Surendra Kumar Saini, Shely Srivastava, Awadhesh Kumar Dixit
{"title":"Gefitinib concurrente con quimiorradiación en el cáncer de cabeza y cuello localmente avanzado","authors":"Surendra Kumar Saini, Shely Srivastava, Awadhesh Kumar Dixit","doi":"10.1016/j.gamo.2016.04.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Chemoradiation is standard treatment in locally advanced oropharyngeal and hypopharyngeal cancer but only few surviving for long term. Novel therapeutic agents targeting EGFR receptors demonstrated survival benefit in palliative setting and radiosensitization in preclinical studies. We compared cisplatin based concurrent chemoradiation with cisplatin and gefitinib based chemoradiation in patients with locoregionally advanced oro-hypo pharyngeal cancer.</p></div><div><h3>Methods</h3><p>Patients of oro-hypo pharyngeal squamous cell carcinoma with age between 18 and 70 and with locally advanced (stage <span>iii</span> and <span>iv</span>, M0) were randomly assigned to receive either radiation with cisplatin 100<!--> <!-->mg/m<sup>2</sup> on d1, 23 and 43 or radiation with cisplatin in same dose plus gefitinib 250<!--> <!-->mg daily started two week before commencing radiotherapy till the end of radiation treatment. Primary and secondary end points were progression free and overall survival, respectively.</p></div><div><h3>Results</h3><p>Out of total 67 patients randomized, 32 received cisplatin with radiation (arm <span>i</span>) and 35 received cisplatin plus gefitinib with radiation (arm <span>ii</span>). Overall response rates (complete and partial) were 62% and 71.42% in arm <span>i</span> and arm <span>ii</span>, respectively, with no statistically significant difference (<em>P</em>=.605). The median progression free survival was 24 months for arm <span>i</span> while it was 35 months for arm <span>ii</span> (<em>P</em> <!-->=<!--> <!-->0.2877, hazard ratio [HR]<!--> <!-->=<!--> <!-->0.688, 95% CI 0.3346-1.4150). The median overall survival was 31 months for arm <span>i</span> and 37 months for arm <span>ii</span> (<em>P</em>=.4344, HR<!--> <!-->=<!--> <!-->0.7542, 95% CI 0.3661-1.5539). Proliferative disease showed trend towards significance in terms of response but could not reach the level of significance (<em>P</em>=.086). No statisticallysignificant difference was found in toxicity profile of two arms.</p></div><div><h3>Conclusion</h3><p>Gefitinib and cisplatin combination is well tolerated concurrently with radiation but does not have impressive effect on response rate, progression free survival and overall survival, but encouraging result was seen in response rate in proliferative morphology.</p></div>","PeriodicalId":41581,"journal":{"name":"Gaceta Mexicana de Oncologia","volume":"15 3","pages":"Pages 138-144"},"PeriodicalIF":0.2000,"publicationDate":"2016-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.gamo.2016.04.002","citationCount":"2","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gaceta Mexicana de Oncologia","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1665920116300232","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2016/5/21 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 2
Abstract
Background
Chemoradiation is standard treatment in locally advanced oropharyngeal and hypopharyngeal cancer but only few surviving for long term. Novel therapeutic agents targeting EGFR receptors demonstrated survival benefit in palliative setting and radiosensitization in preclinical studies. We compared cisplatin based concurrent chemoradiation with cisplatin and gefitinib based chemoradiation in patients with locoregionally advanced oro-hypo pharyngeal cancer.
Methods
Patients of oro-hypo pharyngeal squamous cell carcinoma with age between 18 and 70 and with locally advanced (stage iii and iv, M0) were randomly assigned to receive either radiation with cisplatin 100 mg/m2 on d1, 23 and 43 or radiation with cisplatin in same dose plus gefitinib 250 mg daily started two week before commencing radiotherapy till the end of radiation treatment. Primary and secondary end points were progression free and overall survival, respectively.
Results
Out of total 67 patients randomized, 32 received cisplatin with radiation (arm i) and 35 received cisplatin plus gefitinib with radiation (arm ii). Overall response rates (complete and partial) were 62% and 71.42% in arm i and arm ii, respectively, with no statistically significant difference (P=.605). The median progression free survival was 24 months for arm i while it was 35 months for arm ii (P = 0.2877, hazard ratio [HR] = 0.688, 95% CI 0.3346-1.4150). The median overall survival was 31 months for arm i and 37 months for arm ii (P=.4344, HR = 0.7542, 95% CI 0.3661-1.5539). Proliferative disease showed trend towards significance in terms of response but could not reach the level of significance (P=.086). No statisticallysignificant difference was found in toxicity profile of two arms.
Conclusion
Gefitinib and cisplatin combination is well tolerated concurrently with radiation but does not have impressive effect on response rate, progression free survival and overall survival, but encouraging result was seen in response rate in proliferative morphology.
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