoxicity was observed. The full eight cycles of study treatment could be administered to 75 patients (85%). Side effects necessitated the reduction of the doses of FEC and paclitaxel in one ( 1%) and three patients ( 3%), respectively. Median overall ( OS) and disease-free survival (DFS) have not yet been reached. Five-year OS and DFS have been estimated to be 78% and 61%, respectively. We conclude that FEC followed by paclitaxel is a well-tolerated and feasible regimen in the adjuvant treatment of early breast cancer. Its efficacity is comparable with other commonly used regimens and merits evaluation in a phase III study