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Department of Neurosurgery, Saarland University Medical School, Saarland, Germany. ReginaEymann@web.de
OBJECT: The authors' goal in this paper was to evaluate prospectively the efficacy and safety of a new pediatric gravitational shunt to determine whether it warrants inclusion in a randomized, controlled trial with other shunts. METHODS: A total of 55 children between the ages of 0 and 6 years (median age 0.5 years, average age 4+/-6 years) underwent primary shunt implantation; all received the Miethke Paedi-GAV. The follow-up period ranged between 12 and 77 months (mean 47+/-21 months). The primary end point of the study was the first shunt failure necessitating revision. The 1- and 2-year shunt survival rates were 75 and 68%, respectively. The average failure-free shunt survival duration was 1423 +/- 641 days. Based on imaging findings, no slitlike ventricles occurred. The complication rate was 33%, and the median time to shunt failure was 45 days. Underdrainage occurred in one child (1.8%) and overdrainage in two children (3.6%). CONCLUSIONS: These preliminary results prove the Miethke Paedi-GAV to be a safe and effective pediatric shunt worthy of inclusion in a randomized comparison with other shunts in the pediatric population.

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Department of Neurosurgery, Saarland University Medical School, Saarland, Germany.
Object The authors evaluated the safety and efficacy of antibiotic-impregnated shunt catheters (AISCs) and determined the cost-benefit ratio related to the fact that AISCs increase the implant costs of a shunt procedure by ~$400 per patient. Methods The control group comprised 98 adults with chronic hydrocephalus and 22 children, who were treated without AISCs (non-AISCs). In the treatment group, AISCs (Bactiseal, Codman, Johnson & Johnson) were implanted in 171 adults and 26 children. The minimum follow-up period was 6 months. Results Important risk factors for shunt infections (such as age, comorbidity, cause of hydrocephalus, operating time, and duration of external cerebrospinal fluid drainage prior to shunt placement) did not differ between the study and control groups. In the pediatric AISC group, the frequency of premature, shunt-treated infants and the incidence of external ventricular drainage prior to shunt insertion were actually higher than those in the non-AISC group. When using AISCs, the shunt infection rate dropped from 4 to 0.6% and from 13.6 to 3.8% in the adult and the pediatric cohort, respectively. Overall the infection rate decreased from 5.8 to 1%, which was statistically significant (p = 0.0145). The average costs of a single shunt infection were $17,300 and $13,000 in children and adults, respectively. The cost-benefit calculation assumed to have saved shunt infection-related costs of ~$50,000 in 197 AISC-treated patients due to the reduction in shunt infection rate in this group compared with costs in the control group. Despite the incremental implant costs associated with the use of AISCs, the overall reduction in infection-related costs made the use of AISCs cost beneficial in the authors' department. Conclusions From clinical and economic perspectives, AISCs are seemingly a valuable addition in hydrocephalus therapy.
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Department of Neurosurgery, Saarland University Medical School, Homburg/Saar, Germany. ncmkie@med-rz.uni-saarland.de
OBJECTIVE: A new entity of chronic hydrocephalus was introduced recently in the international literature: longstanding overt ventriculomegaly in adults. Previous experience with this disorder has demonstrated that shunt therapy for such patients involves a considerable risk of overdrainage. In the present study, we aimed to clarify whether this risk could be avoided by use of gravitational shunts. METHODS: A total of 26 adults (age range, 17-75 yr) with macrocephaly and progressive hydrocephalus symptoms underwent implantation of either an adjustable Codman Hakim gravity-assisted shunt (Codman Medos, LeLocle, Switzerland) plus an Aesculap-Miethke ShuntAssistant (Miethke KG, Kleinmachnow, Germany) or a nonadjustable gravitational shunt (Aesculap-Miethke gravity-assisted valve). The follow-up period averaged 29 +/- 13 months (range, 6-48 mo). RESULTS: Significant sustained clinical improvement was achieved in 87% of patients. In more than 90% of patients, Evans index decreased postoperatively by less than 10%. No correlation was documented between the degree of ventricle width reduction and clinical improvement. Only two patients developed subdural hematoma, which was caused by insufficient hydrostatic pressure compensation owing to errors in estimation of intraperitoneal pressure. CONCLUSION: Unlike conventional differential pressure shunts, gravitational shunts can be used in the treatment of high-risk patients with longstanding overt ventriculomegaly in adults. Significant risk of overdrainage can be avoided. Gravitational shunts offer a viable alternative to endoscopic third ventriculostomy, provided the choice and adjustment of the shunt opening pressure is based on a correct assessment of the hydrostatic pressure to be compensated for.
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Department of Neurosurgery, Saarland University Medical School, Homburg-Saar, Germany. Michael.Kiefer@uks.eu
INTRODUCTION: It has been well documented that up to 70% of H-Tx rats' offspring suffer from severe hydrocephalus, which can be fatal if it remains untreated. Some offspring also have non-fatal moderate hydrocephalus allowing a normal life expectancy. The objective of this study was finding other morphological intracranial abnormalities that are not directly related to hydrocephalus. METHOD: An MRT for small animals (Bruker, Biospec, Erlangen Germany) with a 2.4 T magnet at 100 MHz has been used to study 98 apparently non-hydrocephalic H-Tx rats. T2-weighted 2D-RARE, T2-weighted 3D-Turbo-RARE sequence and T1-weighted 3D-gradient-echo sequences were used. RESULTS: Apart from 36% of animals with moderate or mild hydrocephalus, we found one animal with a cystic cerebellar malformation similar to an arachnoid cyst with minimal space occupying effects. Nine rats had a mild or moderate-sized unilateral enlargement of one lateral ventricle, but a causative occlusion of the Foramen of Monroe could not be verified. Finally, one animal with huge hydrocephalus had a midline cystic malformation between both cerebral hemispheres. CONCLUSION: Aside from the well-documented hydrocephalus, H-Tx rats may develop other intracranial malformations that have not yet been documented in the literature.
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Department of Neurosurgery, Saarland University Medical School, Homburg-Saar, Germany. Michael.Kiefer@uks.eu
INTRODUCTION: Gravitational shunts (G-valves) for ventriculo-peritoneal (VP) shunting have been available since 1996. We analyzed shunt complications in patients with a complete minimum follow-up of 5 years. MATERIAL AND METHODS: Between 1996 and 2002, we implanted 282 VP G-valves in various forms of adult chronic hydrocephalus, of which 130 provided a complete data set with an annual follow-up. Adjustable and non-adjustable G-valves were used: the Miethke Dual-Switch valve, the Miethke GAV-valve and a combination of adjustable Codman-Hakim valves with the Miethke Shunt-Assistant. In cases of supposed mechanical shunt failure, the explanted shunts were examined in a bench test. RESULTS: The total complication rate was 21%:3% shunt infections, 3% catheter dislocation/fracture, 5% underdrainage and 9% overdrainage occurred. Half of the overdrainage complications could be managed conservatively. Underdrainage complications resulted from the chosen opening pressure being too high (n = 3), a secondary increase in intraperitoneal pressure (n = 2) or from "real" shunt failure in one case according to bench test results. CONCLUSION: G-valves demonstrate sufficient long-term performance over multiple years, and real shunt-related complications are rare. The frequency of revision due to overdrainage is low (4.5%).
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Department of Neurosurgery, Saarland University Medical School, Homburg-Saar, Germany. Michael.Kiefer@uks.eu
OBJECTIVE: The objective was to assess whether idiopathic normal-pressure hydrocephalus (iNPH) has a worse prognosis than other forms of hydrocephalus, as has been suggested. METHODS: A total of 125 patients with chronic hydrocephalus, 75 of whom suffered from iNPH and the remaining (non-INPH) from sNPH or non-communicating hydrocephalus, were shunted using gravitational valves. Clinical state was assessed with our clinical grading (KI) and a co-morbidity index (CMI). Average follow-up was 5.1 +/- 1.6 years. Statistics: Spearman, Kruskal-Wallis, ANOVA, chi(2)- and the Wilcoxon U tests at a significance level of pi < 0.05 were used. RESULTS: Shunt responder rates for iNPH and non-iNPH were 72% and 86%, respectively. With shorter anamnesis (< or =1 year) or preoperative KI < 6 points, iNPH patients had a similar or even better outcome than non-iNPH patients with longer anamnesis or a worse KI. Most impressive was the influence of co-morbidity: 86% of iNPH patients with a low CMI (< or =3 points) experienced clinical improvement after shunting, which was contrasted by a responder rate of 64% for non-iNPH with worse CMI. CONCLUSION: The diagnosis of iNPH does not by itself mean a worse prognosis, and iNPH patients with favorable preconditions may have a similar or better prognosis than patients with any other kind of hydrocephalus. The worse overall clinical results of iNPH result from late recognition and in most instances worse preconditions.
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Department of Neurosurgery, Saarland University Medical School, Homburg-Saar, Germany. Michael.Kiefer@uks.eu
OBJECTIVE: Thrombosis is a rare but serious consequence of VA-shunts. We present two cases of near fatal thrombosis and its successful (but in case 2, atypical) management. RESULTS: Case 1: A 38-year-old woman with VA-shunt suffered from rapidly progressing heart failure and later from progressing underdrainage signs nine years after shunting due to a thrombus on the atrial shunt catheter that occluded >80% of the right atrium. Cardio-surgical removal of thrombus and VA-shunt catheter and VP-shunting normalized neurological and cardiological state. Case 2: A 40-year-old woman received a VA-shunt 5 years before she suddenly suffered dyspnea and venous congestion. Secondarily, underdrainage occurred. The underlying huge thrombosis of the superior caval vein could not be excised because the necessary thoracotomy would have interrupted vital venous bypasses along the thoracic wall. Anticoagulants (heparin, cumarin) and ETV relieved all neurological and cardiological symptoms. CONCLUSION: Sudden or unexpected symptoms of cardiac failure in the presence of a VA-shunt must be recognized as serious. Interestingly, despite distal shunt occlusion, underdrainage symptoms might be initially mild.
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Department of Neurosurgery, Medical School, Saarland University, Homburg-Saar, Saarland, Germany. Regina.Eymann@uks.eu
OBJECTIVE: Use of silicone to manufacture hydrocephalus shunts has been critical for the successful introduction of modern shunt therapy. However reactions to foreign material cause biodegradation, calcification, and massive scarring, and their impact on the still high shunt failure rate might have been undervalued in the past. We established an animal model to simulate the conditions and reactions with the silicone catheter in human patients. METHODS: We implanted catheters from different hydrocephalus shunt manufacturers available on the world market in 12 four-week old Wistar rats. To mimic shearing forces and tensile stress, the tubes were firmly fixed proximally and distally in a growing rat. The catheters remained in the subcutaneous tissue for 1 year before being removed and studied using scanning electron microscopy and histological studies. RESULTS: All of the implanted long catheters showed fractures and calcification on their surfaces, whereas the short fragmented catheters did not. CONCLUSION: The immunological reactions with silicone and the biodegradation of the material can be simulated in this animal model to study details of the pathophysiology of this process.
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Department of Neurosurgery, Medical School, Saarland University, Homburg-Saar, Saarland, Germany. Regina.Eymann@uks.eu
INTRODUCTION: Shunt infections are still one of the most important complications of shunt surgery. We observed shunt infections coming from wound breakdown due to minimal CSF leakage from subcutaneous CSF accumulation, which is often unavoidable in babies over the borehole, along the fibers of stitches that close the superficial skin. Whether such secondary shunt infections might be overcome by avoiding stitches has been studied. MATERIALS AND METHODS: We examined 90 children experiencing their first shunt insertion between September 1998 and April 2008. We divided the children into two groups. Wound closure was performed with absorbable subcutaneous one-on-one sutures with counter-sunk knots in both groups. In one group, octylcyanoacrylate tissue adhesive was used for the final layer closure of the skin (44 children); in the other group, non-absorbable one-on-one single skin sutures were used (46 children). RESULTS: Using the glue, we reduced the wound dehiscence rate from 24% to 2% and the infection rate from 17% to 0%. CONCLUSION: A minimal change of operative technique substantially affects the shunt infection rate due to the extermination of the "wick-effect" along filaments used to close the skin. Furthermore, Dermabond itself has a bactericidal effect.
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Department of Neurosurgery, Saarland University Medical School, Homburg-Saar, Germany. Michael.Kiefer@uks.eu
OBJECTIVE: In clinical practice, it is often necessary to judge the probability of clinical benefit of invasive ancillary tests given to patients with chronic hydrocephalus before they are performed. The aim of the current study was to establish a screening tool for such prediction. MATERIAL AND METHODS: A total of 125 patients with chronic hydrocephalus were assessed using a clinical (HHS) and comorbidity (CMI) grading. These patients were shunted and followed-up for at least one year. The statistical tools of ANOVA, CHI-squared, Spearman, Kuskal-Wallis, and Wilcoxen-U-Test were applied. RESULTS: The variables discovered to be of use in prediction were age (p = 0.02), anamnesis duration (p = 0.04), CMI (p < 0.000) and HHS (p = 0.001). A decision tree using solely HHS and CMI was established allowing outcome prediction of sufficient power. Interestingly, in patients who had favourable preconditions, older age impeded not a favourable prognosis. CONCLUSION: With our proposed decision tree, a minimum of data allow a clinician to sufficiently judge whether shunting will be of benefit to a patient, which may help to decide whether invasive ancillary tests are justified.
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Department of Neurosurgery, Saarland University Medical School, Homburg-Saar, Germany. Michael.Kiefer@uks.eu
INTRODUCTION: Recently decreased compliance is discussed as an initially disturbed CSF hydrodynamic parameter in hydrocephalus. MATERIALS AND METHODS: In 180 patients with suspected chronic hydrocephalus we performed a dynamic infusion test, which was not used for shunt indication. Shunt indication was based on long-term ICP monitoring. Follow-up was 4.6 +/- 1.8 years. Statistics: Spearman-, Kruskal-Wallis-, Wilcoxen-U-test. RESULTS: Resistance to outflow (Rout) and Pressure Volume Index (PVI) alone provide positive predictive values (PPV) and sensitivity, which might be sufficient in daily practice, while negative predictive values (NPV) and specificity are weak. With an intelligent combined algorithm of Rout and PVI at a critical value of ROF of 13 mm Hg/ml x min and 30 ml, a clearly improved outcome prediction is possible. CONCLUSION: These clinical results support recent opinions concerning the meaning of Compliance and Rout in hydrocephalus patho-physiology.

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Children's National Medical Center, Washington, DC 20010, USA. rshah@cnmc.org
OBJECTIVE: To review national trends in the management of pediatric airway foreign bodies (A-FBs) and esophageal foreign bodies (E-FBs) that obstruct the airway. DESIGN: Retrospective review using a national pediatric data set (Kids' Inpatient Database). SETTING: Pediatric patients admitted across the United States during 2003. PATIENTS: The Kids' Inpatient Database 2003 samples 2 984 129 pediatric discharges from 3438 hospitals in 36 states. MAIN OUTCOME MEASURES: The Kids' Inpatient Database 2003 was analyzed for A-FBs and E-FBs (International Classification of Diseases, Ninth Revision, Clinical Modification codes E911 and E912) in patients 20 years or younger, and weighted data are presented to facilitate national estimates. RESULTS: A total of 2771 patients (59% male) were admitted for an A-FB or an E-FB that was obstructing the airway. The mean (SE) age of the patients was 3.5 (0.17) years; 55% were younger than 2 years. The foreign bodies were classified as food (42%; mean age, 2.5 years) or other (58%; mean age, 4.3 years). The average length of stay was 6.4 days (median [SE], 1.5 [0.6] days), and the average number of procedures was 2.4 (median [SE], 1.3 [0.1] procedures). Seventy-one percent of the patients were treated at teaching hospitals. The mean (SD) total charges were $34 652 ($3543), with regional variation (P <.001). Children's hospitals (28%) had higher mean total charges than nonchildren's hospitals (P =.03); 3.4% of admissions died in the hospital (mean [SE] age, 4.6 [0.9] years), with an average length of stay of 11.7 (SE, 2.7) days and an average of 6.2 (SE, 0.7) procedures. Bronchoscopy (52%), esophagoscopy (28%), and tracheotomy (1.7%) were the primary procedures performed. The rates of positive FB findings for bronchoscopy and esophagoscopy were 37% and 46%, respectively. CONCLUSIONS: Pediatric A-FBs and E-FBs that obstruct the airway occur infrequently. Most of the patients are referred to teaching institutions. Among patients who were admitted with a diagnosis of airway obstruction from an A-FB or an E-FB, the rates of positive findings at surgery were 37% and 46%, respectively. A surprisingly high mortality rate was noted. Alternative education measures should be considered to train physicians in the management of this infrequent, potentially lethal condition.
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From the *Department of Thoracic Oncology Hyogo Cancer Center, Akashi, Hyogo, Japan; daggerDivision of Respiratory Medicine, Department of Internal Medicine, Kobe University Hospital, Kobe, Hyogo, Japan; double daggerDepartment of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan; and section signKyoto University Health Service, Sakyo-ku, Kyoto.
INTRODUCTION:: This study was conducted to evaluate the efficacy and safety and to compare dosing schedules of gemcitabine combined with S-1 in chemo-naïve non-small cell lung cancer patients. METHODS:: Patients with chemo-naïve stage IIIB/IV non-small cell lung cancer were randomized into two treatment arms. Patients were given oral S-1 (60 mg/m/d, twice a day) from days 1 to 14 with gemcitabine (1000 mg/m/d) on days 1 and 8 (arm A) or on days 8 and 15 (arm B). This cycle was repeated every 21 days. RESULTS:: A total of 80 patients were entered in this trial. The primary end point of this study was response rate. The response rates of arm A and arm B were 22.0 and 28.9%, respectively (p = 0.606). Median time to treatment failure in arm A was 3.6 months and 4.8 months in arm B. Median time to progression in arm A was 4.1 months and 5.5 months in arm B. Median survival time in arm A and arm B was 15.5 months and 18.8 months, respectively. The toxicity profile was relatively mild and did not differ very much between two arms. CONCLUSION:: The combination of gemcitabine and S-1 was determined to be feasible and effective for advanced non-small cell lung cancer. We selected arm B for further studies because of its higher response rate and survival data.
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[My paper] Ehab M Khalil
The Department of Radiotherapy and Nuclear Medicine, National Cancer Institute, Cairo University.
PURPOSE: To evaluate treatment outcome and prognostic factors of adults and pediatric medulloblastoma patients treated by adjuvant postoperative craniospinal irradiation (CSI) and chemotherapy. PATIENTS AND METHODS: Between 1997 and 2004, 67 patients were treated in the National cancer Institute- Cairo University; 51 pediatric patients with a median age of 7 years and 16 adult patients with a median age of 25 years. According to the Chang staging system; 50%-35%, 37.5%-47% and 12.5%-18% had T2, T3 and T4 tumors of adults and pediatric patient's population respectively. M1, M2 and M4 were reported in 16%, 3% and in 1.5% respectively. All patients underwent primary surgical resection; near total resection in 25%, Subtotal resection in 61%; with tumor residual < 1.5cm2 in 49% compared to 51% with > 1.5cm2 residual tumor and 14%, had biopsy only. All patients were treated by craniospinal radiotherapy (RT); with a median dose of 34Gy to the whole brain, 54Gy to the posterior fossa and 32Gy to the spinal axis. The median interval between surgery and RT was 45 days and 38 days for the pediatric and adult groups respectively. The median duration of RT was 54 days and 52 days for pediatric and adult patients respectively. Thirty four pediatric patients (67%) received concomitant chemotherapy, while 61% received adjuvant (postoperative) chemotherapy and 57% received sequential chemotherapy. Only 33% of patients did not receive chemotherapy. The median follow-up was 49 months for the whole group of patients (range 11-121). RESULTS:For the pediatric and adult patients, the 5- and 7-year overall and disease-free survival rates were 89%& 78% Vs. 84%& 56% and 80%& 68% Vs. 79%& 52% respectively. Fourteen patients (21%) relapsed (10 pediatric and 4 adults) at a median time of 11 months vs. 23 months and a median follow-up period of 8 and 12 months respectively; Neuro-axis was the most common site of relapse (11 patients). Ninety percent (9/10) of the pediatric relapses were of the high risk group (8 recieved no chemotherapy) and took place within 2 years; similarly all adult relapses were of the high risk group; three relapses took place after 2 years. In univariate analysis, T stages, M stages, extent of surgery, CSF seedling and risk category were significant prognostic factors for disease free survival for the pediatric age group. At 5 years, 87%, 87%, 78%, 85% and 85% of T2, M0, near total resection, negative CSF seedling and low risk patients were estimated to be disease-free respectively, compared to none of the T4, M +, biopsy only, positive CSF seedling patients and only 41% of the high risk patients achieved 5 years without recurrence (p=0.001,<0.001,<0.001,<0.001,<0.001). Patients who did not receive chemotherapy had a 69% 5-year DFS Vs. 76%(p=0.286). For adult patients; only the risk category was a significant prognostic factor with 5-year disease-free survival rate of 100% Vs. 40% for low and high risk respectively (p=0.03). On multivaiate analysis only the risk category and the T-stage were significant prognostic factors for disease free survival for the pediatric age group (p=0.042 and 0.031). CONCLUSION: Survival rates of medulloblastoma pediatric patients were better than the adult ones. Neuro-axis relapse was the most common site of relapse for pediatric patients. Late relapses, lateral tumor location and shorter median follow up were noted in adult patients. Advanced tumor stage, metastases at presentation, limited tumor resection were powerful prognostic factors among the pediatric patients. In addition, high risk category was shown to be a prognostic factor for both pediatric and adult patients. KEY WORDS: Medulloblastoma - treatment results - Prognostic factors.
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Departments of Neurosurgery, and.
Object Hydrocephalus is a notorious neurosurgical disease that carries the adage "once a shunt always a shunt." This study was conducted to review the treatment results of pediatric hydrocephalus. Methods Pediatric patients who underwent ventriculoperitoneal shunt surgery over the past 14 years were reviewed for shunt revisions. Variables studied included age at shunt placement, revision, or replacement; programmable shunts; infection; obstruction; and diagnosis (congenital, posthemorrhagic, craniospinal dysraphism, and others including trauma, tumors, and infection). Multiple regression analysis methods were used to determine independent risk factors for shunt failure and the number of shunt revisions. The Kaplan-Meier method of survival analysis was used to compare etiologies on the 5-year survival (revision-free) rate and the median 5-year survival time. Results A total of 253 patients were studied with an almost equal sex distribution. There were 92 patients with congenital hydrocephalus, 69 with posthemorrhagic hydrocephalus, 48 with craniospinal dysraphism, and 44 with other causes. Programmable shunts were used in 73 patients (other types of shunts were used in 180 patients). A total of 197 patients (78%) underwent revision surgeries due to shunt failures. The mortality rate was 1.6%. Age at first revision, the 5-year survival rate, and the median 5-year survival time were significantly less for both posthemorrhagic and craniospinal dysraphism than for either the congenital or "other" group (p < 0.05). The failure rate and number of revisions were not significantly reduced with programmable shunts compared with either pressure-controlled or no-valve shunts (p > 0.5). Conclusions Posthemorrhagic hydrocephalus and craniospinal dysraphism hydrocephalus had significantly earlier revisions than congenital and other etiologies. Programmable systems did not reduce the failure rate or the average number of shunts revisions.
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Department of Medical Oncology, Léon Bérard Comprehensive Cancer Center, University of Lyon, and EA 4128 SIS Individu Santé, Société
BACKGROUND: Epoetin (EPO) administration reduces the need for transfusion. Identifying patients at high risk of anemia requiring red blood cell (RBC) transfusion is needed. This multicentric phase III trial tested epoetin alpha (EPOalpha) administration according to our risk model on the basis of three clinical parameters: hemoglobin (Hb)<12 g/dl, lymphocytes </=700/mul, and/or performance status (PS)>1. PATIENTS AND METHODS: Patients >/=18 years with chemotherapy-treated solid or hematologic tumors were randomized to 150 UI/kg/TIW s.c. EPOalpha (arm 1) or no EPOalpha (arm 2) and stratified on Hb level at day 0, lymphocyte count, and PS. The primary end point was transfusion rate; secondary end points included overall survival (OS), safety, and quality of life. RESULTS: From September 2000 to January 2005, 218 patients (median age 64 years, 42.7% males) with principally breast cancer, sarcoma, or lung carcinoma were included. In total, 93% patients had PS >1 and 35% had </=700/mul lymphocytes. Baseline Hb levels were 10.1 g/dl (range 6.9-11.9). Two hundred and thirteen patients were assessable for the primary end point: 36% received RBC in arm 1 and 58% in arm 2 (P = 0.0012). Median OS was 7.6 [95% confidence interval (CI): 5-12] and 6 (95% CI: 5-8) months in arms 1 and 2, respectively. Median OS was significantly worse for patients with three prognostic factors (3.6 months) compared with two factors (8.3 months)(P < 0.001). No difference in toxicity (47% versus 41%) or thrombovascular events (4.5% versus 3.7%) was observed. CONCLUSION: Patients at high risk for RBC transfusion according to the ELYPSE model could be given prophylactic EPO with significantly reduced RBC transfusions and no significant impact on side-effects, progression-free survival, and OS.
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Department of Otorhinolaryngology, Mayo Clinic, Rochester, MN.
OBJECTIVE: To identify the presentation of pediatric patients with head and neck manifestations of cat-scratch disease, one of the most common causes of subacute or chronic lymphadenitis in children, and to determine surgical indications and outcomes. STUDY DESIGN: Case series. SUBJECTS AND METHODS: All pediatric patients from infancy to age 19 years who presented with clinical symptoms of cat-scratch disease and had an IgG serological test result of more than 1:128 for Bartonella henselae. RESULTS: Nine patients had cat-scratch disease of the head and neck. Median age at presentation was 4 years; median time from symptom onset to presentation was 20 days. Six (67%) children underwent surgical procedures, and median time from presentation to surgical procedure was 43 days. CONCLUSION: Despite conservative treatment, a minority of pediatric patients with cat-scratch disease may require surgical drainage of abscess and removal of lymph nodes. Surgical treatment provides tissue for diagnosis, is generally well tolerated, affords improved recovery, and has minimal complications.
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Department of Gastrointestinal Medical Oncology, University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Mail Stop 426, Houston, Texas 77030, USA. jajani@mdanderson.org
CONTEXT: Chemoradiation as definitive therapy is the preferred primary therapy for patients with anal canal carcinoma; however, the 5-year disease-free survival rate from concurrent fluorouracil/mitomycin and radiation is only approximately 65%. OBJECTIVE: To compare the efficacy of cisplatin-based (experimental) therapy vs mitomycin-based (standard) therapy in treatment of anal canal carcinoma. DESIGN, SETTING, AND PARTICIPANTS: US Gastrointestinal Intergroup trial RTOG 98-11, a multicenter, phase 3, randomized controlled trial comparing treatment with fluorouracil plus mitomycin and radiotherapy vs treatment with fluorouracil plus cisplatin and radiotherapy in 682 patients with anal canal carcinoma enrolled between October 31, 1998, and June 27, 2005. Stratifications included sex, clinical nodal status, and tumor diameter. INTERVENTION: Participants were randomly assigned to 1 of 2 intervention groups:(1) the mitomycin-based group (n = 341), who received fluorouracil (1000 mg/m2 on days 1-4 and 29-32) plus mitomycin (10 mg/m2 on days 1 and 29) and radiotherapy (45-59 Gy) or (2) the cisplatin-based group (n = 341), who received fluorouracil (1000 mg/m2 on days 1-4, 29-32, 57-60, and 85-88) plus cisplatin (75 mg/m2 on days 1, 29, 57, and 85) and radiotherapy (45-59 Gy; start day = day 57). MAIN OUTCOME MEASURES: The primary end point was 5-year disease-free survival; secondary end points were overall survival and time to relapse. RESULTS: A total of 644 patients were assessable. The median follow-up for all patients was 2.51 years. Median age was 55 years, 69% were women, 27% had a tumor diameter greater than 5 cm, and 26% had clinically positive nodes. The 5-year disease-free survival rate was 60%(95% confidence interval [CI], 53%-67%) in the mitomycin-based group and 54%(95% CI, 46%-60%) in the cisplatin-based group (P =.17). The 5-year overall survival rate was 75%(95% CI, 67%-81%) in the mitomycin-based group and 70%(95% CI, 63%-76%) in the cisplatin-based group (P =.10). The 5-year local-regional recurrence and distant metastasis rates were 25%(95% CI, 20%-30%) and 15%(95% CI, 10%-20%), respectively, for mitomycin-based treatment and 33%(95% CI, 27%-40%) and 19%(95% CI, 14%-24%), respectively, for cisplatin-based treatment. The cumulative rate of colostomy was significantly better for mitomycin-based than cisplatin-based treatment (10% vs 19%; P =.02). Severe hematologic toxicity was worse with mitomycin-based treatment (P <.001). CONCLUSIONS: In this population of patients with anal canal carcinoma, cisplatin-based therapy failed to improve disease-free-survival compared with mitomycin-based therapy, but cisplatin-based therapy resulted in a significantly worse colostomy rate. These findings do not support the use of cisplatin in place of mitomycin in combination with fluorouracil and radiotherapy in the treatment of anal canal carcinoma. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003596.
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Pediatric Intensive Care Unit, Department of Pediatrics, and the Division of Hematology-Oncology, Department of Pediatrics, CHU Sainte-Justine, Université de Montréal, Montréal, Canada.
BACKGROUND: Studies in adults report posttransfusion survival rate (PTSR) at 1 to 10 years of 41 to 67 percent. There are no published studies specifically addressing PTSR in pediatric patients. The objectives of this study were to evaluate PTSR and risk factors associated with death in children receiving transfusions. STUDY DESIGN AND METHODS: A database of all patients receiving their first transfusion between 1990 and 1992 at Sainte-Justine Hospital (SJH) was used. Patients' demographic data, primary diagnosis, surgical procedures, and information on all labile components transfused were collected. Death was confirmed by the SJH database, RAMQ (universal health care provider for Québec residents), and the Quebec Commission for Access to Information (death certificate). RESULTS: The study population consisted of 1100 children. Median age was 16 months (range, 0-204 months). The most frequent primary diagnoses were cardiac disease (22%), prematurity (21.5%), malignant disease (11%), and hematologic disease (9.5%). Patients received a median of three transfusions (range, 1-126). PTSR was 86.9 percent at 1 year and 82.3 percent at 10 years. For nonsurvivors, median survival time was 22 days. Multivariate analysis showed that significant risk factors for death are age of less than 1 month, a diagnosis of malignant disease, more than 20 transfusions, and administration of more than one type of blood component. CONCLUSION: PTSR in children receiving their first transfusion between 1990 and 1992 was considerably higher than the PTSR reported in adults. Death occurred early after the first transfusion; survival rate remained relatively stable thereafter.
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Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, MD, USA.
BACKGROUND AND OBJECTIVE: The Medtronic PS Medical Strata valve has pressure flow characteristics that are noninvasively adjusted with a magnetic tool. The objective of this study was to examine its efficacy during our initial experience with it in shunt-dependent children. MATERIALS AND METHODS: A retrospective review of 53 children with a median age of 2.0 years who had 61 Strata valves implanted. CONCLUSION: The Strata valve is efficacious in the treatment of shunt-dependant hydrocephalus in children. The 1-year shunt survival rate of 67.2% is comparable to that previously reported from a multicenter trial. Of the 30 therapeutically aimed adjustments during the study period, 16 (53.3%) resulted in improvement in abnormal signs or symptoms. Our data indicate that adjustments can be used to treat signs or symptoms of cerebrospinal fluid overdrainage or underdrainage, which may obviate the need for additional surgery.
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Department of Neurosurgery, University of Virginia, Charlottesville, Virginia, USA.
OBJECT: This study was conducted to determine whether proliferative tumor activity, as assessed using the Ki-67 immunohistochemical labeling index (LI), has prognostic utility for patients with Grade II oligoastrocytomas. METHODS: The study period spans the years 1988 to 2000. In a retrospective analysis, the authors selected cases with biopsy-proven diagnoses of Grade II oligoastrocytomas on initial presentation. The authors added new patients to this group and followed all patients prospectively at the University of Virginia Neuro-Oncology Center. Twenty-three adult patients were followed for at least 1 year (median 40.3 months). Eleven patients with Grade II tumors and initial Ki-67 LIs less than 10% had a significantly longer median time to tumor progression (TTP, 51.8 months compared with 9.9 months) and a longer median survival (93.1 months compared with 16.1 months) than 12 patients with initial Ki-67 LIs of 10% or greater. Twelve patients with Grade III oligoastrocytomas had a mean TTP that was similar to the TTP of patients with Grade II tumors and high Ki-67 LIs (mean 4 months compared with 9.9 months) and duration of survival (13.3 months compared with 16.1 months). CONCLUSIONS: Patients with a Grade II oligoastrocytoma and a Ki-67 LI of 10% or greater have a much shorter TTP and potentially a poorer disease prognosis than expected--more similar to patients with a Grade III oligoastrocytoma. These results indicate that in the future a measure of proliferative activity should be taken into consideration along with the World Health Organization grading criteria for oligoastrocytomas.
2010-09-03 00:24:19 © BioInfoBank Institute