Revisión Sistemática de Estudios Observacionales sobre el uso de Erlotinib y Gefitinib en el Tratamiento del Cáncer de Pulmón de Células No Pequenas
DOI:
https://doi.org/10.32635/2176-9745.RBC.2024v70n3.4656Palabras clave:
Clorhidrato de Erlotinib, Gefitinib, Neoplasias Pulmonares/tratamiento farmacológico, Resultado del Tratamiento, Revisión SistemáticaResumen
Introducción: La evaluación del uso de medicamentos a gran escala forma parte del ciclo de vida de la tecnología. Desde la introducción de gefitinib y erlotinib para el tratamiento del cáncer de pulmón de células no pequeñas en el Sistema Único de Salud del Brasil en 2013, no se han publicado revisiones con datos del mundo real. Objetivo: Evaluar los datos sobre la eficacia, seguridad, calidad de vida y adherencia al uso de erlotinib y gefitinib en el tratamiento del cáncer de pulmón no microcítico a partir de una revisión sistemática de estudios observacionales. Método: Se registró un protocolo de revisión sistemática. Se realizaron búsquedas de evidencia en MEDLINE, EMBASE, Cochrane, LILACS y CINAHL. Dos investigadores seleccionaron de forma independiente los estudios, extrajeron los datos y evaluaron la calidad metodológica. El riesgo de sesgo se evaluó mediante la lista de ítems de evaluación crítica del Instituto Joanna Briggs para estudios de cohortes y transversales. Resultados: Se incluyeron ocho estudios de cohortes. Se observaron medianas de supervivencia global y supervivencia libre de progresión mayores con gefitinib y erlotinib en comparación con la quimioterapia. Los estudios mostraron una baja incidencia de acontecimientos adversos, buena calidad de vida y altas tasas de adherencia entre los pacientes que tomaban los fármacos evaluados. Al evaluar el riesgo de sesgo, se observó que todos los estudios presentaban algún tipo de sesgo o criterios de calidad que no se cumplían. Conclusión: Se identificó beneficio clínico en un contexto del mundo real para los fármacos gefitinib y erlotinib incorporados al Sistema Único de Salud del Brasil.
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Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-63. doi: https://doi.org/10.3322/caac.21834 DOI: https://doi.org/10.3322/caac.21834
Santos MO, Lima FCDS, Martins LFL, et al. Estimativa de incidência de câncer no Brasil, 2023-2025. Rev Bras Cancerol 2023;69(1):e-213700. doi: https://doi.org/10.32635/2176-9745.RBC.2023v69n1.3700 DOI: https://doi.org/10.32635/2176-9745.RBC.2023v69n1.3700
Bender E. Epidemiology: the dominant malignancy. Nature. 2014;513:S2-3. doi: https://doi.org/10.1038/513S2a DOI: https://doi.org/10.1038/513S2a
Valerio TS, Emmerick ICM, Sobreira da Silva MJ. Factors associated with late-stage diagnosis and overall survival for lung cancer: an analysis of patients treated in a Brazilian hospital and a US-hospital from 2009 to 2019. Cancer Epidemiol. 2023;86:102443. doi: https://doi.org/10.1016/j.canep.2023.102443 DOI: https://doi.org/10.1016/j.canep.2023.102443
Lima VCCD, Baldotto C, Terra RM, et al. Year in review 2018: lung cancer. Braz J Oncol. 2018;14(49):e-20180007. doi: https://doi.org/10.5935/2526-8732.20180007 DOI: https://doi.org/10.5935/2526-8732.20180007
Abdelgalil AA, Al-Kahtani HM, Al-Jenoobi FI. Erlotinib. In: Brittain H, editor. Profiles of drug substances, excipients and related methodology. London: Academic Press; 2020. p. 93-117. doi: https://doi.org/10.1016/bs.podrm.2019.10.004 DOI: https://doi.org/10.1016/bs.podrm.2019.10.004
Skoulidis F, Heymach JV. Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy. Nat Rev Cancer. 2019;19(9):495-509. doi: https://doi.org/10.1038/s41568-019-0179-8 DOI: https://doi.org/10.1038/s41568-019-0179-8
Mathias C, Prado GF, Mascarenhas E, et al. Lung cancer in Brazil. J Thorac Oncol. 2020;15(2):170-5. doi: https://doi.org/10.1016/j.jtho.2019.07.028 DOI: https://doi.org/10.1016/j.jtho.2019.07.028
Agência Nacional de Vigilância Sanitária (BR). Relatório de recomendação da Comissão Nacional de Incorporação de Tecnologias no SUS – Erlotinibe para câncer de pulmão de células não pequenas. Brasília, DF: Ministério da Saúde; 2013.
Agência Nacional de Vigilância Sanitária (BR). Relatório de Recomendação da Comissão Nacional de Incorporação de Tecnologias no SUS – Gefitinibe para câncer de pulmão de células não pequenas em primeira linha. Brasília, DF: Ministério da Saúde; 2013.
Ministério da Saúde (BR), Secretaria de Atenção Especializada à Saúde. Portaria nº 957, de 26 de setembro de 2014. aprova as diretrizes diagnósticas e terapêuticas do câncer de pulmão [Internet]. Diário Oficial da União, Brasília, DF. 2014 set 29 [acesso 2022 set 20]; Seção 1:59. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/sas/2014/prt0957_26_09_2014.html
Kirwin E, Round J, Bond K, et al. A conceptual framework for life-cycle health technology assessment. Value Health. 2022;25(7):1116-23. doi: https://doi.org/10.1016/j.jval.2021.11.1373 DOI: https://doi.org/10.1016/j.jval.2021.11.1373
University of York. Centre for Reviews and Dissemination. New York: University of York; 2019. PROSPERO - International prospective register of systematic reviews. 2023. [acesso 2023 ago 31]. Disponível em: https://www.crd.york.ac.uk/prospero/display_record. php?ID=CRD42022337969
Moher D, Liberati A, Tetzlaff J, et al. Principais itens para relatar revisões sistemáticas e meta-análises: a recomendação PRISMA. Epidemiol Serv Saúde. 2015;24(2):335-42. doi: https://doi.org/10.5123/S1679-49742015000200017 DOI: https://doi.org/10.5123/S1679-49742015000200017
Munn Z, Moola S, Lisy K, et al. Methodological guidance for systematic reviews of observational epidemiological studies reporting prevalence and cumulative incidence data. Int J Evid Based Healthc. 2015;13(3):147-53. doi: https://doi.org/10.1097/XEB.0000000000000054 DOI: https://doi.org/10.1097/XEB.0000000000000054
Rusdi F, Iskandar H, Hardjianti T, et al. The one year survival rate of lung adenocarcinoma patients treated with chemotherapy or targeted therapy. Enferm Clin. 2020;30(Supl. 4):456-60. doi: https://doi.org/10.1016/j.enfcli.2019.10.120 DOI: https://doi.org/10.1016/j.enfcli.2019.10.120
Jiang SX, Walton RN, Hueniken K, et al. Real-world health utility scores and toxicities to tyrosine kinase inhibitors in epidermal growth fator receptor mutated advanced non-small cell lung cancer. Cancer Med 2019;8(18):7542-55. doi: https://doi.org/10.1002/cam4.2603 DOI: https://doi.org/10.1002/cam4.2603
Brat K, Bratova M, Skrickova J, et al. Real-life effectiveness of first-line anticancer treatments in stage IIIB/IV NSCLC patients: data from the Czech TULUNG Registry. Thorac Cancer. 2020;11(11):3346-56.doi: https://doi.org/10.1111/1759-7714.13679 DOI: https://doi.org/10.1111/1759-7714.13679
Chung CH. EGFR tyrosine kinase inhibitor therapy for lung cancer treatments and their clinical outcomes: a cohort study in Taiwan. Oncol Lett 2019;18(6):6090-100. doi: https://doi.org/10.3892/ol.2019.10942 DOI: https://doi.org/10.3892/ol.2019.10942
Schuette W, Schirmacher P, Eberhardt WE, et al. Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: na observational study. BMC Cancer. 2018;18(1):135. doi: https://doi.org/10.1186/s12885-018-4032-3 DOI: https://doi.org/10.1186/s12885-018-4032-3
Wang XY, Zhou EX. Translational research on epidermal growth factor receptor gene mutations in targeted therapy for patients with advanced non-small cell lung cancer. J Int Trans Med. 2015;3(4):248-52. doi: https://doi.org/10.11910/2227-6394.2015.03.04.04
Wu JY, Yu CJ, Shih JY. Effectiveness of treatments for advanced non–small-cell lung cancer with exon 20 insertion epidermal growth factor receptor mutations. Clin Lung Cancer. 2019;20(6):e620-30. doi: https://doi.org/10.1016/j.cllc.2019.06.018 DOI: https://doi.org/10.1016/j.cllc.2019.06.018
Hess LM, Louder A, Winfree K, et al. Factors associated with adherence to and treatment duration of erlotinib among patients with non-small cell lung cancer. J Manag Care Spec Pharm. 2017;23(6):643-52. doi: https://doi.org/10.18553/jmcp.2017.16389 DOI: https://doi.org/10.18553/jmcp.2017.16389
Timmers L, Boons CC, Moes-Ten Hove J, et al. Adherence, exposure and patients’ experiences with the use of erlotinib in non-small cell lung c a n c e r . J Cancer Res Clin Oncol. 2015;141(8):1481-91. doi: https://doi.org/10.1007/s00432-015-1935-0 DOI: https://doi.org/10.1007/s00432-015-1935-0
Wei YF, Huang WT, Liu TC, et al. Factors associated with improvement in symptoms and quality of life for first-line EGFR-tyrosine kinase inhibitor treatment in patients with EGFR-mutated non-small-cell lung cancer a multicenter prospective SMILE study. J Cancer. 2019;10(17):4151-8. doi: https://doi.org/10.7150/jca.30507 DOI: https://doi.org/10.7150/jca.30507
Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomized phase 3 trial. Lancet Oncol. 2010;11(2):121-8. doi: https://doi.org/10.1016/S1470-2045(09)70364-X DOI: https://doi.org/10.1016/S1470-2045(09)70364-X
Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362(25):2380-8. doi: https://doi.org/10.1056/NEJMoa0909530 DOI: https://doi.org/10.1056/NEJMoa0909530
Gao G, Ren S, Li A, et al. Epidermal growth factor receptor-tyrosinekinase inhibitor therapy is effective as first-line treatment of advanced non-small-cell lung cancer with mutated EGFR: A meta-analysis from six phase III randomized controlled trials. Int J Cancer. 2012;131(5):e822-9. doi: https://doi.org/10.1002/ijc.27396 DOI: https://doi.org/10.1002/ijc.27396
Wang F, Wang LD, Li B, et al. Gefitinib compared with systemic chemotherapy as first-line treatment for chemotherapy-naive patients with advanced non-small cell lung cancer: a meta-analysis of randomised controlled trials. Clin Oncol (R Coll Radiol). 2012;24(6):396-401. doi: https://doi.org/10.1016/j.clon.2011.09.013 DOI: https://doi.org/10.1016/j.clon.2011.09.013
Rosell R, Carcereny E, Gervais R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open- label, randomised phase 3 trial. Lancet Oncol. 2012;13(3):239-46. doi: https://doi.org/10.1016/S1470-2045(11)70393-X DOI: https://doi.org/10.1016/S1470-2045(11)70393-X
Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation- positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open- label, randomised, phase 3 study. Lancet Oncol. 2011;12(8):735-42. doi: https://doi.org/10.1016/S1470-2045(11)70184-X DOI: https://doi.org/10.1016/S1470-2045(11)70184-X
Paz‐Ares L, Soulières D, Melezínek I, et al. Clinical outcomes in non-small-cell lung cancer patients with EGFR mutations: pooled analysis. J Cell Mol Med. 2010;14(1-2):51-69. doi: https://doi.org/10.1111/j.1582-4934.2009.00991.x DOI: https://doi.org/10.1111/j.1582-4934.2009.00991.x
Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol. 2012;30(10):1122-8. doi: https://doi.org/10.1200/JCO.2011.36.8456 DOI: https://doi.org/10.1200/JCO.2011.36.8456
Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013;24(1):54-9. doi: https://doi.org/10.1093/annonc/mds214 DOI: https://doi.org/10.1093/annonc/mds214
Lee SM, Khan I, Upadhyay S, et al. First-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy (TOPICAL): a double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2012;13(11):1161-70. doi: https://doi.org/10.1016/S1470-2045(12)70412-6 DOI: https://doi.org/10.1016/S1470-2045(12)70412-6
Patil VM, Noronha V, Joshi A, et al. Phase III study of gefitinib or pemetrexed with carboplatin in EGFR-mutated advanced lung adenocarcinoma. ESMO Open. 2017;2(1):e000168. doi: https://doi.org/10.1136/esmoopen-2017-000168 DOI: https://doi.org/10.1136/esmoopen-2017-000168
Wu YL, Zhou C, Liam CK, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26(9):1883-9. doi: https://doi.org/10.1093/annonc/mdv270 DOI: https://doi.org/10.1093/annonc/mdv270
Yoshioka H, Shimokawa M, Seto T, et al. Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. Ann Oncol. 2019;30(12):1978-84. doi: https://doi.org/10.1093/annonc/mdz399 DOI: https://doi.org/10.1093/annonc/mdz399
Tada H, Mitsudomi T, Misumi T, et al. Randomized phase III study of gefitinib versus cisplatin plus vinorelbine for patients with resected stage II-IIIA non–small-cell lung cancer with EGFR mutation (IMPACT). J Clin Oncol. 2022;40(3):231-41. doi: https://doi.org/10.1200/JCO.21.01729 DOI: https://doi.org/10.1200/JCO.21.01729
Yue D, Xu S, Wang Q, et al. Updated overall survival and exploratory analysis from randomized, phase II EVAN study of Erlotinib versus Vinorelbine plus cisplatin adjuvant therapy in stage IIIA epidermal growth factor receptor+ non–small-cell lung cancer. J Clin Oncol. 2022;40(34):3912-7. doi: https://doi.org/10.1200/JCO.22.00428 DOI: https://doi.org/10.1200/JCO.22.00428
Peters S, Zimmermann S, Adjei AA. Oral epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non small cell lung cancer: comparative pharmacokinetics and drug drug interactions. Cancer Treat Rev. 2014;40:917-26. doi: https://doi.org/10.1016/j.ctrv.2014.06.010 DOI: https://doi.org/10.1016/j.ctrv.2014.06.010
Takeda M, Okamoto I, Fukuoka M, et al. Successful treatment with erlotinib after gefitinib related severe hepatotoxicity. J Clin Oncol. 2010;28:e273-4. doi: https://doi.org/10.1200/JCO.2009.26.5496 DOI: https://doi.org/10.1200/JCO.2009.26.5496
Anatchkova M, Donelson SM, Skalicky AM, et al. Exploring the implementation of patient-reported outcome measures in cancer care: need for more real-world evidence results in the peer reviewed literature. J Patient Rep Outcomes. 2018;2(1):64. doi: https://doi.org/10.1186/s41687-018-0091-0 DOI: https://doi.org/10.1186/s41687-018-0091-0
Joret R, Matti N, Beck M, et al. Medication adherence and persistence among patients with non-small cell lung cancer receiving tyrosine kinase inhibitors and estimation of the economic burden associated with the unused medicines. J Oncol Pharm Pract. 2022;28(5):1120-9. doi: https://doi.org/10.1177/10781552211012452 DOI: https://doi.org/10.1177/10781552211012452
Verbrugghe M, Verhaeghe S, Lauwaert K, et al. Determinants and associated factors influencing medication adherence and persistence to oral anticancer drugs: a systematic review. Cancer Treat Rev. 2013;39(6):610-21. doi: https://doi.org/10.1016/j.ctrv.2012.12.014 DOI: https://doi.org/10.1016/j.ctrv.2012.12.014
Ghiggia A, Bianco A, Castelli L, et al. Adherence to oral chemotherapy: evidence from a randomised clinical trial. Eur J Cancer Care. 2021;30(1):e13336. doi: https://doi.org/10.1111/ecc.13336 DOI: https://doi.org/10.1111/ecc.13336
Salomone F, Di Costanzo F, Pecoraro G, et al. Health-related quality of life is underestimated and underreported in phase III clinical trials in NSCLC. Lung Cancer. 2022;174: 36-44. doi: https://doi.org/10.1016/j.lungcan.2022.10.003 DOI: https://doi.org/10.1016/j.lungcan.2022.10.003
Van Der Weijst L, Lievens Y, Schrauwen W, et al. Health-related quality of life in advanced non-small cell lung cancer: a methodological appraisal based on a systematic literature review. Front Oncol. 2019;9:715. doi: https://doi.org/10.3389/fonc.2019.00715 DOI: https://doi.org/10.3389/fonc.2019.00715
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