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Purpose: Carboplatin area under the curve (AUC) 5 ml/min on day 1 with gemcitabine 1,250 mg/m2 on day 1 and day 8 is a widely used regimen in advanced non-small cell lung cancer. Grade 3–4 thrombocytopenia and neutropenia are frequent. The aim of this study is to investigate whether toxicity of gemcitabine/carboplatin could be reduced by administering carboplatin on day 8 instead of day 1 without a decrease in response rate (RR). Methods: Patients received gemcitabine 1,250 mg/m2 on days 1 and 8, carboplatin AUC 5 on day 1 (arm A) or day 8 (arm B). Drugs were administered over a 21-day cycle. Toxicity and RR were evaluated weekly and every second cycle, respectively. Results: 71 patients were enrolled into the study. We found 79% (95% CI 61–91%) grade 3–4 toxicity (neutropenia and thrombocytopenia) in arm A and 50% (95% CI 32–68%) in arm B; 66% grade 3–4 thrombocytopenia in arm A and 26% in arm B. We observed 30% grade 4 hematological toxicity in arm A and 3% in arm B. In arm A an overall RR of 20% (95% CI 7.7–38.6%) was seen, and 18.2% (95% CI 7–35.5%) in arm B. Conclusions: Although the study was prematurely closed, the current data are of interest. The schedule with carboplatin on day 8 is associated with substantially lower grade 3–4 neutropenia and thrombocytopenia with comparable dose intensity and RR. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Although leiomyosarcomas (LMSs) form the largest subgroup of soft tissue sarcomas (STSs), the efficacy of chemotherapy in this group is largely unclear, partly because older studies are contaminated with gastrointestinal stromal tumors (GISTs). In this retrospective study we investigated the outcome of first line chemotherapy in 65 patients with unresectable ormetastatic LMS. The overall response rate (ORR) was 18%; and the median progression-free (PFS) and overall survival (OS) were 3.8 and 9.7 months respectively. No statistically significant differences in outcomes for uterine and non-uterine LMS were found. In non-uterine LMS, however, the PFS and OS seemed to be longer for females than for males, potentially negatively affecting outcomes in this group. If our observations are confirmed in other series, they would suggest that studies performed in STS patients should not only stratify for histological subtype but also for uterine versus non-uterine LMS and for gender. [ABSTRACT FROM AUTHOR]

Background: Sentinel node (SN) status is the most important prognostic factor for overall survival in stage I or II melanoma. Yet SN-positive tumours with submicroscopic involvement of the SN (clusters of cells smaller than 0.1 mm) have shown a distant recurrence rate of only 9 per cent at 5 years, as good as that in SN-negative patients. This study compared the outcome after completion lymph node dissection (CLND) in SN-positive tumours with elective total lymph node dissection (TLND) in patients with palpable nodes. Methods: A total of 188 patients were identified; 124 had TLND and 64 had CLND. Median follow-up was 56 and 37 months respectively. There were no significant differences between the groups regarding tumour Breslow thickness, ulceration and site of the primary tumour. Survival rates were calculated from date of primary excision. All patients with primary melanomas on extremities or trunk were included. Results: On univariable analysis, the site of the primary tumour (extremity versus trunk) (P < 0.001), Breslow thickness (P = 0.005) and ulceration (P < 0.001) were prognostic for overall survival. There was a non-significant 13 per cent difference in overall survival at 5 years between CLND and TLND (P = 0.115). Excluding 15 patients who had SN disease with submicrometastases reduced the difference to 6 per cent (P = 0.415). Conclusion: This study showed no significant survival benefit for SN-positive CLND compared with TLND, especially when patients with nodes containing submicrometastases were excluded. [ABSTRACT FROM AUTHOR]

Objective: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily and social activities, and have a decreased quality of life. In this trial, the effect of amantadine on severe fatigue related to GBS was studied.Methods: During the pre-treatment phase, all patients were monitored for 2 weeks. Only patients with severe fatigue, defined as a mean fatigue score of > or = 5.0 on the Fatigue Severity Scale (FSS), were randomised for this double blind, placebo controlled, crossover study. Primary outcome measure was improvement of at least 1 point on the FSS. Secondary outcome measures were impact of fatigue, anxiety and depression, handicap, and quality of life.Results: In total, 80 patients with GBS were randomised, of whom 74 were included for analysis. Fatigue appeared to be reduced already during the pre-treatment phase (p = 0.05), probably due to increased attention provided to the patients. No significant differences in any of the primary and secondary outcome measures were found.Conclusions: Amantadine was not superior to placebo. Because fatigue remains a serious complaint, other studies evaluating new treatment options are strongly recommended. [ABSTRACT FROM AUTHOR]

Objective: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily and social activities, and have a decreased quality of life. In this trial, the effect of amantadine on severe fatigue related to GBS was studied. Methods: During the pre-treatment phase, all patients were monitored for 2 weeks. Only patients with severe fatigue, defined as a mean fatigue score of ⩾5.0 on the Fatigue Severity Scale (FSS), were randomised for this double blind, placebo controlled, crossover study. Primary outcome measure was improvement of at least 1 point on the FSS. Secondary outcome measures were impact of fatigue, anxiety and depression, handicap, and quality of life. Results: In total, 80 patients with GBS were randomised, of whom 74 were included for analysis. Fatigue appeared to be reduced already during the pre-treatment phase (p = 0.05), probably due to increased attention provided to the patients. No significant differences in any of the primary and secondary outcome measures were found. Conclusions: Amantadine was not superior to placebo. Because fatigue remains a serious complaint, other studies evaluating new treatment options are strongly recommended. [ABSTRACT FROM AUTHOR]

In this prospective study, we determined the effects of the time interval between irradiation and implant therapy, implant location, boneresection surgery, and irradiation dose on implant survival. We analyzed the survival of 446 implants inserted after radiotherapy over a period of up to 14 years in 130 consecutive patients treated for oral cancer. The 10-year overall Kaplan-Meier implant survival percentage is 78%. The difference in survival percentages of implants inserted < 1 year and ≥ 1 year after irradiation (76% and 81%, respectively) is not significant. We concluded that implant survival is significantly influenced by the location (maxilla or mandible, 59% and 85%, respectively; p = 0.001), by the incidence of bone-resection surgery in the jaw where the implant was installed (p = 0.04), and by the irradiation dose at the implant site (< 50 Gray or ≥ 50 Gray, p = 0.05). [ABSTRACT FROM AUTHOR]

Objectives: To determine the validity, reliability, and responsiveness of a new overall disability sum score in immune mediated polyneuropathies.Methods: Three impairment measures (MRC sum score, sensory sum score, grip strength (Vigorimeter)) and three disability scales (an overall disability sum score (ODSS), Hughes' functional scale (f score), Rankin scale) were assessed in a cross sectional group of 113 clinically stable patients (83 with Guillain-Barré syndrome, 22 with chronic inflammatory demyelinating polyneuropathy (CIDP), eight with a gammopathy related polyneuropathy). The ODSS was also used serially in 20 patients with recently diagnosed Guillain-Barré syndrome (n = 7) or CIDP (n = 13) and changing clinical conditions. Multiple regression studies were performed to compare the impact of impairment disturbances (independent variables) on the various disability scales (dependent variable).Results: Moderate to good construct validity (stable group: Spearman's rank test (absolute values), r = 0.41-0.79; longitudinal group: multiple correlation coefficient, R = 0.69-0.89; p < 0.006 for all associations) and reliability (intraclass correlation coefficient, R = 0.90-0.95; p < 0.0001) were demonstrated for the ODSS. Its SRM values were high (> 0.8), indicating good responsiveness. Impairment measures accounted for a higher variance proportion of the ODSS compared with the f score and Rankin (R = 0.64 v 0.56 and 0.45, respectively).Conclusions: All clinimetric requirements were met by the overall (arm and leg) disability sum score in immune mediated polyneuropathies. Its use is therefore suggested in evaluating immune mediated polyneuropathies. [ABSTRACT FROM AUTHOR]

Objective: To provide clinically useful vibration threshold normal values.Methods: The graduated Rydel-Seiffer tuning fork was evaluated in 198 healthy controls and 59 patients with a polyneuropathy. The measures were done in triplicate at four locations: the distal interphalangeal joint of the index finger, ulnar styloid process, interphalangeal joint of the hallux, and internal malleolus. The values obtained with this tuning fork in healthy controls and patients with polyneuropathy were compared with the values of an electronic device, the Vibrameter.Results: Vibration sense was better perceived in the arms compared with the legs. There was a significant age related decline of vibration sense at all locations. The values from the Rydel-Seiffer tuning fork and the Vibrameter were significantly correlated in both groups. The sensitivity of these two instruments for the four sites examined in the polyneuropathy group ranged from 29-76% and 31-73%, respectively and was the highest at the hallux for both instruments.Conclusion: This study provides clinical useful normal values of vibration threshold for the Rydel-Seiffer tuning fork. This is a simple and easily applicable instrument that assesses vibration sense semiquantitatively and should therefore have a place in routine neurological examination. [ABSTRACT FROM AUTHOR]

Anaerobic coccoid rods belonging to species of Eubacterium and Peptostreptococcus agglutinate more frequently with sera from patients with Crohn's disease than with sera from patients suffering from other diseases and from healthy subjects. Results of agglutination tests with four strains of coccoid anaerobes were used to estimate the probability that a patient suffers from Crohn's disease. The data on healthy subjects and patients with Crohn's disease were subjected to logistic discriminant analysis. With the methods and interpretation described, 52% of the patients with Crohn's disease were recognized as ‘definite’ or ‘probable’ Crohn's disease and 14% as ‘suspected’. Only 1% of the healthy subjects were classified as ‘suspected’ and none as ‘definite’ or ‘probable’ Crohn's disease. [ABSTRACT FROM PUBLISHER]

In this Dutch national survey piperacillin-tazobactam had a MIC90 of < or = 8 mg/L for Enterobacteriaceae (Enterobacter cloacae excluded) and Pseudomonas aeruginosa, 64 mg/L for E. cloacae, and 4 mg/L for Acinetobacter spp. The corresponding MIC90 values for piperacillin alone were < or = 256 mg/L, 256 mg/L, 16 mg/L and 32 mg/L. Only 15 of 93 piperacillin-tazobactam resistant E. cloacae strains were sensitive for ceftazidime, whereas 41 of 93 ceftazidime-resistant E. cloacae were sensitive to piperacillin-tazobactam. [ABSTRACT FROM AUTHOR]

A retrospective study on the incidence of catheter-related complications and catheter indwelling time ( tCI) during treatment with continuous interleukin-2 (IL-2) infusion in patients with metastatic renal cell cancer, who were equipped with tunnelled central venous catheters (CVC). A group of 72 patients were treated with IL-2-based immunotherapy. Two induction treatment cycles of 35 days each were used. Treatment consisted of IL-2 as a continuous intravenous infusion (c.i.v.) with lymphokine-activated killer cells and interferon α intramuscularly. A tunnelled CVC was inserted at the start of treatment and was kept in place for the duration of the therapy or until the occurrence of complications. Out of 72 CVC, 30 (42%) functioned uneventfully for a median tCI of 64 days. In another 12 clinically uncomplicated cases (16%), catheter tips were positive in routine culture after a median tCI of 33 days. In 18 patients (25%), CVC-related infections were noted, including 8 (11%) local tunnel infections and 10 (14%) septic episodes. These complications occurred at a median tCI of 28 and 20 days respectively. In 15 (83%) of these 18 catheter infections, Staphylococcus aureus was isolated, whereas in the remaining 3 (17%) Staphylococcus epidermidis was found. Subclavian vein thrombosis was noted in 12 (17%) CVC at a median tCI of 31 days; 5 (36%) of these were diagnosed in the first 14 patients. This prompted us to administer prophylactic heparin 15 000 IU c.i.v. daily during IL-2 treatment. Thereafter the incidence of thrombosis dropped to 7 (12%) in the subsequent 58 CVC inserted ( P = 0.03). In conclusion, in contrast to previous reports on the high incidence of CVC-related septicaemia and thrombosis, we observed a relatively low incidence of these complications, which we ascribe to the use of tunnelled catheters and prophylactic heparin. [ABSTRACT FROM AUTHOR]

Objective: To determine which widely used disability measure in Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyneurapathy (CIDP) shows the strongest association with patients' rating scores. Methods: Five disability scales and the Medical Outcomes Study 36-Item Short Form Heath Survey (SF-36) were assessed serially in 20 patients with newly diagnosed GBS (n=7) or CIDP (n=13). Also at each visit, the patent's condition was self-assessed as being worse, unchanged or better. Longitudinal regressions were carried out to determine the association between disability scales (independent variables) and SF-36 and patients' rating scores (dependent variables). Results: Higher associations with the SF-36 were found in the Overall Disability Sum Score (ODSS) than other disability measures. A higher correlation with ODSS changes was also found in the rating scores of the patients. Conclusion: In addition to literature findings, higher associations were found between inflammatory Neuropathy Cause and Treatment Group ODSS and outcome assessed from patients' perceptions in immune-related polyneuropathies than in other commonly used disability scales. [ABSTRACT FROM AUTHOR]