{"id":26176,"date":"2020-07-13T07:33:00","date_gmt":"2020-07-13T07:33:00","guid":{"rendered":"http:\/\/e9353d4765b7bcb602196749106fd08b"},"modified":"2024-11-03T15:16:44","modified_gmt":"2024-11-03T15:16:44","slug":"pyrotinib-in-her2-mutated-advanced-nsclc-previously-treated-with-chemotherapy","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/pyrotinib-in-her2-mutated-advanced-nsclc-previously-treated-with-chemotherapy\/","title":{"rendered":"Pyrotinib in HER2-mutated Advanced NSCLC Previously Treated with Chemotherapy"},"content":{"rendered":"<p>A multicentre, open-label, single-arm, phase II study, conducted in China explored the efficacy and safety of pyrotinib, an oral, irreversible, pan-ErbB tyrosine kinase inhibitor against HER1, HER2, and HER4 in patients with advanced non-small cell lung cancer (NSCLC) harbouring <em>HER2<\/em> mutations, who had received at least one prior platinum-containing chemotherapy for advanced\/metastatic disease. Caicun Zhou of the Shanghai Pulmonary Hospital, Tongji University School of Medicine in Shanghai, China and co-authors reported on 2 July 2020 in the <em>Journal of Clinical Oncology<\/em> that pyrotinib as a single agent showed a promising antitumour activity and an acceptable safety profile in that setting.<\/p>\n<p>Combination of pyrotinib and capecitabine is approved in China for <em>HER2<\/em>-positive advanced breast cancer. A previous study demonstrated more favourable antitumour activity of pyrotinib than afatinib or T-DM1 in the patient-derived <em>HER2<\/em>-mutated lung cancer xenograft model.<\/p>\n<p>Patients with <em>HER2<\/em>-mutated NSCLC account for 1-4% of patients with lung adenocarcinoma. The authors wrote in the study background that targeted therapies against NSCLC harbouring <em>HER2<\/em> mutations remain an unmet need. In this study (NCT02834936), the Chinese investigators explored the efficacy and safety of pyrotinib in patients with advanced NSCLC and <em>HER2<\/em> mutations who had received at least one prior platinum-containing chemotherapy for advanced\/metastatic disease.<\/p>\n<p>The investigators enrolled in this study the patients with stage IIIB or IV <em>HER2<\/em>-mutated lung adenocarcinoma who were previously treated with platinum-based chemotherapy. The primary endpoint was objective response rate (ORR) per independent review committee (IRC).<\/p>\n<p>In total, 60 patients received pyrotinib. At baseline, 58 patients (96.7%) had stage IV disease; 25 patients (41.7%) received at least 2 lines of prior chemotherapy. As of data cut-off on 20 June 2019, IRC-assessed ORR was 30.0% (95% confidence interval [CI] 18.8% to 43.2%).<\/p>\n<p>All subgroups of patients with different <em>HER2<\/em> mutation types showed a favourable ORR. The ORRs were similar between patients with and without brain metastases (25.0% <em>v<\/em><em>s<\/em> 31.3%).<\/p>\n<p>The median duration of response was 6.9 months (95% CI 4.9 to 11.1 months).<\/p>\n<p>The median progression-free survival was 6.9 months (95% CI 5.5 to 8.3 months) per IRC.<\/p>\n<p>The median overall survival was 14.4 months (95% CI 12.3 to 21.3 months).<\/p>\n<p>Treatment-related adverse events of grade 3 or 4 occurred in 28.3% of patients, with the most common being diarrhoea (20.0%; all grade 3). No treatment-related deaths were reported.<\/p>\n<p>A major limitation of this study is the lack of a control arm and the small sample size of patients with missense point mutation in <em>HER2<\/em>. Therefore, the authors were unable to adequately compare the clinical benefit of different subtypes in <em>HER2<\/em> mutations.<\/p>\n<p>A global, multicentre, randomised phase III trial is planned and will be started soon.<\/p>\n<p>The authors concluded that it is the largest study in <em>HER2<\/em>-mutated NSCLC. Pyrotinib 400 mg daily could be given to patients with <em>HER2<\/em>-mutated advanced NSCLC, who had received at least one prior platinum-based chemotherapy. To avoid diarrhoea, the most common adverse event attributable to pyrotinib, the study team recommended prophylactic loperamide.&nbsp;<\/p>\n<p>The study was supported by Jiangsu Hengrui Medicine Co, Ltd.<\/p>\n<p><strong>Reference<\/strong><\/p>\n<p>Zhou C, Li X, Wang Q, et al. <a href=\"https:\/\/ascopubs.org\/doi\/abs\/10.1200\/JCO.20.00297\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label, Single-Arm, Phase II Study<\/a>. JCO; Published online 2 July 2020. DOI: <a href=\"https:\/\/doi.org\/10.1200\/JCO.20.00297\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">https:\/\/doi.org\/10.1200\/JCO.20.00297<\/a>&nbsp;<\/p>\n<p><a href=\"http:\/\/www.esmo.org\/oncology-news\/pyrotinib-in-her2-mutated-advanced-nsclc-previously-treated-with-chemotherapy\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A multicentre, open-label, single-arm, phase II study, conducted in China explored the efficacy and safety of pyrotinib, an oral, irreversible, pan-ErbB tyrosine kinase inhibitor against HER1, HER2, and HER4 in patients with advanced non-small cell lung cancer (NSCLC) harbouring HER2 mutations, who had received at least one prior platinum-containing chemotherapy for advanced\/metastatic disease. Caicun Zhou [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-26176","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=26176"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26176\/revisions"}],"predecessor-version":[{"id":45620,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26176\/revisions\/45620"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}