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Biomedical subjects

G Samonis

Publications and source records attributed to G Samonis.

At least 19 recordsLinked to original sources
PubMed2006

A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.

Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m(-2) on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m(-2) on day 8) (arm IG), repeated every 3 weeks. The total number of cycles administered was 255 in the IG arm and 245 in the G arm; the median number of cycles was 3. In all, 145 patients (71 in arm IG and 74 in arm G) were enrolled; 60 and 70 patients from arms IG and G, respectively, were evaluable. A complete clinical response was achieved in three (4.3%) arm G patients; nine (15%) patients in arm IG and four (5.7%) in arm G achieved a partial response. The overall response rate was: arm IG 15% and arm G 10% (95% CI 5.96-24.04 and 95% CI 2.97-17.03, respectively; P=0.387). The median time to tumour progression was 2.8 months and 2.9 months and median survival time was 6.4 and 6.5 months for the IG and G arms, respectively. One-year survival was 24.3% for the IG arm and 21.8% for the G arm. No statistically significant difference was observed comparing gemcitabine monotherapy versus gemcitabine plus irinotecan in the treatment of advanced pancreatic cancer, with respect to overall and 1-year survival.

Adenocarcinoma↗
PubMed2006

FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG).

To compare the efficacy and toxicity of oxaliplatin (L-OHP) in combination with irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOXIRI) vs irinotecan and 5-FU/LV (FOLFIRI) as first-line treatment of patients with metastatic colorectal cancer (MCC). A total of 283 chemotherapy-naïve patients with MCC were enrolled (FOLFIRI arm: n=146; FOLFOXIRI arm: n=137). In the FOLFOXIRI arm, CPT-11 (150 mg m(-2)) was given on d1, L-OHP (65 mg m(-2)) on d2, LV (200 mg m(-2)) on days 2 and 3 and 5-FU (400 mg m(-2) as i.v. bolus and 600 mg m(-2) as 22 h i.v. continuous infusion) on days 2 and 3. In the FOLFIRI arm, CPT-11 (180 mg m(-2)) was given on d1 whereas LV and 5-FU were administered in the same way as in the FOLFOXIRI regimen. Both regimens were administered every 2 weeks. There was no difference in terms of overall survival (median OS: 19.5 and 21.5 months, for FOLFIRI and FOLFOXIRI, respectively; P=0.337), median time to disease progression (FOLFIRI: 6.9 and FOLFOXIRI: 8.4 months; P=0.17), response rates (33.6 and 43% for FOLFIRI and FOLFOXIRI, respectively; P=0.168). Patients treated with FOLFOXIRI had a significantly higher incidence of alopecia (P=0.0001), diarrhoea (P=0.0001) and neurosensory toxicity (P=0.001) compared with patients treated with FOLFIRI. The present study failed to demonstrate any superiority of the FOLFOXIRI combination compared with the FOLFIRI regimen, although the observed median OS is one of the best ever reported in the literature.

Adenocarcinoma↗
PubMed2006

Serotype distribution and antimicrobial resistance of Salmonella enterica from patients with gastroenteritis in Crete, Greece.

The aim of the present study was to determine the serotype distribution and the evolution of antimicrobial resistance among Salmonella enterica strains isolated from patients with diarrhea in Crete, Greece, during a 5-year period (2000-2004). Among the 401 S. enterica isolates recovered, serotype Enteritidis was the most prevalent (66.6%), followed by serotype Typhimurium (14.2%). The rates of resistance to ampicillin, amoxicillin-clavulanic acid, gentamicin, chloramphenicol, tetracycline, nalidixic acid and trimethoprim-sulfamethoxazole were 8.5, 7, 0.7, 5.4, 14.2, 2.7 and 2.7%, respectively. A marked decrease in resistance was observed during the study period. Resistance and multidrug resistance was most common in serotype Typhimurium. The extended-spectrum beta-lactamase production observed in one strain of S. enterica serotype Virchow and the reduced ciprofloxacin susceptibility detected in 2.7% of the isolates studied are causes of concern.

Drug Resistance, Bacterial↗
PubMed2006

Effectiveness and nephrotoxicity of intravenous colistin for treatment of patients with infections due to polymyxin-only-susceptible (POS) gram-negative bacteria.

The prospective case series study presented here was conducted to assess the outcome of patients with infections caused by polymyxin-only-susceptible (POS) gram-negative bacteria managed with intravenous colistin. Between July 2003 and April 2005 a total of 27 patients were infected with a POS gram-negative bacterium and received intravenous colistin at a dose of 2 million international units (MIU) (160 mg or 66.7 mg colistin base) every 8 h for a mean (+/-SD) duration of 13.9 (+/-7.5) days. Nine patients had ventilator-associated pneumonia and received, in addition to the intravenous colistin therapy, 1 MIU (80 mg or 33.3 mg colistin base) aerosolized colistin every 12 h for a mean (+/-SD) duration of 13 (+/-6.5) days. The predominant pathogens were Pseudomonas aeruginosa (n = 17) and Acinetobacter baumannii (n = 12); in two patients both pathogens were isolated from one clinical specimen. In-hospital mortality and clinical response were 15% and 85%, respectively. Colistin-associated nephrotoxicity was observed in two of the 27 patients. POS gram-negative pathogens represent a major threat for hospitalized patients. Colistin appears to be an effective and safe treatment, even in patients with severe underlying diseases.

Acinetobacter Infections↗
PubMed2006

Morganella morganii infections in a general tertiary hospital.

BACKGROUND: Morganella morganii is a commensal Gram-negative bacillus of the intestinal tract of humans and other mammals and reptiles. Few reports exist in the literature regarding infections caused by this organism. METHODS: A retrospective study at the 650-bed University Hospital of Heraklion, Crete, Greece was performed during a 4-year period (2001-2004) to identify and analyze infections caused by M. morganii. RESULTS: Twenty-four patients had M. morganii isolated from clinical specimens during the study period. Thirteen patients (54%) suffered from skin and soft tissue infections, five from pyelonephritis, three from female genital tract infections, one from pneumonia, one from gangrenous appendicitis, and one from tonsillitis. M. morganii was a constituent of polymicrobial infections in 14 patients (58%). The patients received various antibiotics, i.e., six patients received ciprofloxacin, four piperacillin/tazobactam, two amoxicillin/clavulanic acid, one ticarcillin/clavulanic acid, one ceftriaxone, one imipenem, and one cefuroxime monotherapy, whereas the remaining eight received antibiotic combinations. Two (both debilitated) of 24 patients (8%) died, despite antibiotic treatment. CONCLUSION: Skin and soft tissue infection was the commonest type of infection due to M. morganii in our series. M. morganii is commonly a part of polymicrobial infections and can rarely cause fatalities in debilitated patients.

Adolescent↗
PubMed2006

Native valve Aspergillus endocarditis in two patients with aplastic anaemia.

Native valve fungal endocarditis is an uncommon disease with a high mortality rate. We present the clinical features, histological findings and outcome of 2 patients with native valve Aspergillus endocarditis. Both patients had aplastic anaemia as a predisposing disease. The diagnosis was made by Duke's criteria in 1 case and by histology in the other. Surgery was precluded owing to profound thrombocytopenia. Both patients had fatal outcome despite administration of liposomal amphotericin beta.

Adolescent↗
PubMed2006

Effects of vancomycin, teicoplanin, linezolid, quinupristin-dalfopristin, and telithromycin on murine gut colonization by Candida albicans.

Crl:CDI(ICR) BR adult mice were fed chow containing Candida albicans or regular chow. Both groups were subsequently given either antibiotics acting mainly against Gram-positive organisms or normal saline for 10 days. Stool cultures were performed before, at the end, and one week after discontinuation of treatment to determine the effects on the stool yeast concentration. Candida colonized mice treated with vancomycin, teicoplanin, linezolid, quinupristin-dalfopristin or telithromycin had higher colony counts of yeast in their stools than control Candida fed mice treated with saline. This increase was not statistically significant. Mice fed regular chow treated with the study drugs or saline did not have any yeasts in their stools. Dissemination of Candida was not observed in the visceral organs of any mouse.

Animals↗
PubMed2006

Comparative effects of ertapenem, imipenem, and meropenem on the colonization of the gastrointestinal tract of mice by Candida albicans.

We evaluated the effect of three carbapenems on gut colonization of mice by Candida albicans. A total of 150 Crl:CD1 (ICR) BR mice were fed chow containing C. albicans or regular chow. Both groups were subsequently treated either with one carbapenem or with normal saline for 10 days. Stool cultures to determine colonization by C. albicans were performed immediately before, at the end, and one week after the end of treatment. Candida-colonized mice that received carbapenems had substantially higher C. albicans concentrations than control animals fed C. albicans, especially if they received ertapenem. Mice fed regular chow and treated with the study antibiotics or saline did not have Candida in their stools. Candida was not detected in the internal organs of any group of mice.

Animals↗
PubMed2006

Resistance of Mycobacterium tuberculosis isolates in different populations in Greece during 1993-2002.

OBJECTIVE: To document the prevalence of resistance of Mycobacterium tuberculosis to isoniazid (INH), rifampicin (RMP) and both combined (multidrug resistance [MDR]) in Greece from 1993 to 2002. DESIGN: We studied a single sputum sample per patient from 4108 patients referred to the Greek National Referral Centre for Mycobacteria. Patients were divided into native Greeks, immigrants and repatriated Greeks originating from the former Soviet Union. Prior treatment status was not recorded. RESULTS: A statistically significant increase in resistance to INH and RMP and MDR was noted comparing the years 1993-1997 to 1998-2002 (P < 0.0001). Resistance to INH and RMP and MDR rose from 5.6% to 7.71%, from 1.57% to 4.49% and from 1.23% to 3.98%, respectively, among native Greeks and from 23.63% to 32.91%, from 6.36% to 15.19% and from 6.36% to 13.92% among repatriated Greeks. Smaller changes were seen among immigrants (from 15.43% to 9.57% for INH, from 5.51% to 6.12% for RMP and from 5.71% to 5.32% for MDR). CONCLUSION: We documented an increase in M. tuberculosis resistance to INH and RMP, and MDR. This was mainly limited to native and repatriated Greeks. Although this is likely the result of immigration and of mismanagement of index cases in Greece, molecular methods are needed to better describe the situation.

Antitubercular Agents↗
PubMed2005

Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study.

The aim of this study was to compare the irinotecan/cisplatin regimen with cisplatin as second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) pretreated with a taxane/gemcitabine regimen. Patients (n = 147) with stage IV NSCLC pretreated with a taxane/gemcitabine regimen were randomly assigned to receive either irinotecan (110 mg m(-2), day 1 and 100 mg m(-2), day 8) and cisplatin (80 mg m(-2), day 8) (IC; n = 74) or CDDP (80 mg m(-2), day 1) (C; n = 73) every 3 weeks. Patients treated with IC and C had a median survival of 7.8 and 8.8 months, respectively (P = 0.933). The 1-year survival rate was 34.3% for IC-treated patients and 31.7% for C-treated patients. Cox's regression analysis revealed that response to treatment (hazard ratio (HR) = 2.787; 95% confidence interval (CI): 1.1578-4.922) and performance status (HR = 1.865; 95% CI: 1.199-2.872) was independent prognostic factors for survival. Overall response rate was 22.5% (95% CI: 12.8-32.2%) for IC-treated patients and 7.0% (95% CI: 1.15-13.6%) for C-treated patients (P = 0.012); tumour growth control (partial remission (PR) + stable disease (SD)) was observed in 26 (38%) IC and 25 (36%) C patients (P = 0.878). There was no difference in terms of quality of life between the two chemotherapy arms. The incidence of febrile neutropenia, grade 3 and 4 neutropenia and grade 3 and 4 diarrhoea was significantly higher in the IC- than the C-treated patients. Other toxicities were mild. There were no treatment-related deaths in either arm. The IC regimen did not confer a survival benefit compared with C as second-line treatment of patients with advanced NSCLC pretreated with a taxane/gemcitabine regimen, despite its better efficacy in terms of response rate.

Adult↗
PubMed2005

Veno-occlusive disease of the liver associated with chronic myelomonocytic leukemia treated with vincristine and standard doses of cytarabine.

A unique case of a 72-year-old man with chronic myelomonocytic leukemia (CMML) who developed hepatic veno-occlusive disease (VOD) after treatment with a single dose of vincristine and standard doses of cytarabine is described. Unexpected peroneal nerve palsy suggestive of vincristine neurotoxicity occurred concurrently and pointed to vincristine as the most likely cause of the VOD. To the best of our knowledge, association between vincristine and hepatic VOD has not been previously described in chemotherapy-naive patients with CMML.

Aged↗
PubMed2005

Antimicrobial resistance of Streptococcus pneumoniae isolates in Athens, Greece.

In order to determine the current antibiotic susceptibility of Streptococcus pneumoniae strains in Greece, the present study was performed on 282 clinical isolates collected from patients at the Sotiria Chest Hospital of Athens, Greece, during the years 1997-2003. Susceptibility testing revealed that 52 (18.4%) isolates were not susceptible to penicillin, with 13.1% demonstrating intermediate and 5.3% high-level resistance. One of the penicillin-non-susceptible isolates was also resistant to cefotaxime. Comparison with results of a previous study conducted at the same hospital during the period 1992-1993 showed that penicillin resistance had increased by 4.5%. The results of this study indicate the antimicrobial susceptibility of Streptococcus pneumoniae continues to change in Greece and continuous surveillance remains important for guiding empirical antibiotic therapy.

Anti-Bacterial Agents↗
PubMed2004

Bloodstream infections in patients with solid tumors: associated factors, microbial spectrum and outcome.

BACKGROUND: Although patients with malignant diseases are at increased risk for bloodstream infections (BSIs), limited data are available for those with solid tumors. PATIENTS AND METHODS: The etiology, clinical features and outcome of BSIs were retrospectively studied in patients with solid tumors treated at the Department of Medical Oncology at the University Hospital of Heraklion, Greece, from November 1995 through June 2000. RESULTS: A total of 157 episodes of BSIs was identified among 137 patients over the study period. The majority of the episodes (128; 82%) occurred in non-neutropenic patients. 80 of 157 (51%) of the episodes were healthcare-associated, 35% (55 of 157) were nosocomial and 14% (22 of 157) were community acquired. A single pathogen was isolated in 86% of the episodes. A total of 184 pathogens was isolated (51% gram-negative rods, 44% gram-positive cocci, 3% anaerobes and 3% fungi), while the portal of entry was identified in 104 of 157 (66%) of the episodes. The site of the primary tumor or the metastases were the source of BSI in 39 of 104 (37.5%) of the episodes with an identified source. The overall infectious mortality was 20% and was significantly higher when the initial empirical antibiotic therapy was inappropriate (39%; p < 0.001) and in the presence of shock (63%; p < 0.001). CONCLUSION: BSIs in patients with solid tumors are frequently healthcare associated and in a large percentage the portal of entry can be identified. Neutropenia is not as common as in patients with hematologic malignancies. Inappropriate initial empirical antibiotic therapy and shock are clinical factors associated with worse outcomes.

Adolescent↗
PubMed2004

Dose escalation study on oxaliplatin and capecitabine (Xeloda) in patients with advanced solid tumors.

OBJECTIVES: Capecitabine (CAP) and oxaliplatin (OX) have shown interesting activity in a wide range of solid tumors. A phase I study was conducted in order to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of their combination in patients with refractory solid tumors. PATIENTS AND METHODS: Thirty-three pretreated patients with histologically confirmed inoperable neoplasms were enrolled. The patients' median age was 64 years, 21 were males, and 27 had a WHO performance status of 0-1. OX was administered on days 1 and 8, as a 3-hour intravenous infusion, at escalated doses ranging from 50 to 70 mg/m(2). CAP was administered orally for 14 consecutive days, at escalated doses ranging from 1,200 to 2,100 mg/m(2)/day. Treatment was repeated every 3 weeks. RESULTS: At the dose of 2,100 mg/m(2) (Xeloda) and 70 mg/m(2) (OX), all 3 enrolled patients presented DLT (grade 3 diarrhea, grade 3 asthenia and grade 3 neurotoxicity, respectively), and, thus, the recommended MTD for future phase II studies are 2,000 mg/m(2) for CAP and 70 mg/m(2 )for OX. A total of 145 treatment cycles were administered. Toxicity was very mild. Grade 2/3 neutropenia was observed in 4 (3%) treatment cycles. The main nonhematologic toxicities were grade 2/3 nausea/vomiting (7 cycles; 5%), grade 2/3 neurotoxicity (10 cycles; 7%), grade 2/3 asthenia (8 cycles; 5.5%) and grade 2/3 diarrhea (6 cycles; 4%). There was no treatment-related death. One (4%) complete remission, 2 (8%) partial remissions, and 9 (36%) cases of stable disease were observed among 25 evaluable patients. CONCLUSIONS: The results demonstrate that CAP and OX can be safely combined at clinically relevant doses and that this regimen merits further evaluation.

Aged↗
PubMed2003

A case of Opisthorchis felineus infestation in a pilot from Greece.

We describe the case of a 28-year-old man from Greece with Opistorchis felineus infestation. The patient presented with intense abdominal pain, bilious emesis and eosinophilia. He probably acquired the infection overseas, since he was a commercial airline pilot who used to fly to endemic areas and to consume raw or undercooked fish. He was successfully treated with praziquantel administered in divided doses over a single day. Opisthorchiasis is common to eastern Europe and areas of the former Soviet Union, but extremely rare in Greece. Medical personnel should be cognizant of this parasitic infection, since world travel can spread it to areas of the world unaccustomed to it.

Adult↗
PubMed2003

Sequential administration of cisplatin-etoposide followed by topotecan in patients with extensive stage small cell lung cancer. A multicenter phase II study.

PURPOSE: To evaluate the activity of the sequential administration of cisplatin-etoposide (PE) followed by topotecan (TOP) in patients with extensive stage small cell lung cancer (SCLC). PATIENTS AND METHODS: Previously untreated patients with extensive stage SCLC received 4 cycles of cisplatin 75 mg/m(2) IV on day 1 and etoposide 100 mg/m(2) IV on days 1-3 every 21 days followed by 4 cycles of TOP 1.5 mg/m(2) IV on days 1-5 every 21 days. RESULTS: Thirty-eight patients were entered in the study. Their median age was 63 years and the performance status (WHO) was 0 for 5, 1 for 25 and 2 for 8 patients. All patients were evaluable for toxicity and 32 for response to PE and 25 to TOP. Of the 38 patients receiving PE, 1 (3%) patient achieved complete response (CR) and 17 (45%) partial responses (PR) for an overall response rate to PE of 47% (95% confidence interval: 36.7-68.5%). Four (23.5%) of the 17 patients with PR after PE, achieved CR with TOP. None of the patients with stable or progressive disease after PE responded to TOP. The response rate of the 27 patients receiving TOP following PE was 15% (95% confidence interval: 1.4-28.2%). After a median follow up of 9 months, the median duration of response was 6.5 months, the time to tumor progression 6.5 months, the median survival 8.5 months and the 1-year survival 34%. A total of 136 cycles of PE and 89 cycles of TOP have been administered with a median of 4 cycles/patient for each regimen. There were 2 toxic deaths after PE associated with grade IV febrile neutropenia. Treatment delays due to toxicity occurred in 17 (12%) cycles of PE and 20 (22%) cycles of TOP while doses were reduced in 7 (5%) and 4 (4%) cycles, respectively. Grade 3-4 neutropenia, thrombocytopenia and febrile neutropenia occurred in 24, 2 and 3% of PE cycles and 21, 12 and 1% of TOP. Non-hematologic toxicity was mild. The delivered dose intensity was 100% for PE and 93% for TOP. CONCLUSIONS: The sequential administration of TOP after PE is associated with manageable toxicity and may increase the number of CRs in patients with chemosensitive extensive stage SCLC. However, based on this data and the lack of survival benefit in a previous phase III study, the sequential regimen should not be used outside of a clinical trial.

Adult↗
PubMed2003

A 5-year study of the bacterial pathogens associated with acute diarrhoea on the island of Crete, Greece, and their resistance to antibiotics.

During a 5-year period (1995-1999) a total of 7090 stool samples obtained from patients with acute diarrhoea, mostly community-acquired, were examined for bacterial pathogens, in the Greek island of Crete. One or more enteric pathogens were isolated from 987 patients (14%). Salmonella enterica were the most commonly isolated bacteria (6%), followed by Campylobacter spp. (4.2%), and enteropathogenic Escherichia coli (EPEC) (1.8%). Yersinia enterocolitica (0.6%), Shigella spp. (0.3%), and Aeromonas hydrophila (0.04%), were less frequently isolated. Clostridium difficile was isolated from 65 out of 451 diarrhoeal specimens examined (14.4%). Toxin B was detected in all cases. No verotoxigenic E. coli strains were identified. Resistance to ampicillin was observed in 31.5% of the Salmonella, 58.3% of the Shigella and 31.5% of the EPEC isolates. Resistance to trimethoprim-sulfamethoxazole was observed in 4.4% of the Salmonella, 30.5% of the Shigella, and 18.5% of the EPEC isolates. High percentages of resistance to quinolones (44.5% to norfloxacin, and 40.5% to ciprofloxacin), were found among Campylobacter isolates, while resistance to erythromycin was observed in 14.9% of them. With the present study we continue the surveillance of bacterial pathogens associated with diarrhoeal disease on the island of Crete.

Acute Disease↗