Pediatr Blood Cancer 2014;61:1111–1113
BRIEF REPORT Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients: A Prospective, Observational Study Megan Bodge,
PharmD,
1
* Alexandra Shillingburg,
PharmD,
Pediatric patients between the ages of 12 months and 17 years with a confirmed malignancy who were scheduled to receive aprepitant as part of triple therapy antiemetic prophylaxis for a cycle of moderately- or highly emetogenic chemotherapy were eligible for enrollment. Patients were evaluated for the incidence of nausea, episodes of emesis, interference with activities of daily living (ADLs),
Key words:
Stephan Paul,
MD,
3
and Lisa Biondo,
PharmD, BCPS
2
and appetite through utilization of a patient survey. Eleven patients were enrolled for a total of 20 patient encounters, mean age 9.55 4.85 (range, 12 months–17 years). Aprepitant was welltolerated and complete response (CR) rate was 38.9%. Pediatr Blood Cancer 2014;61:1111–1113. # 2013 Wiley Periodicals, Inc.
aprepitant; antiemetic; children; nausea and vomiting; nutrition; supportive care
INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) remains a significant problem in pediatric patients receiving chemotherapy. CINV has a profound impact on quality-of-life and has the potential to impact nutritional status and activities of daily living (ADLs) [1]. Current standard of care in adult patients receiving highly- or moderately-emetogenic chemotherapy is a prophylactic tripletherapy anti-emetic regimen consisting of a serotonin 5-hydroxytryptamine, type 3 (5-HT3) receptor antagonist, a corticosteroid, and the selective substance P neurokinin-1 (NK-1) receptor antagonist aprepitant (Emend1, Elan Pharma International, Ltd., Athlone, Ireland) [2]. Prospective trial data has been reported detailing the usage of aprepitant in patients as young as 11 years-ofage [3]. Due to the paucity of data in younger patients, specifically those weighing less than 40 kg, questions remain regarding the safety and efficacy of aprepitant in children.
METHODS Male and female patients with confirmed malignancy who were between the ages of 1 and 17 years, scheduled to receive a cycle of highly- or moderately-emetogenic chemotherapy, and scheduled to receive aprepitant as part of an anti-emetic regimen were eligible for enrollment. Patients were excluded if they were pregnant or breastfeeding, concomitantly receiving pimozide, terfenadine, astemizole, or cisapride, had a Child-Pugh score >9, or receiving IV fosaprepitant. Anti-emetic prophylaxis consisted of ondansetron 0.45 mg/kg (maximum of 16 mg per dose) and dexamethasone 7 mg/m2 [2,4–6]. Aprepitant was administered based on patient weight and rounded to the nearest 20 mg (Table I) from a dosing table implemented based on practice at our institution assessed via retrospective review of prior aprepitant usage. Aprepitant was administered in the form on an oral solution or a capsule [7]. Safety and tolerability of aprepitant was assessed daily by a study investigator and adverse event reporting was limited to adverse events which could be directly attributed to aprepitant systemic absorption. A patient survey created utilizing the NCI-CTC Grading System Version 4.0 and a 4-point Likert scale was completed at baseline prior to chemotherapy, daily during chemotherapy administration, and for 5 days following the completion of chemotherapy to evaluate nausea severity, emetic episodes, appetite, and interference C
2
2013 Wiley Periodicals, Inc. DOI 10.1002/pbc.24901 Published online 19 December 2013 in Wiley Online Library (wileyonlinelibrary.com).
with ADLs [8,9]. Survey administration was completed by a study investigator or sent home with the patient’s parent or caregiver. The usage of all breakthrough medications for acute CINV were recorded and assessed. The primary objective for this study was to evaluate the incidence and severity of CINV in pediatric patients receiving aprepitant as part of a standard anti-emetic regimen for highly- or moderately-emetogenic chemotherapy. Secondary objectives sought to evaluate changes in appetite and ADLs, assess adverse events which could be attributed to systemic exposure to aprepitant, and assess usage of rescue medications for acute CINV. Proportions of patients with complete response (CR) (no nausea, vomiting, or use of rescue therapy during the acute phase), No Nausea, No Vomiting, and No use of Rescue Therapy were assessed in 3 phases: 0–24 hours (acute), Days 1–5 post-chemotherapy (delayed), and the acute plus delayed phases (overall).
RESULTS Eleven patients were enrolled for a total of 20 patient encounters. The mean age of the study population was 9.55 4.85 (range, 12 months–17 years) and patients received chemotherapy for 2.4 days on average (range, 1–5 days). Patients with body weight
BRIEF REPORT Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients: A Prospective, Observational Study Megan Bodge,
PharmD,
1
* Alexandra Shillingburg,
PharmD,
Pediatric patients between the ages of 12 months and 17 years with a confirmed malignancy who were scheduled to receive aprepitant as part of triple therapy antiemetic prophylaxis for a cycle of moderately- or highly emetogenic chemotherapy were eligible for enrollment. Patients were evaluated for the incidence of nausea, episodes of emesis, interference with activities of daily living (ADLs),
Key words:
Stephan Paul,
MD,
3
and Lisa Biondo,
PharmD, BCPS
2
and appetite through utilization of a patient survey. Eleven patients were enrolled for a total of 20 patient encounters, mean age 9.55 4.85 (range, 12 months–17 years). Aprepitant was welltolerated and complete response (CR) rate was 38.9%. Pediatr Blood Cancer 2014;61:1111–1113. # 2013 Wiley Periodicals, Inc.
aprepitant; antiemetic; children; nausea and vomiting; nutrition; supportive care
INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) remains a significant problem in pediatric patients receiving chemotherapy. CINV has a profound impact on quality-of-life and has the potential to impact nutritional status and activities of daily living (ADLs) [1]. Current standard of care in adult patients receiving highly- or moderately-emetogenic chemotherapy is a prophylactic tripletherapy anti-emetic regimen consisting of a serotonin 5-hydroxytryptamine, type 3 (5-HT3) receptor antagonist, a corticosteroid, and the selective substance P neurokinin-1 (NK-1) receptor antagonist aprepitant (Emend1, Elan Pharma International, Ltd., Athlone, Ireland) [2]. Prospective trial data has been reported detailing the usage of aprepitant in patients as young as 11 years-ofage [3]. Due to the paucity of data in younger patients, specifically those weighing less than 40 kg, questions remain regarding the safety and efficacy of aprepitant in children.
METHODS Male and female patients with confirmed malignancy who were between the ages of 1 and 17 years, scheduled to receive a cycle of highly- or moderately-emetogenic chemotherapy, and scheduled to receive aprepitant as part of an anti-emetic regimen were eligible for enrollment. Patients were excluded if they were pregnant or breastfeeding, concomitantly receiving pimozide, terfenadine, astemizole, or cisapride, had a Child-Pugh score >9, or receiving IV fosaprepitant. Anti-emetic prophylaxis consisted of ondansetron 0.45 mg/kg (maximum of 16 mg per dose) and dexamethasone 7 mg/m2 [2,4–6]. Aprepitant was administered based on patient weight and rounded to the nearest 20 mg (Table I) from a dosing table implemented based on practice at our institution assessed via retrospective review of prior aprepitant usage. Aprepitant was administered in the form on an oral solution or a capsule [7]. Safety and tolerability of aprepitant was assessed daily by a study investigator and adverse event reporting was limited to adverse events which could be directly attributed to aprepitant systemic absorption. A patient survey created utilizing the NCI-CTC Grading System Version 4.0 and a 4-point Likert scale was completed at baseline prior to chemotherapy, daily during chemotherapy administration, and for 5 days following the completion of chemotherapy to evaluate nausea severity, emetic episodes, appetite, and interference C
2
2013 Wiley Periodicals, Inc. DOI 10.1002/pbc.24901 Published online 19 December 2013 in Wiley Online Library (wileyonlinelibrary.com).
with ADLs [8,9]. Survey administration was completed by a study investigator or sent home with the patient’s parent or caregiver. The usage of all breakthrough medications for acute CINV were recorded and assessed. The primary objective for this study was to evaluate the incidence and severity of CINV in pediatric patients receiving aprepitant as part of a standard anti-emetic regimen for highly- or moderately-emetogenic chemotherapy. Secondary objectives sought to evaluate changes in appetite and ADLs, assess adverse events which could be attributed to systemic exposure to aprepitant, and assess usage of rescue medications for acute CINV. Proportions of patients with complete response (CR) (no nausea, vomiting, or use of rescue therapy during the acute phase), No Nausea, No Vomiting, and No use of Rescue Therapy were assessed in 3 phases: 0–24 hours (acute), Days 1–5 post-chemotherapy (delayed), and the acute plus delayed phases (overall).
RESULTS Eleven patients were enrolled for a total of 20 patient encounters. The mean age of the study population was 9.55 4.85 (range, 12 months–17 years) and patients received chemotherapy for 2.4 days on average (range, 1–5 days). Patients with body weight
