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2.
Paediatr Drugs ; 25(1): 13-25, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36434427

ABSTRACT

The addition of anti-disialoganglioside-2 (GD2) monoclonal antibodies (mAbs) such as dinutuximab and naxitamab to standard therapies for high-risk (HR) neuroblastoma has significantly improved outcomes for children with this devastating disease. The care for these young patients receiving treatment for HR neuroblastoma is complex, with need for the involvement of a multidisciplinary team. Clinical implementation of anti-GD2 mAb treatment requires the same harmonized team approach. The authors share the development process of this coordinated team method and practical recommendations for administration of anti-GD2 mAbs and adverse event (AE) management. Successful collaboration between nurses and other team members ensures optimal treatment and comfort of patients and their families. The primary focus of this approach is to mitigate and manage AEs associated with anti-GD2 mAb treatments, such as pain, hypotension, allergic reactions, and hypertension, and to ensure safe and effective use of anti-GD2 mAbs. The two treatments approved for use in patients with neuroblastoma, dinutuximab for patients with HR disease following a partial response or better to frontline multimodal therapy and naxitamab for refractory or relapsed HR disease in the bone or bone marrow, were studied in different administration settings and follow different regimens and infusion schedules. Therefore, AE management requirements are specific to each treatment. The awareness of these differences and implementation of appropriate AE management strategies in clinical practice are important to ensure the best possible outcomes for patients with HR neuroblastoma.


Subject(s)
Antineoplastic Agents , Neuroblastoma , Child , Humans , Neuroblastoma/drug therapy , Antineoplastic Agents/therapeutic use , Immunotherapy/adverse effects , Immunotherapy/methods , Combined Modality Therapy
3.
PLoS One ; 15(8): e0236706, 2020.
Article in English | MEDLINE | ID: mdl-32760146

ABSTRACT

INTRODUCTION: Due to provider shortages, it is probable that non-Latinx health care providers (HCPs) will treat Latinx patients. Because of this discrepancy, both providers and patients are likely to experience barriers and cultural differences during medical encounters. This article discusses select cultural factors and behaviors such as language, communication styles, and health care practices of Latinx families through the lens of their non-Latinx HCPs. The purpose of this study was to examine how non-Latinx HCPs perceive and describe certain behaviors they observe during healthcare visits with Latinx patients and families, and to illustrate how those behaviors can alternatively be interpreted as representing Latinx cultural norms. METHODS: This qualitative study used a template coding approach to examine narrative interviews conducted with 18 non-Latinx HCPs to report how they described interactions with and the behaviors of their Latinx patients. Template codes were based on well-established Latinx cultural norms (e.g., familismo, respeto, personalismo, simpatía, confianza). RESULTS: Many HCP descriptions of Latinx patient behaviors were coded into the Latinx cultural values categories (familismo, personalismo, simpatía, respeto, and confianza) by the research team. Results suggest that HCPs were not aware of how several of their patients' behaviors may be culturally grounded, and that cultural differences between HCPs and their Latinx patients may exist. DISCUSSION: Understanding how Latinx-specific cultural norms may be exhibited by Latinx patients and their families during healthcare encounters has potential to improve providers' understanding of patient behavior, helping to promote culturally congruent care for Latinxs.


Subject(s)
Delivery of Health Care/standards , Health Behavior/ethnology , Health Personnel/psychology , Hispanic or Latino/psychology , Qualitative Research , Adult , Family , Female , Health Equity , Humans , Income , Male , Professional-Patient Relations
4.
J Pediatr Hematol Oncol ; 42(1): 46-52, 2020 01.
Article in English | MEDLINE | ID: mdl-31725538

ABSTRACT

An exploratory study was conducted to examine the quality of life and pain experienced by patients with pediatric cancer at home after discharge. Physical, cognitive, social, and emotional aspects of quality of life were measured and how these may be affected by age, sex, diagnosis, and pain status. The authors also characterized intensity, location, and quality of pain experienced. A sample of 33 patients participating in a larger study was selected on the basis of having pain on the day of discharge and having completed the Pediatric Quality of Life Inventory Generic, Cancer Module, Multidimensional Fatigue Scale, and the Adolescent Pediatric Pain Tool at home. Cancer diagnoses were leukemias/lymphomas (42.4%), brain/central nervous system tumors (27.3%), sarcomas (24.2%), or other (6.1%). More than half of patients reported pain (n=17; 51.5%). Patients with pain had more fatigue affecting the quality of life (P=0.01), and lower physical and emotional functioning, leading to lower overall health-related quality of life scores (P=0.011). Female individuals and adolescents reported worse emotional functioning (P=0.02 and P=0.05, respectively). Physical, cognitive, and social functioning were lowest among patients diagnosed with sarcomas (P=0.00, P=0.01, and P=0.04, respectively). It is important to understand the symptom experience of patients at home as a first step in moving towards optimal discharge teaching and treatment.


Subject(s)
Fatigue , Pain , Patient Discharge , Quality of Life , Sarcoma , Adolescent , Age Factors , Child , Fatigue/physiopathology , Fatigue/psychology , Female , Humans , Male , Pain/physiopathology , Pain/psychology , Sarcoma/physiopathology , Sarcoma/psychology , Sex Factors
5.
J Pediatr Oncol Nurs ; 36(5): 321-326, 2019.
Article in English | MEDLINE | ID: mdl-31096826

ABSTRACT

Children with cancer often undergo treatments that render them severely immunocompromised. Side effects of treatment place them at risk for developing oral mucositis (OM), which can potentially lead to infection and bacteremia. Staff nurses on an inpatient pediatric oncology unit noted inconsistent daily oral hygiene practices despite assessing OM consistently. Basic oral hygiene can reduce the severity of OM, and evidence-based bundled care has shown to increase consistency of practice. Based on findings and recommendations from the literature, an oral care and hygiene bundle was developed. The oral care bundle included a soft bristled toothbrush, fluoride toothpaste, twice-daily brushing and sodium bicarbonate rinses, lip balm, and oral moisturizer. The hygiene component consisted of a daily bath or shower and daily linen changes. Education on the rationale and purpose for the use of an oral care and hygiene bundle was provided to the inpatient direct care staff prior to implementation on two inpatient oncology units. Audits were performed to measure the adherence of the oral care and hygiene bundle. Central line-associated bloodstream infections were measured in collaboration with the quality and infection prevention departments. Since the oral care and hygiene bundle was implemented, laboratory-confirmed bloodstream infection rates decreased from 1.05 to 0.54 per 1,000 catheter days, while mucosal barrier injury rates decreased from 2.98 to 1.27 per 1,000 catheter days.


Subject(s)
Bacteremia/prevention & control , Catheter-Related Infections/complications , Cross Infection/prevention & control , Infection Control/methods , Oral Hygiene/standards , Patient Care Bundles/standards , Stomatitis/prevention & control , Adolescent , Bacteremia/etiology , Catheterization, Central Venous/adverse effects , Child , Child, Preschool , Cross Infection/etiology , Female , Humans , Infant , Male , Oncology Nursing/standards , Pediatrics/standards , Practice Guidelines as Topic , Stomatitis/etiology
6.
J Pediatr Oncol Nurs ; 36(5): 337-342, 2019.
Article in English | MEDLINE | ID: mdl-31046577

ABSTRACT

Professional certification validates nurses' knowledge and expertise in their specialty. In support of professional development, nursing excellence as a Magnet® designated hospital, and commitment to improve patient outcomes, increasing the number of certified pediatric hematology oncology nurses at Children's Hospital Los Angeles is a priority. Expert certified nurses and educators assessed current staff nurse perceptions of and motivations for becoming certified. A nurse survey was completed, and the results identified barriers to certification and the need for an onsite review course to encourage more nurses to take the Certified Pediatric Hematology Oncology Nurse (CPHON®) exam. The Oncology Nursing Certification Corporation (ONCC) CPHON® test blueprint guided the development of the Children's Hospital Los Angeles review course curriculum. Certified nurse experts volunteered as course instructors to present an overview of pediatric cancer, pediatric hematology, psychosocial review, chemotherapy and related medications, and long-term effects. In addition to course didactics, interactive learning sessions were included to allow participants to question, discuss, and apply new knowledge. Sample test questions were provided to each participant for independent study post-course attendance. Each participant completed course evaluations to measure the usefulness of the content, environment, and teaching methods. Since the implementation of this course, the overall number of certified hematology oncology nurses has increased by 15.3%.


Subject(s)
Certification/standards , Hematology/standards , Neoplasms/nursing , Nursing Staff, Hospital/education , Nursing Staff, Hospital/standards , Oncology Nursing/standards , Pediatric Nursing/standards , Adolescent , Adult , Child , Child, Preschool , Curriculum , Female , Humans , Infant , Infant, Newborn , Los Angeles , Male , Middle Aged , Surveys and Questionnaires
7.
J Pediatr Health Care ; 33(4): 404-414, 2019.
Article in English | MEDLINE | ID: mdl-30846334

ABSTRACT

Malignancy- and cancer-related treatments lead to multiple symptoms. Although treatments focus on cure, few research studies have examined the symptoms that accompany these aggressive and complicated treatments. The purpose of the study was to evaluate the symptoms experienced by children at home. Children (n = 25) and adolescents (n = 33) diagnosed with cancer completed the Memorial Symptoms Assessment Scale during the 5 days at home after discharge from the hospital. The most frequent physical symptoms were fatigue (52.1%), nausea (50.7%), lack of appetite (43.7%), and pain (42.3%). The most frequent psychological symptoms were difficulty sleeping (21.1%), worrying (18.3%), feeling sad (18.3%), and feeling nervous (16.9%). Significant differences were found in the overall physical and psychosocial symptoms and Global Distress Index in patients with and without pain, fatigue, and nausea. Results indicated that physical and psychosocial symptoms and Global Distress Index increased as severity of pain, nausea, and fatigue increased. Children and adolescents were experiencing many symptoms at home but were often not reporting them.


Subject(s)
Neoplasms/psychology , Psychological Distress , Adolescent , Appetite , Child , Fatigue/etiology , Fatigue/psychology , Female , Humans , Male , Nausea/etiology , Nausea/psychology , Neoplasms/complications , Pain/etiology , Pain/psychology , Patient Discharge , Severity of Illness Index , Stress, Psychological/epidemiology , Stress, Psychological/etiology
8.
J Pediatr Oncol Nurs ; 34(3): 160-172, 2017.
Article in English | MEDLINE | ID: mdl-28061552

ABSTRACT

Neuroblastoma, an embryonic cancer of the sympathetic nervous system, is the most common extracranial solid tumor in childhood. Dinutuximab (formerly called ch14.18), a monoclonal antibody targeting the disialoganglioside GD2, has been shown to significantly improve survival rates in patients with high-risk neuroblastoma. However, the safe and effective use of dinutuximab therapy in these high-risk patients requires medical expertise in patient selection, treatment administration, and the monitoring and management of adverse events. Findings of the randomized phase III study (ANBL0032) led to the approval of dinutuximab for the treatment of children with high-risk neuroblastoma. Multi-institutional nursing approaches to implementing standard protocols ensure the effective management of high-risk neuroblastoma patients receiving dinutuximab immunotherapy. Understanding and implementing recommendations for the management of the clinically important and most common adverse events are essential to ensuring patient continuation of therapy and improving patient outcomes.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Maintenance Chemotherapy/nursing , Neuroblastoma/drug therapy , Neuroblastoma/nursing , Nurse's Role , Child , Child, Preschool , Clinical Trials, Phase III as Topic , Humans
9.
Oncol Nurs Forum ; 42(5): 498-506, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26302278

ABSTRACT

PURPOSE/OBJECTIVES: To (a) investigate fatigue and sleep patterns of children and adolescents at home and (b) examine factors associated with fatigue and sleep.. DESIGN: Descriptive with repeated measures
. SETTING: Homes of study participants in Los Angeles and Orange, California
. SAMPLE: 35 children and adolescents with cancer. METHODS: Data were collected using the PedsQL Multidimensional Fatigue Scale, which was completed once at home by each participant, and sleep actigraphs, which were worn for five days at home following discharge from hospitalization
. MAIN RESEARCH VARIABLES: General fatigue, cognitive fatigue, sleep-rest fatigue, sleep duration, sleep quantity, sleep efficiency, and wake after sleep onset
. FINDINGS: More than half of the participants had problems with fatigue at home. Significant correlations were found between sleep/rest fatigue and sleep duration. Factors that affected fatigue were age, gender, and cancer diagnosis. Adolescents had more problems with fatigue than children, and female patients had more problems with fatigue than male patients. Patients with sarcoma had more problems with fatigue than those with leukemia, lymphoma, and other cancer diagnoses. Adolescents slept less than children. CONCLUSIONS: Children and adolescents with cancer have fatigue and sleep problems at home that vary by age, gender, and cancer diagnosis
. IMPLICATIONS FOR NURSING: Data from the current study support the need for nurses to provide teaching about fatigue and sleep at home in children and adolescents with cancer. Future studies are needed to examine interventions that may alleviate fatigue and improve sleep at home
.


Subject(s)
Fatigue/etiology , Neoplasms/complications , Sleep Wake Disorders/etiology , Adolescent , Child , Female , Humans , Male
10.
J Pediatr Oncol Nurs ; 30(1): 18-23, 2013.
Article in English | MEDLINE | ID: mdl-23118023

ABSTRACT

Pediatric hematology oncology nurses face a variety of stressors while working in this specialty field. Through hematology oncology staff group discussions, nurses identified a myriad physical and emotional stressors they experienced, and expressed concern regarding possible burnout. They described facing stressors related to experiencing loss, grief, moral and ethical dilemmas, and administering complex treatment regimens. To address these concerns, a hematology oncology nursing supportive care committee envisioned and implemented 3 off-site self-care retreats. The committee's primary purpose was to create a therapeutic and supportive environment for all participants, while allowing time for relaxation, reflection, and serenity. The primary goals for the retreats were to heal nurses from their reported past trauma and stress and to provide them effective coping strategies for the ongoing stressors they will inevitably face. In a collaborative effort, the committee members developed an agenda including presentations, group discussions, and relaxation activities. Written evaluations were completed by each participant to assess the benefit of the retreat. Overall feedback was extremely positive, with the majority of the participants finding great value in this experience.


Subject(s)
Burnout, Professional/therapy , Hematologic Neoplasms/nursing , Nursing Staff, Hospital/psychology , Oncology Nursing , Self Care , Adaptation, Psychological , Humans , Workforce
11.
J Pediatr Oncol Nurs ; 29(6): 307-15, 2012.
Article in English | MEDLINE | ID: mdl-23087249

ABSTRACT

BACKGROUND: Treatment for most children with cancer includes the use of a central venous catheter (CVC). CVCs provide reliable venous access for delivery of chemotherapy and supportive care. This advantage is mitigated by an increased risk of bloodstream infections (BSIs). Despite the ubiquitous use of CVCs, few prospective studies have been conducted to address infection prevention strategies in pediatric oncology patients. DESIGN: Prospective, crossover pilot study of a CVC team intervention versus standard care. SETTING: Two inpatient oncology units in a metropolitan children's hospital. PATIENTS: A total of 41 patients/135 admissions for the experimental unit (EU) and 41/129 admissions for the control unit (CU). METHODS: Patients received a CVC blood draw bundle procedure by a CVC registered nurse (RN) team member (experimental intervention: EU) for 6 months and by the assigned bedside RN (standard care: CU) for 6 months. Feasibility of implementing a CVC RN team; a significant difference in CVC-related BSIs between the team intervention versus standard care and risk factors associated in the development of CVC-related BSIs were determined. RESULTS: There were 7 CVC-related BSIs/1238 catheter days in the EU group (5.7/1000 catheter days) versus 3 CVC-related BSIs/1419 catheter days in the CU group (2.1/1000 catheter days; P = .97). Selected risk factors were not significantly associated with the development of a CVC-related BSI. CONCLUSIONS: A CVC team in the care of pediatric oncology patients is feasible; however, a larger cohort will be required to adequately determine the effectiveness of the team reducing CVC-related BSIs.


Subject(s)
Catheterization, Central Venous/adverse effects , Neoplasms/therapy , Sepsis/prevention & control , Child , Cross-Over Studies , Female , Hospitals, Pediatric , Humans , Male , Neoplasms/complications , Pilot Projects , Prospective Studies , Sepsis/complications
12.
J Pediatr Oncol Nurs ; 29(1): 14-27, 2012.
Article in English | MEDLINE | ID: mdl-22367766

ABSTRACT

Reducing or eliminating hospital acquired infections is a national quality of care priority. The majority of the 12,400 children diagnosed with cancer each year require long-term intravenous access to receive intensive and complex therapies. These children are at high risk for infection by nature of their disease and treatment, which often involves use of a central venous catheter (CVC). Throughout the nation, nurses assume frontline responsibility for safe, quality CVC care to minimize the risk of potentially life-threatening infections. Substantial financial and human costs are associated with CVC-related bloodstream infections, including prolonged hospital lengths of stay and increased care required to treat these infections. The purpose of this review of the literature is to summarize existing adult and pediatric data on CVC-related bloodstream infections and explore nursing models of CVC care that may improve pediatric oncology patient outcomes.


Subject(s)
Catheter-Related Infections/prevention & control , Catheterization, Central Venous/nursing , Cross Infection/prevention & control , Neoplasms/nursing , Adult , Catheter-Related Infections/etiology , Catheterization, Central Venous/adverse effects , Child , Cross Infection/etiology , Humans , Models, Nursing , Oncology Nursing , Pediatric Nursing
13.
J Nurs Care Qual ; 27(3): 218-25, 2012.
Article in English | MEDLINE | ID: mdl-22269906

ABSTRACT

The primary objective of this study was to test the feasibility of creating a central venous catheter blood draw bundle checklist to ensure adherence to the evidence-based blood draw procedure. This study included establishing checklist reliability and validity and periodic observations in 2 inpatient pediatric oncology units. The findings provided support for the reliability and validity of this checklist based on content validity, test-retest reliability, interrater agreement, and internal consistency and reinforced the need for periodic observations to ensure consistency in proper central venous catheter blood draw procedures.


Subject(s)
Catheterization, Central Venous , Checklist , Guideline Adherence/statistics & numerical data , Neoplasms/nursing , Phlebotomy/methods , Phlebotomy/nursing , Quality Assurance, Health Care/organization & administration , Bacteremia/etiology , Bacteremia/prevention & control , Catheter-Related Infections/etiology , Catheter-Related Infections/prevention & control , Catheterization, Central Venous/adverse effects , Child , Cross Infection/etiology , Cross Infection/prevention & control , Evidence-Based Practice , Feasibility Studies , Hospital Units , Humans , Nursing Evaluation Research , Oncology Nursing , Pediatric Nursing , Pilot Projects , Practice Guidelines as Topic , Prospective Studies , Reproducibility of Results
14.
Adv Neonatal Care ; 10(3): 133-9, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20505423

ABSTRACT

Teratomas belong to a class of tumors known as germ cell tumors. Cervical teratomas are rare and account for 1.5% to 5.5% of all pediatric teratomas. These types of tumors are the result of abnormal development of pluripotent cells. The following case study describes a 36-week male infant who was prenatally diagnosed with a large cervical mass. The neonate was delivered via the EXIT (ex utero intrapartum treatment) procedure, with expert teams present. After stabilization, the infant was transferred to the neonatal intensive care unit (NICU) at Children's Hospital Los Angeles. The teratoma was removed on day of life 5. The pathology report indicated a malignant germ cell tumor. A chemotherapy regimen was developed for this critically ill neonate in the NICU. An interdisciplinary treatment approach allowed safe and optimal quality of care. Baby CM was discharged on day of life 88 without complications and continues to be cancer free and at home thriving.


Subject(s)
Head and Neck Neoplasms/surgery , Infant, Premature, Diseases/surgery , Teratoma/surgery , Antineoplastic Agents/therapeutic use , Chemotherapy, Adjuvant , Delivery, Obstetric/methods , Head and Neck Neoplasms/diagnosis , Head and Neck Neoplasms/etiology , Humans , Infant, Newborn , Infant, Premature, Diseases/diagnosis , Infant, Premature, Diseases/etiology , Intensive Care, Neonatal , Intubation, Intratracheal , Male , Patient Care Team , Prognosis , Teratoma/diagnosis , Teratoma/etiology , Treatment Outcome , Ultrasonography, Prenatal
15.
J Pediatr Hematol Oncol ; 32(4): 327-31, 2010 May.
Article in English | MEDLINE | ID: mdl-20445421

ABSTRACT

INTRODUCTION: Surveillance blood cultures (BCs) are often obtained in hematopoietic stem cell transplant (HSCT) patients for earlier detection of blood stream infections (BSI). The major aim of this study was to determine the utility of the current practice of obtaining surveillance blood cultures from asymptomatic transplant patients upon admission for the preparative regimen. METHODS: We conducted an 8-year retrospective study of all patients consecutively admitted to the hospital for a HSCT from 2000 to 2008. RESULTS: In this retrospective analysis, surveillance BCs from 191 eligible patients were analyzed. The incidence of definitive BSIs was 0.52% (1/191) with 6 BCs from other HSCT patients growing probable contaminants. The overall incidence of positive surveillance BCs was 2.9% (7/238) for the BCs taken and 3.7% (7/191) for patients cultured with coagulase negative staphylococcus being isolated from 6 of the 7 patients. The probability of increased BSI after transplantation in patients with initial positive surveillance BCs compared with those having negative BCs, was not significant (P=0.675). No infection-related mortality was observed during the first 60 days posttransplantation in these patients. CONCLUSIONS: The frequency of positive surveillance BCs in asymptomatic HSCT patients at the time of hospital admission for transplant seems to be extremely low. These results, if confirmed by larger studies, show the reduced utility of obtaining surveillance BC in asymptomatic patients before administration of the conditioning regimen and the need for re-evaluation of this practice.


Subject(s)
Bacteremia/blood , Bacteremia/prevention & control , Blood-Borne Pathogens/isolation & purification , Blood/microbiology , Hematopoietic Stem Cell Transplantation , Infection Control , Adolescent , Bacteremia/etiology , Child , Child, Preschool , Female , Humans , Infant , Male , Neoplasms/blood , Neoplasms/microbiology , Neoplasms/therapy , Population Surveillance , Retrospective Studies
16.
Pediatr Blood Cancer ; 53(6): 978-83, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19637330

ABSTRACT

BACKGROUND: Despite the increasing cure rates for children with acute lymphoblastic leukemia (ALL), patients who relapse continue to have poor prognosis. The Children's Oncology Group (COG) conducted a limited institution Phase II trial of Campath-1H, a monoclonal antibody that targets CD52 on leukemic cells, in children with relapsed or refractory ALL. METHODS: From October 2005 to December 2006, 13 eligible patients were enrolled on the COG phase II study of Campath-1H (ADVL0222). Campath-1H was initially administered as an intravenous infusion over 2 hr, five times per week for 1 week, then three times per week for three additional weeks. Patients with stable disease or better on day 29 could continue on to combination therapy with Campath-1H, methotrexate, and 6-mercaptopurine for two additional cycles. RESULTS: One of 13 patients enrolled had a complete response to Campath-1H and 4 had stable disease. Dose limiting toxicity occurred in two out of nine fully evaluable patients (Grade IV pain and Grade III allergic reaction/hypersensitivity). No patients received combination therapy. Serum Campath-1H concentrations appeared to be somewhat lower in children with ALL compared with adult patients with chronic lymphocytic leukemia. CONCLUSION: Although a single complete response was observed, activity of single agent Campath-1H appears limited. Our study does not support future single agent evaluation of Campath-1H in children with relapsed ALL.


Subject(s)
Antibodies, Monoclonal/administration & dosage , Antibodies, Neoplasm/administration & dosage , Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy , Adolescent , Alemtuzumab , Antibodies, Monoclonal/pharmacokinetics , Antibodies, Monoclonal/toxicity , Antibodies, Monoclonal, Humanized , Antibodies, Neoplasm/toxicity , Antineoplastic Agents/administration & dosage , Child , Child, Preschool , Female , Humans , Male , Precursor Cell Lymphoblastic Leukemia-Lymphoma/diagnosis , Salvage Therapy , Treatment Failure , Treatment Outcome , Young Adult
17.
Br J Haematol ; 128(1): 49-58, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15606549

ABSTRACT

Thrombocytopenia remains the major dose-limiting toxicity of myelosuppressive chemotherapy in children with solid tumours. Recombinant human interleukin-11 (rhIL-11) has been approved by the Food and Drug Administration as treatment for adults with solid tumours and lymphomas with severe chemotherapy-induced thrombocytopenia. We conducted a phase I/II trial of rhIL-11 following ifosfamide, carboplatin and etoposide (ICE) chemotherapy in children with solid tumours or lymphomas. Patients received ifosfamide 1800 mg/m(2)/d for 5 d, carboplatin 400 mg/m(2)/d for 2 d and etoposide 100 mg/m(2)/d for 5 d with rhIL-11 subcutaneous (s.c.) at 25-125 microg/kg/d on days 6-33. Forty-seven patients with median age 10.5 years (range, 0.7-26 years) were studied. Median days to absolute neutrophil count >/=0.5 x 10(9)/l, platelet count >/=50 x 10(9)/l and platelet transfusions were 23, 18, 18, 16.5 and 18.5, 21, 20, 18 and 3, 3, 4, and 2 d at doses 25, 50, 75 and 100 Schulteg/kg respectively. There was a dose-dependent increase in C(max) (7.6-25.5 ng/ml), AUC(0-rho) (57-209 ng.h/ml) and T(1/2) (4-8.2 h) respectively. There was a 4% incidence of anti-IL-11 antibody formation. Clinically important adverse events to rhIL-11 were papilloedema and periosteal bone formation. In summary, rhIL-11 was well tolerated at doses of

Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Interleukin-11/administration & dosage , Neoplasms/drug therapy , Thrombocytopenia/therapy , Adolescent , Adult , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/administration & dosage , Carboplatin/adverse effects , Child , Child, Preschool , Drug Administration Schedule , Etoposide/administration & dosage , Etoposide/adverse effects , Female , Humans , Ifosfamide/administration & dosage , Ifosfamide/adverse effects , Infant , Interleukin-11/pharmacokinetics , Interleukin-11/therapeutic use , Lymphoma/blood , Lymphoma/drug therapy , Lymphoma/immunology , Male , Neoplasms/blood , Neoplasms/immunology , Platelet Count , Recombinant Proteins/administration & dosage , Recombinant Proteins/therapeutic use , Thrombocytopenia/blood , Thrombocytopenia/chemically induced
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