Intravenous Fosaprepitant Versus Oral Aprepitant for Children Receiving Highly Emetogenic Chemotherapy: An Investigator‐Initiated Randomized, Open‐Label, Non‐Inferiority Trial
ABSTRACT Background Fosaprepitant is non‐inferior to aprepitant in adults receiving highly emetogenic chemotherapy (HEC). We evaluated whether fosaprepitant is non‐inferior to aprepitant in children receiving HEC. Methods In this open‐label, non‐inferiority trial, children aged 5–18 years, receiving their first cycle of HEC, were randomized 1:1 to the fosaprepitant or aprepitant group. The fosaprepitant group received a single intravenous dose of 4 mg/kg (max 150 mg). The aprepitant group received oral aprepitant capsules (weight 15 to <30 kg: 80 mg Days 1–3; weight ≥30 kg, or age ≥12 years: 125 mg Day 1, 80 mg Days 2 and 3). Both groups received ondansetron and dexamethasone. The primary outcome was the complete response (CR) rate of vomiting during the acute phase (AP) with a non‐inferiority margin of 15%. Secondary outcomes included CR rates in the delayed (DP) and overall phases (OP), grade of vomiting, incidence and severity of nausea, and adverse effects. Results A total of 279 children were included in the modified intention‐to‐treat analysis (fosaprepitant group: 140; aprepitant group: 139). In AP, the difference of CR rate between fosaprepitant [76 (54.3%)] and aprepitant groups [84 (60.4%)] was −6.1% [90% CI: −15.7% to +3.6%], with the lower limit exceeding −15%, failing to establish non‐inferiority. The CR rate with fosaprepitant versus aprepitant was 62.1% ( n = 87) versus 65.5% ( n = 91) in DP (difference: –3.4%; 90% CI: –12.7% to 6.1%) and 42.9% ( n = 60) versus 49.6% ( n = 69) in the OP (difference: –6.7%; 90% CI: –16.5% to 3.1%). Grade of vomiting, incidence and severity of nausea, and adverse effects were similar between the two groups. Conclusions Non‐inferiority of fosaprepitant compared to aprepitant was not demonstrated in children undergoing their first cycle of HEC. Trial Registration Clinical Trials Registry, India (CTRI/2019/05/019082).
Impact of Gender of the Child on Health Care–Seeking Behavior of Caregivers of Childhood Patients With Cancer: A Mixed-Methods Study
PURPOSE Gender bias against girls may affect health-seeking behavior and outcomes of childhood cancer. This study aimed to study the nature and extent of gender bias in health care among caregivers of childhood patients with cancer and also in community. METHODS This cross-sectional mixed-methods study was conducted in a tertiary cancer hospital and an urban community between July 2021 and July 2023. Qualitative component included 26 in-depth interviews (IDI) and four focus group discussions (FGDs) with caregivers of children with cancer. IDIs and FGDs were conducted by a psychologist and continued until thematic saturation was reached. For quantitative part, a gender-bias questionnaire was finalized which was administered to 230 caregivers in hospital and 311 participants from the community, with children in family. RESULTS Most participants did not perceive personal gender bias; however, many acknowledged noticing gender bias in others. This bias was linked to girls being considered financial burdens and having reduced marital prospects due to illness. Reducing treatment costs, improving access, and education targeting societal mindsets were suggested measures to mitigate bias. In community, no significant difference was observed among the respondents based on sex of youngest child in family. However, in hospital, caregivers of male children were less likely to offer similar care to a child of opposite sex than that reported by caregivers of female children ( P = .01) for ailments like fever/diarrhea. Similar difference was not observed for other health care scenarios. CONCLUSION Gender bias against girls, including that in health care access, is influenced by societal norms. Even with little personal perception of bias, there was a significant perceived bias observed in others by the participants. This study identified the existence of gender bias affecting health care choices, including cancer care.
The Utility and Impact of Telemedicine in Childhood Cancer Care: A Mixed Methods Study
ABSTRACTBackgroundWhile teleconsultation has proven feasible for adult cancer patients, its utility in childhood cancer care in India is unknown. This study assesses caregiver satisfaction, feasibility, and the economic impact of teleconsultation for children with cancer.ProcedureThis mixed methods study was conducted in the pediatric cancer outpatient service at a tertiary care cancer center in India. Routine care teleconsultations were performed via telephone or email. Caregivers who received teleconsultations during the study period or 6 months prior were interviewed by phone. Data collected included demographic details, teleconsultation usage patterns, caregiver satisfaction, reasons for satisfaction or dissatisfaction, and cost savings. Logistic regression identified baseline characteristics associated with satisfaction. In‐depth interviews were conducted in a separate cohort till thematic saturation.ResultsCaregivers of 465 children were included for telephonic and eight for in‐depth interviews Among the respondents, 72.8% (n = 339) were satisfied with teleconsultation, and 85.4% (n = 397) of those planned to continue using it. Significant reasons for satisfaction were cost and time savings, while difficulty explaining issues caused dissatisfaction. Multivariable analysis showed parental education above high school [OR: 1.59, p = 0.035] increased satisfaction likelihood, while a residential distance of greater than 100 km from the hospital [OR: 0.62, p = 0.033] decreased it. Median cost savings per visit was $24.2 (range: $1–$846). Cost savings did not determine satisfaction magnitude. Frequently cited themes included cost and time savings and the need for literacy to benefit from teleconsultation.ConclusionsTeleconsultation is feasible and effective for routine childhood cancer care, even in resource‐constrained settings.