Hematology, Transfusion and Cell Therapy VOLUME 40, ISSUE 1, JANUARY-MARCH, 2018 ISSN 2531-1379 w VOLUME 45, ISSUE 3, July/September, 2023 ISSN 2531-1379
TaggedH1Hematology, Transfusion and Cell Therapy TaggedP ISSN 2531-1379 print version ISSN 2531-1387 online versionTaggedEnd EDITOR INCHIEF Eduardo Magalh~aes Rego, Ribeir~ao Preto, Brazil DEPUTYEDITOR Erich Vinicius de Paula, Campinas, Brazil ASSOCIATE EDITORS Alfredo Mendrone Junior S~ao Paulo, Brazil Belinda Pinto Sim~oes Ribeir~ao Preto, Brazil Behnaz Bayat Giessen, Germany Carla Luana Dinardo S~ao Paulo, Brazil CarlosS ergio Chiattone S~ao Paulo, Brazil C armino Antonio de Souza Campinas, Brazil DanteM ario Langhi Junior S~ao Paulo, Brazil Dimas Tadeu Covas Ribeir~ao Preto, Brazil Elvira Deolinda Rodrigues Pereira Velloso S~ao Paulo, Brazil Fabiola Traina Ribeir~ao Preto, Brazil Helio Moraes de Souza Uberaba, Brazil Irene Lorand-Metze Campinas, Brazil Jos e Orlando Bordin S~ao Paulo, Brazil Luis Fernando S. Bouzas Rio de Janeiro, Brazil Marcelo Pasquini Wisconsin, USA M arcio Nucci Rio de Janeiro, Brazil Marcos Borato Viana Belo Horizonte, Brazil Marcos de Lima Cleveland, USA Margareth Castro Ozelo Campinas, Brazil Maria Helena Pitombeira Fortaleza, Brazil Maria Stella Figueiredo S~ao Paulo, Brazil Marilda de Souza Gon¸calves Salvador, Brazil Nelson Hamerschlak S~ao Paulo, Brazil Nelson Spector Rio de Janeiro, Brazil Nicola Conran Campinas, Brazil PauloS ergio da Silva Santos S~ao Paulo, Brazil Roberto Passetto Falc~ao Ribeir~ao Preto, Brazil Rodrigo Tocantins Calado Ribeir~ao Preto, Brazil Sara Teresinha Olalla Saad Campinas, Brazil Silvia Maria Meira Magalh~aes Fortaleza, Brazil Valder Arruda Philadelphia, USA Vanderson Rocha S~ao Paulo, Brazil Vania Tietsche de Moraes Hungria S~ao Paulo, Brazil Editorial Board Alois Gratw€ohl Basel, Switzerland Alvaro Urbano-Ispizua Barcelona, Spain Andrea Bacigalupo Genoa, Italy ^Angelo Maiolino Rio de Janeiro, Brazil Antonio Fabron J unior Marilia, Brazil Christian Gisselbrecht Paris, France Corrado Tarella Turin, Italy Daniel Tabak Rio de Janeiro, Brazil DavidG omez Almaguer Mexico City, Mexico Elbio A. DAmico S~ao Paulo, Brazil Enric Carreras Barcelona, Spain Eugenia Maria Amorim Ubiali - Ribeir~ao Preto, Brazil Fernando Ferreira Costa, Campinas, Brazil Frederico Luiz Dulley S~ao Paulo, Brazil Gino Santini Genoa, Italy Guillermo Dighiero Montevideo, Uruguay Guillermo Ruiz-Arguelles Puebla, Mexico Jesus Fernando San Miguel Salamanca, Spain Jo~ao Carlos Pina Saraiva Bel em, Brazil La ercio de Melo Belo Horizonte, Brazil L ılian Maria Castilho Campinas, Brazil Linamara Rizzo Batistella S~ao Paulo, Brazil Lucia Mariano da Rocha Silla Porto Alegre, Brazil Marcos Antonio Zago Ribeir~ao Preto, Brazil Maria de Lourdes L. F. Chauffaile S~ao Paulo, Brazil Maria do Socorro P. de Oliveira Rio de Janeiro, Brazil Mario Cazolla Pavia, Italy Mary Evelyn Flowers Seattle, USA Nelson Abrahin Fraiji Manaus, Brazil Nelson J. Chao Durham, USA Paul M. Ness Baltimore, USA PauloC esar Naoum S~ao Jos e do Rio Preto, Brazil Raul C. Ribeiro Memphis, USA Raul Gabus Montevideo, Uruguay Ricardo Pasquini Curitiba, Brazil Richard K. Burt Chicago, USA Sergio Giralt New York, USA V^ania Tietsche Hungria S~ao Paulo, Brazil Vicente Odone Filho S~ao Paulo, Brazil PAST EDITORS Antonio P. Capanema 1973-1981; Milton A. Ruiz 1981-1990; Carlos S. Chiattone 1991-1994; Milton A. Ruiz 1995-2014; Fernando Ferreira Costa 2015-2022. The Hematology, Blood Transfusion and Cell Therapy succeeded the Revista Brasileira de Hematologia e Hemoterapia (Brazilian Journal of Hematology and Hemotherapy) , ISSN 1516-8484, which succeeded the Boletim da Sociedade Brasileira de Hematologia e Hemoterapia (Bulletin of the Brazilian Society of Hematology and Hemotherapy) ISSN 0102-7662, which was published from 1973 to 1998 with 179 issues in 20 volumes. ABHH Rua Diogo de Faria, 775/conjunto 133 04037-002 Vila Clementino - S~ao Paulo/SP - Brazil (11) 2369-7767 / (11) 2338-6764 (WhatsApp) E-mail: abhh@abhh.org.br www.abhh.org.br HTCT Internal Editorial Committee Executive Secretary: Luciana de Souza secretaria@rbhh.org | www.htct.com.br The Hematology, Transfusion and Cell Therapy is the offi cial publication of the Associa¸c~ao Brasileira de Hematologia, Hemoterapia e Terapia Celular (ABHH), the Associazione Italo-Brasiliana di Ematologia (AIBE), Eurasian Hematology Oncology Group (EHOG), and the Sociedade Brasileira de Oncologia Pedi atrica (SOBOPE), published by Elsevier Editora Ltda. The journal is indexed to the Literatura Latino-Americana e do Caribe em Ci^encias da Sa ude (Lilacs), SciELO Brazil, PubMed/PMC, Web of Science (ESCI), Extramed and Scopus. It is distributed for free to regional libraries and Medical, Pharmacy and Biochemistry Schools in Brazil and sister societies in South, Central and North America and Europe. 2023 Associa¸c~ao Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. All rights reserved. All rights reserved and protected by law 9.610 - 19/02/98. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or any information storage and retrieval system, without permission in writing from ABHH and the Publisher. 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Board Of Directors 2022-2023 President Jos e Francisco Comenalli Marques J unior Vice-President Angelo Maiolino Administrative Director DanteM ario Langhi J unior Vice Administrative Director Silvia Maria Meira Magalh~aes Scientific Director Dimas Tadeu Covas Vice-Scientific Director Rodrigo do Tocantins Calado Financial Diretor Alfredo Mendrone J unior Vice Financial Director Leny Nascimento da Motta Passos Director of Communications Renato Sampaio Tavares Vice-Director of Communications Jorge Vaz Pinto Neto Director of Institutional RelationsEduardo Magalh~aesRego Vice-Director of Institutional RelationsCarlosS ergio Chiattone Director of Professional PracticeGlaciano Nogueira Ribeiro Vice-Director of Professional PracticeCelso Rodrigues Arrais Commitee Coordinator Carmino Antonio de Souza Emeritus Scientific Director Roberto Passetto Fal¸c~ao General Manager AlineAch^e Deliberative Committee Elected 2020-2023 Leny Nascimento da Motta Passos Edvan de Queiroz Cruso e Jorge Vaz Pinto Neto Glaciano Nogueira Ribeiro Gustavo Henrique Silveira Fabiana Akil V^ania Tietsche de Moraes Hungria Violete Petitto Laforga Jos e Eduardo Bernardes Rodrigo do Tocantins Calado de Saloma Rodrigues Celso Arrais Rodrigues da Silva Alfredo Mendrone Junior Jos e Francisco Comenalli Marques J unior Ana Clara Kneese Virgilio do Nascimento Katia Borgia Barbosa Pagnano Elected 2022-2025 Aderson da Silva Araujo Angelo Maiolino Carla Luana Dinardo Eduardo Magalh~aesRego Jo~ao Paulo de Oliveira GuimarÐes Karina Correia Barcelos Monika Conchon Renato Luiz Guerino Cunha Renato Sampaio Tavares Rodolfo Delfi ni Can¸cado Silvia Maria Meira MagalhÐes Talita Maira Bueno da Silveira Thiago Xavier Carneiro Vanderson Rocha Vaneuza Araujo Moreira Funke Lifelong Deliberative Committee Carlos Sergio Chiattone Carmino Antonio de Souza DanteM ario Langhi J unior Dimas Tadeu Covas Eur ıpedes Ferreira Fernando Ferreira Costa H elio Moraes de Souza H elioRamos Jo~ao Carlos Pina Saraiva Jos e Orlando Bordin Jos eKerbauy Marco Antonio Zago Milton Artur Ruiz Nelson Ibrahim Fraiji Nelson Hamerschlak Nelson Spector Orion de Bastos Ricardo Pasquini Roberto Passetto Falc~ao Romeu Ibrahim de Carvalho Sara Teresinha Olalla Saad Therezinha Verrastro de Almeida Ubiratan Ouvinha Peres Past Presidents of Sociedade Brasileira de Hematologia e Hemoterapia 1950 Walter Oswaldo Cruz 1951 Michel Abujamra 1954 Darcy Lima 1955 Jos e Candido C. Villela 1957 Joaquim M. Barreto 1959 Oswaldo Kessler Ludwing 1961 Walter Hupsel 1963 Rui Faria 1965 Orion Bastos 1967 Ubiratan Ouvinha Peres 1970 Oswaldo Mellone 1973 Pedro Cl ovis Junqueira 1975 Pedro Cl ovis Junqueira 1977 Maria Nazareth Petrucelli 1979 Celso Carlos de C. Guerra 1981 Jacob Rosenblit 1983 Luiz Gast~ao M. Rosenfeld 1985 Augusto Luiz Gonzaga 1987 Helio Ramos 1988 Milton Artur Ruiz 1990 Nelson Hamerschlak 1992Eur ıpedes Ferreira 1994 Jo~ao Carlos Pina Saraiva 1996 Jo~ao Pedro E. M. Pereira 1998 Celso Carlos de C. Guerra 2000 Dante M ario Langhi Junior 2002 Dante M ario Langhi Junior 2004 Carlos S ergio Chiattone 2006 Carlos S ergio Chiattone 2008 Carlos S ergio Chiattone Past Presidents of Col egio Brasileiro de Hematologia 1965 Hildebrando M. Marinho 1967 Michel Abujamra 1969 Romeu Ibrahim de Carvalho 1971 Paulo Barbosa da Costa 1973 Romildo Lins 1975 Renato Rego Failance 1977 Dilson Jos e Fernandes 1981 Jos eKerbauy 1985 Eurico Coelho 1989 Romeu Ibrahim de Carvalho 1993 Jos eKerbauy 1997 Roberto Passetto Falc~ao 2005 Jos e Orlando Bordin Past Presidents of Associa¸c~ao Brasileira de Hematologia, Hemoterapia e Terapia Celular 2009 Carlos S ergio Chiattone Jos e Orlando Bordin 2010-2013: Carmino Antonio deSouza 2014-2017: Dimas Tadeu Covas 2018-2021: Dante Langhi J unior Associa¸c~ao Brasileira de Hematologia, Hemoterapia e Terapia Celular
Associazione Italo-Brasiliana di Ematologia Board of Directors - 2021-2022 President Carlos S. Chiattone (Brazil) Vice-President Stefano Luminari Scientific Director −Brazil Carmino Antonio de Souza Treasurer −Brazil Natalia Zing Honorary PresidentsGino Santini and Angelo Maiolino and Ricardo Pasquini Scientific Director −ItalyMaurizio Martelli Treasurer −ItalyLuca Arcaini Board of Advisors - Brazil Eduardo Magalh~aes Rego, Eliana C. M. Miranda, Guilherme Duffl es, Irene de Almeida Biasoli, Marcia Torresan Delamain, Milton Artur Ruiz, Sergio A.B. Brasil, Thais Fischer Board of Advisors - Italy Angelo Michelle Carella, Gian Luca Gaidano, Ignazio Majolino, Maurizio Martelli, Robin Fo a, Teodoro Chisesi Associazione Italo-Brasiliana di Ematologia Viale Benedetto XV 16100 - Genoa GE Italy Eurasian Hematology Oncology Group Board of Directors President Giuseppe Saglio Vice-President Birol Guvenc General Secretaryehmus Ertop Member Ahmad Ibrahim, Lebanonn Member Burhan Ferhanoglu, Turkiye Member Carmino de Souza, Brazil Member Claudio Cerchione, Italy Member Jean FranO´ ois Rossi, France Member Moshe Mittelman, Israel Member Tariq Mughal, USA Member Vera Donnenberg, USA Eurasian Hematology Oncology Group www.ehog.net - sekreterlik@hematoloji.org.tr Yurt Mahallesi Kurttepe Cad. 71517 Sokak No.2 Sabahattin Akg€un Apt. Kat.1 Daire.1 ¸Cukurova - Adana Phone: 00 90 555 881 01 99 Sociedade Brasileira de Oncologia Pedi atrica Board of Directors - 2021-2022 President Nevi¸colino Pereira de Carvalho Filho 1st Vice-President Flavia Delgado Martins 1st SecretaryCarla Renata Pacheco Donato Macedo 1st Treasurer Tatiana El Jaick Bonif acioCosta 2nd Vice-President Mario Jos e Aguiar de Paula 2nd SecretaryMaristella Bergamo Francisco dos Reis 2nd Treasurer Carolina Madalena Souza Pinto Alvares Members of Advisory Board Andrea Maria Capellano, Elione Soares de Albuquerque, Elvis Terci Valera, Simone dos Santos Aguiar, Val eria Pereira Paiva Sociedade Brasileira de Oncologia Pedi atrica www.sobope.org.br - sobope@uol.com.br / sobope@sobope.org.br 94/53 04077-020 S~ao Paulo-SP Phone: 55 11 5052-7537
TaggedH1CONTENTSTaggedEnd Original Articles Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial Aziz Eghbali, Fatemeh Khazaei Kohpar, Kazem Ghaffari, Roghayeh Rahimi Afzal, Aygin Eghbali and Ali Ghasemi ................................................................................................ .................................................. 281 Translation, cross-cultural adaptation and validation of the sickle cell self-efficacy scale (SCSES) Iara Alves de Sousa, Ilka Afonso Reis, Adriana Silvina Pagano, Joseph Telfair and Heloísa de Carvalho Torres ................................................................................................ .......................... 290 Need for hemodialysis in patients undergoing hematopoietic stem cell transplantation: risk factors and survival in a retrospective cohort Eduardo Cerello Chapchap, Marisa Petrucelli Doher, Lucila Nassif Kerbauy, Talita Rantin Belucci, Fabio Pires de Souza Santos, Andreza Alice Feitosa Ribeiro and Nelson Hamerschlak .............................. 297 Comparison of characteristics and laboratory tests of COVID-19 hematological patients from France and Brazil during the pre-vaccination period: identification of prognostic profiles for survival Lilith Faucheux, Lucas Bassolli de Oliveira Alves, Sylvie Chevret and Vanderson Rocha .......................... 306 Frequencies of genetic variants of the Rh, Kell, Duffy, Kidd, MNS and Diego systems of northwest Rio Grande do Sul, Brazil Scheila da Silva Soares, Josiane Rodrigues Aquino, Francini Petrolli, Tiago Bittencourt de Oliveira, Silvana Almeida and Marilu Fiegenbaum ................................................................................................... 317 Lower expression of NOTCHcomponents in peripheral blood mononuclear cells of allogeneic hematopoietic cell transplant patients Marcos Paulo Colella, Beatriz Corey Morini, Fernanda Niemann, Matheus Rodrigues Lopes, Sara Olalla Saad and Patricia Favaro ................................................................................................ .......... 324 Evaluation of lymphocyte count, T-cell subsets and neutrophil-to-lymphocyte ratio as early predictors for severity and outcome of COVID-19 disease−a report from a highly complex hospital in Brazil DouglasC^amara de Oliveira, Beatriz Sanada Spiri, Yara Carolina Schluga, Julie Lilian Pimentel Justus, Francisco Diego Negr~ao Lopes Neto and Ana Paula de Azambuja .............................................................. 330 Targeting patient blood management’sfirst pillar: A multicentric retrospective study on preoperative anemia Gustavo de Carvalho Duarte, Glaciano Nogueira Ribeiro, Mariangela Moschen, Rodrigo Spessotto Morais Toledo, Jos e Orlando Bordin and Dante Mario Langhi ....................................... 338 TaggedFigure TaggedEnd Hematology, Transfusion and Cell Therapy www.htct.com.br TaggedFigure TaggedEnd Volume45•Number 3•July/September 2023
Knowledge, attitudes and practices of resident doctors and interns on safe blood transfusion practices: a survey-based study Gopal Krushna Ray, Somnath Mukherjee, Suman Sudha Routray, Ansuman Sahu, Debasish Mishra, Archana Naik and Satya Prakash ............................................................................................................... 342 Prevalence of hypogonadism in transfusion-dependent b-thalassemia patients of Bangladesh: investigating the role of serum ferritin level as a diagnostic tool Romana Chowdhury, Mohammad Azmain Iktidar, Mushfiq Newaz Ahmed, Mohammad Mehedi Hasan, Md. Mazharul Hoque Tapan, Sheikh Saiful Islam Shaheen, Atiar Rahman and Ayesha Khatun .............. 350 Review Articles Brazilian dental consensus on dental management in hematopoietic stem cell transplantation− Part I −pre-HSCT Maria Elvira Pizzigati Correa, Fabiana Caramori Noal Granzotto, Lara Maria Alencar Ramos Innocentini, Thiago de Carvalho Reis, Emilze Mafra de Lima, Renata de Freitas Varanda, Paulo S ergio da Silva Santos, Luiz Alberto Valente Soares Junior, Leticia Mello Bezinelli, Fernanda de Paula Eduardo, Walmyr Ribeiro Melo, H eliton Spíndola Antunes and Leandro Dorigan De Macedo ....................................... 358 Dental consensus on HSCT−Part II: dental Care during HSCT Marcella Ferreira Gobbi, Mariana Henriques Ferreira, Danielle Lima Corr^ea de Carvalho, Geisa Badauy Lauria Silva, Karina Silva Moreira Macari, Lilian de Jesus Neves, PauloS ergio da Silva Santos, Luiz Alberto Valente Soares Junior, Walmyr Ribeiro Melo, H eliton Spíndola Antunes, Leandro Dorigan De Macedo, Fernanda de Paula Eduardo and Leticia Mello Bezinelli ................................................................................................ ................................... 368 Dentistry consensus on HSCT−Part III: Special topics−Dentistry on HSCT PauloS ergio da Silva Santos, Fabiana Caramori Noal Granzotto, H eliton Spindola Antunes, Emilze Mafra de Lima, Renata de Freitas Varanda, Karina Maccari, Leticia Mello Bezinelli, Walmyr Ribeiro Melo, Luiz Alberto Valente Soares Junior, Leandro Dorigan De Macedo and Fernanda de Paula Eduardo ......................................................................................................................... 379 Infections in patients with chronic lymphocytic leukemia Mariana Guarana and Marcio Nucci ........................................................................................................... 387 Case Reports Pregnancy in a woman with congenital F-VII deficiency: a brief review of recent literature and case report Rima Hajjar, Inaam Hatoum, Amina Krounbi, Rabih Chahine, Rahif Jalloul and Mohamad K. Ramadan ................................................................................................ ................................ 394 Management of refractory chronic pain in sickle cell disease with intrathecal drug delivery system Plinio Duarte Mendes, Karen Miranda Chequer, Clara Martins Azevedo Eyer Thomaz, Gustavo Marcio Silvino Assun¸c~ao, Felipe Duarte Augusto and Gilberto de Almeida Fonseca Filho .......... 399 Cold agglutinin syndrome secondary to splenic marginal zone lymphoma: a case report Julia Plentz Portich, Bruna Blos, Leo Sekine and Juliana Pires Marafon Franz ............................................ 403 Secondary vasculopathy due to catastrophic antiphospholipid syndrome Alexandre Sacchetti Bezerra, Carolina Kassab Wroclawski, Gabriel Ricci Lorber and Cyrillo Cavalheiro Filho ................................................................................................ ................................ 406 Letters to the Editor Autoimmune hemolytic anemia and COVID-19 vaccination Jeremy W. Jacobs ................................................................................................ .......................................... 410
Images in Clinical Hematology Strongyloides stercoralis: Intriguing cough in an acute lymphoblastic leukemia patient Michael Blaine Winterton and Ghulam Ghous ............................................................................................ 412 Persistent platelet sattelitism despite normal platelet counts Stijn Van Hees, Frederic Winnock and Paul Meuleman .............................................................................. 414
Original article TaggedH1Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapyinduced nausea and vomiting: A triple-blinded randomized clinical trialTaggedEnd TaggedPAziz Eghbali a, Fatemeh Khazaei Kohpar b, Kazem Ghaffari c,d, Roghayeh Rahimi Afzal b, Aygin Eghbali e, Ali Ghasemi f,g,* TaggedEnd TaggedP aClinical Research Development Center of Aliasghar Hospital, Iran University of Medical Sciences, Tehran, Iran bArak University of Medical Sciences, Arak, Iran c Department of Base and Laboratory Sciences, Khomein University of Medical Sciences, Khomein, Iran dMolecular and Medicine Research Center, Khomein University of Medical Sciences, Khomein, Iran e Iran University of Medical Sciences, Tehran, Iran. f Department of Biochemistry and Hematology, Semnan University of Medical Sciences, Semnan, Iran g Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran TaggedEnd TAGGEDPARTICLE INFO Article history: Received 1 December 2021 Accepted 13 February 2022 Available online 29 March 2022TaggedEnd TAGGEDPA B S T R A C T Introduction: This study was performed to evaluate the degree of 3-day chemotherapyinduced nausea and vomiting (CINV) in children with cancer who received highly emetogenic chemotherapy (HEC) to ascertain the efficacy of aprepitant single-dose on dayL 1 plus granisetron and dexamethasone (DEX). Methods: This clinical trial study was conducted on 120 patients in the age range of 5 to 18 years old who received chemotherapy. Patients were divided into two groups; Group A received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3 and Group B received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3. All groups received granisetron 3 mg/m2 on day 1 and DEX on days 1 to 3. The primary and secondary endpoints were to evaluate the proportion of patients with acute, delayed and overall CINV within each group. Results: There were no significant differences between the two groups for vomiting, nausea or the use of rescue therapy. The number of patients without vomiting on day 1 was similar in both groups (96.5%vs. 98.3%, respectively; p=0.848). TaggedEndTaggedPKeywords: Aprepitant Dexamethasone Granisetron Nausea VomitingTaggedEnd TaggedEnd * Corresponding author at: Department of Biochemistry and Hematology, Faculty of Medicine Semnan University of Medical Sciences, Semnan, Iran. E-mail address: a.qasemi2012@yahoo.com (A. Ghasemi). https://doi.org/10.1016/j.htct.2022.02.004 2531-1379/ 2022 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier España, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). TaggedEndhematol transfus cell ther. 2023;45(3):281−289 TaggedFigure TaggedEnd Hematology, Transfusion and Cell Therapy www.htct.com.br TaggedFigure TaggedEnd
TaggedEndTaggedPConclusion: According to the results of this study, a single dose of aprepitant 125 mg/kg was as effective as administering three doses of aprepitant on 3 days. Therefore, the use of a single dose of aprepitant in combination with other standard treatment regimens to prevent CINV in children who received HEC was safe and efficacious and canbebeneficial. 2022 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier España, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).TaggedEnd TaggedH1IntroductionTaggedEnd TaggedPChemotherapy-induced nausea and vomiting (CINV) are one of the distressful effects of chemotherapy, which may result in the patient’s anxiety and depression. These two symptoms are the first and second most-feared side effects of chemotherapy. The pathophysiology of CINV is highly complicated and it will significantly disturb the life quality of patients with cancer.1,2 Combination therapy of 5-hydroxytryptamine-3 (5HT3) receptor antagonists with dexamethasone (DEX) has a significant effect on acute CINV.3 The most common standard therapy for CINV control in children is the use of antagonists of receptor 5-HT3 in combination, with or without a corticosteroid.4,5 TaggedEnd TaggedPThe5-HT3 receptor antagonists include dolasetron, ondansetron, palonosetron, tropisetron and granisetron.6 Granisetron (Kytril) is a selective 5-HT3 receptor antagonist which is recommended by clinical practice guidelines as an effective and potent antiemetic drug.7 Application of antagonists of receptor 5-HT3, along (Shouldn’t this be “prolonged”???) with DEX, can improve CINV in the acute stage, but the delayed CINV has remained an important clinical issue.8,9 TaggedEnd TaggedPAprepitant is one of the drugs approved by the FDA for the control of acute and chronic CINV which acts as a neurokinin 1 (NK1) receptor antagonist.10 Regarding its pharmacokinetics, it requires lower doses of DEX, which has distinguished it from other groups. The side effects of this group are also negligible, compared to other groups.11 Aprepitant has been approved for use in combination with a selective 5 HT3−receptor antagonist, such as granisetron, in adults.12 These patients, undergoing highly emetogenic chemotherapy (HEC) with uncontrolled CINV, usually require longer hospitalization, but the combined effects of granisetron and aprepitant in the prevention of CINV in children undergoing chemotherapy have been less studied. This clinical trial was performed to evaluate the degree of 3-day CINV in children with cancer undergoing HEC to ascertain the efficacy of aprepitant single-dose on day 1 plus granisetron and DEX versus aprepitant on days 1 to 3, in combination with granisetron and DEX.TaggedEnd TaggedH1Methods and materialsTaggedEnd TaggedH2Study populationTaggedEnd TaggedPA randomized, triple-blind clinical trial was performed, enrolling 176 children in the age range of 5 to 18 years old TaggedEndTaggedPwho were chemotherapy candidates for acute lymphoblastic leukemia, rhabdomyosarcoma, Wilms tumor, acute myeloid leukemia, osteosarcoma and hepatocellular carcinoma at the Amir-Kabir Hospital in Arak, Iran. This study was a retrospective observational study over a 12-month period.TaggedEnd TaggedPThese patients were scheduled to receive an HEC (Doxorubicin, Cyclophosphamide, Vincristine, Cisplatin, Dacarbazine, Vinblastine, Bleomycin and Actinomycin D). The enrollment of participants, as well as the allocation and allocation of intervention instructions, was performed by a pediatrician and researcher. Randomization was performed using random number generation in Excel software; each patient had an identical number (ID) based on the visiting sequence and these IDs were entered into the Excel software. Thereafter, the“RAND” function was included in another column and the RAND function was entered for each patient, which automatically generated random numbers in Excel rows. After applying the ascending sorting, the random numbers and the patient IDs positions were changed randomly. The sorted IDs were divided into two groups. This study was approved by the Ethics Committee of Arak University of Medical Sciences (ethical committee code number: IR.ARAKMU.REC.1396.46). The trial was registered at the Iranian Registry of Clinical Trials as IRCT20100127003210N19. The inclusion criteria included the following: the presence of cancer confirmed by the molecular assays and histopathological examination; patients who had not received chemotherapy or radiotherapy for 6 months prior to the study; patients who did not have other clinical features, such as anemia, leukopenia and thrombocytopenia; patients who had other disorders causing CINV, such as hypocalcemia, central nervous system malignancy and gastrointestinal disorders; patients who did not have uncontrolled diabetes; patients with normal liver and kidney function, and; patients with normal immune systems. Furthermore, patients with hypertension, fever, severe infection, tinnitus and cardiovascular disease and patients with respiratory problems were excluded from this study. Based on the type of study, the sample size was calculated using Pass 11 software with type I (a) error left at 5 % and type II (b) error left at 20 %, and study power of 90%. The mean§standard deviation (SD) was 10.6 §0.6 in group A and 11.3 §0.4 in group B. The sample size of 51 patients was determined for each group, but considering the possibility of some patients missing, the minimum sample size of 57 was considered.TaggedEnd TaggedH2Therapeutic protocolTaggedEnd TaggedPEligible children received HEC, including cisplatin, anthracycline and cyclophosphamide combinations (e.g., fluorouracil, TaggedEnd282 hematol transfus cell ther. 2023;45(3):281−289
TaggedEndTaggedPepirubicin, doxorubicin and docetaxel). Random numbers generated on the computer were used for randomization. For all principal researchers, patients, and study evaluators, except for the experienced trained physician of the AmirKabir Hospital, randomization was blinded (triple-blinded) to the study. Study bias, through masking the patients and study evaluator, was reduced. After obtaining informed written consent and based on the anti-emetic treatment regimen, patients were divided into group A, 60 patients who received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3, a single dose of granisetron at 3 mg/m2 intravenously (i.v.) on day 1, half an hour before HEC, along with 0.1 mg/kg of DEX on day 1 and 0.1 mg/kg daily on days 2 and 3, 1 hour before HEC and group B, 60 patients who received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3, a single dose of granisetron 3 mg/m2 (i.v.) on day 1, along with 0.1 mg/kg of DEX orally on day 1, and 0.1 mg/kg daily on days 2 and 3, 1 hour before HEC. The shape and size of the placebo drugs were similar to those of the original drugs. Patients were asked not to discontinue or alter medication during the study. Information on the patient chemotherapy history (naive or non-naive to TaggedEndTaggedPchemotherapy) was extracted from their records. There had been a 6-month chemotherapy-free period since the prior chemotherapy of the patients who had a history of chemotherapy and these patients did not have CINV at the time of the study. Figure 1 summarizes the doses and administrative sequences of antiemetics.TaggedEnd TaggedH2Evaluation of CINVTaggedEnd TaggedPA single emetic episode was considered as at least one episode of vomiting, separated by less than a 5-minute interval, during the current chemotherapy cycle. Nausea is a feeling in the stomach that may be accompanied by vomiting. The severity of nausea was assessed by using a visual analogic scale (VAS), ranging from 0 to 100 mm (VAS < 5mm = least severe [no nausea], VAS < 25mm = no significant nausea, 100 = most severe). Patients were asked to record in a diary the number of emetic episodes and the severity of nausea during the 72 hours following chemotherapy. A coordinator had conversations with patients during these three days to ensure that patients recorded all cases of vomiting and nausea correctly. The primary efficacy endpoint was the TaggedEnd TaggedFigure Figure1–Flowchart of the study.TaggedEnd hematol transfus cell ther. 2023;45(3):281−289 283
TaggedEndTaggedPpercentage of patients with a complete response (CR). The CR wasdefined as no emesis, no significant nausea (or mild nausea, VAS < 25) and no use of rescue therapy during day 1 (acute phase) following the chemotherapy cycle. Secondary efficacy endpoints included CR for the days 2 and 3 (delayed phase) and overall phases (days 1 - 3) after the chemotherapy cycle and no emetic episodes (vomiting events) and nausea (mild nausea), no use of rescue antiemetic therapy (prescribed for the treatment of chemotherapy-induced emesis that did not respond to the initial prophylactic treatment) within the three- day study period, time to first breakthrough antiemetics administered, number of vomiting episodes and the severity of nausea (mild, moderate or severe) within three days.TaggedEnd TaggedH2Statistical analysisTaggedEnd TaggedPStatistical analyses were performed using the SPSS version 18 (Inc., Chicago, IL, USA). Ap <0.05 was considered statistically significant. Data were expressed as mean§SD for numerical variables. The two groups were compared using Pearsonʼs x 2 test (or Fisherʼs exact test) for categorical variables and the Student t-test for continuous variables.TaggedEnd TaggedH1ResultsTaggedEnd TaggedH2Patient findingsTaggedEnd TaggedPOf a total of 120 patients with cancer, 68 patients (56.7%) were male and 52 patients (43.3%) were female. The mean§SDage of the patients at diagnosis was 9.47 §3.05 years (range 5 - 18 years). During the study, 7 patients dropped out and were excluded from the study due to not receiving chemotherapy or antiemetic drugs (4 patients in group A, 3 patients in group B). TaggedEndTaggedPAsafinal result, 113 patients remained in the study. Two treatment groups received a single dose of granisetron and DEX, whereas 56 patients received the 3-day aprepitant regimen orally and 57 patients received a single dose of aprepitant on day 1 and placebo on days 2 and 3. The clinical and demographicfindings of all patients are shown in Table 1. No statistically significant differences were found between the clinical and demographicfindings of the patients in the two groups (p> 0.05). There were no statistically significant differences in age, gender, weight, height, body mass index, history of CINV due to pregnancy, history of alcohol consumption and history of motion sickness of the patients in the two groups (p > 0.05). Most of patients (96.5%vs. 94.8% in groups A and B, respectively) had no history of chemotherapy (naive to chemotherapy) (p = 0.622). The most common types of cancers were osteosarcoma (30.3%vs. 21% in group A and B, respectively), acute lymphoblastic leukemia (21.5% vs. 24.6% in groups A and B, respectively), and Wilms tumor (19.6%vs. 22.8% in groups A and B, respectively). Doses and types of chemotherapy were similar in both groups, and there was no difference (data not shown).TaggedEnd TaggedH2Primary and secondary efficacy ratesTaggedEnd TaggedPAs shown in Table 2 and Figure 1, the number of patients without vomiting on the first day was similar in both groups (96.5%vs. 98.3%, respectively; p = 0.848). The severity of nausea on the first, second and third days, as well as significant nausea (VAS > 25mm) and overall nausea, were not significantly different between patients in the two groups (Table 2 and Figure 2). Moreover, the rate of use of breakthrough antiemetic medication in patients of both groups was almost the same (p>0.05, Table 2 and Figure 3). As shown in Table 2 and Figure 4, the CR on the second and third days was almost the TaggedEnd Table1 – Clinical and demographic findings of patients Characteristics GroupA(n=56) GroupB (n=57) p-value Gender, (%) 0.644a Female 25 (44.6) 23 (40.3) Male 31 (55.4) 34 (59.7) Age, years§SD; 10.21§2.81 9.10§3.13 0.689b Min-Max 7- 18 5 -16 Type of cancer; (%) 0.891a Acute lymphoblastic leukemia 12 (21.5) 14 (24.6) Rhabdomyosarcoma 6 (10.8) 7 (12.3) Wilms tumor 11 (19.6) 13 (22.8) Acute myeloid leukemia 4 (7) 3 (5.3) Osteosarcoma 17 (30.3) 12 (21) Hepatocellular carcinoma 6 (10.8) 8 (14) History of alcohol consumption, Yes (%) 2 (3.5) 3 (5.2) 0.662a Chemotherapy regimen, (%) 0.974a Dox + CP + Vincristine 18 (32.1) 20 (35.1) Dox + Cisplatin 16 (28.6) 15 (26.3) Dox + Dacarbazine + Vinblastine + Bleomycin 13 (23.2) 12 (21.1) Actinomycin D + Vincristine + CP 9 (16.1) 10 (17.5) Prior chemotherapy (non-naïve, %) 2 (3.5) 3 (5.2) 0.622a History of motion sickness, Yes (%) 4 (7.1) 6 (10.5) 0.527a SD: Standard of deviation; NA: not applicable; BMI: body mass index; CP: Cyclophosphamide; Dox: Doxorubicin. a Pearsonʼs x 2 test was used. b Student t-test was used. TaggedEnd284 hematol transfus cell ther. 2023;45(3):281−289
TaggedEndTaggedPsame in patients in both groups A and B (62.5%vs. 64.9%and 58.9% vs. 59.6%, respectively; p > 0.05). During the overall phase, the CR was observed in 51.8% of patients in group A and 52.6% of patients in group B (p = 1.000). No serious side effects were observed while taking the medication during the study (Table 3).TaggedEnd TaggedH1DiscussionTaggedEnd TaggedPThe current pilot study revealed that a single dose of aprepitant provided 3-day aprepitant-like efficacy in children who were receiving HEC. In this study, the occurrence of vomiting TaggedEnd Table2 – Status of CINV, rescue therapy and complete response of the patients in the two groups Characteristics GroupA(n=56) GroupB (n=57) p-value Nauseaa (mean§SD); Day1 13.6§31.4 9.8§18.3 0.638e Day2 16.7§22.4 12.2§15.8 0.531e Day3 11.3§26.9 17.7§21.1 0.652e Overall phase 13.4§19.6 14.3§17.5 0.937e Vomitingb (n,%); Day1 2 (3.5) 1 (1.7) 0.848e Day2 4 (7.1) 3 (5.2) 0.779e Day3 5 (8.9) 3 (5.2) 0.448e Overall phase 5 (8.9) 3 (5.2) 0.448e Rescue therapyc (n,%); Day1 7 (12.5) 5 (8.8) 0.368f Day2 23 (41.1) 16 (28.1) 0.105f Day3 26 (46.4) 19 (33.3) 0.109f Overall phase 27 (48.2) 21 (36.8) 0.151f Complete responsed (n,%); Day1 39 (69.6) 42 (73.7) 0.680f Day2 35 (62.5) 37 (64.9) 0.846f Day3 33 (58.9) 34 (59.6) 1.000f Overall phase 29 (51.8) 30 (52.6) 1.000f CINV: Chemotherapy-induced Nausea and Vomiting; VAS: Visual analog scale; n: number. a Severity of nausea using VAS. b Number patients with emesis (%). c Number of patients with breakthrough medication administered. d Absence of vomiting and nausea. e Determined by using the Pearsonʼs x 2 test (3-dayvs. 1-day). f Determined by using the Fisher Exact test. TaggedEnd TaggedFigure Figure2–The proportion of patients without vomiting during days 1 - 3 after HEC. No statistically significant differences were found between the two groups (p>0.05).TaggedEnd hematol transfus cell ther. 2023;45(3):281−289 285
TaggedEndTaggedPand nausea in group A was found in less than 10% and 20% of patients, respectively. In other words, the use of a single dose of aprepitant protects against vomiting in more than 90% of patients and nausea in more than 80% of patients. Previous studies have shown that adding aprepitant to standard treatment improves CR rates, compared to standard treatment in acute, overall and delayed phases.13,14 Hesketh et al. reported that the use of aprepitant in addition to the standard dual therapy, compared to the standard therapy, only improved the rate of CR in the acute TaggedEndTaggedP(78% vs. 89%), delayed (55% vs. 75%) and overall phases (52% vs. 72%).15 Similar results were reported in our study Figure 5.TaggedEnd TaggedPIn accordance with our results, DiIorio et al. reported that a single dose of aprepitant reduced the number of episodes and severity of nausea and vomiting, the need for additional antiemetics and the length of stay.16 Furthermore, Saito et al. reported that aprepitant was safely used and may be equally useful for pediatric patients receiving HEC,17 which was consistent with the results of our study.TaggedEnd TaggedEnd TaggedFigure Figure4–The proportion of patients without rescue therapy during days 1 - 3 after HEC. No statistically significant differences were found between the two groups (p>0.05).TaggedEnd TaggedEnd TaggedFigure Figure3–The proportion of patients without significant nausea (VAS<25mm) during days 1 - 3 after HEC. No statistically significant differences were found between the two groups (p>0.05).TaggedEnd TaggedEnd286 hematol transfus cell ther. 2023;45(3):281−289
TaggedPThe CINV is one of the undesirable side effects of chemotherapy regimens for patients with cancer. Therefore, to improve the quality of life of patients receiving chemotherapy, it is necessary to assess the severity of the CINV. The effect of aprepitant-containing antiemetics in children receiving chemotherapy drugs in this study is similar to that in other studies.TaggedEnd TaggedPJanelsins et al. reported that the application of serotonin receptor antagonists, along with DEX, can improve the CINV in the acute stage, but the delayed N/V has remained an important clinical issue.18,19 Aprepitant is one of the drugs approved by the FDA for the treatment of CINV in March 2003. Aprepitant is effective in preventing acute and chronic CINV in patients undergoing HEC, including cisplatin- and anthracycline-containing therapies.20 TaggedEnd TaggedPHerrington and colleagues reported a comparison trial with aprepitant, combined with palonosetron and DEX, in patients who were 18 years of age or older.21 Their Arm A TaggedEndTaggedPpatients received aprepitant 125 mg orally on day 1, followed by 80 mg orally on days 2 and 3, while Arm B received only aprepitant 125 mg orally on day 1 and placebo on days 2 and 3. All groups received palonosetron 0.25 mg (i.v.) on day 1, plus DEX on days 1 to 4. However, there were no statistical differences for emesis, nausea or the use of breakthrough antiemetic medication between Arm A and Arm B,21 whichwas consistent with our findings. In Arms A and B, 93% of the patients were vomiting-free from days 1 to 5,21 compared to 91.5% and 94.8%, respectively, in our study.TaggedEnd TaggedPIn another study, Oyama et al. evaluated the efficacy of aprepitant at 285 mg in patients with gastric cancer (median age 65 years) treated with S-1, plus cisplatin, for the prevention of CINV.22 They prescribed aprepitant at 125 mg orally 60 min before the cisplatin infusion, granisetron at 3 mg (i.v.) 30 min and DEX at 9.9 mg (i.v.) on day 1; oral aprepitant at 80 mg daily along with oral DEX at 8 mg on days 2 and 3, and; oral DEX at 8 mg on day 4. The CR was 98.1%, 88.7% and 88.7% TaggedEnd TaggedFigure Figure5–The proportion of patients with complete response during days 1 - 3 after HEC. No statistically significant differences were found between the two groups (p>0.05).TaggedEnd TaggedEnd Table3 – Comparison of side effects between the two groups Characteristics GroupA(n=56) GroupB (n=57) p-value Most common nonserious clinical adverse events, (%) 0.824a Anemia 13 (23.2) 10 (17.5) Headache 4 (7.1) 6 (10.5) Constipation 9 (16) 11 (19.3) Diarrhea 11 (19.6) 8 (14) Fatigue 8 (14.3) 9 (15.8) N: number. a Pearsonʼs x 2 test was used. hematol transfus cell ther. 2023;45(3):281−289 287
TaggedEndTaggedPin the acute, delayed and overall periods, respectively. The percentage of patients without vomiting during the first 24 hours was 98.1% and for the delayed and overall phases, 92.5% and 92.5%, respectively. In addition, the proportions of patients without significant nausea (VAS < 25) during the acute, delayed and overall periods were 98.1%, 69.8% and 69.8%, respectively. The proportions of patients without rescue therapy were 96.2%, 100% and 96.2 in the overall, acute and delayed periods, respectively.22 TaggedEnd TaggedPIn a study, Grunberg et al. evaluated the efficacy of a single daily dose of aprepitant at 285 mg in patients with solid tumors for the prevention of acute and delayed CINV.23 They prescribed a single dose of aprepitant at 285 mg orally, along with palonosetron and DEX, to breast cancer patients with a median age of 52 years who were to undergo a chemotherapy regimen with cyclophosphamide and anthracycline. The CRs were 78%, 59%, and 50% in the acute, delayed and overall periods, respectively. The percentage of patients without vomiting during the first 24 hours was 100% and for the delayed and overall phases, 97% and 97, respectively. Additionally, the percentages of patients without significant nausea (VAS< 25) during the acute, delayed and overall periods were 75, 62% and 56%, respectively.23 However, it should be noted that the use of larger doses of aprepitant may interfere with chemotherapy drugs, such as cyclophosphamide and doxorubicin.TaggedEnd TaggedPIn a study on the efficacy of aprepitant and fosaprepitant in CINV in 26 children and teenagers with cancer (who were 11 months to 17 years), the authors found that the use of aprepitant and fosaprepitant had optimal effectiveness on decreasing CIVN, which was similar to the results of this study.24 In another study in patients aged 6 months to 17 years being treated with emetogenic chemotherapy, the authors recorded that the combination of aprepitant with ondansetron, with or without DEX, was useful in the prevention of CINV.25 Thesefindings were, to some extent, similar to the results of this study and the limited difference could be attributed to the difference in the evaluated groups. In a study on the efficacy of aprepitant in the CINV of children suffering from cancer, the authors showed that aprepitant can be employed as a standard treatment for children suffering from severe CINV.26 Megan et al. showed that aprepitant appeared to be safe and well-tolerated in children weighing less than 40 kg, but that it might not completely reduce the CINV.27 In this study, it was shown that the combination of granisetron and aprepitant could render most patients CINV-free during days 1 to 3 after chemotherapy.TaggedEnd TaggedPIn a double-blinded randomized clinical trial, Kang et al. assessed the efficacy of aprepitant on the CINV of children suffering from cancer who were also undergoing chemotherapy. Their results revealed that the 3-dose oral aprepitant, in combination with ondansetron, with or without DEX, can significantly prevent the CINV in children undergoing chemotherapy, when compared with controls or those treated solely with ondansetron, with or without DEX.28 Shillingburg et al. conducted a study addressing the efficacy of aprepitant and fosaprepitant on the CINV among 26 children and teenagers with cancer. They reported no side effects due to the administration of aprepitant and, hence, they concluded that aprepitant and fosaprepitant could be well tolerated in children.29 No serious side effects were seen in this study.TaggedEnd TaggedH1ConclusionTaggedEnd TaggedPIn conclusion, the current study has shown that a single dose of aprepitant of 125 mg/kg was as effective as administering three doses of aprepitant over 3 days. Therefore, using a single dose of aprepitant of 125 mg/kg is less expensive and has similar efficacy for HEC regimens. Furthermore, the use of a single dose of aprepitant, in combination with other standard treatment regimens, to prevent the CINV in children who received highly emetogenic chemotherapy was safe and efficacious and could be beneficial.TaggedEnd TaggedH1Conflicts of interestTaggedEnd TaggedPNone.TaggedEnd TaggedH1AcknowledgmentsTaggedEnd TaggedPWe would like to thank the Research Council of Arak University of Medical Sciences, which has provided funding for this research (Grant 1719). We would also like to thank all the staff of the Blood and Oncology Department of the Amirkabir Hospital in Arak, Iran.TaggedEnd taggedh1referencestaggedend TaggedP 1. Li Q-W, Yu M-W, Wang X-M, Yang G-W, Wang H, Zhang C-X, et al. Efficacy of acupuncture in the prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: a multi-center, single-blind, randomized, sham-controlled clinical research. Chinese Med. 2020;15:1–11.TaggedEnd TaggedP 2. Najafi S, Haghighat S, Raji Lahiji M, RazmPoosh E, Chamari M, Abdollahi R, et al. Randomized study of the effect of dietary counseling during adjuvant chemotherapy on chemotherapy induced nausea and vomiting, and quality of life in patients with breast cancer. Nutr Cancer. 2019;71(4):575–84.TaggedEnd TaggedP 3. Miyoshi T, Miyashita H, Matsuo N, Odawara M, Hori M, Hiraki Y, et al. Palonosetron versus granisetron in combination with aprepitant and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting after moderately emetogenic chemotherapy: a single-institutional retrospective Cohort Study. Biol Pharm Bull. 2021;44(10):1413–8.TaggedEnd TaggedP 4. Gupta K, Walton R, Kataria S. Chemotherapy-induced nausea and vomiting: pathogenesis, recommendations, and new trends. Cancer Treat Res Commun. 2021;26:100278.TaggedEnd TaggedP 5. Sherani F, Boston C, Mba N. Latest update on prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients. 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