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PubMed1998

Safety of oral propafenone in the treatment of arrhythmias in infants and children (European retrospective multicenter study). Working Group on Pediatric Arrhythmias and Electrophysiology of the Association of European Pediatric Cardiologists.

This study was designed to assess adverse effects of oral propafenone in a large number of pediatric patients. Retrospective data from 27 European centers covering 772 patients treated with oral propafenone were analyzed. The following arrhythmias were treated: reentrant supraventricular tachycardia in 388 patients, atrial ectopic tachycardia in 66, junctional ectopic tachycardia in 39, atrial flutter in 21, ventricular premature complexes in 140, ventricular tachycardia in 78, and other arrhythmias in 39 patients. Two hundred forty-nine patients (32.3%) had structural heart disease. Significant electrophysiologic side effects and proarrhythmia were found in 15 of 772 patients (1.9%): sinus node dysfunction in 4, complete atrioventricular block in 2, aggravation of supraventricular tachycardia in 2, acceleration of ventricular rate during atrial flutter in 1, ventricular proarrhythmia in 5, and unexplained syncope in 1 patient. Cardiac arrest or sudden death occurred in 5 of 772 patients (0.6%): 2 patients had supraventricular tachycardia due to the Wolff-Parkinson-White syndrome and a normal heart; the remaining 3 patients had structural heart disease. Overall, adverse cardiac events were more common in the presence (12 of 249 patients, 4.8%) than in the absence (8 of 523 patients, 1.5%) of structural heart disease (p <0.01). There was no difference between patients treated for supraventricular and ventricular arrhythmias. Thus, propafenone is a relatively safe drug for the treatment of several pediatric tachyarrhythmias. Proarrhythmic effects seem to be less frequent than those reported for encainide or flecainide and occur predominantly in patients with structural heart disease.

Administration, Oral↗
PubMed1999

Management of pediatric liver injuries: a 13-year experience at a pediatric trauma center.

PURPOSE: This study of traumatic liver injuries (LI) in children reviews the authors' management and identifies the indications for surgical intervention. METHODS: A total of 11,761 admissions over 13 years to a regional pediatric trauma center were surveyed. RESULTS: LI were identified in 328 children. Mechanisms included 39% pedestrians struck by a vehicle, 34% motor vehicle occupants, 13% falls or discrete blows to the abdomen, 5% bicycle injuries, 5% child abuse, and 4% penetrating injuries. Eighty-seven of patients with LI were treated nonoperatively with a mortality rate of 17%. Six percent of deaths were attributed to the LI and massive hemorrhage, all of which presented with cardiopulmonary resuscitation (CPR) in progress, with the remainder of deaths attributed to massive head, neck, or chest injuries (HNCI, 90%) and sepsis (4%). Surgery was performed in 13% of all LI and included major hepatic vascular injury (MHVI) repairs (34%), hepatorrhaphies (34%), lobectomies (27%), and biliary repairs (4%). Excluding the nonoperative group deaths, the need for blood transfusion of more than 25 mL/kg in the first 2 hours as an indicator of surgical necessity or a MHVI had, respectively, a sensitivity of 34% and 67%, specificity of 98% and 97%, positive predictive value of 79% and 53%, negative predictive value of 89% and 98%, and prediction accuracy of 88% and 95%. In the surgical management group, the mortality rate was 23% with 40% of deaths attributed to MHVI, 30% a combination of MHVI and HNCI, 20% massive HNCI, and 10% sepsis. CONCLUSIONS: The majority of pediatric LI are not associated with hemodynamic instability and can be successfully managed nonoperatively (72%). Hemodynamic instability, as defined by the need for blood transfusion in excess of 25 mL/kg within the first 2 hours, was a strong indicator of a MHVI, which was often a lethal injury (70%).

Adolescent↗
PubMed2004

The PedsQL in pediatric asthma: reliability and validity of the Pediatric Quality of Life Inventory generic core scales and asthma module.

The PedsQL is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents ages 2-18. The PedsQL 4.0 Generic Core Scales were developed to be integrated with the PedsQL Disease-Specific Modules. The PedsQL3.0 Asthma Module was designed to measure pediatric asthma-specific HRQOL. The PedsQL was administered to 529 families. Internal consistency reliability was demonstrated for the PedsQL 4.0 Total Score (alpha = 0.90 child, 0.91 parent report) and Asthma Module (average alpha = 0.71 child, 0.86 parent report). The PedsQL 4.0 distinguished between healthy children and children with asthma. The validity of the PedsQL Asthma Module was demonstrated through intercorrelations with a previously standardized asthma disease- specific instrument. Responsiveness was demonstrated through patient change over time as a result of clinical intervention. The results demonstrate the reliability, validity, and responsiveness of the PedsQL required for an outcome measure in pediatric asthma clinical trials and research.

Adolescent↗
PubMed2000

Sirolimus in pediatric gastrointestinal transplantation: the use of sirolimus for pediatric transplant patients with tacrolimus-related cardiomyopathy.

Hypertrophic obstructive cardiomyopathy (HOCM) associated with the use of tacrolimus is a rare complication of liver and intestinal transplantation seen almost exclusively among pediatric patients. Reduction of tacrolimus dosage or conversion to cyclosporin A (CsA) has been used as an effective treatment in reviewed cases. We present three pediatric transplant recipients who developed hypertrophic obstructive cardiomyopathy while under tacrolimus immunosuppression and were treated with conversion to sirolimus (Rapamycin). The patients (ages 6 yr, 12 yr and 11 months) were transplant recipients (liver, n = 2; liver and intestine, n = 1) who developed significant cardiomyopathy 15 and 96 months post-transplant. One patient died of post-transplant lymphoproliferative disorder 21 days after starting sirolimus. One patient had received two liver transplants and had been on CsA for 12 yr before conversion to tacrolimus at 60 months post-transplant for acute and chronic rejection. The surviving patients were receiving mycophenolate mofetil, tacrolimus and steroids at the time of diagnosis. Dose reduction of tacrolimus and treatment with beta blockers failed to alleviate the hemodynamic changes. The patients were converted to sirolimus 1.6, 37 and 148 months post-transplant and maintained a whole-blood trough level of 15-20 ng/mL 21 days after starting sirolimus. Repeat echocardiograms in the surviving patients showed improvement in cardiomyopathy. One patient had one rejection episode (intestinal biopsy, mild acute cellular rejection) after starting sirolimus that responded to a transient increase in steroids. The early demise of the third patient after sirolimus conversion prevented an adequate assessment of cardiomyopathy. Conversion to sirolimus was associated with a reduction in the cardiomyopathy of the two surviving patients while still providing effective immunosuppression. To our knowledge this observation has not been previously reported.

Acute Disease↗
PubMed2003

Changing trends in pediatric transplantation: 2001 Annual Report of the North American Pediatric Renal Transplant Cooperative Study.

The North American Pediatric Renal Transplant Cooperative Study has collected clinical information on children undergoing a renal transplantation since 1987. This cooperative group now includes over 150 participating medical centers in the United States, Canada, Mexico, and Costa Rica. This report covers the years from 1987 through 2001 and includes data on 7545 renal transplants in 6878 patients. This report demonstrates changing trends in many areas of pediatric transplantation including increasing numbers of African American and Hispanic children receiving transplantation, remarkable improvements in the rate of acute rejection, rejection reversal, and short- and long-term allograft survival. In the most recent cohorts of patients, we now see that 1-yr allograft survival is no different in cadaver donor compared to living donor recipients and in infants compared to all other age groups. However, this analysis also reveals areas of continued challenges including inferior outcomes in African American and adolescent populations, chronic rejection, and the adverse effects of immunosuppression.

Black People↗
PubMed2002

Changes in pediatric diabetes care throughout a 30-yr period at one institution for pediatric diabetology in Germany.

AIMS: The objective of the present study was to investigate putative changes in pediatric diabetes care at one institution between 1969 and 1998. METHODS: A structured questionnaire was used to analyze all medical records from the Hospital for Children and Adolescents of the University of Leipzig, Germany, from 1969 to 1998, in order to review the number of cases of type 1 diabetes mellitus and the length of hospital stay of children with diabetes during the 30-yr period. RESULTS: Between 1969 and 1998, 441 children and adolescents (211 boys and 230 girls) with newly diagnosed diabetes mellitus type 1 were treated at the Hospital for Children and Adolescents in Leipzig. The number of patients newly diagnosed increased from 55 between 1969 and 1973 to 105 between 1994 and 1998 (p < 0.0003). The initial therapy and diabetes education were carried out in an in-patient setting. The average duration of hospital stay was 36 d in the years 1969-73, and 17 d in the years 1994-98 (p < 0.0002). This reduction of time spent in hospital was achieved by establishing structured training courses and exact planning of treatment in relation to the degree of illness at presentation. CONCLUSION: The number of patients with type 1 diabetes mellitus receiving care in this single institution between the years 1969 and 1998 has increased continuously. With the help of quality-assured structured training courses in a clinic for pediatric diabetes care, a dramatic reduction of the duration of hospital stay was achieved.

Journal Article↗
PubMed2003

Pediatric post-transplant diabetes: data from a large cohort of pediatric heart-transplant recipients.

A retrospective analysis of 381 pediatric heart-transplant recipients was performed to determine the frequency, characteristics, and risk factors for post-transplant diabetes. The rate of post-transplant diabetes was 1.8% with antithymocyte globulin, cyclosporine and azathioprine as primary immunosuppressive therapy. Time from transplant to diabetes was 0.25-13 years. Diabetes was characterized by reversibility, and lack of insulinopenia and autoimmunity. The post-transplant diabetes rate in tacrolimus-converted children (n = 45) was 8.8%. In tacrolimus-converted children, age at transplant, mean and maximum tacrolimus blood levels, and first-year rejection episodes were higher in the post-transplant diabetes group, which also consistently had DR-mismatched transplants and HLA DR3/DR4 haplotypes. Body mass index was not different between diabetic and control tacrolimus-converted children. In conclusion, pediatric post-transplant diabetes may be related to reversible insulin resistance. Tacrolimus levels, HLA DR mismatch, and older age at transplant may predispose to post-transplant diabetes.

Adolescent↗
PubMedDate not supplied

[Antiinfectious prophylaxis in pediatric oncology. Work group "Quality Assurance" of Society for Pediatric Oncology and Hematology (GPOH)].

Infections in disease- and/or chemotherapy-related neutropenia are major, often emergency-type problems in the treatment of pediatric oncology patients and explain the ongoing discussion about antiinfectious prophylaxis. The different aspects of prophylaxis and an overview on the literature are presented. Antiinfectious prophylaxis in pediatric oncology includes the following issues: 1. General aspects such as information for patients and parents on neutropenia and risk of infectious diseases and indication and management of reverse isolation and barrier isolation; 2. antibacterial prophylaxis with oral non-absorbable and oral absorbable antibiotics; 3. Pneumocystis carinii (Pc) prophylaxis; 4. antifungal prophylaxis to prevent disseminated candidiasis and aspergillosis; 5. antiviral prophylaxis, especially varicella-zoster-virus (VZV) post-exposure prophylaxis and cytomegalovirus (CMV) prophylaxis; 6. immunoglobulins and hematopoietic growth-factors (HGF); 7. active immunization. An evaluation of those measures leads to the following conclusions: A major controversy exists regarding antibacterial and antifungal prophylaxis. Probably not effective are the use of reverse isolation and of oral, non-absorbable antibiotics. Oral absorbable antibiotics, antifungal prophylaxis using fluconazole and amphotericin B and the use of hematopoietic growth factors are likely to be effective. Clearly effective are strict hand-washing procedures, Pc and CMV prophylaxis and passive vaccination against VZV in case of VZV exposure of a seronegative patient.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

[Establishment of a uniform common data set for pediatric oncology. Applied Informatics Study Group of the GPOH (Society of Pediatric Oncology and Hematology)].

Large multicenter trials have made a major contribution to the improvement of treatment results in childhood malignancies. Coordination and central documentation ensure the quality of treatment and permit clinical and scientific investigations. This kind of cooperation requires a vast amount of documentation, which by itself has become a critical factor in answering important medical questions. The problems result from non-standardized documentation systems in different studies, from insufficient integration of clinical work and documentation and from a lack of application of modern computer based data management systems. The working group "Applied Informatics" of the German "Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)" has started a project to create an uniform basic data set for the German pediatric oncology group. Relevant initial diagnostic data, information about planned and realized treatment as well as data concerning negative event had to be standardized. A minimal common data set with a substantially reduced documentation, which is applicable for all patients and trials, would have failed to fulfil the clinical as well as the research needs. The data set presented here is a detailed information structure introduced as a basic tool for the improvement of data management in the German pediatric oncology group. This first version of the basic data set will need further development, since some of the problems still need to be resolved and the requirements for such data pools are changing. Based on this data set new computer software and clinical information systems have to be developed to enable documentation and processing of all clinical and study related data.

Child↗
PubMed1993

Society of Pediatric Psychology Task Force Report: pediatric psychology and injury control.

Injuries are the major causes of death for children. Pediatric psychology offers significant contributions to the multidisciplinary efforts necessary to prevent injuries and reduce harm to children. This Task Force Report reviews epidemiological data, characteristics of children's injuries, passive and active interventions for reducing injuries, and research, policy, and evaluation issues for individual and community injury control efforts. Directions for future pediatric psychology efforts are identified and placed in a context of collaborative efforts required to advance the control of children's injuries.

Adolescent↗
PubMed1999

Empirically supported treatments in pediatric psychology: recurrent pediatric headache.

OBJECTIVE: To review the empirical research examining behavioral treatments for recurrent pediatric headache. METHODS: Thirty-one investigations published after 1980 were reviewed using predetermined criteria to evaluate the adequacy of research methodologies. A modification of criteria proposed for evaluating the efficacy of psychological interventions for adults (Task Force on Promotion and Dissemination of Psychological Procedures, 1995) was used to evaluate the adequacy of evidence available for individual intervention strategies. RESULTS: Sufficient evidence exists to conclude that relaxation/self-hypnosis is a well-established and efficacious treatment for recurrent headache. Furthermore, enough evidence exists to conclude that thermal biofeedback alone is a probably efficacious treatment. Other promising interventions have been tested that combine relaxation and biofeedback or integrate other cognitive-behavioral treatment approaches, but are limited by inadequate research methodologies. CONCLUSIONS: We discuss the importance of developmentally based conceptual models and the impact of diagnostic heterogeneity and offer specific recommendations for future intervention research in the area of recurrent pediatric headache.

Child↗
PubMed1995

Fetal arrhythmias, pediatric arrhythmias, and pediatric electrophysiology.

The practice of pediatric electrophysiology has been altered drastically and irrevocably over the past 5 years. With the advent of widespread application of transcatheter radiofrequency ablative techniques in young patients, decision-making in the management of childhood arrhythmias has focused less on palliative medical therapies and more on the potential for curative, nonsurgical interventions. This review examines the published contributions in the area of pediatric catheter ablation, antiarrhythmic drug therapy, postoperative arrhythmias, fetal arrhythmias, and electrocardiographic phenomena after cardiac transplantation.

Adolescent↗
PubMed2005

Factor analysis of the Pediatric Symptom Checklist with a chronically ill pediatric population.

The psychometric properties and factor structure of a widely used screening measure for behavioral and emotional dysfunction, the Pediatric Symptom Checklist (PSC), was extended to a population of chronically ill children. Parents of 404 children ranging from 6 to 17 years of age and diagnosed with either insulin-dependent diabetes mellitus (IDDM) or sickle cell disease (SCD) completed the PSC while waiting for a routine medical appointment. The measure's internal consistency was found to be high, Cronbach's alpha = .89, and test-retest reliability across 4 months was observed to be acceptable, r = .77. A principal components analysis with an oblique (promax) rotation yielded a four-factor solution with factors that included items representative of internalizing, externalizing, attention, and chronic illness-related problems, respectively. Cronbach alpha estimates ranged from .78 to .83 for the first three factors but was lower for the chronic illness-related problems factor (Cronbach's alpha = .60). A three-factor solution and reliability estimates were recomputed without the chronic illness items that yielded the same reliability estimates for each of the three factors and for the full scale. The three-factor solution was also found to be similar to a published factor structure obtained with a primary care sample, r(c) = .90-.91. The findings lend support to extending the PSC's clinical utility to tertiary care pediatric settings. Further research is recommended with a broader range of chronic illness groups to increase generalizability.

Anemia, Sickle Cell↗
PubMed1996

Pediatric blunt cardiac injury: epidemiology, clinical features, and diagnosis. Pediatric Emergency Medicine Collaborative Research Committee: Working Group on Blunt Cardiac Injury.

AIM: The goal of this study was to describe the epidemiology, clinical presentation, diagnostic methods, and outcome in a large series of children with blunt cardiac injury (BCI). METHODS: A multicenter retrospective review of all individuals less than 18 years of age diagnosed with a BCI from 1983 to 1993 was conducted. Cases included all those with a discharge diagnosis of myocardial contusion, concussion, ventricular disruption, or unspecified BCI. RESULTS: A total of 184 cases of BCI were identified in 16 participating centers. The median age was 7.4 years, and 73% were male. Myocardial contusions accounted for 95% of the diagnoses. The leading mechanisms were motor vehicle crashes involving a pedestrian (39.7%) or passenger (31.0%). The majority (87%) had multiple system trauma, with a mean Injury Severity Score of 27.2 (SD +/- 14.4). Pulmonary contusions were present in 50.5% and rib fractures in 23.0%. The most common diagnostic test performed was a 12-lead electrocardiogram (EKG) (82%), followed by a MB band of creatine phosphokinase (CPK-MB) (69%) and echocardiogram (65%). All three tests were performed in 50%. In these patients, agreement among various diagnostic test pairs was fair (echocardiogram vs. EKG, kappa = 0.27) to poor (echocardiogram vs. CPK-MB, kappa = 0.07 and EKG vs. CPK-MB, kappa = 0.08). No hemodynamically stable patient who presented with a normal sinus rhythm subsequently developed a cardiac arrhythmia or cardiac failure. There were 25 deaths (13.6%), 3 of which were caused by acute pump failure secondary to massive cardiac injury. The remainder died of head or abdominal injuries. Of the 159 (86.4%) patients surviving, 8 (5% of survivors) had significant cardiac sequela, most commonly mitral or tricuspid insufficiency or ventricular septal defect. CONCLUSIONS: Pediatric BCI is usually diagnosed in the context of severe multiple system trauma and is less commonly an isolated event. Because of the lack of a standard, various diagnostic tests are used in the diagnosis of BCI, and these tests rarely agree. In hospitalized pediatric patients with BCI, unanticipated complications are rare. Significant sequela, although uncommon, do occur and follow-up of children with BCI should be ensured.

Accidents, Traffic↗
PubMed1999

Area under the plasma concentration-time curve for total, but not for free, mycophenolic acid increases in the stable phase after renal transplantation: a longitudinal study in pediatric patients. German Study Group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients.

Mycophenolate mofetil, an ester prodrug of the immunosuppressant mycophenolic acid (MPA), is widely used for maintenance immunosuppressive therapy in pediatric renal transplant recipients. However, little is known about the pharmacokinetics of MPA in this patient population in the stable transplant phase, and dosage guidelines are preliminary. The authors therefore compared the pharmacokinetics of MPA, free MPA, and the renal metabolite MPA glucuronide (MPAG) in the initial (sampling at 1 and 3 weeks) and stable phases (sampling at 3 and 6 months) posttransplant in 17 children (age, 12.0 +/- 0.77 years; range, 5.9 to 15.8 years), receiving the currently recommended dose of 600 mg MMF/m2 body surface area (BSA) twice a day. Plasma concentrations of MPA and MPAG were measured by reverse phase HPLC. Because MPA is extensively bound to serum albumin and only the free drug is presumed to be pharmacologically active, the authors also analyzed the MPA free fraction by HPLC after separation by ultrafiltration. The intraindividual variability of the area under the concentration-time curves (AUC0-12) of MPA throughout the 12-hour dosing interval was high in the immediate posttransplant period, but declined in the stable phase, whereas the interindividual variability remained unchanged. The median MPA-AUC0-12 values increased 2-fold from 32.4 (range, 13.9 to 57.0) mg x h/L at 3 weeks to 65.1 (range, 32.6 to 114) mg x h/L at 3 months after transplantation, whereas the median AUC0-12 values of free MPA did not significantly change over time. This discrepancy can be attributed to a 35% decline of the MPA free fraction from 1.4% in the initial phase posttransplant to 0.9% (p < 0.01) in the stable phase. In conclusion, pediatric renal transplant recipients given a fixed MMF dose exhibit a 2-fold increase of the AUC0-12 of total MPA in the stable phase posttransplant and a 35% decrease of the MPA free fraction, whereas the AUC0-12 of free MPA remains unchanged over time. Because the latter pharmacokinetic variable is theoretically best predictive of the clinical immunosuppressive efficacy of MMF, these findings may have consequences for the dosing recommendations of MMF in renal transplant recipients.

Adolescent↗
PubMed1991

Graft thrombosis in pediatric renal transplant recipients. A report of the North American Pediatric Renal Transplant Cooperative Study.

Data from the North American Pediatric Renal Transplant Cooperative Study were analyzed to determine the incidence and possible causes of graft thrombosis in pediatric renal transplant recipients. Between January 1987, and November 1989, 1045 renal transplants in recipients less than 18 years of age were registered in the study, including 484 living-related donor and 561 cadaver donor transplants. There were 213 graft failures (67 LRD, 146 CAD), and of these 27 were caused by thrombosis (8 LRD, 19 CAD). Thrombosis occurred in 2.6% of all transplants and accounted for 22.5% (27/120) of all graft failures that occurred in the first 60 days following transplantation. Among the LRD recipients, there were 24 graft failures in those less than 6 years of age, and 7 of these were due to thrombosis, compared to 1 thrombosis in 43 graft losses in recipients greater than 6 years (P less than 0.01). In recipients less than 6 years old, the thrombosis rate for those who received transplants without prior dialysis was 4/32 (12.5%) versus 3/109 (2.8%) with prior dialysis. Among the CAD recipients, age of the recipient did not influence graft thrombosis. Donor age, however, was strongly associated with the risk of thrombosis, as was cold storage time. Donor age and cold storage time were not independently distributed within the population, with longer cold storage times required for younger donors. Both factors, however, independently affected outcome. Other factors, including prior nephrectomy, prior transplant, center size, and use of cyclosporine were not associated with increased risk of thrombosis in LRD or CAD recipients. We conclude that graft thrombosis is an important cause of renal graft loss in children. In LRD transplants the risk of graft thrombosis is increased in recipients less than 6 years old, and preliminary data suggest that the lack of prior dialysis may be associated with thrombotic risk in these patients. CAD transplant recipients who receive grafts from young donors, particularly those with long cold storage time, are at increased risk for graft failure due to thrombosis.

Adolescent↗
PubMed1992

The effect of donor age on graft survival in pediatric cadaver renal transplant recipients--a report of the North American Pediatric Renal Transplant Cooperative Study.

Data from the North American Pediatric Renal Transplant Cooperative Study were analyzed to determine the effect of donor age on graft survival for pediatric recipients of cadaver donor renal transplants. Between January 1, 1987, and November 16, 1990, 787 cadaver donor renal transplants in children less than 18 years of age were registered in the study. The ages of the donors were less than or equal to 5 years in 203 transplants, between 6 and 9 years in 87, between 10 and 39 in 389, and greater than or equal to 40 years in 108. The risk of graft loss was related to donor age by a proportional hazards analysis. The ideal donor age was 20-25 years. The risk of graft loss was increased by both young and old donor age. The risk of graft loss from a neonate donor was 2.7-fold that of the ideal donor, and the risk from a 50-year-old donor was 1.8-fold that of the ideal donor. The relationship between donor age and graft survival was not affected by the age of the recipient. Cold storage time had an added impact on graft survival: grafts with cold storage time greater than 24 hr were 1.5 times more likely to fail than grafts with shorter cold storage time for all donor ages. Analysis of the causes of graft failure revealed that 9.9% of grafts from donors less than or equal to 5 years of age were lost due to vascular thrombosis, primary nonfunction, and other technical causes, compared with 4.6% in 6-9, 4.4% in 10-39, and 2.8% in greater than or equal to 40-year-old donors. We conclude that kidneys from both young and old donors are at increased risk for graft loss, and this increased risk is seen in all recipient age groups. Many of the losses from the young donors--but not older donors--may be due to technical causes. Knowledge of these risks can be used to develop strategies for optimal utilization of kidneys from young and old donors.

Adolescent↗
PubMedDate not supplied

Pediatric phase II cancer chemotherapy trials: a Pediatric Oncology Group study.

PURPOSE: This study reviewed the Pediatric Oncology Group experience with phase II clinical trials in children (< 21 years of age) with refractory tumors. PATIENTS AND METHODS: Patients registered in Pediatric Oncology Group phase II studies were evaluated. Patients had to be < 21 years of age with recurrent and refractory measurable disease. Tumor types and response rates were determined. Death on therapy from either drug toxicity, progressive disease, infection, or hemorrhage was measured. Tumor-specific, disease-free survival curves were calculated by Kaplan-Meier analysis. RESULTS: Between 1984 and 1994, 2,465 patient entries were made on 45 phase II trials. Malignancies registered included acute lymphocytic leukemia (ALL) (16.7%), acute myeloid leukemia (AML) (12.0%), osteogenic sarcoma (7.8%), neuroblastoma (7.2%), astrocytoma (7.2%), medulloblastoma (7.1%), glioma (6.7%), ependymoma (6.1%), and others (29.2%). The overall response rate was 19.6% (CR + PR) for children entered on phase II trials. Tumor-specific response rates ranged from 62.1% (23/37) for children with Hodgkin's disease to no responses (0/23) in patients with hepatoblastoma. When comparing single versus multiagent trials, a significantly better initial response rate was seen in the latter studies. However, 5-year survival was comparable. Progression-free survival for all tumor histologies were 12.9% and 9.2% at 2 and 5 years, respectively. Death on study was seen in 11.6% of the patients; however, only three deaths were directly related to drug toxicity. There were no significant gender differences in regards to response, progressive disease, or death on study. CONCLUSION: Phase II studies conducted in children offer a considerable likelihood of therapeutic benefit without exposing these patients to untoward toxicity.

Antineoplastic Agents↗