Hypoalbuminemia in children with cancer treated with chemotherapy.

BACKGROUND: Hypoalbuminemia is a well-recognized finding associated with cancer, but its prevalence and prognostic significance have not been well studied in children with cancer. OBJECTIVE: To determine the prevalence of hypoalbuminemia prior to starting chemotherapy in children with cancer and its association with relapse-free survival (RFS) and overall survival (OS). DESIGN/METHOD: We performed a single institution, IRB-approved, retrospective review of pediatric oncology patients diagnosed between 1998 and 2012. Five-year survival was estimated using the Kaplan-Meier method; groups were compared using Cox regression. RESULTS: We identified 659 pediatric patients with a first diagnosis of cancer and a serum albumin level prior to starting chemotherapy. Mean age was 8.6 years (SD = 5.8); 62% were male and 92% were non-Hispanic. Hypoalbuminemia prior to starting chemotherapy was present at least once in 302 (45.8%). The five-year RFS and OS of those with hypoalbuminemia and without hypoalbuminemia were not significantly different. However, patients with severe hypoalbuminemia (defined as a value 10% or more below the lower limit of normal) had inferior RFS and OS for patients with hematologic/lymphatic malignancies, and inferior RFS for patients with metstatic Ewing sarcoma. CONCLUSION: Hypoalbuminemia prior to starting chemotherapy in pediatric oncology patients is common (nearly half in this cohort). Severe hypoalbuminemia was associated with inferior 5-year RFS in some subgroups.

Effect of a Daily Text Messaging and Directly Supervised Therapy Intervention on Oral Mercaptopurine Adherence in Children With Acute Lymphoblastic Leukemia: A Randomized Clinical Trial.

Importance: Suboptimal adherence to oral mercaptopurine treatment in children with acute lymphoblastic leukemia (ALL) increases the risk of relapse. A frequently expressed barrier to adherence is forgetfulness, which is often overcome by parental vigilance. Objective: To determine whether a multicomponent intervention, compared with education alone, will result in a higher proportion of patients with ALL who have mercaptopurine adherence rates 95% or higher, for all study participants and among patients younger than 12 years and vs those aged 12 years and older. Design, Setting, and Participants: The adherence intervention trial was an investigator-initiated, multi-institutional, parallel-group, unblinded, randomized clinical trial conducted between July 16, 2012, and August 8, 2018, at 59 Children's Oncology Group institutions in the US, enrolling patients with ALL diagnosed through age 21 years and receiving mercaptopurine for maintenance. The date of final follow-up was January 2, 2019. Data analysis was performed from February to October 2019. Interventions: Patients were randomized 1:1 to education alone or the intervention package, which consisted of education and personalized text message reminders daily to prompt directly supervised therapy. Four weeks of baseline adherence monitoring were followed with a 16-week intervention. Main Outcomes and Measures: The primary end point was the proportion of patients with adherence rates 95% or higher over the duration of the intervention for all study participants, and for those younger than 12 years vs those aged 12 years and older. Results: There were 444 evaluable patients (median age, 8.1 years; interquartile range, 5.3-14.3 years), including 230 in the intervention group and 214 in the education group. Three hundred two patients (68.0%) were boys, 180 (40.5%) were non-Hispanic White, 170 (38.3%) were Hispanic, 43 (9.7%) were African American, and 51 (11.5%) were Asian or of mixed race/ethnicity. The proportion of patients with adherence rates 95% or higher did not differ between the intervention vs education groups (65% vs 59%; odds ratio, 1.33; 95% CI, 1.0-2.0; P = .08). Exploratory analyses showed that among patients aged 12 years and older, those in the intervention group had higher mean (SE) adherence rates than those in the education group (93.1% [1.1%] vs 90.0% [1.3%]; difference, 3.1%; 95% CI, 0.1%-6.0%; P = .04). In particular, among patients aged 12 years and older with baseline adherence less than 90%, those in the intervention group had higher mean (SE) adherence rates than those in the education group (83.4% [2.5%] vs 74.6% [3.4%]; difference, 8.8%; 95% CI, 2.2%-15.4%; P = .008). No safety concerns were identified. Conclusions and Relevance: Although this multicomponent intervention did not result in an increase in the proportion of patients with ALL who had mercaptopurine adherence rates 95% or higher, it did identify a high-risk subpopulation to target for future adherence intervention strategies: adolescents with low baseline adherence. Trial Registration: ClinicalTrials.gov Identifier: NCT01503632.