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EFFICACY AND SAFETY OF APREPITANT FOR PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING IN PEDIATRIC PATIENTS
Author(s): ,
Giovanna Giagnuolo
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
,
Salvatore Buffardi
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
,
Luciano Marchese
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
,
Rosanna Parasole
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
,
Fara Petruzziello
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
,
Antonia De Matteo
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
,
Rosanna Cuccurullo
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
Vincenzo Poggi
Affiliations:
pediatric hemato-oncology,Santobono Pausilipon Hospital,naples,Italy
(Abstract release date: 05/19/16) EHA Library. Parasole R. 06/09/16; 134761; PB1861
Dr. Rosanna Parasole
Dr. Rosanna Parasole
Contributions
Abstract
Abstract: PB1861

Type: Publication Only

Background
Chemotherapy-induced nausea and vomiting (CINV) are common side effects for cancer patients with a considerable impact on quality of life. Traditional regimens to prevent CINV commonly contain a combination of corticosteroid plus ondansetron, a 5-hydroxytryptamine receptor antagonist. Nevertheless, CINV persist in 20-30% of patients and in 40% remains even after of chemotherapy (delayed nausea and vomiting). The NK-1 receptor inhibitor aprepitant, in addition to usual anti-emetic therapy, seems to improve both acute and delayed nausea and vomiting in adults. Preliminary studies have shown good efficacy and tolerability also in adolescents; however, trials of using aprepitant in pediatric hemato-oncologic disease are limited.

Aims
Here, we report our experience about the safety and the efficacy of aprepitant in children and adolescents with Hodgkin Lymphoma (HL), treated with highly emetogenic chemotherapy.

Methods
Pediatric patients aged >10 years and with diagnosis of HL received aprepitant as part of triple antiemetic prophylaxis during a cycle of chemotherapy. Aprepitant was administered orally at a dose of 125 mg on Day 1 and 80 mg on Days 2 and 3; at the same time, patients received ondansetron at a dosage of 4 mg/mq and dexamethasone (0.5-2 mg/kg). The efficacy of the drug was evaluated through a questionnaire given to the patient in the next cycle, after obtaining informed consent. Toxicity was evaluated according to CTCAE criteria (v 4.02: Sept. 15, 2009).

Results
Ten patients were enrolled between January 2015 and January 2016; nine received a first line chemotherapies (COPP/ABV, ABVD), while only one of them underwent a fourth-line therapy (Bendamustine); mean age was 13.6 (range 11-16 yrs) and mean number of cycle administered was 3.8 (range 1-6). Five of ten patients reported nausea with a variable intensity from 2 to 6, measured with a scale from 1 to 10; only two patients reported vomiting (2 and 4 episodes). All patients experienced a grade III-IV neutropenia and a a slight increase in transaminases, effects likely related to chemotherapy; no other side effects were registered. 

Conclusion
In our experience, aprepitant, in combination with ondansetron and dexamethasone, significantly decreased the incidence of CINV in children receiving highly emetogenic chemotherapy. We obtained a complete response rate of 50% with a good toxicity profile. This results make us continue to use aprepitant in our patients, since the reduction of nausea and vomiting sensation represents a considerable advantage on quality of life and therapeutic efficacy.

Session topic: E-poster

Keyword(s): Hodgkin's disease, Supportive care
Abstract: PB1861

Type: Publication Only

Background
Chemotherapy-induced nausea and vomiting (CINV) are common side effects for cancer patients with a considerable impact on quality of life. Traditional regimens to prevent CINV commonly contain a combination of corticosteroid plus ondansetron, a 5-hydroxytryptamine receptor antagonist. Nevertheless, CINV persist in 20-30% of patients and in 40% remains even after of chemotherapy (delayed nausea and vomiting). The NK-1 receptor inhibitor aprepitant, in addition to usual anti-emetic therapy, seems to improve both acute and delayed nausea and vomiting in adults. Preliminary studies have shown good efficacy and tolerability also in adolescents; however, trials of using aprepitant in pediatric hemato-oncologic disease are limited.

Aims
Here, we report our experience about the safety and the efficacy of aprepitant in children and adolescents with Hodgkin Lymphoma (HL), treated with highly emetogenic chemotherapy.

Methods
Pediatric patients aged >10 years and with diagnosis of HL received aprepitant as part of triple antiemetic prophylaxis during a cycle of chemotherapy. Aprepitant was administered orally at a dose of 125 mg on Day 1 and 80 mg on Days 2 and 3; at the same time, patients received ondansetron at a dosage of 4 mg/mq and dexamethasone (0.5-2 mg/kg). The efficacy of the drug was evaluated through a questionnaire given to the patient in the next cycle, after obtaining informed consent. Toxicity was evaluated according to CTCAE criteria (v 4.02: Sept. 15, 2009).

Results
Ten patients were enrolled between January 2015 and January 2016; nine received a first line chemotherapies (COPP/ABV, ABVD), while only one of them underwent a fourth-line therapy (Bendamustine); mean age was 13.6 (range 11-16 yrs) and mean number of cycle administered was 3.8 (range 1-6). Five of ten patients reported nausea with a variable intensity from 2 to 6, measured with a scale from 1 to 10; only two patients reported vomiting (2 and 4 episodes). All patients experienced a grade III-IV neutropenia and a a slight increase in transaminases, effects likely related to chemotherapy; no other side effects were registered. 

Conclusion
In our experience, aprepitant, in combination with ondansetron and dexamethasone, significantly decreased the incidence of CINV in children receiving highly emetogenic chemotherapy. We obtained a complete response rate of 50% with a good toxicity profile. This results make us continue to use aprepitant in our patients, since the reduction of nausea and vomiting sensation represents a considerable advantage on quality of life and therapeutic efficacy.

Session topic: E-poster

Keyword(s): Hodgkin's disease, Supportive care

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