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SUPPORTIVE CARE TO MINIMIZE EARLY DEATH DURING INDUCTION FOR PEDIATRIC PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL); A REPORT FROM THE CHILDREN’S ONCOLOGY GROUP TRIAL AAML1331
- Matthew A. Kutny, United States of America
- Todd Alonzo, United States of America
- Robert Gerbing, United States of America
- Yi-Cheng Wang, United States of America
- Alan Gamis, United States of America
- E. Anders Kolb, United States of America
- Oussama Abla, Canada
- James Feusner, United States of America
- John Gregory, United States of America
- Madhvi Rajpurkar, United States of America
Abstract
Background and Aims
Acute promyelocytic leukemia (APL) has high cure rates but an increased risk of early death during induction. Here we report that the Children’s Oncology Group (COG) AAML1331 trial had a very low early death rate when using enhanced and detailed supportive care measures.
Methods
COG AAML1331 eligibility included age 1-21.99 years with standard risk (SR; WBC<10,000/µL) and high risk (HR; WBC≥10,000/µL) newly diagnosed, PCR confirmed APL. Induction included ATRA 12.5mg/m^2/dose BID and ATO 0.15mg/kg daily starting Day 1 for 28-70 days (until hematologic CR); HR patients also received idarubicin 12mg/m^2 ×4 doses. With each enrollment, the site PI received email alert regarding supportive care with direct contact of study committee experts to discuss complications.
Results
There were 156 patients (100 SR, 56 HR) evaluable during induction. There was one (0.6%) induction death. This compared favorably to the 4% (4/101) induction death rate on the preceding COG APL trial AAML0631 (P=0.08).
In contrast to AAML0631, ATRA pre-treatment was encouraged at first suspicion of APL. To prevent differentiation syndrome (DS), dexamethasone 2.5mg/m^2/dose twice daily on days 1-14 for all HR APL and for SR APL when WBC rose to >10,000/µL (hyperleukocytosis). DS was reported in 24% (24/100) SR APL and 30.4% (17/56) HR APL. Hyperleukocytosis in SR APL also required hydroxyurea 30mg/kg/dose (maximum 1000mg/dose) 4 times daily. DS required temporary holding ATRA/ATO and starting dexamethasone 5.8mg/m^2/dose (maximum 10mg/dose) IV q12h for minimum 3 days. Coagulopathy surveillance was required and treatment included maintaining platelet count >50,000/µL, fibrinogen >150 mg/dL, and PT and PTT within normal range. Inpatient hospitalization was strongly recommended until induction day 15, WBC <10,000 and resolution of complications.
Conclusions
Our experience on AAML1331 suggests that detailed and aggressive supportive care as well as direct communication with national disease experts can help minimize early death events in pediatric APL.
CRITICAL DETERIORATION AS A QUALITY METRIC FOR HOSPITALIZED PEDIATRIC ONCOLOGY PATIENTS IN LATIN AMERICA: A MULTICENTER STUDY
- Asya Agulnik, United States of America
- Adolfo Cárdenas, Mexico
- Angela K. Carrillo, United States of America
- Purva Bulsara, United States of America
- Marcela Garza, United States of America
- Yvania Alfonso Carreras, Haiti
- Manuel Alvarado, Panama
- Patricia J. Calderón, Nicaragua
- Rosdali Díaz, Peru
- Claudia De León, Guatemala
- Claudia Del Real, Mexico
- Tania Huitz, Mexico
- Angélica Martínez, Mexico
- Scheybi Miralda, Honduras
- Erika Montalvo, Ecuador
- Octavia Negrín, Dominican Republic
- Alejandra Osuna, Mexico
- Clara K. Perez Fermin, Dominican Republic
- Estuardo Pineda, El Salvador
- Dora Soberanis, Guatemala
- Maria Susana Juárez Tobias, Mexico
- Zhaohua Lu, United States of America
- Carlos Rodriguez-Galindo, United States of America
Abstract
Background and Aims
Hospitalized pediatric hematology-oncology (PHO) patients have frequent deterioration requiring Intensive Care Unit (ICU) interventions, particularly in resource-limited settings. Critical deterioration (CD), defined as an unplanned ICU transfer requiring life-sustaining interventions within 12 hours, is a pragmatic metric to evaluate the quality of hospital care, however, it has not been investigated in settings with resource limitations. This study evaluates CD as a quality metric in PHO patients hospitalized in Latin America and the Caribbean.
Methods
In 2017, we implemented a prospective registry of deterioration events among hospitalized PHO patients, defined as unplanned transfer to a higher level-of-care, the use of ICU-level interventions on the floor, or a floor non-palliative death, in 16 collaborating pediatric cancer centers in 10 countries in the region. Monthly PHO hospital admissions and hospital-inpatient-days were also reported. CD was defined as above including use of ICU-level intervention on the floor. We report the analysis of the first year of data collection (June 2017-May 2018).
Results
In the 12 months of data collection, 553 deterioration events were reported in hospitalized PHO patients among 119,414 inpatient-days, with 309 (59%) meeting criteria for CD, representing a rate of 2.59/1000-inpatient-days, and occurring more frequently than floor cardiopulmonary arrests (0.68/1000-inpatient-days). Controlling for multiple sampling, patients with CD had higher event mortality (41.1% vs 13.1%, p<0.001), fewer median ICU-free-days (7 vs 28, p<0.001), ventilator-free-days (13 vs 28, p<0.001), and vasoactive-free-days (16 vs 28, p<0.001). Centers with higher rates of CD had higher rates of event mortality (p=0.009).
Conclusions
In PHO patients hospitalized in resource-limited settings, CD is over 3 times more common than floor cardiopulmonary arrests and associated with higher mortality and fewer event-free-days. Center rates of CD are associated with event mortality rates. CD represents a useful metric to assess the quality of care for hospitalized PHO patients in these settings.
REDUCING PAIN IN CHILDREN WITH CANCER AT HOME A FEASIBILITY OF THE KLIK PAIN MONITOR APP
Abstract
Background and Aims
We developed a mobile app allowing families of children with cancer to report pain at home, enabling healthcare professionals (HP’s) to offer timely support. We assessed feasibility of, and adherence to the app, as well as user experiences and determinants of implementation.
Methods
Children with cancer (0-18 years, all diagnoses) used the app at home for three weeks. Children or parent(s) reported pain scores (Numerical Rating Scale) twice daily. When pain was clinically significant (4 or higher), families were contacted by a HP within 120 minutes (scores 4-6) or within 30 minutes (scores 7-10). After using the app, children/parents and HP’s completed a feasibility questionnaire and were interviewed about their experiences. Adherence was assessed using log-data. Determinants of implementation (from the HP’s point of view) were assessed with questionnaires.
Results
Twenty-seven children (M age = 7.3 years, 51.8% male, response rate 68%) and six HP’s participated.
Feasibility questionnaires revealed that families and HP’s find the app learnable, usable, and desirable.
Sixty-three percent of families (N=17) used the app for the required three weeks, and 37% (N=10) used the app for a shorter period (Min=7 days; Max=37 days; Mean=21 days). Only 18.5% (N=5) of families adhered in reporting pain twice daily for three weeks. Of the total of 976 reported NRS scores, twenty clinically significant pain scores were reported by twelve families (2%). In 30% of cases (N=6 out of 20), families were not called within the set timeframe due to the daily workload (HP adherence = 70%).
Experiences with the app were generally positive, yet barriers are anticipated for implementation in a larger group due to HP’s high workload.
Conclusions
First results of the app seem promising, yet barriers must be addressed. We are currently planning a RCT to assess effectivity of the app in reducing pain at home in children with cancer.
STRESS AND PERCEPTION OF PROCEDURAL PAIN MANAGEMENT IN CHINESE PARENTS OF CHILDREN WITH CANCER
Abstract
Background and Aims
Children with cancer are exposed to treatment-related pain and invasive procedures. This study examines Chinese parents’ stress and perception towards procedural pain control in children with cancer.
Methods
We recruited 265 parents (72.8% mothers, age 36.5[6.8] years) of children with hematological cancer (74.7%) and solid tumors (25.3%) from ambulatory clinics of two major public hospitals in Hong Kong and Guangzhou, China. Both hospitals have similar pain control measures, which typically include midazolam, ketamine and opioids. Parents used a scale (0–10) to rate perceived pain experienced by their child when undergoing lumbar puncture (LP), bone marrow (BM) aspirate or/and biopsy. They reported their stress level and perception of analgesics using the adapted Pain Flexibility Scale for Parents (PFS) and Parental Medication Attitude Questionnaire (Parental-MAQ). Multiple linear regression was used to identify factors associated with perception variables.
Results
Results on the PFS showed that parents were worried (31.7%) and had difficulty with concentration (57.7%) when the child was in pain. Among parents whose children had undergone a LP (n=207), 39.1% perceived that their child still experienced severe pain (pain score≥7) even with existing pain control measures, while 42.9% indicated suboptimal pain control with child’s BM biopsy (n=156). Responses on the Parental-MAQ revealed parents’ concerns or misconception over the use of analgesics, such as fear of side effects (69.4%) and addiction (44.9%), and that analgesics should only be reserved for severe pain (47.2%) or should be avoided (55.1%). After adjusting for child's age and diagnosis, parents who were older (β=-0.32; P<0.001) and attained ≤ high school education (β=0.38; P<0.001) had poorer perception of analgesics. Higher parental stress was associated with fear and avoidance of analgesics (P=0.0052).
Conclusions
Subgroups of Chinese parents demonstrated distress over their child’s pain and misconceptions over the use of analgesics. Future work includes devising culturally-relevant stress relief and education interventions for these parents.
PREVALENCE AND PREDICTORS OF HIGH-INTENSITY END-OF-LIFE CARE AMONG ADOLESCENTS AND YOUNG ADULTS WITH CANCER IN ONTARIO: A POPULATION-BASED STUDY USING THE IMPACT COHORT
Abstract
Background and Aims
Adolescents and young adults (AYA) with cancer may experience elevated rates of high-intensity (HI) care at the end-of-life (EOL) and consequently, increased suffering. Population-based studies are limited by incomplete clinical information. Locus of care (LOC – pediatric vs. adult) disparities in AYA EOL care are unstudied.
Methods
Retrospective decedent population-based cohort study of Ontario AYA diagnosed 1992-2012 at 15-21 years of age with 6 prevalent cancers. Chart-abstracted clinical data were linked to administrative data. The primary composite outcome (HI-EOL care) included: intravenous chemotherapy ≤14 days from death; or >1 emergency department visit, hospitalization, or intensive care unit (ICU) admission ≤30 days from death. Secondary outcomes included measures of most invasive (MI) EOL care: ventilation ≤14 days from death, and death in ICU. Factors associated with HI-EOL were examined.
Results
Of 483 patients, 60.5% experienced HI-EOL care, 20.3% were ventilated ≤14 days from death, and 22.8% died in the ICU. Patients with hematological malignancies (vs. solid tumors) were at greatest risk of HI-EOL care (OR, 2.3; 95CI, 1.5-3.5, p<0.01), ventilation (OR, 5.4; 95CI, 3.0-9.7, p<0.01), and death in an ICU (OR, 4.9; 95CI, 2.8-8.5, p<0.01). AYA who died in pediatric centers were more likely to experience MI-EOL measures compared to those dying in adult centers (ventilation, OR 3.2, 95CI 1.3-7.6, p=0.01). Assessment of interactions showed LOC-based disparities widening over time. AYA living in rural areas were also at higher risk of experiencing mechanical ventilation (OR, 2.0; 95CI, 1.0-3.8, p=0.04) and death in ICU (OR, 2.1; 95CI, 1.1-4.0, p=0.02).
Conclusions
AYA with cancer experience high rates of HI-EOL care, with patients in pediatric centers and those living in rural areas at highest risk of MI-EOL care. Our study is the first to identify LOC-based disparities in AYA EOL care. Future studies should explore mechanisms underlying these disparities.
INTEGRATED PALLIATIVE CARE SERVICES WITHIN A PEDIATRIC HEMATOLOGY-ONCOLOGY PROGRAM IN MALAWI, 2017-2020
Abstract
Background and Aims
In sub-Saharan Africa (SSA), childhood cancer affects over 100,000 children annually. Palliative care services are essential as poor outcomes arise from delayed presentation with advanced disease. While palliative care is a human right, equitable distribution is generally lacking with only 4% of African countries reporting services for noncommunicable diseases. We aim to describe the distribution of patients who were served by the pediatric hematology-oncology (PHO) palliative care program in Lilongwe, Malawi.
Methods
IRB-approved retrospective three-year review (2017- 2020) of Texas Children’s Hospital Global HOPE (Hematology-Oncology Pediatric Excellence) palliative care program in Lilongwe, Malawi. The team utilizes a multidisciplinary approach to address physical, social, psychosocial, and spiritual needs. Services include inpatient, outpatient, end-of-life care, home visits, strengthening of referral systems by outreach and capacity building, and family-centered education.
Results
Over a 3-year period, 315 patients were enrolled. Of these, 57% (n=179) were male. The median age was 7 years (5 months - 22 years). Patients came from 17 out of 28 districts within Malawi. Diagnoses were distributed as follows: 43% solid tumors (n=135), 22% lymphoma (n=68), 15% leukemia (n=47) and 21% had benign hematologic disease (n=65). A total of 100 home visits were conducted. Forty percent of patients have died (n=125), with 22% of deaths occurring in the hospital (n=28), 53% at home (n=66), and 25% at an unknown location (n=31).
Conclusions
Palliative care is a critical component of PHO programs worldwide, particularly in SSA. As PHO programs are mainly based in tertiary hospitals serving large regions of the country, programs should leverage existing networks to ensure optimal care to children and their families. At the wish of guardians, most deaths occurred in home-based settings with program support provided. This Global HOPE program serves as a model in SSA.