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Biomedical subjects

N Dombros

Publications and source records attributed to N Dombros.

At least 19 recordsLinked to original sources
PubMed1999

Postoperative radiation and concomitant bolus fluorouracil with or without additional chemotherapy with fluorouracil and high-dose leucovorin in patients with high-risk rectal cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group.

BACKGROUND: Randomized studies have shown that postoperative chemotherapy with or without radiation therapy (RT) improved local control and survival of patients with stages II or III rectal cancer. However, the optimal sequence of treatments and the optimal chemotherapeutic regimen have not been defined. Modulation of fluorouracil (FU) by leucovorin (LV) has yielded a highly significant difference in response rate from that of FU monotherapy, as suggested by an overview of randomized trials in patients with advanced colorectal cancer. However, this difference in response rate did not translate into a survival benefit. PURPOSE: To evaluate the impact on the disease-free survival (DFS) and overall survival (OS) of patients with stages II or III rectal cancer of postoperative RT and concomitant bolus FU administration alone or with additional chemotherapy using FU and high-dose LV. PATIENTS AND METHODS: From October 1989 until February 1997, 220 patients were randomized postoperatively to receive either one cycle of chemotherapy with FU (600 mg/m2/week x 6 followed by a two-week rest) and leucovorin (LV, 500 mg/m2/week x 6 as a two-hour infusion) followed by pelvic RT with concomitant FU (400 mg/m2) as a rapid intravenous injection during the first three and last three days of RT, and three more cycles of the same chemotherapy with FU and LV (standard, group A, 111 patients) or pelvic RT with concomitant FU only (experimental, group B, 109 patients). RESULTS: As of August 1998, after a median follow-up of 4.9 years, there was no significant difference in either three-year DFS (Group A, 70.3%; group B, 68.2%, P = 0.53) or OS (group A, 77%; group B, 73.3%. P = 0.75). Cox multivariate analysis revealed stage of disease, number of infiltrated nodes, tumor grade, presence of regional implants and perforation to be significant prognostic factors. The incidence of severe side effects was significantly higher in the patients in group A than in those in group B (32.4% vs. 4.6%, P < 0.0001). CONCLUSIONS: The incorporation of additional chemotherapy with FU and LV into postoperative concomitant RT and bolus infusion of FU does not offer a > or = 10% three-year survival benefit over that of concomitant RT and bolus infusion of FU, and significantly increases toxicity in patients with stages II or III rectal cancer.

Adult↗
PubMed1999

Survival and complications of 225 catheters used in continuous ambulatory peritoneal dialysis: one-center experience in Northern Greece.

This study reports our experience with permanent peritoneal catheters. From July 1983 until December 1997, 225 catheters were implanted surgically in 207 patients (120 males, 87 females) with mean age of 58+/-16 years (range: 2-82 years), and a mean duration of continuous peritoneal dialysis (CAPD) of 21.9+/-21.3 months (range: 1-145 months). Two hundred and seventeen catheters were used in 199 patients suffering from end-stage renal disease (ESRD), and 8 catheters in 8 patients with end-stage heart failure resistant to medical therapy. One patient used 3 catheters and 16 patients used 2 catheters. The catheters used were: Tenckhoff, 2; Oreopoulos-Zellerman-1 (OZ-1), 10; OZ-2, 205; and OZ-pediatric, 8. All catheters were implanted by the same surgical team, through a paramedian incision under local anesthesia. By life table analysis, the actuarial survival rates at 1 year, 2 years, 3 years, and 5 years were 97%, 92%, 87%, and 82% respectively for all catheters. The catheter-related complications were: 5 obstructions, 2 dislodgments, 13 dialysate leaks (6 early; 7 late), 90 exit-site/tunnel infections (in 56 patients), 2 cuff extrusions, and 37 hernias (in 31 patients). Eighteen catheters were replaced for persistent peritonitis (15 cases), dislodgment (1 case), obstruction (1 case), and accidental shortening (1 case). The total observation period was 4526 patient-months. The overall incidence of peritonitis was one episode per 15 patient-months, and of exit-site/tunnel infections was one episode per 50 patient-months, with a significant improvement during the last years. We conclude that OZ catheters implanted surgically through a paramedian incision have a very high survival rate and a low complication rate.

Adolescent↗
PubMed1998

Estimating urea clearance in patients on continuous ambulatory peritoneal dialysis: a multivariate analysis.

The purpose of this study was to determine if Kt/V urea in continuous ambulatory peritoneal dialysis (CAPD) could be estimated by a multivariate model based upon simple clinical observations. The study included 439 clearance studies in 301 CAPD patients followed in 8 dialysis centers. Weekly urea clearance, 24 h urine volume and 24 h drain volume were normalized to body water by the formulae of Watson (Kt/V, UV/V and DV/V respectively). Adequate dialysis was defined as Kt/V > or = 2.0 weekly. Subjects at 2 units were used to derive the models, while others were used for model validation. Stepwise multiple linear regression was performed on the derivation set (DS) to identify the clinical variables that correlated with Kt/V. The model was then used to estimate Kt/V for the validation set (VS). In the DS, 110 clearance studies were performed in subjects with residual renal function. Multiple linear regression showed that weekly Kt/V was defined by the expression: Kt/V=1.48 + 24.1 (UV/V) + 2.92(DV/V) - 0.049 (serum creatinine) (r=0.750, p<0.001). In 204 VS studies, the correlation between estimated and measured Kt/V was 0.633. There were marked differences in the proportion of adequately dialyzed patients when Kt/V estimated from the formula shown was <2.0, between 2.0 and 2.3, and >2.3 weekly (7.9%, 54.7% and 79.7%, respectively; p 2.3 weekly (8.1%, 68.8%, and 100%, respectively; p<0.001). The risk of low Kt/V can be estimated by multivariate linear models requiring only simple clinical measurements.

Female↗
PubMed1997

Paclitaxel by 3-h infusion and carboplatin in anthracycline-resistant advanced breast cancer. A phase II study conducted by the Hellenic Cooperative Oncology Group.

37 patients with advanced breast cancer resistant to anthracyclines were treated with paclitaxel 200 mg/m2 by 3-h infusion and carboplatin at an area under the curve of 7 mg.min/ml every 4 weeks with G-CSF support. There were 5 (14%, 95% CI 3-25%) complete and 11 (30%, 95% CI 15-45%) partial responders. Median duration of response was 11.5 months (range 5.2-16.8+), median time to progression 8 months (range 0.26-16.8+) and median survival 12 months (range 0.5-19.6+). Grade 3-4 leucopenia (27%), thrombocytopenia (10%) and diarrhoea (5%) were noted. In conclusion, the combination of paclitaxel and carboplatin is active and well tolerated in patients with advanced breast cancer resistant to anthracyclines.

Adolescent↗
PubMed1997

Paclitaxel by three-hour infusion and carboplatin in advanced carcinoma of nasopharynx and other sites of the head and neck. A phase II study conducted by the Hellenic Cooperative Oncology Group.

BACKGROUND: Paclitaxel has been demonstrated to have significant activity in recurrent or metastatic head and neck cancer (HNC). In addition, the combination of paclitaxel and cisplatin is active in untreated patients with inoperable HNC. Substitution of carboplatin for cisplatin allows the treatment to be delivered on an outpatient basis. PURPOSE OF THE STUDY: To evaluate the activity and toxicity of the combination of paclitaxel by three-hour infusion and carboplatin as first-line chemotherapy in patients with recurrent or metastatic HNC. PATIENTS AND METHODS: From March 1994 until August 1996, 49 patients with recurrent or metastatic HNC were treated with paclitaxel (200 mg/m2, by three-hour infusion) followed by carboplatin at an AUC of 7 mg.min/ml, every four weeks. G-CSF was administered prophylactically on days 2 to 12 of each cycle. There were 41 men and 8 women with a median age of 57 years (range 23-73). The majority of the patients were symptomatic and they had recurrent disease locoregionally. Fourteen patients had nasopharyngeal cancer (NPC) and 35 had squamous cell cancers of other areas of the head and neck region (non-NPC). RESULTS: At the completion of treatment, two patients with NPC demonstrated complete and six partial responses for an overall response rate of 57% (95% CI 29%-82%). Among patients with non-NPC, the response rate was 23% (95% CI 9%-37%). After a median follow up period of 15 months, the median time to progression was 4.3 months in the non-NPC group and 16.5 months in the NPC group. At the time of the analysis, median survival had not been reached in NPC while it was 7.3 months in non-NPC patients. Grade 3-4 toxicities included anemia (2%) and leukopenia, thrombocytopenia, stomatitis, nausea/vomiting and diarrhea (4% each). CONCLUSIONS: The combination of paclitaxel and carboplatin appears to be well tolerated but only moderately active in patients with advanced non-NPC of the head and neck region. However, its activity appears promising in NPC and deserves further investigation.

Adult↗
PubMed1996

A phase II study of paclitaxel in advanced breast cancer resistant to anthracyclines.

33 women with advanced breast cancer resistant to anthracyclines were treated with paclitaxel 175 mg/m2 in a 3 h infusion every 3 weeks. The median age was 53 years (range 30-72) and the median performance status was 1 (range 0-2). 24 (73%) patients had visceral metastases while 22 (67%) had > or = two involved sites. 23 (70%) patients received anthracycline or mitoxantrone in an adjuvant setting and 21 (64%) for advanced disease. There were two (6%, 95% confidence interval (CI) 1-20%) complete responses (CRs) and 12 (36%, 95% CI 20-55%) partial responses (PRs). Median dose intensity of paclitaxel delivered was 58 mg/m2/week. Median time to progression was 24 weeks (range 4-61) and median survival was 41 weeks (range 8-66). Grade 3-4 toxicities included leucopenia (9%), stomatitis (3%), alopecia (91%), neurotoxicity (9%), infection (3%) and diarrhoea (3%). In conclusion, paclitaxel at a dose of 175 mg/m2 exhibits significant activity in advanced breast cancer resistant to anthracyclines.

Adult↗
PubMed1996

Prolonged intraperitoneal infusion of 5-fluorouracil using a novel carrier solution.

A novel peritoneal carrier solution, Icodextrin 20 (7.5%), has allowed exploration of prolonged, intraperitoneal (i.p.) infusion of the cytotoxic drug 5-fluorouracil (5-FU). A phase I and pharmacokinetic study was performed to determine the toxicities and maximum tolerated dose of prolonged and continuous intraperitoneal 5-FU in patients with peritoneal carcinomatosis. Seventeen patients were entered into this study. Each patient had a Tenckhoff catheter placed into the peritoneal cavity under general anaesthetic. After initial flushing and gradual increase in exchange volumes with Icodextrin 20, 5-FU was administered daily from Monday to Friday, 50% as a bolus in the exchange bag and 50% in an elastomeric infusor device delivering continuous 5-FU to the peritoneal cavity at 2 ml h-1. Treatment was continued for 12 weeks or until intolerable toxicity developed. Abdominal pain and infective peritonitis proved to be the main dose-limiting toxicities. Initial problems with infective peritonitis were overcome by redesign of the delivery system, and it proved possible to deliver 300 mg m-2 5-FU daily (5 days per week) for 12 weeks. Pharmacokinetic studies showed i.p. steady-state 5-FU concentrations (mean 47 500 ng ml-1) that were > 1000-fold higher than systemic venous levels (mean 30 ng ml-1).

Adult↗
PubMed1993

Psychiatric and psychosocial status of elderly patients undergoing dialysis.

We investigated the psychiatric and psychosocial status of 31 elderly (age > 65 years) end-stage renal disease patients undergoing hemodialysis (HD) (17 patients) and continuous ambulatory peritoneal dialysis (CAPD) (14 patients). There was no difference between the two groups in terms of age (67.3 +/- 2.3 and 68.5 +/- 4.3 in HD and CAPD groups, respectively), duration of dialysis treatment, and biochemical profile. The psychiatric and psychosocial status of the patients was assessed using the standardized psychiatric interview (SPI), Hamilton's depression scale (HRS-D), and a questionnaire for the evaluation of the psychosocial impact of the method of treatment. Sixteen of 31 patients presented with psychiatric morbidity (9 mild, 5 moderate, 2 severe). However, there was no significant relationship between psychiatric morbidity and method of dialysis (HD or CAPD). The mean values of SPI (21.47 +/- 16.38 and 17.14 +/- 13) and HRS-D (20.91 +/- 17.33 and 15.41 +/- 13.13) scores for the HD and CAPD groups, respectively, did not differ significantly. The analysis of the results of the questionnaire regarding the impact of the method of treatment on psychosocial status indicated that the HD patients felt that their lives were more dependent on factors that they could not influence (i.e., the dialysis equipment, etc.). Our findings suggest that the psychiatric status of elderly patients undergoing chronic dialysis treatment is not affected by the method of treatment, a factor that should be taken into consideration when deciding the proper dialysis treatment for these patients.

Aged↗
PubMed1992

Struvite stone formation by Corynebacterium group F1: a case report.

Struvite stones are caused by urea-splitting, usually gram-negative, organisms. A case of aggressive struvite stone production caused by Corynebacterium group F1 is reported that responded to the appropriate antibiotic treatment. To our knowledge this organism has never been associated previously with struvite stone formation.

Adult↗
PubMed1991

Single-dose pefloxacin pharmacokinetics and metabolism in patients undergoing continuous ambulatory peritoneal dialysis (CAPD).

Seven adult patients on continuous ambulatory peritoneal dialysis (CAPD) received one dose of pefloxacin, a novel quinolone antibiotic, orally and intravenously on two separate occasions to characterize the pharmacokinetics and metabolism of the drug. Concentrations of both pefloxacin and its active metabolite N-desmethyl-pefloxacin (norfloxacin) were measured in serum and dialysate by HPLC. Half-life, total body clearance and peritoneal clearance were determined. The overall elimination half-life was 19.9h. Relative to the IV dose the bioavailability following oral administration of pefloxacin was 76%. The mean serum and dialysate concentrations were similar up to 24 h after the oral or IV dose. After a 6-h dwell time the dialysate concentration of pefloxacin was 2.24 mg/L which is above the MIC90 for most bacteria responsible for peritonitis in CAPD patients. The peritoneal clearance of pefloxacin averaged 2.5 mL/min. Serum concentrations of the metabolite norfloxacin were less than 0.5 mg/L during the 24 h study period. We conclude that pefloxacin might be equally effective in the treatment of peritonitis of CAPD after oral or IV administration. Since the peritoneal clearance contributes insignificantly to the elimination of pefloxacin during CAPD, the proposed maintenance regimen of an oral or IV 400 mg dose/day seems to be a reasonable therapy for infections in CAPD patients.

Administration, Oral↗
PubMed1990

Peritonitis-related deaths in continuous ambulatory peritoneal dialysis (CAPD) patients.

A total of 636 episodes of peritonitis occurred in 440 patients who entered our continuous ambulatory peritoneal dialysis (CAPD) program from September 1977 to February 1988. Sixteen patients (8 male and 8 female, aged 37-77 years) died during an episode of peritonitis (fatality rate 2.5%). They had been on CAPD for 3 to 105 (average 39) months. Six of them were diabetics. The peritonitis rate among these 16 patients were 1 episode per 12 patient months, while the corresponding figure for the whole (440) CAPD population was 14 patient months. Risk factors present in the 16 patients were: cardiovascular disease (12), cerebrovascular accident (2) peripheral artery disease (1) and pulmonary fibrosis (1). Fever and leukocytosis were present on admission in 11 patients, while total serum proteins and albumin were significantly lower (p less than 0.001) than the corresponding values before peritonitis (56 +/- 8 vs. 65 +/- 5). Staph. aureus was isolated in 8 patients (50%), multiple organisms in 6, Pseudomonas and Candida albicans in 1 each. An abdominal abscess was found in 4 (25%) patients. The peritoneal catheter was removed between the 5th and 10th day in 6 and after the 10th day in 7 patients. Peritonitis with sepsis was the cause of death in 13 patients. Contributing factors were cardiovascular accident in 9, uremic coma in 2, extensive GI bleeding in 2, GI perforation in 2, intestinal infarction in 1, and pneumonia in 2 patients. We conclude that the risk of peritonitis-related death in CAPD patients is increased with Staph. aureus or multibacterial peritonitis. Contributing factors are concomitant cardiovascular disease and delayed (greater than 5 days) catheter removal.

Cardiovascular Diseases↗
PubMed1989

Pharmacokinetics of aztreonam administered i.p. in continuous ambulatory peritoneal dialysis (CAPD) patients.

The pharmacokinetics of Aztreonam (AZT) administered i.p. in six stable patients undergoing continuous ambulatory peritoneal dialysis (CAPD) for end-stage renal disease (ESRD) were studied. One gram of AZT was added into a 2 L bag of dialysate (Medital-Bieffe) just prior to infusion into the peritoneal cavity. The dwell time was 8 h. The serum maximum concentration of AZT was 42.5 +/- 12.4 mg/L (mean +/- SD), achieved in 4.6 +/- 1.0 h. The elimination half-life was 2.4 +/- 0.8 h, almost equal to that found in normal subjects (1.7-2 h). The pharmacokinetic parameters of elimination, as elimination rate constant and clearance of AZT from peritoneal cavity were found 0.305 +/- 0.101 h-1 and 10.05 +/- 3.7 mL/min, respectively, while the bioavailability via the peritoneal membrane was 90.8 +/- 3.05% of administered dose. It is concluded that AZT is eliminated from dialysate at a high rate after i.p. administration and its dialysate and serum levels exceed the MIC for the majority of sensitive organisms including Pseudomonas species. Aztreonam appears to be a potentially useful antibiotic for CAPD peritonitis.

Adult↗
PubMed1982

Nail patella-like renal lesions in the absence of skeletal abnormalities.

Glomerular lesions typical of the nail-patella syndrome were found in the renal biopsy of a patient with microscopic hematuria. Extensive clinical and radiologic examinations failed to reveal skeletal or other abnormalities characteristic of this syndrome. The possibility that the typical ultrastructural changes of the nail patella syndrome may be present in other renal diseases must be considered.

Adult↗