{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T02:47:04Z","timestamp":1747190824756,"version":"3.40.5"},"reference-count":31,"publisher":"Wiley","license":[{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Oncology"],"published-print":{"date-parts":[[2022,9,1]]},"abstract":"<jats:p>Background. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor. It was approved in Cuba for the indication of inoperable malignant tumors of the esophagus of epithelial origin. The purpose of this study was to evaluate the safety, overall and progression-free survival, clinical response, and quality of life, in adult patients with inoperable esophageal tumors of epithelial origin treated with nimotuzumab in a practical context. Material and Methods. The number of patients who developed adverse events was determined, and the frequency, seriousness, causality, and severity of these adverse events were determined. It also determined the median of survival and progression-free survival and rates at 12 and 24 months and the quality of life. Results. A total of 111 patients were included. The proportion of serious and related AE with the use of nimotuzumab was 1.3%. Most of the related AEs were mild and moderate, and the most frequent AEs were diarrhea, chills, and tremors. New diagnosed patients who received nimotuzumab concurrent with chemotherapy and radiotherapy reached a median OS of 12.2 months (95% CI, 6.9\u201317.5) and 12- and 24-month survival rates of 51.0% and 17.0%, respectively. Median PFS was 7.8 months (95% CI, 6.2\u20139.5), and 12- and 24-month PFS rates were 39.3% and 11.2%, respectively. A favorable evolution of the general state of health (<jats:inline-formula>\n                     <a:math xmlns:a=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M1\">\n                        <a:mi>p<\/a:mi>\n                        <a:mo>=<\/a:mo>\n                        <a:mn>0.03<\/a:mn>\n                     <\/a:math>\n                  <\/jats:inline-formula>) was obtained from the beginning of treatment until month 12, with a significant reduction in the appearance of nausea (<jats:inline-formula>\n                     <c:math xmlns:c=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M2\">\n                        <c:mi>p<\/c:mi>\n                        <c:mo>=<\/c:mo>\n                        <c:mn>0.009<\/c:mn>\n                     <\/c:math>\n                  <\/jats:inline-formula>), insomnia (<jats:inline-formula>\n                     <e:math xmlns:e=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M3\">\n                        <e:mi>p<\/e:mi>\n                        <e:mo>=<\/e:mo>\n                        <e:mn>0.04<\/e:mn>\n                     <\/e:math>\n                  <\/jats:inline-formula>), constipation (<jats:inline-formula>\n                     <g:math xmlns:g=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M4\">\n                        <g:mi>p<\/g:mi>\n                        <g:mo>=<\/g:mo>\n                        <g:mn>0.04<\/g:mn>\n                     <\/g:math>\n                  <\/jats:inline-formula>), eating difficulties (<jats:inline-formula>\n                     <i:math xmlns:i=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M5\">\n                        <i:mi>p<\/i:mi>\n                        <i:mo>=<\/i:mo>\n                        <i:mn>0.0006<\/i:mn>\n                     <\/i:math>\n                  <\/jats:inline-formula>), and choking when swallowing (<jats:inline-formula>\n                     <k:math xmlns:k=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M6\">\n                        <k:mi>p<\/k:mi>\n                        <k:mo>=<\/k:mo>\n                        <k:mn>0.0001<\/k:mn>\n                     <\/k:math>\n                  <\/jats:inline-formula>), but increased in dysphagia (<jats:inline-formula>\n                     <m:math xmlns:m=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M7\">\n                        <m:mi>p<\/m:mi>\n                        <m:mo>=<\/m:mo>\n                        <m:mn>0.02<\/m:mn>\n                     <\/m:math>\n                  <\/jats:inline-formula>). Conclusions. The administration of nimotuzumab was safe in the real-world setting. New diagnosed patients that received nimotuzumab concurrent with chemotherapy and radiotherapy reached a higher overall and progression-free survival and better quality of life than the rest of the patients. Trial registration is RPCEC00000215 (Cuban Registry of Clinical Trials; https:\/\/registroclinico.sld.cu\/en\/home). It is registered prospectively on June 30, 2016.<\/jats:p>","DOI":"10.1155\/2022\/4128946","type":"journal-article","created":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T16:50:21Z","timestamp":1662051021000},"page":"1-11","source":"Crossref","is-referenced-by-count":2,"title":["Nimotuzumab in the Treatment of Inoperable Esophageal Tumors of Epithelial Origin"],"prefix":"10.1155","volume":"2022","author":[{"given":"Sandra","family":"Gonz\u00e1lez Fern\u00e1ndez","sequence":"first","affiliation":[{"name":"Conrado Ben\u00edtez Hospital, Libertadores & P. Mart\u00ed, CP: 90100, Santiago de Cuba, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yohan","family":"Amador Garc\u00eda","sequence":"additional","affiliation":[{"name":"Jos\u00e9 Ram\u00f3n L\u00f3pez Tabranes Hospital, Carretera Central Km. 101, CP. 40 100, Matanzas, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucien Gregoria","family":"Boris Porras","sequence":"additional","affiliation":[{"name":"III Congreso Hospital, 2da y 26 de Julio, Pinar Del R\u00edo, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liuba","family":"Mojena Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Vladimir Ilich Lenin Hospital, 4 Lenin Avenue, Holgu\u00edn, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis Laureano","family":"Soler Porro","sequence":"additional","affiliation":[{"name":"Manuel Ascunce Domenech Hospital, Carretera Central Oeste Km 4 1\/2, Camag\u00fcey, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustavo","family":"Pish Mart\u00ed","sequence":"additional","affiliation":[{"name":"Celia S\u00e1nchez Manduley Hospital, Avenida Camilo Cienfuegos Km 1, V\u00eda Campechuela, CP: 87510, Manzanillo, Granma, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liem","family":"Fonseca Chon","sequence":"additional","affiliation":[{"name":"Ernesto Guevara de La Serna Hospital, Ave. 2 Diciembre, No. 1, CP:75100, Las Tunas, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yelec","family":"Estrada Guerra","sequence":"additional","affiliation":[{"name":"Antonio Luaces Iraola Hospital, Calle M\u00e1ximo Gomez, No. 257, e\/ 4ta y Onelio Hern\u00e1ndez, CP: 65200, Ciego de \u00c1vila, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge Manuel","family":"\u00c1lvarez Blanco","sequence":"additional","affiliation":[{"name":"Camilo Cienfuegos Hospital, Bartolom\u00e9 Mas\u00f3, No. 128, CP. 60 100, Havana, Sancti Sp\u00edritus, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Acralys","family":"Garabito Perdomo","sequence":"additional","affiliation":[{"name":"Celestino Hern\u00e1ndez Robau Hospital, Avenida Liberaci\u00f3n, No. 99, Santa Catalina, CP. 50100, Santa Clara, Villa Clara, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F\u00e9lix B\u00e1rbaro","family":"Santel Odio","sequence":"additional","affiliation":[{"name":"Agosthino Neto Hospital, Carretera El Salvaor Km 1, CP: 95100, Guant\u00e1namo, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis Alfonso","family":"Varona V\u00e1zquez","sequence":"additional","affiliation":[{"name":"Gustavo Alderegu\u00eda Lima Hospital, Ave 5 de Septiembre y Esq. Calle 51-A, CP: 55100, Cienfuegos, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoel Mario","family":"Ricardo Serrano","sequence":"additional","affiliation":[{"name":"Carlos Manuel de C\u00e9spedes Hospital, Carretera Km1 V\u00eda Santiago de Cuba, CP: 85100, Bayamo, Granma, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisette","family":"Chao Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Medical and Surgical Research Center (CIMEQ), Calle 216 y 11B, Reparto Siboney, Havana, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yisel","family":"Avila Albuerne","sequence":"additional","affiliation":[{"name":"Cuba\u2019s National Clinical Trials Coordinating Center, 60 & 5th Avenue, Playa, Havana, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lizet","family":"S\u00e1nchez Vald\u00e9s","sequence":"additional","affiliation":[{"name":"Center of Molecular Immunology, 216 & 15 Street, Atabey, Havana, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen Elena","family":"Viada Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Center of Molecular Immunology, 216 & 15 Street, Atabey, Havana, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mayra","family":"Ramos Suzarte","sequence":"additional","affiliation":[{"name":"Center of Molecular Immunology, 216 & 15 Street, Atabey, Havana, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3570-0317","authenticated-orcid":true,"given":"Yaimarelis","family":"Saumell N\u00e1poles","sequence":"additional","affiliation":[{"name":"Center of Molecular Immunology, 216 & 15 Street, Atabey, Havana, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","reference":[{"key":"1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"2","first-page":"30","article-title":"Direcci\u00f3n de registros m\u00e9dicos y estad\u00edsticas de salud","author":"D. Salud","year":"2014","journal-title":"Ministerio de Salud P\u00fablica de cuba"},{"article-title":"Clinical practice guideline in oncology: esophageal and esophagogastric junction cancer","year":"2019","author":"National Comprehensive Cancer Network (NCCN)","key":"3"},{"key":"4","doi-asserted-by":"publisher","DOI":"10.21037\/jgo.2017.06.12"},{"key":"5","doi-asserted-by":"publisher","DOI":"10.3390\/ijms19113491"},{"key":"6","doi-asserted-by":"publisher","DOI":"10.2147\/OTT.S111691"},{"key":"7","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-015-1393-8"},{"key":"8","doi-asserted-by":"publisher","DOI":"10.4161\/cbt.11.4.14097"},{"key":"9","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2017.00382"},{"key":"10","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.28915"},{"key":"11","doi-asserted-by":"publisher","DOI":"10.4161\/cbt.19849"},{"key":"12","first-page":"58","article-title":"A pilot study of Nimotuzumab combined with cisplatin and 5-FU in patients with advanced esophageal squamous cell carcinoma","volume":"4","author":"Y. Ling","year":"2012","journal-title":"Journal of Thoracic Disease"},{"key":"13","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.2147\/OTT.S50945","article-title":"Nimotuzumab combined with radiotherapy for esophageal cancer: preliminary study of a Phase II clinical trial","volume":"6","author":"J. Liang","year":"2013","journal-title":"Onco Targets and Therapy"},{"key":"14","doi-asserted-by":"crossref","first-page":"486","DOI":"10.1111\/cas.12894","article-title":"Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial","volume":"107","author":"M. Lu","year":"2016","journal-title":"Cancer Science"},{"key":"15","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-011-9735-0"},{"key":"16","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2017.10.005"},{"key":"17","doi-asserted-by":"publisher","DOI":"10.5144\/1658-3876.2011.182"},{"key":"18","doi-asserted-by":"publisher","DOI":"10.4161\/cbt.5.4.2522"},{"key":"19","doi-asserted-by":"publisher","DOI":"10.1016\/S1359-6349(09)71685-4"},{"key":"20","doi-asserted-by":"publisher","DOI":"10.1517\/14712598.2011.546341"},{"key":"21","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2011.29.15_suppl.2059"},{"key":"22","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-010-9619-8"},{"key":"23","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1038\/nrc1970","article-title":"Mechanisms of cutaneous toxicities to EGFR inhibitors","volume":"6","author":"M. E. Lacouture","year":"2006","journal-title":"Nature Review Cancer"},{"key":"24","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9440(10)63654-1"},{"key":"25","first-page":"4139","article-title":"Epidermal growth factor receptor (EGFR)-targeted therapies in esophagogastric cancer","volume":"33","author":"S. Ayyappan","year":"2013","journal-title":"Anticancer Research"},{"key":"26","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70096-2"},{"key":"27","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70102-5"},{"key":"28","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-017-0631-7"},{"key":"29","doi-asserted-by":"publisher","DOI":"10.4103\/sajc.sajc_89_18"},{"key":"30","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.16694"},{"key":"31","doi-asserted-by":"publisher","DOI":"10.1097\/SPC.0000000000000128"}],"container-title":["Journal of Oncology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/downloads.hindawi.com\/journals\/jo\/2022\/4128946.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/downloads.hindawi.com\/journals\/jo\/2022\/4128946.xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/downloads.hindawi.com\/journals\/jo\/2022\/4128946.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T16:50:30Z","timestamp":1662051030000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.hindawi.com\/journals\/jo\/2022\/4128946\/"}},"subtitle":[],"editor":[{"given":"Haigang","family":"Wu","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2022,9,1]]},"references-count":31,"alternative-id":["4128946","4128946"],"URL":"https:\/\/doi.org\/10.1155\/2022\/4128946","relation":{},"ISSN":["1687-8469","1687-8450"],"issn-type":[{"type":"electronic","value":"1687-8469"},{"type":"print","value":"1687-8450"}],"subject":[],"published":{"date-parts":[[2022,9,1]]}}}