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J de Irala

Publications and source records attributed to J de Irala.

9 recordsLinked to original sources
PubMed2001

Fixed higher dose schedule of suramin plus hydrocortisone in patients with hormone refractory prostate carcinoma a multicenter Phase II study.

BACKGROUND: Using a fixed higher-dose schedule, the efficacy and toxicity of suramin plus hydrocortisone were assessed in patients with metastatic hormone-refractory prostate carcinoma (HRPC). METHODS: Fifty consecutive patients with HRPC (including those in whom hormonotherapy was withdrawn) and an Eastern Cooperative Oncology Group performance status of 0-2 were recruited. Treatment was comprised of a bolus intravenous infusion of 200 mg of suramin followed by suramin (500 mg/m(2) intravenously [i.v.] over 24 hours) given daily over 5 days as a loading course, followed by suramin (350 mg/m(2) i.v. over 2 hours) administered weekly for 12 weeks. This 12-week course was repeated at 6-month intervals. All patients received concomitant hydrocortisone. RESULTS: Five hundred fifty weekly doses of therapy were delivered over the course of the entire study. A partial response, based on a > 50% decrease in the prostate specific antigen (PSA) level, was achieved in 27 patients (54%; 95% confidence interval [95% CI], 44.7-65.0%), 16 of whom (32%; 95%CI, 23.9-43.2%) had a > 75% decrease in their PSA levels. The measurable disease objective response rate was 18% (95% CI, 2.3-51.8%). Of the 37 patients with bone pain requiring analgesia, 27 patients (73%; 95% CI, 55.9-86.2%) reduced their medication consumption to a lower level on the World Health Organization analgesic ladder. The median duration of response was 15.5 weeks (range, 6-70 weeks), the median time to disease progression was 13 weeks, and the median overall survival time was 11 months. Treatment generally was well tolerated. Fatigue and severe lymphopenia were the most commonly reported significant toxicities. In addition, there was 1 septic toxic death reported, and 10% of the patients were found to have NCI Grade 3-4 neurotoxicity. CONCLUSIONS: The results of the current study demonstrated that the fixed-dose suramin regimen administered herein showed high, although short-lived, activity and a good tolerance profile in HRPC patients.

Aged↗
PubMed2001

Perception of body image as indicator of weight status in the European union.

OBJECTIVE: To identify the factors associated with an adequate perception of body image in relation to body weight. MATERIAL AND METHODS: An observational, cross-sectional study was conducted in a representative sample of the European Union (7,155 men and 8,077 women). Body Mass Index (BMI) was grouped into four categories, perceived body image was assessed using the nine silhouettes drawing scheme. A multivariable logistic regression model for each sex was used to adjust for potentially confounding variables. RESULTS: Underweight men and women classified themselves better than other groups (92.9% of correct answers among men and 79.3% among women). Overall, women classified themselves better than men (57.6% vs. 32.7%). DISCUSSION: Perceived body image as a method of assessment for body weight has different validity depending on sociodemographic or attitudinal categories. Perceived body image as an estimate of the nutritional status has a limited individualized application. Thus, perhaps it could be applied as a proxy measure of adiposity among slim males and among slim and overweight females, but not among the other groups.

Adolescent↗
PubMed2000

Paclitaxel, cisplatin, and gemcitabine combination chemotherapy within a multidisciplinary therapeutic approach in metastatic nonsmall cell lung carcinoma.

BACKGROUND: Cisplatin-based chemotherapy combinations improve quality of life and survival in advanced nonsmall cell lung carcinoma (NSCLC). The emergence of new active drugs might translate into more effective regimens for the treatment of this disease. METHODS: The objective of this study was to determine the feasibility, response rate, and toxicity of a paclitaxel, cisplatin, and gemcitabine combination to treat metastatic NSCLC. Thirty-five consecutive chemotherapy-naive patients with Stage IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0-2 were treated with a combination of paclitaxel (135 mg/m(2) given intravenously in 3 hours) on Day 1, cisplatin (120 mg/m(2) given intravenously in 6 hours) on Day 1, and gemcitabine (800 mg/m(2) given intravenously in 30 minutes) on Days 1 and 8, every 4 weeks. Although responding patients were scheduled to receive consolidation radiotherapy and 24 patients received preplanned second-line chemotherapy after disease progression, the response and toxicity rates reported refer only to the chemotherapy regimen given. RESULTS: All the patients were examined for toxicity; 34 were examinable for response. An objective response was observed in 73.5% of the patients (95% confidence interval [CI], 55.6-87.1%), including 4 complete responses (11.7%). According to intention-to-treat, the overall response rate was 71.4% (95% CI, 53. 7-85.4%). After 154 courses of therapy, the median dose intensity was 131 mg/m(2) for paclitaxel (97.3%), 117 mg/m(2) for cisplatin (97.3%), and 1378 mg/m(2) for gemcitabine (86.2%). World Health Organization Grade 3-4 neutropenia and thrombocytopenia occurred in 39.9% and 11.4% of patients, respectively. There was one treatment-related death. Nonhematologic toxicities were mild. After a median follow-up of 22 months, the median progression free survival rate was 7 months, and the median survival time was 16 months. CONCLUSIONS: The combination of paclitaxel, cisplatin, and gemcitabine is well tolerated and shows high activity in metastatic NSCLC. This treatment merits further comparison with other cisplatin-based regimens.

Adult↗
PubMed1997

[Abnormally broad confidence intervals in logistic regression: interpretation of results of statistical programs].

This study describes the behavior of eight statistical programs (BMDP, EGRET, JMP, SAS, SPSS, STATA, STATISTIX, and SYSTAT) when performing a logistic regression with a simulated data set that contains a numerical problem created by the presence of a cell value equal to zero. The programs respond in different ways to this problem. Most of them give a warning, although many simultaneously present incorrect results, among which are confidence intervals that tend toward infinity. Such results can mislead the user. Various guidelines are offered for detecting these problems in actual analyses, and users are reminded of the importance of critical interpretation of the results of statistical programs.

Confidence Intervals↗
PubMed1997

Nosocomial infection in an intensive-care unit: identification of risk factors.

OBJECTIVE: To identify risk factors predictive of nosocomial infection in an intensive-care unit (ICU) and to identify patients with a higher risk of nosocomial infection using a predictive model of nosocomial infection in our ICU. DESIGN: Prospective study; daily concurrent surveillance of intensive-care-unit patients. SETTING/PATIENTS: All patients admitted for at least 24 hours to the ICU of a tertiary-level hospital from February to November 1994 were followed daily. METHODS: Variables measuring extrinsic and intrinsic risk factors for nosocomial infection were collected on each patient during their ICU stay, and the Cox Proportional Hazards multivariable technique was used to identify the variables significantly associated with infection. RESULTS: The population studied consisted of 944 patients. The main risk factors identified were intrinsic; the significant extrinsic risk factors identified were head of the bed in a horizontal (< 30 degrees) position (this variable presented the highest increase of the infection hazard ratio) and the use of sedative medication. Patients presenting the highest risk scores using the predictive model are those with the highest risk of nosocomial infection. CONCLUSIONS: The important preventive measures derived from our results are that underlying conditions suffered by the patient at the ICU admission should be corrected promptly, the depression of the patient's level of consciousness with sedatives should be monitored carefully, and the horizontal position of the head of the bed should be avoided totally. Patients with a high risk of infection can be the target of special preventive measures.

APACHE↗
PubMedDate not supplied

[Estimation of cost associated with incorrect surgical prophylaxis in a third level hospital center].

BACKGROUND: The constant increase of pharmaceutical costs is of great concern to the administrators of the Spanish National Health Service. Antibiotics administered as prophilaxis prior to surgery, play an important role in this increase. The compliance of physicians with protocols for chemoprophylaxis is therefore an important factor in the control of these pharmaceutical costs. The degree of compliance with the pre-established protocols of prophylaxis prior to surgery are examined in a tertiary level hospital during 1992 and the extra costs due to the lack of compliance with these protocols are estimated using a sample of 371 subjects. The object of this study is to describe the degree of the fulfillment of the protocols of surgical chemoprophylaxis in a tertiary level hospital and to estimate the minimum additional cost due to the wrong chemoprophylaxis. METHODS: A descriptive study was made of the surgical prophylaxis using a sample of 371 subjects. The cost was estimated from the price of the antibiotics administered. RESULTS: A total of 267 (71.9% IC95% = 67.3-76.5) subjects had received incorrect prophylaxis. The most important causes of incorrect prophylaxis were the wrong antibiotic choice and the excessive duration of their administration. The incorrect prophylaxis was responsible for an additional cost of 1,117,287 ptas. The application of these estimates to the entire 1992 surgical population, at our center, would yield an estimated additional cost of 39,409,965 pesetas. CONCLUSIONS: Our health services would have substantial savings if protocols for prophylaxis prior to surgery were strictly followed by physicians.

Adult↗