Challenges in Chronic Myeloid Leukemia Management in South America.


Journal

Current hematologic malignancy reports
ISSN: 1558-822X
Titre abrégé: Curr Hematol Malig Rep
Pays: United States
ID NLM: 101262565

Informations de publication

Date de publication:
10 2021
Historique:
accepted: 03 09 2021
pubmed: 17 10 2021
medline: 27 11 2021
entrez: 16 10 2021
Statut: ppublish

Résumé

Chronic myeloid leukemia (CML) management in developing countries has improved in the last years, but the availability of therapeutic resources, monitoring, reimbursement, and financial issues may be a challenge and interfere with the best practices and results of CML treatment. This review points out the main challenges in CML management in South America. In this review, we describe the access to tyrosine kinase inhibitors and monitoring in different countries of South America. We also address the ongoing discontinuation trials, the progress, and limitations of hematopoietic stem cell transplantation in the last years. There are still many challenges for achieving the best outcomes for CML patients in South America. The continuous efforts to provide continuous education, access to tyrosine kinase inhibitors, and monitoring, providing reference centers for CML management and hematopoietic stem cell transplantation may improve patients' outcomes.

Identifiants

pubmed: 34655027
doi: 10.1007/s11899-021-00654-0
pii: 10.1007/s11899-021-00654-0
doi:

Substances chimiques

Antineoplastic Agents 0
Protein Kinase Inhibitors 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

440-447

Informations de copyright

© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Références

Cortes J, De Souza C, Ayala-Sanchez M, Bendit I, Best-Aguilera C, Enrico A, et al. Current patient management of chronic myeloid leukemia in Latin America: a study by the Latin American Leukemia Net (LALNET). Cancer. 2010;116(21):4991–5000.
doi: 10.1002/cncr.25273
Pavlovsky C, Mela Osorio MJ. Chronic myeloid leukemia: what is the best strategy to start and monitor treatment outside academic centers? Curr Oncol Rep. 2018;20(1):4.
doi: 10.1007/s11912-018-0653-6
Abello-Polo VS-M, Claudia Peña, Angela et al. ACHO (Asociación Colombiana de Hematología y Oncología), RENEHOC researchers. Impact of Insurance Differences in Outcomes in Colombian Patients with Chronic Myeloid Leukemia (CML). Clinical Lymphoma, Myeloma and Leukemia. 2020:S240
Méndez Y, Giraldo-Castaño Mn, Rocha MF. Estudio sobre la identificación de necesidades emocionales, sociales y de acceso a los servicios de salud, de los pacientes diagnosticados con leucemia mieloide crónica en Colombia  https://www.funleucemialinfoma.org/wp-content/uploads/2019/07/Paper-Estudio-LMC.pdf : Fundación Colombiana de Leucemia y Linfoma; 2018. Accessed 11 Apr 2021.
Ylescas-Soria J, de la Torre-Lujan AH, Herrera LA, Miranda D, Grimaldo F, Rivas S, et al. Prognostic factors for overall survival in patients with chronic myeloid leukemia treated with imatinib at the National Cancer Institute - Mexico, from 2000 to 2016. Cancer Med. 2019;8(6):2942–9.
doi: 10.1002/cam4.2201
Laurell AC, Giovanella L. Health Policies and Systems in Latin America. Oxford Research Encyclopedias, Global Public Health; 2018.
Kanavos P, Colville Parkin G, Kamphuis B, Gill J. Latin America Healthcare System Overview. A comparative analysis of fiscal space in healthcare. https://www.lse.ac.uk/business-and-consultancy/consulting/assets/documents/latin-america-healthcare-system-overview-report-english.pdf : London School of Economics and Political Science; 2019. Accessed 12 Apr 2021.
Guérin A, Chen L, Dea K, Wu EQ, Goldberg SL. Economic benefits of adequate molecular monitoring in patients with chronic myelogenous leukemia. J Med Econ. 2014;17(2):89–98.
doi: 10.3111/13696998.2013.862251
EiCM L. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121(22):4439–42.
doi: 10.1182/blood-2013-03-490003
Campaign MA. Untangling the web of antiretroviral price reductions. https://msfaccess.org/utw ; 2016. Accessed 11 Apr 2021.
Margolese HC, Wolf Y, Desmarais JE, Beauclair L. Loss of response after switching from brand name to generic formulations: three cases and a discussion of key clinical considerations when switching. Int Clin Psychopharmacol. 2010;25(3):180–2.
doi: 10.1097/YIC.0b013e328337910b
Saavedra D, Vizcarra F. Deleterious effects of non-branded versions of imatinib used for the treatment of patients with chronic myeloid leukemia in chronic phase: a case series on an escalating issue impacting patient safety. Leuk Lymphoma. 2014;55(12):2813–6.
doi: 10.3109/10428194.2014.893302
Chouffai Z. Hematologic relapse after 2 years on a non-authorized copy version of imatinib in a patient with chronic myeloid leukemia in chronic phase: a case report. Case Rep Oncol. 2010;3(2):272–6.
doi: 10.1159/000319150
Ćojbašić I, Mačukanović-Golubović L, Vučić M, Ćojbašić Ž. Generic imatinib in chronic myeloid leukemia treatment: long-term follow-up. Clin Lymphoma Myeloma Leuk. 2019;19(9):e526–31.
doi: 10.1016/j.clml.2019.05.006
Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodríguez P, Márquez S, Guarneri C, et al. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clin Ther. 2009;31(10):2224–32.
doi: 10.1016/j.clinthera.2009.10.009
Arora R, Sharma M, Monif T, Iyer S. A Multi-centric bioequivalence trial in Ph+ chronic myeloid leukemia patients to assess bioequivalence and safety evaluation of generic imatinib mesylate 400 mg tablets. Cancer Res Treat. 2016;48(3):1120–9.
doi: 10.4143/crt.2015.436
Jung JA, Kim N, Yang JS, Kim TE, Kim JR, Song GS, et al. Bioequivalence study of two imatinib formulations after single-dose administration in healthy Korean male volunteers. Drug Res (Stuttg). 2014;64(12):651–5.
doi: 10.1055/s-0034-1367059
Pagnano K, Fava C, Miranda E, Giuseppe Saglio. Efficacy and safety of generic imatinib compared to Glivec in chronic phase - chronic myeloid leukemia - a multicenter, observational study. Blood. 2018;132:46.
doi: 10.1182/blood-2018-99-113718
Varela Ines A, Bendek G, Pavlovsky Carolina, Freitas MF, et al. Real world efficacy evaluation of branded and copy imatinib in chronic myeloid leukemia: a retrospective multicentric study from Argentina. Blood. 2020;136:36–7.
doi: 10.1182/blood-2020-137792
Baccarani M, Saglio G, Goldman J, Hochhaus A, Simonsson B, Appelbaum F, et al. Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet. Blood. 2006;108(6):1809–20.
doi: 10.1182/blood-2006-02-005686
Hughes T, Deininger M, Hochhaus A, Branford S, Radich J, Kaeda J, et al. Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood. 2006;108(1):28–37.
doi: 10.1182/blood-2006-01-0092
Branford S, Fletcher L, Cross N, Müller MC, Hochhaus A, Dong-Wook Kim, et al. Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials. Blood 2008 112 8.
Ruiz MS, Sánchez MB, Vera Contreras YM, Agrielo E, Alonso M, Altuna ME, et al. Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: findings and recommendations. Clin Chem Lab Med. 2020;58(12):2025–35.
doi: 10.1515/cclm-2019-1283
Ribeiro BF, Vergílio BR, Miranda EC, Almeida MH, Delamain MT, da Silveira RA, et al. BCR-ABL1 transcript levels at 3 and 6 months are better for identifying chronic myeloid leukemia patients with poor outcome in response to second-line second-generation tyrosine kinase inhibitors after imatinib failure: a report from a single institution. Acta Haematol. 2015;134(4):248–54.
doi: 10.1159/000430835
Boquimpani C, Schaffel R, Biasoli I, Bendit I, Spector N. Molecular responses at 3 and 6 months after switching to a second-generation tyrosine kinase inhibitor are complementary and predictive of long-term outcomes in patients with chronic myeloid leukemia who fail imatinib. Leuk Lymphoma. 2015;56(6):1787–92.
doi: 10.3109/10428194.2014.974047
Boquimpani CM, Abdo ANR, Martins DP, Lima LBA, Torriani MS, Bendit I. Inclusion of molecular monitoring (BCR-ABL1) in the treatment of chronic myeloid leukemia in the Brazilian Public Health System (SUS): an urgent need for treatment management. Hematol Transfus Cell Ther. 2021;43(1):50–7.
doi: 10.1016/j.htct.2020.02.002
De Souza CA, Vigorito AC, Ruiz MA, Nucci M, Dulley FL, Funcke V, et al. Validation of the EBMT risk score in chronic myeloid leukemia in Brazil and allogeneic transplant outcome. Haematologica. 2005;90(2):232–7.
pubmed: 15710577
Bittencourt H, Funke V, Fogliatto L, Magalhães S, Setubal D, Paz A, et al. Imatinib mesylate versus allogeneic BMT for patients with chronic myeloid leukemia in first chronic phase. Bone Marrow Transplant. 2008;42(9):597–600.
doi: 10.1038/bmt.2008.218
Hochhaus A, Baccarani M, Silver RT, Schiffer C, Apperley JF, Cervantes F, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966–84.
doi: 10.1038/s41375-020-0776-2
Pasquini MC. Hematopoietic cell transplantation for chronic myeloid leukemia in developing countries: perspectives from Latin America in the post-tyrosine kinase inhibitor era. Hematology. 2012;17(Suppl 1):S79-82.
doi: 10.1179/102453312X13336169155853
Phelan R, Arora, M., Chen, M. Current use and outcome of hematopoietic stem cell transplantation: CIBMTR summary slides, 2020. In: CIBMTR, editor. https://www.ecosia.org/search/q=Current+use+and+outcome+of+hematopoietic+stem+cell+transplantation%3A+CIBMTR+summary+slides%2C+2020&addon=safari&addonversion=4.2.1.512020 . Accessed 5 Apr 2021.
Eckrich M, Pasquini M. Hematopoietic cell transplantation in Latin America. Hematology. 2012;17(Suppl 1):S189–91.
doi: 10.1179/102453312X13336169157059
Jaimovich G, Gale RP, Hanesman I, Rolón JM. The state of haematopoietic cells transplantation in Latin America. Lancet Haematol. 2021;8(1):e20–1.
doi: 10.1016/S2352-3026(20)30410-5
Jaimovich G, Martinez Rolon J, Baldomero H, Rivas M, Hanesman I, Bouzas L, et al. Latin America: the next region for haematopoietic transplant progress. Bone Marrow Transplant. 2017;52(5):671–7.
doi: 10.1038/bmt.2016.361
Gale RP, Seber A, Bonfim C, Pasquini M. Haematopoietic cell transplants in Latin America. Bone Marrow Transplant. 2016;51(7):898–905.
doi: 10.1038/bmt.2016.35
Padula WV, Larson RA, Dusetzina SB, Apperley JF, Hehlmann R, Baccarani M, et al. Cost-effectiveness of Tyrosine Kinase Inhibitor Treatment Strategies for Chronic Myeloid Leukemia in Chronic Phase After Generic Entry of Imatinib in the United States. J Natl Cancer Inst 2016 108 7.
Etienne G, Guilhot J, Rea D, Rigal-Huguet F, Nicolini F, Charbonnier A, et al. Long-Term Follow-Up of the French Stop Imatinib (STIM1) Study in Patients With Chronic Myeloid Leukemia. J Clin Oncol. 2017;35(3):298–305.
doi: 10.1200/JCO.2016.68.2914
Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, et al. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018;19(6):747–57.
doi: 10.1016/S1470-2045(18)30192-X
Hochhaus A, Saussele S, Rosti G, Mahon FX, Janssen JJWM, Hjorth-Hansen H, et al. Chronic myeloid leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2018 29 (Suppl 4):iv261.
Baccarani M, Abruzzese E, Accurso V, Albano F, Annunziata M, Barulli S, et al. Managing chronic myeloid leukemia for treatment-free remission: a proposal from the GIMEMA CML WP. Blood Adv. 2019;3(24):4280–90.
doi: 10.1182/bloodadvances.2019000865
Deninger M, Shah N, Altman J. NCCN guidelines: chronic myeloid leukemia. national Comprehensive Cancer Network (NCCN) Guidelines [Internet]. 2019.
Pavlovsky C, Abello Polo V, Barbosa Pagnano KB, Varela AI, Lopez CA, Bianchini M, Boquimpani C, Torrescasana Centrone R, Conchon M, Delgado N, Araújo Moreira Funke V, Giere IA, Pinto IL, Meillon-Garcia L, Moiraghi B, Ramon Navarro J, Pilleux L, Prado AI, Soledad Undurraga M, Cortes J. Treatment free remission in patients with chronic myeloid leukemia: recommendations of LALNET expert panel. Blood Adv 2021; https://doi.org/10.1182/bloodadvances.2020003235
Pagnano K. BCR-ABL1 level monitoring in chronic myeloid leukemia by real time polymerase chain reaction in Brazil – not so real. Rev Bras Hematol Hemoter. 2017:197–8.
Mahon FX, Boquimpani C, Kim DW, Benyamini N, Clementino NCD, Shuvaev V, et al. Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2. Open-Label Study Ann Intern Med. 2018;168(7):461–70.
pubmed: 29459949
Hochhaus A, Masszi T, Giles FJ, Radich JP, Ross DM, Gómez Casares MT, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia. 2017;31(7):1525–31.
doi: 10.1038/leu.2017.63
Isoppo CC, Braga AGO, Chaves HVS, Duarte GO, Delamain MT, Pagnano KBB. Descontinuaçao de Inhibidores de Tirosinquinase na práctica clínica: Relato de quatro casos. Hematology Transfusion and Cell Therapy. 2020;42(S2):120–1.
doi: 10.1016/j.htct.2020.10.203
Moura AC, Delamain MT, Duarte GBO, Lorand-Metze I, Souza CA, Pagnano KBB. Management of chronic myeloid leukemia during pregnancy: a retrospective analysis at a single center. Hematol Transfus Cell Ther. 2019;41(2):125–8.
doi: 10.1016/j.htct.2018.10.001
Pagnano K, Seguro F, Miranda E, Bendit I. Duration of Major Molecular Response and Discontinuation in Deep Molecular Response (MR4.5) Were Associated with Longer Treatment-Free Survival after Imatinib Discontinuation - Results from Two Prospective Brazilian Trials. Blood. 2019;134:1655.
doi: 10.1182/blood-2019-125368
Pagnano KBB, Lopes ABP, Miranda EC, Delamain MT, Duarte GO, Rodrigues BRV, et al. Efficacy and safety of pioglitazone in a phase 1/2 imatinib discontinuation trial (EDI-PIO) in chronic myeloid leukemia with deep molecular response. Am J Hematol. 2020;95(12):E321–3.
doi: 10.1002/ajh.25986
Lopes AM, Eliana Oliveira Póvoa , Valquíria Mariane Vergílio , Bruna Rocha Pavan Furlin , Graziele Cristina Torresan Delamain, Marcia Borba Duarte, Gislaine Souza, Carmino Antonio De Paula, Erich V Pagnano, Katia B. Pioglitazone Did Not Affect PPAR- Γ , STAT5 , HIF2 α and CITED2 Gene Expression in Chronic Myeloid Leukemia Patients with Deep Molecular Response. Blood 2019 134.
Seguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, et al. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021;101:106516.
doi: 10.1016/j.leukres.2021.106516
Pavlovsky , Carolina, Varela AI, Fernandez I, Beatriz Moiraghi B. High Level of Successful TKI Discontinuation in Chronic Myeloid Leukemia (CML) Patients: Preliminary Results of AST-Argentina Stop Trial. Blood [Internet] 2020 136 Supl 1.
Abello Polo V, Sossa Melo C, Peña A, Casas C, Gomez R, Osuna M. Treatment Free Remission in Patients with Chronic Myeloid Leukemia (CML): A Real-World Cohor of Patients in Colombia. Clinical Lymphoma, Myeloma & Leukemia [Internet] 2020 S244.

Auteurs

Katia B Pagnano (KB)

Centro de Hematologia E Hemoterapia, Universidade Estadual de Campinas, Campinas, SP, Brazil. kborgia@unicamp.br.

Ana Ines Varela (AI)

Hospital J.M. Ramos Mejía, Sanatorio Las Lomas, Buenos Aires, Argentina.

Carolina Pavlovsky (C)

FUNDALEU, Buenos Aires, Argentina.

Israel Bendit (I)

Laboratory of Medical Investigation in Pathogenesis and Targeted Therapy in Onco-Immuno-Hematology (LIM/31), Department of Hematology, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.

Vaneuza A M Funke (VAM)

Complexo Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil.

Virginia Abello Polo (VA)

Facultad de Medicina, Fundación Universitaria de Ciencias de La Salud. Servicio de Hematología, Hospital de San José. Servicio de Hematología, Clínica del Country, Bogotá, Colombia.

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