EGFR基因19del和L858R突變肺腺癌患者化療與靶向治療療效比較
發(fā)布時間：2019-06-06 02:16
【摘要】：背景肺癌是常見惡性腫瘤,嚴重危害人類健康,其發(fā)病率及死亡率居高不下,成為威脅人類健康的首位腫瘤性死亡原因[1-3],,全球每年大約有150萬人死于肺癌[4],因此對肺癌的診斷、治療、預防等方面工作任重而道遠。肺癌主要分為NSCLC和SCLC兩大類[38],NSCLC主要包括腺癌(≥40%)、鱗癌(30%)、大細胞癌(10%)及其他類型肺癌[5、39]。由于肺癌早期臨床表現(xiàn)隱匿,65%患者就診時已發(fā)生遠處轉(zhuǎn)移[39],臨床分期多為III期/IV期[6],失去手術根治的機會。對于EGFR基因突變肺癌患者化療、靶向治療為其主要治療方式,本文主要探討臨床分期為IIIB/IV期的EGFR突變肺腺癌患者化療與靶向治療的療效及生存期差異問題。目的比較EGFR 19del突變肺腺癌患者化療與EGFR-TKIs靶向治療療效和生存期的差異;比較EGFR L858R突變肺腺癌患者化療及靶向治療療效和生存期的差異;為進一步證實化療與靶向治療療效在不同突變位點的差異性,將患者按治療方式進行分組,比較同一治療方式下不同位點突變患者療效的差異,進而為不同位點EGFR突變肺腺癌患者選擇最佳治療方案提供臨床依據(jù)。方法收集2010年1月至2015年12月間于第三軍醫(yī)大學新橋醫(yī)院就診的EGFR基因發(fā)生19del和L858R突變的病例資料完整的IIIB/IV期ECOG評分≤2分的肺腺癌患者,采用回顧性分析的方法,將病例按突變類型分為19del突變組和L858R突變組,分別對兩組患者進行化療和靶向治療療效(客觀緩解率ORR、疾病控制率DCR)及生存期(無進展生存期PFS、總生存期OS)的研究;將病例按一線治療方式分為化療組和靶向治療組,分別對兩組患者進行不同突變位點的療效和生存期差異的研究。結果一.同一位點突變不同治療方式療效的比較1.1共收集符合納入標準的EGFR 19del突變病例69例,其中化療組26例(37.68%),靶向治療組43例(62.32%),兩組患者臨床資料基線一致;化療組患者PR 8例,SD 11例,PD 7例,靶向治療組,PR 25例,SD 16例,PD 2例,兩組患者均無達CR者;化療和靶向治療組ORR分別為30.77%和58.14%(P=0.027);DCR分別為70.38%和95.35%(P=0.022);PFS分別為7.108個月和10.652個月(P=0.018);OS分別為24.387個月和27.600個月(P=0.170)。1.2共收集符合納入標準的EGFR L858R突變病例68例,其中化療組40例(58.8%),靶向治療組28例(41.2%),兩組患者臨床資料基線一致;化療和靶向治療組ORR分別為45.0%和17.9%(P=0.020);DCR分別為95.0%和71.4%(P=0.012),PFS分別為9.901個月和6.746個月(P=0.045);OS分別為21.738個月和23.611個月(P=0.378)。二.不同位點突變同一治療方式療效的比較2.1化療組患者共66例,其中19del突變26例(39.39%),L858R突變40例(60.61%),兩組患者臨床資料基線一致;19del突變和L58R突變組ORR分別為30.77%和45.0%(P=0.048);DCR分別為70.38%和95.0%(P=0.023);PFS分別為7.108個月和9.901個月(P=0.020);OS分別為24.387個月和21.738個月(P=0.974)。2.2靶向治療組患者共71例,其中19del突變組43例(60.56%),L858R突變組28例(39.44%);兩組患者臨床資料基線一致;19del突變和L58R突變組ORR分別為58.14%和17.9%(P=0.001);DCR分別為95.35%和71.4%(P=0.011);PFS分別為10.652個月和6.746個月(P=0.022);OS分別為27.600個月和23.611個月(P=0.734)結論1.對于EGFR 19del突變肺腺癌患者,靶向治療組的ORR、DCR及PFS均優(yōu)于化療治療組;OS未見明顯優(yōu)勢;2.對于EGFR L858R突變肺腺癌患者,化療治療組患者的ORR、DCR及PFS均較靶向治療組有明顯優(yōu)勢,OS優(yōu)勢不明顯。3.對采用化療的EGFR突變肺腺癌患者,L858R突變組的ORR、DCR及PFS較19del組有明顯優(yōu)勢;OS優(yōu)勢不明顯;4.對采用靶向治療的EGFR突變肺腺癌患者,19del突變組的ORR、DCR及PFS優(yōu)于L858R突變組,OS未見明顯優(yōu)勢。5.臨床實際工作中對EGFR基因突變肺腺癌患者的治療方案宜根據(jù)其突變位點進行個體化選擇使患者獲得最大受益。
[Abstract]:Background Lung cancer is a common malignant tumor, which is a serious threat to human health. Its morbidity and mortality are high. It is the first cause of cancer death that is threatening human health[1-3], and about 1.5 million people die in lung cancer[4] every year, so the diagnosis and treatment of lung cancer, There is a long way to go in such areas as prevention and so on. Lung cancer is mainly divided into two categories: NSCLC and SCLC[38]. NSCLC mainly includes adenocarcinoma (40%), squamous cell carcinoma (30%), large cell carcinoma (10%) and other types of lung cancer[5,39]. In the early stage of lung cancer,65% of the patients had a distant metastasis[39], and the clinical stage was stage III/ IV[6], and the chance of radical operation was lost. In this paper, the effect of chemotherapy and targeted therapy of EGFR mutant lung adenocarcinoma in the stage of stage IIIB/ IV and the difference of survival time were mainly discussed in this paper. Objective To compare the difference of the efficacy and survival of EGFR-TKIs in the treatment of EGFR-19 del-mutant lung adenocarcinoma and to compare the difference of the efficacy and survival of the chemotherapy and targeted therapy in patients with lung adenocarcinoma with EGFR-L858R. In order to further confirm the difference of the effect of chemotherapy and targeted therapy on different mutation sites, The patients were grouped according to the treatment mode, the difference of the curative effect of different site mutation patients in the same treatment mode is compared, and the clinical basis is provided for selecting the optimal treatment scheme for patients with different positions of EGFR mutation lung adenocarcinoma. Methods The patients with lung adenocarcinoma who had an ECOG score of 19 del and L858R from January 2010 to December 2015 in Xinqiao Hospital of the Third Military Medical University were collected. The method of retrospective analysis was adopted. The cases were divided into 19 del mutation group and L858R mutation group according to the mutation type, and the treatment effect (objective response rate ORR, disease control rate DCR) and survival time (no progression-free survival PFS and overall survival time OS) of the two groups of patients were studied. The cases were divided into the chemotherapy group and the target treatment group according to the first-line treatment method, and the difference of the curative effect and the survival time of the two groups of patients with different mutation sites was studied. As a result. A total of 69 cases of EGFR 19 del mutation were collected, including 26 cases (37.68%) and 43 (62.32%) of the group. There were 7 cases of PD,25 of PR,16 of SD and 2 with PD. The ORR of chemotherapy and target group was 30.77% and 58.14%, respectively (P = 0.027), and that of DCR was 70.38% and 95.35% (P = 0.022). The PFS was 7.108 months and 10.652 months (P = 0.018), respectively. The OS was 24.387 months and 27.600 months (P = 0.170). 1.2 In total,68 cases of EGFR L858R mutation were collected, including 40 cases (58.8%) of the chemotherapy group and 28 (41.2%) of the target treatment group, and the baseline of the clinical data of the two groups was consistent; and the ORR of the chemotherapy and targeted therapy group was 45.0% and 17.9% (P = 0.020), respectively; DCR was 95.0% and 71.4%, respectively (P = 0.012), PFS was 9.901 months and 6.746 months (P = 0.045), and the OS was 21.738 months and 23.611 months (P = 0.378), respectively. II. A total of 66 patients were treated with different site mutation in the same treatment mode, including 26 (39.39%) of 19 del,40 (60.61%) of L858R, and 0.77% and 45.0%, respectively (P = 0.048), and 70.38% and 95.0% (P = 0.023), respectively. The PFS was 7.108 months and 9.901 months (P = 0.020), and the OS was 24.387 months and 21.738 months (P = 0.974). The ORR of the 19 del mutation and the L58R mutation group was 58.14% and 17.9%, respectively (P = 0.001); the DCR was 95.35% and 71.4% (P = 0.011), respectively; the PFS was 10.652 months and 6.746 months (P = 0.022), respectively; the OS was 27.600 months and 23.611 months (P = 0.734) Conclusion 1, respectively. For EGFR-19-del-mutant lung adenocarcinoma patients, the ORR, DCR, and PFS in the targeted treatment group were superior to the chemotherapy-treated group; the OS did not have a significant advantage;2. For EGFR-L858R mutant lung adenocarcinoma patients, the ORR, DCR, and PFS in the chemotherapy-treated group were significantly superior to those of the targeted treatment group, and the OS advantage was not obvious. The ORR, DCR, and PFS of the L858R mutant group were significant in the patients with EGFR mutation with chemotherapy, and the OS advantage was not obvious;4. The ORR, DCR, and PFS of the 19 del mutation group were superior to the L858R mutation group in the patients with EGFR mutant lung adenocarcinoma using the targeted therapy, and no significant advantage was observed in the OS. In the clinical practice, the treatment scheme of EGFR gene mutation in patients with lung adenocarcinoma should be individualized according to its mutation site to make the patient benefit most.
【學位授予單位】：第三軍醫(yī)大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R734.2
本文編號：2493994
[Abstract]:Background Lung cancer is a common malignant tumor, which is a serious threat to human health. Its morbidity and mortality are high. It is the first cause of cancer death that is threatening human health[1-3], and about 1.5 million people die in lung cancer[4] every year, so the diagnosis and treatment of lung cancer, There is a long way to go in such areas as prevention and so on. Lung cancer is mainly divided into two categories: NSCLC and SCLC[38]. NSCLC mainly includes adenocarcinoma (40%), squamous cell carcinoma (30%), large cell carcinoma (10%) and other types of lung cancer[5,39]. In the early stage of lung cancer,65% of the patients had a distant metastasis[39], and the clinical stage was stage III/ IV[6], and the chance of radical operation was lost. In this paper, the effect of chemotherapy and targeted therapy of EGFR mutant lung adenocarcinoma in the stage of stage IIIB/ IV and the difference of survival time were mainly discussed in this paper. Objective To compare the difference of the efficacy and survival of EGFR-TKIs in the treatment of EGFR-19 del-mutant lung adenocarcinoma and to compare the difference of the efficacy and survival of the chemotherapy and targeted therapy in patients with lung adenocarcinoma with EGFR-L858R. In order to further confirm the difference of the effect of chemotherapy and targeted therapy on different mutation sites, The patients were grouped according to the treatment mode, the difference of the curative effect of different site mutation patients in the same treatment mode is compared, and the clinical basis is provided for selecting the optimal treatment scheme for patients with different positions of EGFR mutation lung adenocarcinoma. Methods The patients with lung adenocarcinoma who had an ECOG score of 19 del and L858R from January 2010 to December 2015 in Xinqiao Hospital of the Third Military Medical University were collected. The method of retrospective analysis was adopted. The cases were divided into 19 del mutation group and L858R mutation group according to the mutation type, and the treatment effect (objective response rate ORR, disease control rate DCR) and survival time (no progression-free survival PFS and overall survival time OS) of the two groups of patients were studied. The cases were divided into the chemotherapy group and the target treatment group according to the first-line treatment method, and the difference of the curative effect and the survival time of the two groups of patients with different mutation sites was studied. As a result. A total of 69 cases of EGFR 19 del mutation were collected, including 26 cases (37.68%) and 43 (62.32%) of the group. There were 7 cases of PD,25 of PR,16 of SD and 2 with PD. The ORR of chemotherapy and target group was 30.77% and 58.14%, respectively (P = 0.027), and that of DCR was 70.38% and 95.35% (P = 0.022). The PFS was 7.108 months and 10.652 months (P = 0.018), respectively. The OS was 24.387 months and 27.600 months (P = 0.170). 1.2 In total,68 cases of EGFR L858R mutation were collected, including 40 cases (58.8%) of the chemotherapy group and 28 (41.2%) of the target treatment group, and the baseline of the clinical data of the two groups was consistent; and the ORR of the chemotherapy and targeted therapy group was 45.0% and 17.9% (P = 0.020), respectively; DCR was 95.0% and 71.4%, respectively (P = 0.012), PFS was 9.901 months and 6.746 months (P = 0.045), and the OS was 21.738 months and 23.611 months (P = 0.378), respectively. II. A total of 66 patients were treated with different site mutation in the same treatment mode, including 26 (39.39%) of 19 del,40 (60.61%) of L858R, and 0.77% and 45.0%, respectively (P = 0.048), and 70.38% and 95.0% (P = 0.023), respectively. The PFS was 7.108 months and 9.901 months (P = 0.020), and the OS was 24.387 months and 21.738 months (P = 0.974). The ORR of the 19 del mutation and the L58R mutation group was 58.14% and 17.9%, respectively (P = 0.001); the DCR was 95.35% and 71.4% (P = 0.011), respectively; the PFS was 10.652 months and 6.746 months (P = 0.022), respectively; the OS was 27.600 months and 23.611 months (P = 0.734) Conclusion 1, respectively. For EGFR-19-del-mutant lung adenocarcinoma patients, the ORR, DCR, and PFS in the targeted treatment group were superior to the chemotherapy-treated group; the OS did not have a significant advantage;2. For EGFR-L858R mutant lung adenocarcinoma patients, the ORR, DCR, and PFS in the chemotherapy-treated group were significantly superior to those of the targeted treatment group, and the OS advantage was not obvious. The ORR, DCR, and PFS of the L858R mutant group were significant in the patients with EGFR mutation with chemotherapy, and the OS advantage was not obvious;4. The ORR, DCR, and PFS of the 19 del mutation group were superior to the L858R mutation group in the patients with EGFR mutant lung adenocarcinoma using the targeted therapy, and no significant advantage was observed in the OS. In the clinical practice, the treatment scheme of EGFR gene mutation in patients with lung adenocarcinoma should be individualized according to its mutation site to make the patient benefit most.
【學位授予單位】：第三軍醫(yī)大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R734.2
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