Masato Karayama , Takafumi Suda , Kiyotaka Yoh , Kazuhiro Usui , Yukio Hosomi , Kazuma Kishi , Go Naka , Kageaki Watanabe , Shu Tamano , Kohei Uemura , Hideo Kunitoh
{"title":"表皮生长因子受体(EGFR)阳性 NSCLC 术后复发患者与新发不可切除疾病患者的奥希替尼疗效差异:前瞻性观察研究","authors":"Masato Karayama , Takafumi Suda , Kiyotaka Yoh , Kazuhiro Usui , Yukio Hosomi , Kazuma Kishi , Go Naka , Kageaki Watanabe , Shu Tamano , Kohei Uemura , Hideo Kunitoh","doi":"10.1016/j.lungcan.2024.108037","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Although clinical trials of systemic chemotherapy for advanced non-small-cell lung cancer (NSCLC) have included both postoperative recurrence and <em>de novo</em> unresectable cases, postoperative recurrence is reported to have a better efficacy and prognosis. However, there are no efficacy data of first-line osimertinib for postoperative recurrence.</div></div><div><h3>Methods</h3><div>We conducted a post hoc analysis of a multicenter, prospective, observational study that evaluated the efficacy of first-line osimertinib in patients with <em>epidermal growth factor receptor (EGFR)</em>-positive NSCLC. The patients were divided into two groups: those with postoperative recurrence (recurrence group, n = 167) and those with <em>de novo</em> unresectable disease (<em>de novo</em> group, n = 385).</div></div><div><h3>Results</h3><div>The recurrence group had a significantly better Eastern Cooperative Oncology Group performance status (ECOG-PS, <em>p</em> < 0.001) and fewer bone metastases (<em>p</em> < 0.001), brain metastases (<em>p</em> < 0.001), cancer pleurisy (<em>p</em> = 0.006), pleural dissemination (<em>p</em> = 0.003), liver metastases (<em>p</em> = 0.017), and adrenal metastases (<em>p</em> = 0.009) at the start of osimertinib than the <em>de novo</em> group. The recurrence group had a significantly better progression-free survival (PFS) and overall survival (OS) than the <em>de novo</em> group (hazard ratio [HR] = 0.62, 95 % confidence interval [CI], 0.49–0.81, <em>p</em> < 0.001; and HR = 0.58, 95 % CI, 0.43–0.79, <em>p</em> < 0.001, respectively). In a 1:1 propensity score-matching analysis, the matched recurrence group had significantly better PFS and OS than the matched de novo group (HR = 0.72, 95 % CI, 0.52–0.99, <em>p</em> = 0.034; and HR = 0.65, 95 % CI, 0.44–0.95, <em>p</em> < 0.001, respectively).</div></div><div><h3>Conclusion</h3><div>Patients with <em>EGFR</em>-positive NSCLC and postoperative recurrence have a better ECOG-PS and fewer distant metastases at the start of first-line osimertinib, and better PFS and OS than those with <em>de novo</em> unresectable disease. Postoperative recurrence should be considered as a stratification factor in future clinical trials for advanced <em>EGFR</em>-positive NSCLC.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"198 ","pages":"Article 108037"},"PeriodicalIF":4.5000,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Difference in efficacy of osimertinib between patients with EGFR-positive NSCLC with postoperative recurrence and those with de novo unresectable disease: A prospective, observational study\",\"authors\":\"Masato Karayama , Takafumi Suda , Kiyotaka Yoh , Kazuhiro Usui , Yukio Hosomi , Kazuma Kishi , Go Naka , Kageaki Watanabe , Shu Tamano , Kohei Uemura , Hideo Kunitoh\",\"doi\":\"10.1016/j.lungcan.2024.108037\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Although clinical trials of systemic chemotherapy for advanced non-small-cell lung cancer (NSCLC) have included both postoperative recurrence and <em>de novo</em> unresectable cases, postoperative recurrence is reported to have a better efficacy and prognosis. However, there are no efficacy data of first-line osimertinib for postoperative recurrence.</div></div><div><h3>Methods</h3><div>We conducted a post hoc analysis of a multicenter, prospective, observational study that evaluated the efficacy of first-line osimertinib in patients with <em>epidermal growth factor receptor (EGFR)</em>-positive NSCLC. The patients were divided into two groups: those with postoperative recurrence (recurrence group, n = 167) and those with <em>de novo</em> unresectable disease (<em>de novo</em> group, n = 385).</div></div><div><h3>Results</h3><div>The recurrence group had a significantly better Eastern Cooperative Oncology Group performance status (ECOG-PS, <em>p</em> < 0.001) and fewer bone metastases (<em>p</em> < 0.001), brain metastases (<em>p</em> < 0.001), cancer pleurisy (<em>p</em> = 0.006), pleural dissemination (<em>p</em> = 0.003), liver metastases (<em>p</em> = 0.017), and adrenal metastases (<em>p</em> = 0.009) at the start of osimertinib than the <em>de novo</em> group. The recurrence group had a significantly better progression-free survival (PFS) and overall survival (OS) than the <em>de novo</em> group (hazard ratio [HR] = 0.62, 95 % confidence interval [CI], 0.49–0.81, <em>p</em> < 0.001; and HR = 0.58, 95 % CI, 0.43–0.79, <em>p</em> < 0.001, respectively). In a 1:1 propensity score-matching analysis, the matched recurrence group had significantly better PFS and OS than the matched de novo group (HR = 0.72, 95 % CI, 0.52–0.99, <em>p</em> = 0.034; and HR = 0.65, 95 % CI, 0.44–0.95, <em>p</em> < 0.001, respectively).</div></div><div><h3>Conclusion</h3><div>Patients with <em>EGFR</em>-positive NSCLC and postoperative recurrence have a better ECOG-PS and fewer distant metastases at the start of first-line osimertinib, and better PFS and OS than those with <em>de novo</em> unresectable disease. Postoperative recurrence should be considered as a stratification factor in future clinical trials for advanced <em>EGFR</em>-positive NSCLC.</div></div>\",\"PeriodicalId\":18129,\"journal\":{\"name\":\"Lung Cancer\",\"volume\":\"198 \",\"pages\":\"Article 108037\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-11-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lung Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0169500224005713\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lung Cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0169500224005713","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Difference in efficacy of osimertinib between patients with EGFR-positive NSCLC with postoperative recurrence and those with de novo unresectable disease: A prospective, observational study
Background
Although clinical trials of systemic chemotherapy for advanced non-small-cell lung cancer (NSCLC) have included both postoperative recurrence and de novo unresectable cases, postoperative recurrence is reported to have a better efficacy and prognosis. However, there are no efficacy data of first-line osimertinib for postoperative recurrence.
Methods
We conducted a post hoc analysis of a multicenter, prospective, observational study that evaluated the efficacy of first-line osimertinib in patients with epidermal growth factor receptor (EGFR)-positive NSCLC. The patients were divided into two groups: those with postoperative recurrence (recurrence group, n = 167) and those with de novo unresectable disease (de novo group, n = 385).
Results
The recurrence group had a significantly better Eastern Cooperative Oncology Group performance status (ECOG-PS, p < 0.001) and fewer bone metastases (p < 0.001), brain metastases (p < 0.001), cancer pleurisy (p = 0.006), pleural dissemination (p = 0.003), liver metastases (p = 0.017), and adrenal metastases (p = 0.009) at the start of osimertinib than the de novo group. The recurrence group had a significantly better progression-free survival (PFS) and overall survival (OS) than the de novo group (hazard ratio [HR] = 0.62, 95 % confidence interval [CI], 0.49–0.81, p < 0.001; and HR = 0.58, 95 % CI, 0.43–0.79, p < 0.001, respectively). In a 1:1 propensity score-matching analysis, the matched recurrence group had significantly better PFS and OS than the matched de novo group (HR = 0.72, 95 % CI, 0.52–0.99, p = 0.034; and HR = 0.65, 95 % CI, 0.44–0.95, p < 0.001, respectively).
Conclusion
Patients with EGFR-positive NSCLC and postoperative recurrence have a better ECOG-PS and fewer distant metastases at the start of first-line osimertinib, and better PFS and OS than those with de novo unresectable disease. Postoperative recurrence should be considered as a stratification factor in future clinical trials for advanced EGFR-positive NSCLC.
期刊介绍:
Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.