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Biomedical subjects

C Gallo

Publications and source records attributed to C Gallo.

At least 127 records · Page 7Linked to original sources
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Single-agent gemcitabine as second-line treatment in patients with advanced non small cell lung cancer (NSCLC): a phase II trial.

BACKGROUND: Although the use of salvage chemotherapy in advanced non-small cell lung cancer (NSCLC) is controversial, pretreated symptomatic patients often need some kind of treatment to achieve symptoms relief. Gemcitabine is one of the most active new drugs in advanced NSCLC and preliminary reports suggest that it is active also in patients previously treated with platinum compounds. AIM: to evaluate activity and toxicity and the effect on quality of life of gemcitabine in platinum-pretreated patients with advanced NSCLC. METHODS: single-stage phase 2 trial with p0 = 5%, p1 = 20%, alfa = 5%, beta = 10%; 34 patients required and 4 objective responses expected to warrant further studies. Gemcitabine was administered at dose of 1000 mg/m2, i.v., d 18-15, every 4 weeks, for a maximum of 6 cycles. Quality of life was measured by EORTC C-30 and LC-13 questionnaires. RESULTS: from September 1996 to July 1998, 30 patients have been enrolled. There were 6 (20% exact 95% CI 8-39%) partial responses (2 responses were in pts with brain metastases and 2 in patients progressed during first-line chemotherapy). All patients (but one died because myocardial infarction, progressed; median time to progression was 10 weeks (95% CI 7-12); 28 patients died; median survival was 22 weeks (95% CI 17-29). Quality of life analysis showed no significant change but for the improvement of cough after 3 cycles of chemotherapy. There was no severe toxicity. CONCLUSION: gemcitabine is active as second line for patients with advanced NSCLC who received platinum-based first line treatment. In view of such results randomized trials comparing gemcitabine versus best supportive care are warranted.

Adult↗
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Carboplatin, cisplatin and paclitaxel in the treatment of patients with epithelial ovarian cancer.

BACKGROUND: Prognosis of advanced ovarian cancer is unsatisfactory. Chemotherapy can be intensified combining active drugs at their highest possible doses. PATIENTS AND METHODS: In this phase I/II trial, 77 untreated patients received escalating doses of paclitaxel (135, 155, 175, 195 and 215 mg/m2, infused over 3 hours) with carboplatin (AUC 3.6) and cisplatin (60 mg/m2). Nine, 16, 13, 8 and 3 patients were treated at the five levels, respectively. A further 28 patients were treated at the maximum tolerable dose (MTD). RESULTS: Dose-limiting toxicities (one WHO grade 3 constipation, one grade 2 prolonged peripheral neurotoxicity and one grade 3 cardiac toxicity) occurred at 215 mg/m2 in 3 out of 3 patients. MTD was reached at level 4 paclitaxel dose (195 mg/m2). Response was evaluated in 62 patients. A complete response was achieved in 23 patients (37.1%-95% CI 25.2-50.3), including 16 (25.8%) pathological and partial response in 28 (45.2%), for an overall response rate of 82.3% (95% exact CL: 70.5%-90.8%). The probability of response was affected by the degree of initial debulking (p = 0.002) and not by the paclitaxel dose. In patients with stage III-IV disease, median progression-free survival was 17 months (95% CI 14-25). After a median follow-up of 28 months, median survival had not been reached; 2-year estimated survival was 67%. CONCLUSION: Paclitaxel can be safely given at the dose of 195 mg/m2 in combination with carboplatin (AUC 3.6) and cisplatin (60 mg/m2). This combination is active and safe and could be considered in clinical settings requiring intensive short treatment.

Adult↗
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Carboplatin + epirubicin +VP-16 + lenograstim followed by radiotherapy + carboplatin as radiosensitizer in limited small cell lung cancer. A multicenter phase II study.

UNLABELLED: A phase II trial was undertaken to test the activity and toxicity of carboplatin (300 mg/m2, i.v. day 1) + epirubicin (75 mg/m2, i.v. day 1) + VP-16 (100 mg/m2, i.v. days 1 to 3) + lenograstim (5 mcg/kg, s.c. days 6 to 15) administered every 3 weeks for 4 cycles and subsequent chest irradiation (50 Gy) + daily carboplatin (25 mg/m2) in the first-line treatment of adults affected by limited small cell lung cancer (SCLC). PATIENTS AND METHODS: A single-stage phase II design was used; the complete response (CR) rate after chest radiotherapy was the primary end-point. Twenty-three CRs were required out of 38 patients to consider the treatment worthy of further study. Prophylactic cranial irradiation (PCI) was planned in case of CR. Patients aged < or = 70 were eligible if they had limited SCLC, a performance status not worse than 2 by the ECOG scale and no prior chemotherapy or radiotherapy. RESULTS: From January 1995 to April 1999, 33 patients were enrolled; the median age was 60 years. All the patients started chemotherapy; 23 patients received chest irradiation and concurrent daily carboplatin; 11 patients also received PCI. Toxicity was generally mild. Sixteen CRs (48.5%, 95% CI: 30.8-66.5) were recorded; the objective response rate was 72.7% (95% CI: 54.5-86.7). The median time-to-progression was 7.9 months (95% CI: 6.5-10.4). The median-survival was 10.7 months (95% CI: 9.2-16.1). CONCLUSION: Induction chemotherapy with carboplatin + epirubicin + VP-16 followed by chest irradiation plus concurrent daily carboplatin is well-tolerated but not sufficiently active to warrant further study in the treatment of patients with limited SCLC.

Adult↗
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[Heart complications in general surgery: results of a multicenter study].

Cardiac events are the most dangerous postoperative complications since they may be easily followed by the death of the patient. The related risk factors were prospectively evaluated in a study of 1182 patients. Stepwise regression logistic model was employed for statistical analysis. Preoperative cardiac and respiratory failure, ventricular arrhytmias, compromission of the nutritional status, presence of neoplastic disease and prolonged anesthesia over two hours were the only significative factors related to postoperative cardiac complications. Advanced age was not a major risk factor. The results of the study require a prospective validation. They are however comparable to those observed in the literature Preoperative cardiac evaluation is of utmost importance for cardiac prognosis and various instrumental, sometimes invasive diagnostic procedures have been proposed. The Authors provide a usefull, simple and widely employable system of general and cardiac assessment for the determination of cardiac risk.

Adolescent↗
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[The risk factors for liver and kidney complications in general surgery: the results of a prospective multicenter study].

A method for preoperative assessment of surgical risk, in function of several risk factors, was developed using the multiple logistic function, as a model of multivariate statistical analysis. This model has the advantage to express the two considered outcomes (perioperative complications and death) in numerical terms of probability. The data were obtained from 1182 consecutive patients, 14 yrs or more, admitted to six centres in various regions of Italy. Stepwise logistic regression model was applied to a set of preoperative and operative factors, three of which were found to significantly correlate with postoperative hepatic failure: compromission hepatic function time of surgical operation > 120' and nutritional status. The factors significantly correlate with postoperative renal failure were: compromission renal function, bacterial contamination during surgery, time of surgical operation > 120'.

Adolescent↗
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[Multifactorial surgical risk index of the development of respiratory complications].

Respiratory events are between the most frequent postoperative complications. The preoperative conditions associated with postoperative respiratory failure were evaluated in a prospective study of 1182 patients from six Italian Surgical Units. Multiple regression logistic analysis was employed for statistical evaluation and a predictive prognostic score was derived. Only the presence of the following conditions was significant in affecting postoperative respiratory outcomes: preoperative respiratory and cardiac failure, hypotransferrinemia, prolonged surgical procedures (above the 2 hours) and peroperative bacterial contamination. Advanced age did not appear as a major risk factor. Studies on the predetermination of the pulmonary complications have been widely published. Historical risk factors include the presence of respiratory disease, smoking habits, obesity and thoracic or upper abdominal surgical procedures. Although the results of the present study need a prospective confirmation, the predictive scoring system proves to be a usefull tool that can be employed in most of the General Surgery Units.

Abdomen↗
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[Evaluation of the surgical risk in general surgery: usefulness of a predictive system based on statistical analysis].

1182 patients were prospectively studied in order to evaluate the surgical risk factors. Stepwise regression logistic procedure was employed for statistical analysis. Postoperative complications included death, cardiac, respiratory, hepatic and renal failure, wound infection and sepsis. Various preoperative conditions were associated with postoperative complications but some of them, as malnutrition or operations prolonged over two hours, occurred more frequently. Age did not appear as a major risk factor. The determination of surgical risk is a major problem in general surgical practice and many attempts have been realized in order to predict postoperative outcome. Clinical judgment is still nowadays fundamental but predictive scores based on statistical analysis have proved to be valid and useful tools. The authors underline the importance of surgical risk prediction in therapeutic programming, especially in the aged and in cancer patient. The surgical or non surgical option and the type of operation to be performed result from a careful evaluation of operative risk and expectancy and quality of life.

Adolescent↗
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[Evaluation of prognostic factors in general surgery; methodological aspects of a multicenter prospective study of 1182 patients].

Surgical risk is defined as the probability of occurrence of early or late complications. For each patient, knowledge of factors affecting surgical risk in a basic step when evaluating prognosis after surgery and determining therapeutic decision. A greater and more effective information may be obtained studying variables within the context of the other ones that more or less condition them. Such a "multivariate" approach allows simultaneously investigating all characteristics by taking account of their correlations. Specification of the problem, choice of the relevant variables, data collection and statistical data processing were considered. Pros and cos of multiple logistic regression model in the assessment of surgical risk were reviewed. The index could be used to identify the most important factors in determining surgical risk and quantify their respective importance. In this way surgical patients could be classified according to risk level. This approach also allow for the concurrent investigation of various potential risk factors and their interactions. For this reason it is termed multifactorial.

Adolescent↗
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[Analysis of mortality and relative prognostic factors in general surgery: use of the multiple logistic regression model].

Surgical risk is defined as the occurrence of complications arising in the individual as a result of surgical stress. The ability to forecast these consequences is an important factor in determining decision taken by surgeon. Several attempts have been made to quantify postsurgical prospects but up till now no overall solution has been found. This paper attempts to define a multifactorial risk index for adults subjected to surgery, with respect to immediate and early per- and post-surgical complications. 1182 adult patients, 14 yrs or more, surgically treated not for urgency during 1985 in six Italian centres, were prospectively studied in order to derive a multivariate prognostic index of after surgery mortality. Stepwise logistic regression model was applied to a set of preoperative and operative factors, five of which were found significantly correlate with death: nutritional status, renal failure, reintervention, bacterial contamination during surgery, age greater than 70 years. Thus, from regression coefficients, scores were derived for modalities of significant variables, allowing to build four classes of risk patients: low (less than 1%), medium (between 1% and 10%), high (between 10% and 50%), extremely high risk (greater than 50%).

Adolescent↗
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[Identification of the patient at risk of postoperative infectious complications: risk factors and their evaluation].

The authors report their results of a prospective study on 1182 patients who underwent surgical operation relatively on postoperative infections. Studied variables were: structural and anamnestic: sex, age, smoking, drinking; clinical: evidence of functional changes in various organs, as assessed upon clinical basis and laboratory results; pertinent to surgical intervention: entity, duration, anaesthesia; during and early-after-surgery complications (until discharge or within 30 days since intervention). Stepwise logistic regression model was applied to this set of preoperative and operative factors, four of which were found significantly correlate with postoperative infections: bacterial contamination during surgery, duration surgical intervention greater than 120', cholestasis, serum albumin.

Adolescent↗
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[Mortality and clinico-prognostic significance of risk factors in geriatric surgery].

A prospective study for assessment of operative risk in elderly patients was carried in 1182 adult patients, 14 yrs or more, surgically treated not for urgency during 1985 in six Italian centres. Looking for meaningful relations among prognostic factors and outcome of disease is a relevant topic in biomedical of surgical risk was the use of multiple logistic function. Anamnestic, clinical and surgical variables were "explicative" variables, while occurrence of death and postoperative complications were "response" variables. Multipathology (myocardiosclerosis, respiratory failure) frequently associated with advanced age (greater than 70 yrs) contribute to determine the prognosis in surgery of elderly patient. Stepwise logistic regression model was applied to a set of preoperative and operative factors, five of which were found to significantly correlate with death: nutritional status, renal failure, reintervention, bacterial contamination during surgery, age greater than 70 years. From our data some conclusion may be drown: it is emphasized the major role of surgical factors in affecting the postoperative risk; among clinical variables, renal failure furnishes the most relevant contribution to prognosis; advanced age itself does not substantially affect the surgical risk, its role being confounded by association with other pathologies.

Adult↗
PubMedDate not supplied

Management of hypertension in chronic kidney disease: the Italian multicentric study.

BACKGROUND: Guidelines have indicated the achievement of blood pressure target (BP <130/80 mmHg) as a priority in the conservative treatment of chronic kidney disease (CKD), but the current implementation of these recommendations in clinical practice is unknown. METHODS: We assessed control rates, treatment and clinical correlates of hypertension in 1201 adult non-dialyzed CKD patients followed up by a nephrologist for at least 6 months. RESULTS: Estimated glomerular filtration rate (GFR) was 32 (SD 15) mL/min/1.73 m2. BP target was not achieved in 88% of patients (95% confidence interval (95% CI): 86-90%). In 84% of patients, BP levels were also above the target at the first visit to the nephrology unit 4.5 yrs previously. The risk of not achieving BP target during the nephro-logy follow-up was associated with older age (odds ratio (OR): 1.24, 95% CI 1.06-1.45, p=0.008), diabetes (OR: 2.25, 95% CI 1.20-4.20, p=0.011), and the duration of hypertension (OR: 1.13, 95% CI 1.02-1.24, p=0.016). Among patients with uncontrolled BP, about 70% received multidrug antihypertensive therapy including renin-angiotensin system (RAS) inhibitors; conversely, diuretic treatment was prescribed in a minority of patients (37%), and at insufficient doses in half the cases, despite the insufficient implementation of a low salt diet (18%). CONCLUSIONS: BP target was not reached in most CKD patients routinely seen in the renal clinics. The main barrier to guideline implementation is possibly the inadequate treatment of extracellular volume expansion despite the large prevalence of factors, such as older age and diabetes, which further enhance the intrinsic BP salt sensitivity of CKD.

Aged↗
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[The organization of a working group for the prevention of decubitus lesions].

The authors report the results of a two years monitoring program focused on patients at risk of and with bedsores in the general hospital of Castelfranco Veneto. The purpose of the multidisciplinary exercise (which saw the participation of nurses, pharmacists, doctors) was the activation and the evaluation of treatment protocols. The overall recruited sample included 679 patients, with a prevalence of 61% of lesions at the occasion of the first observation, and of 57% in the last one. The hardly quantitatively different prevalence is better understood from a qualitative point of view: the number of lesions per patients drops slightly from 1.9 to 1.7; one out of four of the "at risk" patients became "at no risk"; a 30% improvement is observed with respect to treatment efficacy. It is suggested that a positive effect may be obtained through a sustained attention to the problem and the careful definition of the interventions to be planned.

Humans↗