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PubMed1996

Magnetic resonance imaging changes after stereotactic radiation therapy for childhood low grade astrocytoma.

BACKGROUND: Stereotactic radiotherapy (SRT) is fractionated radiotherapy delivered under stereotactic guidance to produce highly focal and precise therapy. We studied the incidence of imaging changes that can mimic tumor progression after completion of SRT for childhood low grade astrocytoma. METHODS: Between June 1992 and September 1994, we prospectively treated 28 children with low grade astrocytomas with SRT. The patients ranged in age from 2 to 22 years (median: 10 yrs) and none had received prior radiation therapy or radiosurgery. Routine fractionation was employed (180-200 centigray[cGy]) to a total dose of 5220-6000 cGy over 5 to 6 weeks. All of the patients underwent initial and follow-up magnetic resonance imaging (MRI) according to protocol. RESULTS: Median clinical follow-up for the 28 patients was 24 months (range, 5-32 mos) with a median radiographic follow-up of 15 months (range, 3-26 mos). Fifteen patients had reduction in tumor size, one patient had stable disease. Twelve patients (43%) developed increased size of the lesion, increased signal intensity or enhancement, cysts or cavitations, and an increase in edema or mass effect on follow-up MRI. Most of these changes occurred between 9 and 12 months after the start of SRT and resolved or decreased by 15 to 21 months. All but one patient had normal or stable neurologic examinations. CONCLUSIONS: Treatment-related MRI changes are common after conventionally fractionated schedules using stereotactic radiation techniques for patients with low grade astrocytomas. These changes can be distinguished from tumor progression by their transient nature as well as the general absence of clinical symptoms.

Adolescent↗

PubMed1989

Prospective study of amikacin versus netilmicin in the treatment of severe infection in hospitalized patients.

PURPOSE: Four previous studies comparing netilmicin and amikacin have yielded inconclusive results concerning efficacy and rates of nephrotoxicity and ototoxicity. For this reason, we conducted a prospective, randomized, controlled trial of the two drugs in the treatment of hospitalized patients with severe infection. PATIENTS AND METHODS: A total of 202 patients were enrolled in the study; 100 received netilmicin and 102 received amikacin. Concomitant antimicrobials were restricted to metronidazole and benzylpenicillin. Peak and trough aminoglycoside levels were assayed within the first 36 hours and at least every 72 hours thereafter. A full blood cell count, serum electrolytes, creatinine, bilirubin, and liver enzymes were measured before therapy, weekly thereafter, and within 48 hours after the discontinuation of therapy. Nephrotoxicity and ototoxicity were assessed in patients. A standard agar dilution procedure was used to determine minimal inhibitory concentrations. RESULTS: No significant pretreatment differences were found between the two groups. Patients in the amikacin group responded significantly better to treatment than did patients in the netilmicin group (90% versus 79%; p less than 0.05). A notable finding was the markedly inferior response rate of Pseudomonas aeruginosa infections to netilmicin as compared with amikacin (13 of 24 with a favorable response compared with 25 of 26). No significant difference in ototoxicity was found, whereas nephrotoxicity appeared to be significantly less with amikacin (4% versus 12%, p less than 0.05). Although amikacin seemed less nephrotoxic than netilmicin, this may have been related to the significantly greater number of patients with initial renal dysfunction who received netilmicin. CONCLUSIONS: Amikacin appears to be significantly more efficacious than netilmicin for the treatment of P. aeruginosa infections, especially those in non-urinary tract sites. There is no apparent difference between the two drugs in terms of ototoxicity.

Acute Disease↗

PubMed1991

Infection in the myelodysplastic syndromes.

PURPOSE: To determine the incidence, characteristics, and outcome of infection in patients with myelodysplastic syndromes (MDS) and risk factors that may lead to infection. PATIENTS AND METHODS: We reviewed infections that occurred in 86 consecutive patients with MDS who received care from 1968 to 1986 at a university-affiliated Veterans Affairs Medical Center. Time lines charting the course of each patient with MDS were created and included infections, MDS subgroup at the time of presentation and at the time of each infection, peripheral neutrophil counts, and therapies for MDS. RESULTS: Infections occurred at a rate of nearly one per patient year of observation. Infection rates were associated with MDS subgroup as follows: refractory anemia with or without ringed sideroblasts (RA +/- RS) less than refractory anemia with excess blasts (RAEB) less than RAEB in transformation (RAEB-T). The group of RA +/- RS patients who had erythroid abnormalities but minimal or no dyspoiesis of other cell lines had the lowest rate of infections. Infection rates were higher in patients with less than or equal to 1,000 neutrophils/microL blood than in patients with greater than 1,000 neutrophils/microL blood for each classifiable MDS subgroup. Neutrophil concentration and MDS subgroup were independent risk factors for infection in patients with MDS. Bacterial pneumonias and skin abscesses were the most common infections. Infection was the most common cause of death during MDS, accounting for 64% of deaths, and was more common than transformation to acute leukemia as a cause of death. CONCLUSION: Infection is a common, life-threatening problem in patients with MDS. Neutropenia and MDS subgroup are each risk factors for infection. Clinicians should aggressively evaluate patients with fever and MDS for infection, especially pneumonia and skin infections.

Adult↗

PubMed2005

Results of an antimicrobial control program at a university hospital.

PURPOSE: The results of the first five years of an ongoing antimicrobial control program are reported. METHODS: In 1998, a multidisciplinary antimicrobial subcommittee of the pharmacy and therapeutics committee of a university hospital was formed and charged with making formulary interventions in an effort to reduce rising antimicrobial resistance rates and drug expenditures. In 1999, a number of measures were implemented for controlling antimicrobial use. Selected antimicrobials with the potential for inappropriate use or whose inappropriate use had been documented were placed in the control of physicians in the infectious diseases (ID) division. Prior approval by an ID physician was required before the pharmacy could dispense these agents. Other key interventions included removal of ceftazidime and cefotaxime from the formulary, restriction of vancomycin and carbapenem use, and replacement of ciprofloxacin with levofloxacin as the sole fluoroquinolone on the formulary. Data regarding antimicrobial use and expenditures between 1998 and 2002 were compared and analyzed. RESULTS: Antimicrobial use was reduced by 80% for third-generation cephalosporins and 15% for vancomycin following the implementation of the new antimicrobial policies. Antimicrobial-resistance patterns for many important gram-negative pathogens, including Pseudomonas aeruginosa, demonstrated a reversal of previous increases. In addition, the rate of methicillin-resistant Staphylococcus aureus decreased by an average of 3% each year from 1999 to 2002. Pharmacy expenditures for all antimicrobials, including antiviral, antifungal, and antibacterial agents, decreased 24.7%, with a cumulative cost saving of 1,401,126 US dollars, without inflation assumptions. CONCLUSION: The implementation of an antimicrobial control program decreased the use of selected antimicrobial agents and resulted in substantial reduction of expenditures for antimicrobials.

Anti-Infective Agents↗

PubMed1996

Prophylactic antibiotics for the prevention of early infection in multiple myeloma.

PURPOSE: Patients with multiple myeloma are at increased risk for bacterial infection. During the first 2 months of initial chemotherapy the rate of infection is twice that experienced during the remainder of the disease course. As many as one-third of these early infections are fatal, and many more prevent adequate administration of chemotherapy. This study was designed to determine whether the morbidity and mortality of early infection can be prevented by prophylactic administration of trimethoprim-sulfamethoxazole (TMP-SMX). PATIENTS AND METHODS: Eligible patients about to begin chemotherapy for multiple myeloma were randomly assigned to prophylaxis for 2 months or to no prophylaxis (control). Antibiotic prophylaxis consisted of TMP-SMX 160/800 mg orally every 12 hours administered for the first 2 months of initial chemotherapy. All patients were observed for infection for 3 months after the start of chemotherapy. RESULTS: Of 57 patients entered into the study, 54 were evaluable, representing 13.1 patient-years of observation. The 28 TMP-SMX patients and 26 control patients were comparable in terms of chemotherapy regimen, age, gender, stage, and bone marrow function. Bacterial infection during the 3-month study period occurred in 11 control patients but in only 2 patients assigned TMP-SMX (P = 0.004). Eight severe infections occurred in controls compared with 1 in a TMP-SMX patient (P = 0.010) leading to 4 and 1 infection deaths, respectively (P = not significant). Severe infections included 5 pneumonias (3 with sepsis), 2 urinary tract infections with complicating pneumonia or sepsis, 1 diverticulitis with perforation, and 1 staphylococcal scalded skin syndrome. None of the 4 nonbacterial infections was severe. The rate of bacterial infection was 2.43 per patient-year for controls and 0.29 per patient-year for the TMP-SMX group (P = 0.001). Toxicity (skin rash 6 patients, nausea 1 patient) was not life-threatening but required discontinuation of TMP-SMX in 25% of patients. CONCLUSION: Administering TMP-SMX for the first 2 months of initial chemotherapy is effective, inexpensive prophylaxis for early bacterial infection in multiple myeloma.

Aged↗

PubMed1999

Study of cavernosal arterial anatomy using color and power Doppler sonography: impact on hemodynamic parameter measurement.

PURPOSE: We report on color and power Doppler ultrasound to study cavernosal arterial anatomy, and evaluate the impact of vascular anatomy on the measurement of hemodynamic parameters. MATERIALS AND METHODS: Cavernosal arterial anatomy of 42 patients with erectile dysfunction was evaluated using color and power Doppler ultrasound. A computerized waveform analysis was used to measure peak systolic velocity, end diastolic velocity and resistive indexes at various sites, including the penile crura, and proximal mid and distal penile shaft. Hemodynamic parameters were measured in each artery in cases of bifurcated or multiple cavernosal arteries. RESULTS: A total of 80 corpora were adequately evaluated. We observed a single artery without major proximal branches in 37 corpora, a single artery with major proximal branches in 17, bifurcated arteries in 15, 2 cavernosal arteries in 4 and marked arterial tortuosity in 1. In 6 corpora the main cavernosal artery arose from the superficial dorsal artery. The peak systolic velocity was highest at the proximal and decreased progressively at the distal site. The peak systolic velocity plus or minus standard deviation at the mid shaft averaged 69.3+/-30.0% of that at the proximal penile shaft. Of the 15 corpora with bifurcated arteries 67% had a 40% or greater difference in peak systolic velocity between the branches. Complete or partial occlusion of the cavernosal artery was identified in 3 corpora, and a dramatic difference in peak systolic velocity proximal and distal to the stenotic area was demonstrated. CONCLUSIONS: Cavernosal arterial anatomy is variable and hemodynamic parameters differ at various sites of measurement. Parameters should be measured at a consistent proximal site to obtain a reliable assessment. Variations in vascular anatomy and cavernosal artery pathology should be considered when interpreting color Doppler sonography and before penile vascular surgery.

Adult↗

PubMed2005

The use of autologous concentrated growth factors to promote syndesmosis fusion in the Agility total ankle replacement. A preliminary study.

BACKGROUND: The Agility (DePuy, Warsaw, Indiana) total ankle replacement has been in use since 1984. One of the most common complications continues to be delayed union or nonunions of the distal tibiofibular syndesmosis. In the reported studies on the Agility ankle the delayed union and nonunion rate can be as high as 38%. METHODS: Since 1999, 114 Agility total ankle replacements were done at two centers in the United States without the use of autologous concentrated growth factors. Since July of 2001, 66 Agility ankles were implanted with Symphony (DePuy, Warsaw, Indiana) augmented bone grafting. The standard operative technique was followed in all the patients. Prospective data was collected on all patients. The standard ankle radiographs were taken preoperatively and postoperative at 8 weeks, 12 weeks, 16 weeks, 6 months, and yearly. CT scans were obtained at 6 months if fusion at the syndesmosis was questionable. The Graphpad Instat software (Graphpad Software Inc., San Diego, CA) was used for statistical analysis. The two-tailed unpaired t-test was used, and the value <0.05 was considered significant. RESULTS: There was no statistical difference in the demographic data for the two groups. In 114 ankle replacements without autologous concentrated growth factors 70 fused at 8 weeks (61%), 14 fused at 12 weeks (12%), 13 fused at 6 months (12%). There were 17 nonunions (15%); delayed unions (3 to 6 months) and nonunions, therefore, equaled 27%. The syndesmosis fused in 50 of the 66 ankle replacements (76%) that had autologous concentrated growth fractures at 8 weeks (76%); 12 fused at 3 months (18%), 2 fused at 6 months (3%), 2 had nonunions (3%). Delayed unions (3 to 6 months) and nonunions equaled 6%. There was a statistically significant improvement in the 8- and 12-week fusion rates, and a statistically significant reduction in delayed unions and nonunions. CONCLUSION: Autologous concentrated growth factors appear to make a significant positive difference in the syndesmosis union rate in total ankle replacements.

Adult↗

PubMed2005

Breast cancer prevention in community clinics: will low-income Latina patients participate in clinical trials?

BACKGROUND: Latinas have low rates of participation in breast cancer prevention trials. We evaluated the feasibility and effectiveness of a randomized trial of brief counseling and print materials compared to print materials alone to increase intent to participate in a breast cancer prevention trial. METHODS: We enrolled 450 women Spanish-speaking women from three urban community primary care clinics. The outcome was intent, defined as might, probably, or definitely would enroll in the trial. We also examined results using a more stringent definition restricted to probably and definitely intend to participate. RESULTS: The trial was feasible within these busy clinics, and 96% of women agreed to participate. The level of breast cancer knowledge was fairly high (66% correct answers), but understanding about clinical trials was lower (40.5% correct answers). Using the less stringent criteria for intent, 72% of women stated that they intended to enroll in the STAR trial if eligible, but rates of intent decreased to 52% with framing that included medication side effects and 45% if uterine cancer was mentioned (P < 0.01 for trend). Using the more stringent definition, slightly fewer than half of the women indicated an interest in participating, with the same trend towards decreasing intent with increasing presentation of side effects. The intervention was only effective using the less stringent definition and if no side effects were mentioned (77% intent vs. 67% in the intervention and control groups, respectively, P = 0.03). Intention was independently associated with greater worry about breast cancer and younger age, but not acculturation or knowledge. CONCLUSIONS: Latina women are interested in participating in clinical trials to prevent breast cancer, although interest declines with increasing discussion of side effects. Unfortunately, brief education only increased rates of intention using the least stringent definition and when no side effects were presented in framing the question. Future work should focus on qualitative research to understand the theoretical foundations of preventive health behaviors in this population.

Adult↗

PubMed2001

Children with headache suspected of having a brain tumor: a cost-effectiveness analysis of diagnostic strategies.

OBJECTIVE: To assess the clinical and economic consequences of 3 diagnostic strategies-magnetic resonance imaging (MRI), computed tomography followed by MRI for positive results (CT-MRI), and no neuroimaging with close clinical follow-up-in the evaluation of children with headache suspected of having a brain tumor. Three risk groups based on clinical variables were evaluated. MATERIALS AND METHODS: A decision-analytic Markov model and cost-effectiveness analysis was performed incorporating the risk group prior probability, MRI and CT sensitivity and specificity, tumor survival, progression rates, and cost per strategy. Outcomes were based on quality-adjusted life year (QALY) gained and incremental cost per QALY gained. RESULTS: For low-risk children with chronic nonmigraine headaches of >6 months' duration as the sole symptom (prior probability of brain tumor 0.01%), no neuroimaging with close clinical follow-up was less costly and more effective than the 2 neuroimaging strategies. For the intermediate-risk children with migraine headache and normal neurologic examination (prior probability of brain tumor 0.4%), CT-MRI was the most effective strategy but cost >$1 million per QALY gained compared with no neuroimaging. For high-risk children with headache of <6 months' duration and other clinical predictors of a brain tumor such as an abnormal neurologic examination (prior probability of brain tumor 4%), the most effective strategy was MRI, with cost-effectiveness ratio of $113 800 per QALY gained compared with no imaging. CONCLUSION: Our analysis suggests that MRI maximizes QALY gained at a reasonable cost-effectiveness ratio in children with headache at high risk of having a brain tumor. Conversely, the strategy of no imaging with close clinical follow-up is cost saving in low-risk children. Although the CT-MRI strategy maximizes QALY gained in the intermediate-risk patients, its additional cost per QALY gained is high. In children with headache, appropriate selection of patients and diagnostic strategy may maximize quality-adjusted life expectancy and decrease costs of medical workup.

Adult↗

PubMed2004

Intracerebral abscess in children: historical trends at Children's Hospital Boston.

OBJECTIVES: A previous study performed at Children's Hospital Boston describing the natural history of intracerebral abscess between 1945 and 1980 demonstrated a decline in mortality after 1970. This current study examines the occurrence of intracerebral abscess at Children's Hospital Boston between 1981 and 2000, inclusive, and compares the results with the previous study. Our objectives were to determine whether there had been a change in the predisposing factors, whether there were changes in the microbiology of intracerebral abscesses, and whether mortality rate had continued to decline. METHODS: To ensure that all occurrences of intracerebral abscess treated at Children's Hospital Boston between 1981 and 2000 were identified, we searched 4 separately maintained databases for the keywords "brain" or "abscess" or the International Classification of Diseases, Ninth Revision code 324.x. This search yielded the names of 386 patients. Of these 386 patients, a solitary intracerebral abscess or multiple noncontiguous intracerebral abscesses could be confirmed in 54 patients on the basis of cranial imaging (computed tomography or magnetic resonance imaging) or autopsy reports. The complete retrospective review of the medical records of these 54 patients constitutes the basis for this study. RESULTS: Congenital heart disease was the most common predisposing factor during both eras. Compared with the previous era, important historical trends identified include a reduction in the number of abscesses that occurred in the settings of sinus or otitic infection (11% during 1981-2000 vs 26% during 1945-1980), an increase in number of intracranial abscesses in infants (18% vs 7%) and in the setting of immunosuppression (16% vs 1%), an increase in the number of children who were treated with antibiotics alone (22% vs 1%), a stable overall mortality rate (24% vs 27%), and the identification of Citrobacter and fungus as causes of intracranial abscess not observed during the previous era of 1945-1980. Citrobacter was observed only during the neonatal period. Fungi were the causative organisms predominantly in the setting of immunosuppression. CONCLUSIONS: Intracerebral abscess in children continues to be associated with high rates of neurologic impairment and death. Because earlier detection may reduce morbidity and mortality, intracranial abscess should be considered when evaluating children with new-onset neurologic signs or symptoms, especially in children who have acute immunosuppression and disseminated fungal disease or fungemia.

Adolescent↗

PubMed1998

Hemodynamic patterns of pharmacologically induced erection: evaluation by color Doppler sonography.

PURPOSE: Penile erection is achieved through hemodynamic mechanisms that can be assessed best with color flow imaging and Doppler waveform analysis. We performed dynamic studies using computer assisted analysis to assess the hemodynamic patterns of pharmacologically induced erection. MATERIALS AND METHODS: A total of 73 color Doppler ultrasound studies was performed in 66 patients with erectile dysfunction. Various blood flow parameters, including peak systolic velocity, end diastolic velocity, mean flow rate, resistive index and artery diameter, were observed continuously and recorded frequently for about 30 minutes after intracorporeal injection of papaverine/phentolamine/prostaglandin E1 mixture. A computerized Doppler waveform analysis of 3 curves or greater was performed for each recording to minimize error. A second injection was administered if the first injection failed to induce a rigid erection. Status of the erection was observed and recorded throughout the study. A computerized graph was generated for each corpus. RESULTS: After intracorporeal injection the time to reach normal or peak velocity varied from 1 to 24 minutes. Among 146 corpus units in 73 color Doppler ultrasound studies we observed the following hemodynamic patterns: I-normal maximal peak systolic velocity (35 cm. per second or greater), sustained; Ia-end diastolic velocity 0 or less with complete erection response (19 units); Ib-end diastolic velocity greater than 0 or incomplete erection response (14 units); II-normal maximal peak systolic velocity (35 cm. per second or greater), transient; IIa-end diastolic velocity 0 or less with complete erection response (21 units); IIb-end diastolic velocity greater than 0 or incomplete erection response (12 units); III-borderline maximal peak systolic velocity (30 to 35 cm. per second); IIIa-end diastolic velocity 0 or less with complete erection response (10 units); IIIb-end diastolic velocity greater than 0 or incomplete erection response (8 units); IV-low maximal peak systolic velocity (less than 30 cm. per second); IVa-end diastolic velocity 0 or less with complete erection response (24 units); and IVb-end diastolic velocity greater than 0 or incomplete erection response (38 units). CONCLUSIONS: Erection is a complex and dynamic process. A new classification of hemodynamic patterns is presented that aids in assessing and interpreting more thoroughly blood flow parameters to stratify more precisely the hemodynamic patterns of erectile dysfunction.

Adult↗

PubMed2005

The presentation of anxiety in children with pervasive developmental disorders.

OBJECTIVE: Although the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV) diagnostic criteria generally discourage the diagnosis of other Axis I disorders in children with pervasive developmental disorder (PDD), anxiety symptoms are often observed in this clinical population. Moreover, there are some albeit limited data that suggest an association between anxiety and psychotic symptoms in children. Because co-occurring psychiatric symptoms have important clinical implications, this study examined anxiety and psychotic symptoms in children with and without PDD. METHOD: Parents and teachers completed the Early Childhood Inventory-4 (ECI-4) or the Child Symptom Inventory (CSI-4) for children evaluated in a developmental disabilities clinic (PDD) or a child psychiatry outpatient clinic (non-PDD). Children were divided into four groups: 3-5- year-olds with (n = 182) and without (n = 135) PDD, and 6-12-year-olds with (n = 301) and without (n = 191) PDD. The 6-12-year-olds were further divided into high-anxious and low-anxious subgroups based on CSI-4 ratings and compared with regard to severity of psychotic symptoms. RESULTS: Teachers rated preschoolers with PDD as exhibiting more severe anxiety symptoms than the non-PDD group; however, the converse was true for parent ratings. For 6-12- year-olds, both parents and teachers rated children with PDD as significantly more anxious than non-PDD clinic referrals. In general, the severity of anxiety symptoms varied by PDD subtype (Asperger's disorder > PDDNOS > Autistic disorder) and IQ (high > low). Furthermore, highly anxious 6-12-year-olds with PDD received significantly higher parent and teacher ratings of psychotic symptom severity (strange behaviors, hearing voices, illogical thinking, inappropriate affect, and odd thoughts) than our low-anxious group, even when controlling for PDD symptom severity. Moreover, the relation between anxiety level and psychotic symptom severity was similar for both PDD and non-PDD children. Parent and teachers differed in their perceptions of the severity of specific anxiety symptoms. In addition, parent- versus teacher-defined anxiety level groups varied with regard to the differential severity of psychotic symptoms. This finding highlights the importance of continued investigation of source-specific syndromes in children with PDD. Two case vignettes are presented. CONCLUSION: Anxiety appears to be a clinically important concern in many children with PDD. Similarities in anxiety symptom presentation and their association with psychotic symptoms in both children with and without PDD support the possibility of: (1) psychiatric comorbidity in the former; (2) at least some overlap in causal mechanisms for anxiety and psychotic symptoms in both PDD and non-PDD children; and (3) a unique diagnostic entity comprised of PDD, anxiety, and psychotic symptoms. Lastly, clinicians should seriously consider dual diagnoses in children with PDD.

Anxiety Disorders↗

PubMed2003

A phase I trial of etanidazole and hyperfractionated radiotherapy in children with diffuse brainstem glioma.

PURPOSE: To determine the toxicity and maximum tolerated dose of etanidazole administered concurrently with hyperfractionated radiation therapy (HRT) for children with brainstem glioma. METHODS AND MATERIALS: Eighteen patients with brainstem glioma were treated with etanidazole and HRT on a dose escalation protocol (Phase I trial) between 1990 and 1996. All patients had MRI confirmation of diffuse pontine glioma and signs/symptoms of cranial nerve deficit, ataxia, or long tract signs of <6 months' duration. Cervicomedullary tumors were excluded. Patients (median age: 8.5 years; 11 males, 7 females) received HRT to the tumor volume plus a 2-cm margin with parallel-opposed 6-15-MV photons. The total dose was 66 Gy in 44 fractions (1.5 Gy b.i.d., with at least 6 h between fractions) for the first 3 patients and 63 Gy in 42 fractions for the subsequent 15 patients. Etanidazole was administered as a rapid i.v. infusion 30 min before the morning fraction of HRT. Planned doses of etanidazole were 1.8 g/m(2) x 17 doses (30.6 g/m(2)) at Step 1 to a maximum of 2.4 g/m(2) x 21 doses (50.4 g/m(2)) at Step 8. Dose escalation was planned with 3 patients at each of the 8 levels. RESULTS: Three patients were treated at each dose level except Level 2, on which only 1 patient was treated. The highest dose level achieved was Level 7, which delivered a total etanidazole dose of 46.2 g/m(2). Two patients were treated at this level, and both patients experienced Grade 3 toxicity in the form of a diffuse cutaneous rash. Three patients received a lower dose of 42 g/m(2) (dose Level 6) without significant toxicity, and this represents the maximum tolerated dose (MTD). There were 23 cases of Grade 1 toxicity (10 vomiting, 5 peripheral neuropathy, 2 rash, 2 constipation, 1 weight loss, 3 others), 11 cases of Grade 2 toxicity (4 vomiting, 2 skin erythema, 2 constipation, 1 arthralgia, 1 urinary retention, 1 hematologic), and 4 Grade 3 toxicities (2 rash, 1 vomiting, 1 skin desquamation). Grade 2 or 3 peripheral neuropathy was not seen at any dose level. The median survival from the start of treatment was 8.5 months (range: 3-58 months). CONCLUSION: The MTD of etanidazole in children receiving HRT for brainstem glioma is 42 g/m(2), with cutaneous rash as the dose-limiting toxicity. This is in contrast to the adult experience, which demonstrates a 24% lower MTD of 34 g/m(2) limited by peripheral neuropathy.

Adolescent↗

PubMed2005

Stereotactic radiotherapy for localized low-grade gliomas in children: final results of a prospective trial.

PURPOSE: To evaluate the efficacy of stereotactic radiotherapy (SRT) for small, localized, pediatric brain tumors and to determine the patterns of failure. METHODS AND MATERIALS: A total of 81 patients were enrolled in an institutional review board-approved prospective Dana-Farber Cancer Institute protocol between 1992 and 1998. Of the 81 patients, 50 had low-grade astrocytoma, 23 had residual or recurrent craniopharyngioma, 4 had posterior fossa ependymoma, and 4 had other histologic types. All patients underwent biopsy for diagnosis, with the exception of patients with neurofibromatosis and radiographic evidence of an optic system tumor. The neurocognitive outcome for all patients was also an endpoint of the study and will be reported separately. This report focused on the patients with low-grade gliomas only. Of the 50 patients, 26 were males and 24 females; the median age was 9 years (range, 2-26 years). The indications for treatment of patients with low-grade gliomas were progression during or after chemotherapy or progression after surgery alone. SRT was delivered using a dedicated 6-MV linear accelerator. Immobilization was accomplished with a removable head-frame. CT and MRI fusion was used for treatment planning. The target volume generally included the preoperative tumor plus a 2-mm margin for the planning target volume. The median collimator size was 47.25 mm (range, 30-60 mm). Three to nine arcs were used to deliver a mean total dose of 52.2 Gy in 1.8-Gy daily fractions. RESULTS: With a median follow-up of 6.9 years (range, 0.9-10.2 years), the progression-free survival rate was 82.5% at 5 years and 65% at 8 years. The overall survival was 97.8% at 5 years and 82% at 8 years. Six patients had local progression. Two of the patients with local progression had pathologic progression to anaplastic astrocytoma 3 and 7 years after initial SRT. Five patients, all with optic system/hypothalamic primary tumors, developed central nervous system dissemination 1.0-7.4 years after SRT. One patient developed a presumed radiation-induced primitive neuroectodermal tumor 6 years after initial treatment. Six patients died, three of dissemination, two of progression to higher grade tumors, and one of a secondary radiation-induced tumor. All 6 cases of local progression were within the primary tumor bed at the time of progression and had received the full prescription dose. No marginal failures occurred. CONCLUSION: Stereotactic radiotherapy provides excellent local control for children with small, localized low-grade glial tumors. Marginal failures have not been observed, supporting the use of limited margins to minimize late sequelae using stereotactic immobilization and planning techniques.

Adolescent↗

PubMed1994

Stereotactic radiotherapy for pediatric and adult brain tumors: preliminary report.

PURPOSE: Stereotactic radiotherapy is a new modality that combines the accurate focal dose delivery of stereotactic radiosurgery with the biological advantages of conventional radiotherapy (1.8-2.0 Gy/day using 25-30 fractions). The modality requires sophisticated treatment planning, dedicated high-energy linear accelerator, and relocatable immobilization devices. We report here our early experience using stereotactic radiotherapy for intracranial neoplasms. METHODS AND MATERIALS: Between June 1992 and September 1993, we treated 82 patients with central nervous system lesions using stereotactic radiotherapy, delivered from a dedicated 6 MV stereotactic linear accelerator. A head fixation frame provided daily relocatable setup using a dental plate for all patients over 8 years of age. A modified head frame, which does not require a mouthpiece, was used for children requiring anesthesia. The patients ranged in age from 9 months to 76 years. Thirty-three patients were children less than 21 years of age. Selection criteria for the protocol included: (a) focal, small (< 5 cm) radiographically distinct lesions known to be radiocurable (pituitary adenoma, craniopharyngioma, meningioma, acoustic neuroma, pilocytic astrocytoma, retinoblastoma), and (b) lesions located in regions not amenable to surgery or radiosurgery such as the brain stem or chiasm. Standard fractionation and conventional doses were delivered. Patients with low-grade astrocytoma, oligodendroglioma, or ependymoma were treated using a dose escalation regime consisting of conventional doses plus a 10% increase. RESULTS: Although follow-up is 16 months (range 3-16 months), posttreatment radiographic studies in 77 patients have been consistent with changes similar to those found after conventional radiation therapy. To date, reduction of up to 50% of the original volume has been noted in 19 out of 77 patients, and 4 patients had a complete response, 2 with dysgerminoma, and 1 each with astrocytoma and retinoblastoma. In 56 patients disease was either stable or the follow-up was too short for evaluation. While the follow-up is relatively short, there have been no in-field or marginal recurrences. The only unexpected radiographic findings were in three patients with pilocytic astrocytomas, who developed asymptomatic edema in the treatment volume. Accuracy in daily fractionation was excellent. In over 2000 patient setups with 41,000 scalp measurements, reproducibility was found to be within 0.41 mm (median) of baseline readings, allowing for precise immobilization throughout the treatment course. The treatment in all cases was well tolerated with minimal acute effects. Our stereotactic radiotherapy facility can provide fractionated therapy for 10-12 patients a day efficiently and accurately. CONCLUSIONS: The treatment and relocatable stereotactic head frames were well tolerated with minimal acute effects. No long-term sequelae have been noted, although the observation period is short. To fully define the role of stereotactic radiotherapy, we are conducting prospective studies to evaluate neurocognitive and neuroendocrine effects. We expect that this innovative approach will make a significant impact on the treatment of intracranial neoplasms, particularly in children.

Adolescent↗